B. PACKAGE LEAFLET

Package leaflet: Information for the patient

Nemdatine 5 mg film-coated tablets memantine hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor or pharmacist.

• – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What Nemdatine is and what it is used for

• 2. What you need to know before you take Nemdatine

• 3. How to take Nemdatine

• 4. Possible side effects

• 5. How to store Nemdatine

• 6. Contents of the pack and other information

1. What Nemdatine is and what it is used for

How does Nemdatine work

Nemdatine contains the active substance memantine hydrochloride. Nemdatine belongs to a group of medicines known as anti-dementia medicines.

Memory loss in Alzheimer’s disease is due to a disturbance of message signals in the brain. The brain contains so-called N-methyl-D-aspartate (NMDA)-receptors that are involved in transmitting nerve signals important in learning and memory. Nemdatine belongs to a group of medicines called NMDA-receptor antagonists. Nemdatine acts on these NMDA-receptors improving the transmission of nerve signals and the memory.

What is Nemdatine used for

Nemdatine is used for the treatment of adult patients with moderate to severe Alzheimer’s di­sease.

2. What you need to know before you take Nemdatine

Do not take Nemdatine

• – if you are allergic to memantine hydrochloride or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before taking Nemdatine

• – if you have a history of epileptic seizures

• – if you have recently experienced a myocardial infarction (heart attack), or if you are suffering from congestive heart failure or from an uncontrolled hypertension (high blood pressure).

In these situations the treatment should be carefully supervised, and the clinical benefit of Nemdatine reassessed by your doctor on a regular basis.

If you suffer from renal impairment (kidney problems), your doctor should closely monitor your kidney function and if necessary adapt the memantine doses accordingly.

The use of medicinal products called amantadine (for the treatment of Parkinson’s di­sease), ketamine (a substance generally used as an anaesthetic), dextromethorphan (generally used to treat cough) and other NMDA-antagonists at the same time should be avoided.

Children and adolescents

Nemdatine is not recommended for children and adolescents under the age of 18 years.

Other medicines and Nemdatine

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular, Nemdatine may change the effects of the following medicines and their dose may need to be adjusted by your doctor:

• – amantadine, ketamine, dextromethorphan

• – dantrolene, baclofen

• – cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine

• – hydrochlorothiazide (or any combination with hydrochlorothi­azide)

• – anticholinergics (substances generally used to treat movement disorders or intestinal cramps)

• – anticonvulsants (substances used to prevent and relieve seizures)

• – barbiturates (substances generally used to induce sleep)

• – dopaminergic agonists (substances such as L-dopa, bromocriptine)

• – neuroleptics (substances used in the treatment of mental disorders)

• – oral anticoagulants

If you go into hospital, let your doctor know that you are taking Nemdatine.

Nemdatine with food and drink

You should inform your doctor if you have recently changed or intend to change your diet substantially (e.g. from normal diet to strict vegetarian diet) or if you are suffering from states of renal tubulary acidosis (RTA, an excess of acid-forming substances in the blood due to renal dysfunction (poor kidney function)) or severe infections of the urinary tract (structure that carries urine), as your doctor may need to adjust the dose of your medicine.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

The use of memantine in pregnant women is not recommended.

Breast-feeding

Women taking Nemdatine should not breast-feed.

Driving and using machines

Your doctor will tell you whether your illness allows you to drive and to use machines safely. Also, Nemdatine may change your reactivity, making driving or operating machinery inappropriate.

Nemdatine contains lactose monohydrate

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Nemdatine

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Dosage

The recommended dose of Nemdatine for adults and older people is 20 mg once a day.

In order to reduce the risk of side effects this dose is achieved gradually by the following daily treatment scheme:

Week 1	One 5 mg tablet
Week 2	Two 5 mg tablets
Week 3	Three 5 mg tablets
Week 4 and beyond	Four 5 mg tablets once a day

The usual starting dose is one tablet once a day (1× 5 mg) for the first week. This is increased to two tablets once a day (1× 10 mg) in the second week and to three tablets once a day (1× 15 mg) in the third week. From the fourth week on, the usual dose is 4 tablets once a day (1× 20 mg).

Dosage in patients with impaired kidney function

If you have impaired kidney function, your doctor will decide upon a dose that suits your condition. In this case, monitoring of your kidney function should be performed by your doctor at specified intervals.

Administration

Nemdatine should be administered orally once a day. To benefit from your medicine you should take it regularly every day at the same time of the day. The tablets should be swallowed with some water.

The tablets can be taken with or without food.

Duration of treatment

Continue to take Nemdatine as long as it is of benefit to you. Your doctor should assess your treatment on a regular basis.

If you take more Nemdatine than you should

• – In general, taking too much Nemdatine should not result in any harm to you. You may experience increased symptoms as described in section 4 ‘Possible side effects’.

• – If you take a large overdose of Nemdatine, contact your doctor or get medical advice, as you may need medical attention.

If you forget to take Nemdatine

• – If you find you have forgotten to take your dose of Nemdatine, wait and take your next dose at the usual time.

• – Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

In general, the observed side effects are mild to moderate.

Common (affects 1 to 10 users in 100)

• – Headache, sleepiness, constipation, elevated liver function test, dizziness, balance disorders, shortness of breath, high blood pressure and drug hypersensitivity

Uncommon (affects 1 to 10 users in 1,000)

• – Tiredness, fungal infections, confusion, hallucinations, vomiting, abnormal gait, heart failure and venous blood clotting (thrombosis/throm­boembolism)

Very Rare (affects less than 1 user in 10,000)

• – Seizures

Not known (frequency cannot be estimated from the available data)

• – Inflammation of the pancreas, inflammation of the liver (hepatitis) and psychotic reactions

Alzheimer’s disease has been associated with depression, suicidal ideation and suicide. These events have been reported in patients treated with memantine.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Nemdatine

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after ‘EXP’.

The expiry date refers to the last day of that month.

Do not store above 25°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Nemdatine contains

• – The active substance is memantine hydrochloride. Each film-coated tablet contains 5 mg memantine hydrochloride equivalent to 4.15 mg memantine.

• – The other ingredients are: Tablet core: Microcrystalline cellulose, crospovidone Type A, talc and magnesium stearate. Tablet coat (Opadry II White 33G28435): Hypromellose 6cP, titanium dioxide (E171), lactose monohydrate, macrogol 3350 and triacetin.

What Nemdatine looks like and contents of the pack

Nemdatine 5 mg film-coated tablets (tablets) are white, oval shaped, biconvex, 8 mm x 4.5 mm in size, with the marking “M5” engraved on one side.

Pack sizes

Blister packs: 42 and 98 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Actavis Group PTC ehf.

Reykjavikurvegi 76–78

220 Hafnarfjöröur

Iceland

Manufacturer

Actavis Group PTC ehf.

Reykjavikurvegur 76–78

220 Hafnarfjordur

Iceland

Actavis Ltd.

BLB 015–016 Bulebel Industrial Estate

Zejtun ZTN 3000Malta

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgie/Belgiqu­e/Belgien Actavis Group PTC ehf. IJsland/Islan­de/Island Tél/Tel: +354 5503300	Lietuva UAB Teva Baltics Tel: +370 52660203
Etnrapua TeBa OapMa EAfl Ten: +359 24899585	Luxembourg/Lu­xemburg Actavis Group PTC ehf. Islande/Island Tel/Tel: +354 5503300
Česká republika Teva Pharmaceuticals CR, s.r.o. Tel: +420 251007111	Magyarorszag Teva Gyogyszergyar Zrt. Tel: +36 12886400
Danmark Teva Denmark A/S Tlf: +45 44985511	Malta Teva Pharmaceuticals Ireland L-Irlanda Tel: +44 2075407117
Deutschland Actavis Group PTC ehf. Island Tel: +354 5503300	Nederland Actavis Group PTC ehf. IJsland Tel: +354 5503300
Eesti UAB Teva Baltics Eesti filiaal Tel: +372 6610801	Norge Teva Norway AS Tlf: +47 66775590
EZZáSa Specifar A.B.E.E. Tql: +30 2118805000	Österreich ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1970070
España Actavis Group PTC ehf. Islandia Tel: +354 5503300	Polska Teva Pharmaceuticals Polska Sp. z o.o. Tel: +48 223459300
France Actavis Group PTC ehf. Islande Tél: +354 5503300	Portugal Actavis Group PTC ehf. Islandia Tel: +354 5503300
Hrvatska Pliva Hrvatska d.o.o. Tel: +385 13720000	Romania Teva Pharmaceuticals S.R.L. Tel: +40 212306524

Package leaflet: Information for the patient

Nemdatine 10 mg film-coated tablets memantine hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor or pharmacist.

• – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What Nemdatine is and what it is used for

• 2. What you need to know before you take Nemdatine

• 3. How to take Nemdatine

• 4. Possible side effects

• 5. How to store Nemdatine

• 6. Contents of the pack and other information

1. What Nemdatine is and what it is used for

How does Nemdatine work

Nemdatine contains the active substance memantine hydrochloride. Nemdatine belongs to a group of medicines known as anti-dementia medicines.

Memory loss in Alzheimer’s disease is due to a disturbance of message signals in the brain. The brain contains so-called N-methyl-D-aspartate (NMDA)-receptors that are involved in transmitting nerve signals important in learning and memory. Nemdatine belongs to a group of medicines called NMDA-receptor antagonists. Nemdatine acts on these NMDA-receptors improving the transmission of nerve signals and the memory.

What is Nemdatine used for

Nemdatine is used for the treatment of adult patients with moderate to severe Alzheimer’s di­sease.

2. What you need to know before you take Nemdatine

Do not take Nemdatine

• – if you are allergic to memantine hydrochloride or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before taking Nemdatine

• – if you have a history of epileptic seizures

• – if you have recently experienced a myocardial infarction (heart attack), or if you are suffering from congestive heart failure or from an uncontrolled hypertension (high blood pressure).

In these situations the treatment should be carefully supervised, and the clinical benefit of Nemdatine reassessed by your doctor on a regular basis.

If you suffer from renal impairment (kidney problems), your doctor should closely monitor your kidney function and if necessary adapt the memantine doses accordingly.

The use of medicinal products called amantadine (for the treatment of Parkinson’s di­sease), ketamine (a substance generally used as an anaesthetic), dextromethorphan (generally used to treat cough) and other NMDA-antagonists at the same time should be avoided.

Children and adolescents

Nemdatine is not recommended for children and adolescents under the age of 18 years.

Other medicines and Nemdatine

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular, Nemdatine may change the effects of the following medicines and their dose may need to be adjusted by your doctor:

• – amantadine, ketamine, dextromethorphan

• – dantrolene, baclofen

• – cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine

• – hydrochlorothiazide (or any combination with hydrochlorothi­azide)

• – anticholinergics (substances generally used to treat movement disorders or intestinal cramps)

• – anticonvulsants (substances used to prevent and relieve seizures)

• – barbiturates (substances generally used to induce sleep)

• – dopaminergic agonists (substances such as L-dopa, bromocriptine)

• – neuroleptics (substances used in the treatment of mental disorders)

• – oral anticoagulants

If you go into hospital, let your doctor know that you are taking Nemdatine.

Nemdatine with food and drink

You should inform your doctor if you have recently changed or intend to change your diet substantially (e.g. from normal diet to strict vegetarian diet) or if you are suffering from states of renal tubulary acidosis (RTA, an excess of acid-forming substances in the blood due to renal dysfunction (poor kidney function)) or severe infections of the urinary tract (structure that carries urine), as your doctor may need to adjust the dose of your medicine.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

The use of memantine in pregnant women is not recommended.

Breast-feeding

Women taking Nemdatine should not breast-feed.

Driving and using machines

Your doctor will tell you whether your illness allows you to drive and to use machines safely. Also, Nemdatine may change your reactivity, making driving or operating machinery inappropriate.

Nemdatine contains lactose monohydrate

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Nemdatine

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Dosage

The recommended dose of Nemdatine for adults and older people is 20 mg once a day.

In order to reduce the risk of side effects this dose is achieved gradually by the following daily treatment scheme:

Week 1	Half a 10 mg tablet
Week 2	One 10 mg tablet
Week 3	One and a half 10 mg tablets
Week 4 and beyond	Two 10 mg tablets once a day

The usual starting dose is half a tablet once a day (1× 5 mg) for the first week. This is increased to one tablet once a day (1× 10 mg) in the second week and to 1 and a half tablets once a day (1× 15 mg) in the third week. From the fourth week on, the usual dose is 2 tablets once a day (1× 20 mg).

Dosage in patients with impaired kidney function

If you have impaired kidney function, your doctor will decide upon a dose that suits your condition. In this case, monitoring of your kidney function should be performed by your doctor at specified intervals.

Administration

Nemdatine should be administered orally once a day. To benefit from your medicine you should take it regularly every day at the same time of the day. The tablets should be swallowed with some water.

The tablets can be taken with or without food.

Duration of treatment

Continue to take Nemdatine as long as it is of benefit to you. Your doctor should assess your treatment on a regular basis.

If you take more Nemdatine than you should

• – In general, taking too much Nemdatine should not result in any harm to you. You may experience increased symptoms as described in section 4 ‘Possible side effects’.

• – If you take a large overdose of Nemdatine, contact your doctor or get medical advice, as you may need medical attention.

If you forget to take Nemdatine

• – If you find you have forgotten to take your dose of Nemdatine, wait and take your next dose at the usual time.

• – Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

In general, the observed side effects are mild to moderate.

Common (affects 1 to 10 users in 100)

• – Headache, sleepiness, constipation, elevated liver function test, dizziness, balance disorders, shortness of breath, high blood pressure and drug hypersensitivity

Uncommon (affects 1 to 10 users in 1,000)

• – Tiredness, fungal infections, confusion, hallucinations, vomiting, abnormal gait, heart failure and venous blood clotting (thrombosis/throm­boembolism)

Very Rare (affects less than 1 user in 10,000)

• – Seizures

Not known (frequency cannot be estimated from the available data)

• – Inflammation of the pancreas, inflammation of the liver (hepatitis) and psychotic reactions

Alzheimer’s disease has been associated with depression, suicidal ideation and suicide. These events have been reported in patients treated with memantine.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Nemdatine

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton, blister and bottle label after ‘EXP’. The expiry date refers to the last day of that month.

Do not store above 25°C.

<[For HDPE bottle only:]>

Use within 100 days after opening.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Nemdatine contains

• – The active substance is memantine hydrochloride. Each film-coated tablet contains 10 mg memantine hydrochloride equivalent to 8.31 mg memantine.

• – The other ingredients are: Tablet core: Microcrystalline cellulose, crospovidone Type A, talc

and magnesium stearate. Tablet coat (Opadry II White 33G28435): Hypromellose 6cP, titanium dioxide (E171), lactose monohydrate, macrogol 3350 and triacetin.

What Nemdatine looks like and contents of the pack

Nemdatine 10 mg film-coated tablets (tablets) are white, capsule-shaped, biconvex, 9.8 mm x 4.9 mm in size, with score line and the marking “M 10” engraved on the scored side

Pack sizes

Blister packs: 28, 30, 42, 50, 56, 60, 98 and 112 film-coated tablets.

Bottle: 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Actavis Group PTC ehf.

Reykjavikurvegi 76–78

220 Hafnarfjöröur

Iceland

Manufacturer

Actavis Group PTC ehf.

Reykjavikurvegur 76–78

220 Hafnarfjordur

Iceland

Actavis Ltd.

BLB 015–016 Bulebel Industrial Estate

Zejtun ZTN 3000

Malta

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgie/Belgiqu­e/Belgien Actavis Group PTC ehf. IJsland/Islan­de/Island Tél/Tel: +354 5503300	Lietuva UAB Teva Baltics Tel: +370 52660203
Etnrapua TeBa OapMa EAfl Ten: +359 24899585	Luxembourg/Lu­xemburg Actavis Group PTC ehf. Islande/Island Tel/Tel: +354 5503300
Česká republika Teva Pharmaceuticals CR, s.r.o. Tel: +420 251007111	Magyarorszag Teva Gyogyszergyar Zrt. Tel: +36 12886400
Danmark Teva Denmark A/S Tlf: +45 44985511	Malta Teva Pharmaceuticals Ireland L-Irlanda Tel: +44 2075407117
Deutschland Actavis Group PTC ehf. Island Tel: +354 5503300	Nederland Actavis Group PTC ehf. IJsland Tel: +354 5503300
Eesti UAB Teva Baltics Eesti filiaal Tel: +372 6610801	Norge Teva Norway AS Tlf: +47 66775590
EMáSa Specifar A.B.E.E. Tql: +30 2118805000	Österreich ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1970070
España Actavis Group PTC ehf. Islandia Tel: +354 5503300	Polska Teva Pharmaceuticals Polska Sp. z o.o. Tel: +48 223459300
France Actavis Group PTC ehf. Islande Tél: +354 5503300	Portugal Actavis Group PTC ehf. Islandia Tel: +354 5503300

Package leaflet: Information for the patient

Nemdatine 15 mg film-coated tablets memantine hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor or pharmacist.

• – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What Nemdatine is and what it is used for

• 2. What you need to know before you take Nemdatine

• 3. How to take Nemdatine

• 4. Possible side effects

• 5. How to store Nemdatine

• 6. Contents of the pack and other information

1. What Nemdatine is and what it is used for

How does Nemdatine work

Nemdatine contains the active substance memantine hydrochloride. Nemdatine belongs to a group of medicines known as anti-dementia medicines.

Memory loss in Alzheimer’s disease is due to a disturbance of message signals in the brain. The brain contains so-called N-methyl-D-aspartate (NMDA)-receptors that are involved in transmitting nerve signals important in learning and memory. Nemdatine belongs to a group of medicines called NMDA-receptor antagonists. Nemdatine acts on these NMDA-receptors improving the transmission of nerve signals and the memory.

What is Nemdatine used for

Nemdatine is used for the treatment of adult patients with moderate to severe Alzheimer’s di­sease.

2. What you need to know before you take Nemdatine

Do not take Nemdatine

• – if you are allergic to memantine hydrochloride or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before taking Nemdatine

• – if you have a history of epileptic seizures

• – if you have recently experienced a myocardial infarction (heart attack), or if you are suffering from congestive heart failure or from an uncontrolled hypertension (high blood pressure).

In these situations the treatment should be carefully supervised, and the clinical benefit of Nemdatine reassessed by your doctor on a regular basis.

If you suffer from renal impairment (kidney problems), your doctor should closely monitor your kidney function and if necessary adapt the memantine doses accordingly.

The use of medicinal products called amantadine (for the treatment of Parkinson’s di­sease), ketamine (a substance generally used as an anaesthetic), dextromethorphan (generally used to treat cough) and other NMDA-antagonists at the same time should be avoided.

Children and adolescents

Nemdatine is not recommended for children and adolescents under the age of 18 years.

Other medicines and Nemdatine

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular, Nemdatine may change the effects of the following medicines and their dose may need to be adjusted by your doctor:

• – amantadine, ketamine, dextromethorphan

• – dantrolene, baclofen

• – cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine

• – hydrochlorothiazide (or any combination with hydrochlorothi­azide)

• – anticholinergics (substances generally used to treat movement disorders or intestinal cramps)

• – anticonvulsants (substances used to prevent and relieve seizures)

• – barbiturates (substances generally used to induce sleep)

• – dopaminergic agonists (substances such as L-dopa, bromocriptine)

• – neuroleptics (substances used in the treatment of mental disorders)

• – oral anticoagulants

If you go into hospital, let your doctor know that you are taking Nemdatine.

Nemdatine with food and drink

You should inform your doctor if you have recently changed or intend to change your diet substantially (e.g. from normal diet to strict vegetarian diet) or if you are suffering from states of renal tubulary acidosis (RTA, an excess of acid-forming substances in the blood due to renal dysfunction (poor kidney function)) or severe infections of the urinary tract (structure that carries urine), as your doctor may need to adjust the dose of your medicine.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

The use of memantine in pregnant women is not recommended.

Breast-feeding

Women taking Nemdatine should not breast-feed.

Driving and using machines

Your doctor will tell you whether your illness allows you to drive and to use machines safely. Also, Nemdatine may change your reactivity, making driving or operating machinery inappropriate.

Nemdatine contains lactose monohydrate

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Nemdatine

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Dosage

The recommended dose of Nemdatine for adults and older people is 20 mg once a day.

In order to reduce the risk of side effects this dose is achieved gradually by the following daily treatment scheme:

Week 1	One 5 mg tablet
Week 2	One 10 mg tablet
Week 3	One 15 mg tablet
Week 4 and beyond	One 20 mg tablet once a day

The usual starting dose is 5 mg memantine once a day for the first week. This is increased to 10 mg memantine in the second week and to 15 mg memantine once a day in the third week. From the fourth week on, the usual dose is 20 mg memantine once a day.

Dosage in patients with impaired kidney function

If you have impaired kidney function, your doctor will decide upon a dose that suits your condition. In this case, monitoring of your kidney function should be performed by your doctor at specified intervals.

Administration

Nemdatine should be administered orally once a day. To benefit from your medicine you should take it regularly every day at the same time of the day. The tablets should be swallowed with some water.

The tablets can be taken with or without food.

Duration of treatment

Continue to take Nemdatine as long as it is of benefit to you. Your doctor should assess your treatment on a regular basis.

If you take more Nemdatine than you should

• – In general, taking too much Nemdatine should not result in any harm to you. You may experience increased symptoms as described in section 4 ‘Possible side effects’.

• – If you take a large overdose of Nemdatine, contact your doctor or get medical advice, as you may need medical attention.

If you forget to take Nemdatine

• – If you find you have forgotten to take your dose of Nemdatine, wait and take your next dose at the usual time.

• – Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

In general, the observed side effects are mild to moderate.

Common (affects 1 to 10 users in 100)

• – Headache, sleepiness, constipation, elevated liver function test, dizziness, balance disorders, shortness of breath, high blood pressure and drug hypersensitivity

Uncommon (affects 1 to 10 users in 1,000)

• – Tiredness, fungal infections, confusion, hallucinations, vomiting, abnormal gait, heart failure and venous blood clotting (thrombosis/throm­boembolism)

Very Rare (affects less than 1 user in 10,000)

• – Seizures

Not known (frequency cannot be estimated from the available data)

• – Inflammation of the pancreas, inflammation of the liver (hepatitis) and psychotic reactions

Alzheimer’s disease has been associated with depression, suicidal ideation and suicide. These events have been reported in patients treated with memantine.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Nemdatine

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after ‘EXP’. The expiry date refers to the last day of that month.

Do not store above 25°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the pack and other information

What Nemdatine contains

• – The active substance is memantine hydrochloride. Each film-coated tablet contains 15 mg

memantine hydrochloride equivalent to 12.46 mg memantine.

• – The other ingredients are: Tablet core: Microcrystalline cellulose, crospovidone Type A, talc and magnesium stearate. Tablet coat (Opadry II Orange 33G230001): Hypromellose 6cP, titanium dioxide (E171), lactose monohydrate, macrogol 3350, triacetin and iron oxide yellow, red and black (E172).

What Nemdatine looks like and contents of the pack

Nemdatine 15 mg film-coated tablets (tablets) are orange, oval shaped, biconvex, 11.4 mm x 6.4 mm in size, with the marking “M15” engraved on one side.

Pack sizes

Blister packs: 7, 42 and 98 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Actavis Group PTC ehf.

Reykjavikurvegi 76–78

220 Hafnarfjöröur

Iceland

Manufacturer

Actavis Group PTC ehf.

Reykjavikurvegur 76–78

220 Hafnarfjordur

Iceland

Actavis Ltd.

BLB 015–016 Bulebel Industrial Estate

Zejtun ZTN 3000

Malta

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgie/Belgiqu­e/Belgien Actavis Group PTC ehf. IJsland/Islan­de/Island Tél/Tel: +354 5503300	Lietuva UAB Teva Baltics Tel: +370 52660203
Etnrapua TeBa OapMa EAfl Ten: +359 24899585	Luxembourg/Lu­xemburg Actavis Group PTC ehf. Islande/Island Tel/Tel: +354 5503300
Česká republika Teva Pharmaceuticals CR, s.r.o. Tel: +420 251007111	Magyarorszag Teva Gyogyszergyar Zrt. Tel: +36 12886400
Danmark Teva Denmark A/S Tlf: +45 44985511	Malta Teva Pharmaceuticals Ireland L-Irlanda Tel: +44 2075407117
Deutschland Actavis Group PTC ehf. Island Tel: +354 5503300	Nederland Actavis Group PTC ehf. IJsland Tel: +354 5503300
Eesti UAB Teva Baltics Eesti filiaal Tel: +372 6610801	Norge Teva Norway AS Tlf: +47 66775590
EMáSa Specifar A.B.E.E. Tql: +30 2118805000	Österreich ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1970070
España Actavis Group PTC ehf. Islandia Tel: +354 5503300	Polska Teva Pharmaceuticals Polska Sp. z o.o. Tel: +48 223459300
France Actavis Group PTC ehf. Islande Tél: +354 5503300	Portugal Actavis Group PTC ehf. Islandia Tel: +354 5503300
Hrvatska Pliva Hrvatska d.o.o. Tel: +385 13720000	Romania Teva Pharmaceuticals S.R.L. Tel: +40 212306524

Package leaflet: Information for the patient

Nemdatine 5 mg film-coated tablets

Nemdatine 10 mg film-coated tablets

Nemdatine 15 mg film-coated tablets

Nemdatine 20 mg film-coated tablets memantine hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor or pharmacist.

• – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What Nemdatine is and what it is used for

• 2. What you need to know before you take Nemdatine

• 3. How to take Nemdatine

• 4. Possible side effects

• 5. How to store Nemdatine

• 6. Contents of the pack and other information

1. What Nemdatine is and what it is used for

How does Nemdatine work

Nemdatine contains the active substance memantine hydrochloride. Nemdatine belongs to a group of medicines known as anti-dementia medicines.

Memory loss in Alzheimer’s disease is due to a disturbance of message signals in the brain. The brain contains so-called N-methyl-D-aspartate (NMDA)-receptors that are involved in transmitting nerve signals important in learning and memory. Nemdatine belongs to a group of medicines called NMDA-receptor antagonists. Nemdatine acts on these NMDA-receptors improving the transmission of nerve signals and the memory.

What is Nemdatine used for

Nemdatine is used for the treatment of adult patients with moderate to severe Alzheimer’s di­sease.

2. What you need to know before you take Nemdatine

Do not take Nemdatine

• – if you are allergic to memantine hydrochloride or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before taking Nemdatine

• – if you have a history of epileptic seizures

• – if you have recently experienced a myocardial infarction (heart attack), or if you are suffering

from congestive heart failure or from an uncontrolled hypertension (high blood pressure).

In these situations the treatment should be carefully supervised, and the clinical benefit of Nemdatine reassessed by your doctor on a regular basis.

If you suffer from renal impairment (kidney problems), your doctor should closely monitor your kidney function and if necessary adapt the memantine doses accordingly.

The use of medicinal products called amantadine (for the treatment of Parkinson’s di­sease), ketamine (a substance generally used as an anaesthetic), dextromethorphan (generally used to treat cough) and other NMDA-antagonists at the same time should be avoided.

Children and adolescents

Nemdatine is not recommended for children and adolescents under the age of 18 years.

Other medicines and Nemdatine

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular, Nemdatine may change the effects of the following medicines and their dose may need to be adjusted by your doctor:

• – amantadine, ketamine, dextromethorphan

• – dantrolene, baclofen

• – cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine

• – hydrochlorothiazide (or any combination with hydrochlorothi­azide)

• – anticholinergics (substances generally used to treat movement disorders or intestinal cramps)

• – anticonvulsants (substances used to prevent and relieve seizures)

• – barbiturates (substances generally used to induce sleep)

• – dopaminergic agonists (substances such as L-dopa, bromocriptine)

• – neuroleptics (substances used in the treatment of mental disorders)

• – oral anticoagulants

If you go into hospital, let your doctor know that you are taking Nemdatine.

Nemdatine with food and drink

You should inform your doctor if you have recently changed or intend to change your diet substantially (e.g. from normal diet to strict vegetarian diet) or if you are suffering from states of renal tubulary acidosis (RTA, an excess of acid-forming substances in the blood due to renal dysfunction (poor kidney function)) or severe infections of the urinary tract (structure that carries urine), as your doctor may need to adjust the dose of your medicine.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

The use of memantine in pregnant women is not recommended.

Breast-feeding

Women taking Nemdatine should not breast-feed.

Driving and using machines

Your doctor will tell you whether your illness allows you to drive and to use machines safely. Also, Nemdatine may change your reactivity, making driving or operating machinery inappropriate.

Nemdatine contains lactose monohydrate

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Nemdatine

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The Nemdatine treatment initiation pack is only to be used for the beginning of the treatment with Nemdatine.

Dosage

The recommended treatment dose of 20 mg per day is achieved by a gradual increase of the Nemdatine dose during the first 3 weeks of treatment. The treatment scheme is also indicated on the treatment initiation pack. Take one tablet once a day.

Week 1 (day 1–7):

Take one 5 mg tablet once a day (white, oval-shaped) for 7 days.

Week 2 (day 8–14):

Take one 10 mg tablet once a day (white, capsule shaped) for 7 days.

Week 3 (day 15–21):

Take one 15 mg tablet once a day (orange, oval shaped) for 7 days.

Week 4 (day 22–28):

Take one 20 mg tablet per day (dark pink, oval shaped) for 7 days.

Week 1	5 mg tablet
Week 2	10 mg tablet
Week 3	15 mg tablet
Week 4 and beyond	20 mg tablets once a day

Maintenance dose

The recommended daily dose is 20 mg once a day.

For continuation of the treatment please consult your doctor.

Dosage in patients with impaired kidney function

If you have impaired kidney function, your doctor will decide upon a dose that suits your condition. In this case, monitoring of your kidney function should be performed by your doctor at specified intervals.

Administration

Nemdatine should be administered orally once a day. To benefit from your medicine you should take it regularly every day at the same time of the day. The tablets should be swallowed with some water.

The tablets can be taken with or without food.

Duration of treatment

Continue to take Nemdatine as long as it is of benefit to you. Your doctor should assess your treatment on a regular basis.

If you take more Nemdatine than you should

• – In general, taking too much Nemdatine should not result in any harm to you. You may experience increased symptoms as described in section 4 ‘Possible side effects’.

• – If you take a large overdose of Nemdatine, contact your doctor or get medical advice, as you may need medical attention.

If you forget to take Nemdatine

• – If you find you have forgotten to take your dose of Nemdatine, wait and take your next dose at the usual time.

• – Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

In general, the observed side effects are mild to moderate.

Common (affects 1 to 10 users in 100)

• – Headache, sleepiness, constipation, elevated liver function test, dizziness, balance disorders, shortness of breath, high blood pressure and drug hypersensitivity

Uncommon (affects 1 to 10 users in 1,000)

• – Tiredness, fungal infections, confusion, hallucinations, vomiting, abnormal gait, heart failure and venous blood clotting (thrombosis/throm­boembolism)

Very Rare (affects less than 1 user in 10,000)

• – Seizures

Not known (frequency cannot be estimated from the available data)

• – Inflammation of the pancreas, inflammation of the liver (hepatitis) and psychotic reactions

Alzheimer’s disease has been associated with depression, suicidal ideation and suicide. These events have been reported in patients treated with memantine.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. Y ou can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Nemdatine

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after ‘EXP’. The expiry date refers to the last day of that month.

Do not store above 25°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Nemdatine contains

• – The active substance is memantine hydrochloride. Each film-coated tablet contains 5, 10, 15, or 20 mg memantine hydrochloride equivalent to 4.15, 8.31, 12.46 or 16.62 mg memantine.

• – The other ingredients for Nemdatine 5, 10, 15 and 20 mg film-coated tablets are: Tablet core: Microcrystalline cellulose, crospovidone Type A, talc and magnesium stearate. Tablet coat: Hypromellose 6cP, titanium dioxide (E171), lactose monohydrate, macrogol 3350 and triacetin. The 15 mg tablets furthermore contain iron oxide yellow, red and black (E172). The 20 mg tablets furthermore contain iron oxide red and yellow (E172).

What Nemdatine looks like and contents of the pack

Nemdatine 5 mg film-coated tablets (tablets) are white, oval shaped, biconvex, 8 mm x 4.5 mm in size, with the marking “M5” engraved on one side.

Nemdatine 10 mg film-coated tablets (tablets) are white, capsule-shaped, biconvex, 9.8 mm x 4.9 mm in size, with score line and the marking “M 10” engraved on the scored side.

Nemdatine 15 mg film-coated tablets (tablets) are orange, oval shaped, biconvex, 11.4 mm x 6.4 mm in size, with the marking “M15” engraved on one side.

Nemdatine 20 mg film-coated tablets (tablets) are dark pink, oval shaped, biconvex, 12.6 mm x 7 mm in size, with the marking “M20” engraved on one side.

One treatment initiation pack contains 28 tablets in 4 blisters in a wallet pack or a multipack of 4 blisters in 4 separate immediate cartons and one outer carton with 7 tablets of Nemdatine 5 mg, 7 tablets of Nemdatine 10 mg, 7 tablets of Nemdatine 15 mg and 7 tablets of Nemdatine 20 mg.

Marketing Authorisation Holder

Actavis Group PTC ehf.

Reykjavikurvegi 76–78

220 Hafnarfjordur

Iceland

Manufacturer

Actavis Group PTC ehf.

Reykjavikurvegur 76–78

220 Hafnarfjordur

Iceland

Actavis Ltd.

BLB 015–016 Bulebel Industrial Estate

Zejtun ZTN 3000

Malta

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgie/Belgiqu­e/Belgien Actavis Group PTC ehf. IJsland/Islan­de/Island Tél/Tel: +354 5503300	Lietuva UAB Teva Baltics Tel: +370 52660203
Efcnrapua TeBa OapMa EAfl Ten: +359 24899585	Luxembourg/Lu­xemburg Actavis Group PTC ehf. Islande/Island Tel/Tel: +354 5503300
Česká republika Teva Pharmaceuticals CR, s.r.o. Tel: +420 251007111	Magyarorszag Teva Gyogyszergyar Zrt. Tel: +36 12886400
Danmark Teva Denmark A/S Tlf: +45 44985511	Malta Teva Pharmaceuticals Ireland L-Irlanda Tel: +44 2075407117
Deutschland Actavis Group PTC ehf. Island Tel: +354 5503300	Nederland Actavis Group PTC ehf. IJsland Tel: +354 5503300

Eesti UAB Teva Baltics Eesti filiaal Tel: +372 6610801	Norge Teva Norway AS Tlf: +47 66775590
EMáSa Specifar A.B.E.E. Tql: +30 2118805000	Österreich ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1970070
España Actavis Group PTC ehf. Islandia	Polska Teva Pharmaceuticals Polska Sp. z o.o. Tel: +48 223459300

Tel: +354 5503300

France Actavis Group PTC ehf. Islande Tél: +354 5503300	Portugal Actavis Group PTC ehf. Islandia Tel: +354 5503300
Hrvatska Pliva Hrvatska d.o.o. Tel: +385 13720000	Romania Teva Pharmaceuticals S.R.L. Tel: +40 212306524
Ireland Teva Pharmaceuticals Ireland Tel: +44 2075407117	Slovenija Pliva Ljubljana d.o.o. Tel: +386 15890390
Ísland Actavis Group PTC ehf. Sími: +354 5503300	Slovenská republika TEVA Pharmaceuticals Slovakia s.r.o. Tel: +421 257267911
Italia Actavis Group PTC ehf. Islanda	Suomi/Finland Teva Finland Oy Puh/Tel: +358 201805900

Tel: +354 5503300

Kùnpoç Specifar A.B.E.E. EUáSa

Sverige Teva Sweden AB Tel: +46 42121100

Tql: +30 2118805000

Latvija UAB Teva Baltics filiäle Latvijä Tel: +371 67323666

United Kingdom (Northern Ireland) Teva Pharmaceuticals Ireland Ireland Tel: +44 2075407117

This leaflet was last revised in {MM/YYYY}

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:

/.

Package leaflet: Information for the patient

Nemdatine 20 mg film-coated tablets memantine hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor or pharmacist.

• – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What Nemdatine is and what it is used for

• 2. What you need to know before you take Nemdatine

• 3. How to take Nemdatine

• 4. Possible side effects

• 5. How to store Nemdatine

• 6. Contents of the pack and other information

1. What Nemdatine is and what it is used for

How does Nemdatine work

Nemdatine contains the active substance memantine hydrochloride. Nemdatine belongs to a group of medicines known as anti-dementia medicines.

Memory loss in Alzheimer’s disease is due to a disturbance of message signals in the brain. The brain contains so-called N-methyl-D-aspartate (NMDA)-receptors that are involved in transmitting nerve signals important in learning and memory. Nemdatine belongs to a group of medicines called NMDA-receptor antagonists. Nemdatine acts on these NMDA-receptors improving the transmission of nerve signals and the memory.

What is Nemdatine used for

Nemdatine is used for the treatment of adult patients with moderate to severe Alzheimer’s di­sease.

2. What you need to know before you before you take Nemdatine

Do not take Nemdatine

• – if you are allergic to memantine hydrochloride or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before taking Nemdatine

• – if you have a history of epileptic seizures

• – if you have recently experienced a myocardial infarction (heart attack), or if you are suffering from congestive heart failure or from an uncontrolled hypertension (high blood pressure).

In these situations the treatment should be carefully supervised, and the clinical benefit of Nemdatine reassessed by your doctor on a regular basis.

If you suffer from renal impairment (kidney problems), your doctor should closely monitor your kidney function and if necessary adapt the memantine doses accordingly.

The use of medicinal products called amantadine (for the treatment of Parkinson’s di­sease), ketamine (a substance generally used as an anaesthetic), dextromethorphan (generally used to treat cough) and other NMDA-antagonists at the same time should be avoided.

Children and adolescents

Nemdatine is not recommended for children and adolescents under the age of 18 years.

Other medicines and Nemdatine

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular, Nemdatine may change the effects of the following medicines and their dose may need to be adjusted by your doctor:

• – amantadine, ketamine, dextromethorphan

• – dantrolene, baclofen

• – cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine

• – hydrochlorothiazide (or any combination with hydrochlorothi­azide)

• – anticholinergics (substances generally used to treat movement disorders or intestinal cramps)

• – anticonvulsants (substances used to prevent and relieve seizures)

• – barbiturates (substances generally used to induce sleep)

• – dopaminergic agonists (substances such as L-dopa, bromocriptine)

• – neuroleptics (substances used in the treatment of mental disorders)

• – oral anticoagulants

If you go into hospital, let your doctor know that you are taking Nemdatine.

Nemdatine with food and drink

You should inform your doctor if you have recently changed or intend to change your diet substantially (e.g. from normal diet to strict vegetarian diet) or if you are suffering from states of renal tubulary acidosis (RTA, an excess of acid-forming substances in the blood due to renal dysfunction (poor kidney function)) or severe infections of the urinary tract (structure that carries urine), as your doctor may need to adjust the dose of your medicine.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

The use of memantine in pregnant women is not recommended.

Breast-feeding

Women taking Nemdatine should not breast-feed.

Driving and using machines

Your doctor will tell you whether your illness allows you to drive and to use machines safely. Also, Nemdatine may change your reactivity, making driving or operating machinery inappropriate.

Nemdatine contains lactose monohydrate

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Nemdatine

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Dosage

The recommended dose of Nemdatine for adults and older people is 20 mg once a day.

In order to reduce the risk of side effects this dose is achieved gradually by the following daily treatment scheme. For up-titration other tablet strengths are available.

At the beginning of treatment you will start by using Nemdatine 5 mg film-coated tablets once a day. This dose will be increased weekly by 5 mg until the recommended (maintenance) dose is reached. The recommended maintenance dose is 20 mg once a day, which is reached at the beginning of the 4th week.

Dosage in patients with impaired kidney function

If you have impaired kidney function, your doctor will decide upon a dose that suits your condition. In this case, monitoring of your kidney function should be performed by your doctor at specified intervals.

Administration

Nemdatine should be administered orally once a day. To benefit from your medicine you should take it regularly every day at the same time of the day. The tablets should be swallowed with some water.

The tablets can be taken with or without food.

Duration of treatment

Continue to take Nemdatine as long as it is of benefit to you. Your doctor should assess your treatment on a regular basis.

If you take more Nemdatine than you should

• – In general, taking too much Nemdatine should not result in any harm to you. You may experience increased symptoms as described in section 4 ‘Possible side effects’.

• – If you take a large overdose of Nemdatine, contact your doctor or get medical advice, as you may need medical attention.

If you forget to take Nemdatine

• – If you find you have forgotten to take your dose of Nemdatine, wait and take your next dose at the usual time.

• – Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

In general, the observed side effects are mild to moderate.

Common (affects 1 to 10 users in 100)

• – Headache, sleepiness, constipation, elevated liver function test, dizziness, balance disorders, shortness of breath, high blood pressure and drug hypersensitivity

Uncommon (affects 1 to 10 users in 1,000)

• – Tiredness, fungal infections, confusion, hallucinations, vomiting, abnormal gait, heart failure and venous blood clotting (thrombosis/throm­boembolism)

Very Rare (affects less than 1 user in 10,000)

• – Seizures

Not known (frequency cannot be estimated from the available data)

• – Inflammation of the pancreas, inflammation of the liver (hepatitis) and psychotic reactions

Alzheimer’s disease has been associated with depression, suicidal ideation and suicide. These events have been reported in patients treated with memantine.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Nemdatine

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton, blister and bottle label after ‘EXP’. The expiry date refers to the last day of that month.

Do not store above 25°C.

<[For HDPE bottle only:]>

Use within 100 days after opening.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Nemdatine contains

• – The active substance is memantine hydrochloride. Each film-coated tablet contains 20 mg memantine hydrochloride equivalent to 16.62 mg memantine.

• – The other ingredients are: Tablet core: Microcrystalline cellulose, crospovidone Type A, talc and magnesium stearate. Tablet coat (Opadry II Pink 33G240000): Hypromellose 6cP, titanium dioxide (E171), lactose monohydrate, macrogol 3350, triacetin and iron oxide red and yellow (E172).

What Nemdatine looks like and contents of the pack

Nemdatine 5 mg film-coated tablets (tablets) are white, oval shaped, biconvex, 8 mm x 4.5 mm in size, with the marking “M5” engraved on one side.

Pack sizes

Blister packs: 42 and 98 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Actavis Group PTC ehf.

Reykjavikurvegi 76–78

220 Hafnarfjöröur

Iceland

Manufacturer

Actavis Group PTC ehf.

Reykjavikurvegur 76–78

220 Hafnarfjordur

Iceland

Actavis Ltd.

BLB 015–016 Bulebel Industrial Estate

Zejtun ZTN 3000Malta

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgie/Belgiqu­e/Belgien Actavis Group PTC ehf. IJsland/Islan­de/Island Tél/Tel: +354 5503300	Lietuva UAB Teva Baltics Tel: +370 52660203
Etnrapua TeBa OapMa EAfl Ten: +359 24899585	Luxembourg/Lu­xemburg Actavis Group PTC ehf. Islande/Island Tel/Tel: +354 5503300
Česká republika Teva Pharmaceuticals CR, s.r.o. Tel: +420 251007111	Magyarorszag Teva Gyogyszergyar Zrt. Tel: +36 12886400
Danmark Teva Denmark A/S Tlf: +45 44985511	Malta Teva Pharmaceuticals Ireland L-Irlanda Tel: +44 2075407117
Deutschland Actavis Group PTC ehf. Island Tel: +354 5503300	Nederland Actavis Group PTC ehf. IJsland Tel: +354 5503300
Eesti UAB Teva Baltics Eesti filiaal Tel: +372 6610801	Norge Teva Norway AS Tlf: +47 66775590
EZZáSa Specifar A.B.E.E. Tql: +30 2118805000	Österreich ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1970070
España Actavis Group PTC ehf. Islandia Tel: +354 5503300	Polska Teva Pharmaceuticals Polska Sp. z o.o. Tel: +48 223459300
France Actavis Group PTC ehf. Islande Tél: +354 5503300	Portugal Actavis Group PTC ehf. Islandia Tel: +354 5503300
Hrvatska Pliva Hrvatska d.o.o. Tel: +385 13720000	Romania Teva Pharmaceuticals S.R.L. Tel: +40 212306524

Package leaflet: Information for the patient

Nemdatine 10 mg film-coated tablets memantine hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor or pharmacist.

• – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

– If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What Nemdatine is and what it is used for

• 2. What you need to know before you take Nemdatine

• 3. How to take Nemdatine

• 4. Possible side effects

• 5. How to store Nemdatine

• 6. Contents of the pack and other information

1. What Nemdatine is and what it is used for

How does Nemdatine work

Nemdatine contains the active substance memantine hydrochloride. Nemdatine belongs to a group of medicines known as anti-dementia medicines.

Memory loss in Alzheimer’s disease is due to a disturbance of message signals in the brain. The brain contains so-called N-methyl-D-aspartate (NMDA)-receptors that are involved in transmitting nerve signals important in learning and memory. Nemdatine belongs to a group of medicines called NMDA-receptor antagonists. Nemdatine acts on these NMDA-receptors improving the transmission of nerve signals and the memory.

What is Nemdatine used for

Nemdatine is used for the treatment of adult patients with moderate to severe Alzheimer’s di­sease.

2. What you need to know before you take Nemdatine

Do not take Nemdatine

• – if you are allergic to memantine hydrochloride or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before taking Nemdatine

• – if you have a history of epileptic seizures

• – if you have recently experienced a myocardial infarction (heart attack), or if you are suffering from congestive heart failure or from an uncontrolled hypertension (high blood pressure).

In these situations the treatment should be carefully supervised, and the clinical benefit of Nemdatine reassessed by your doctor on a regular basis.

If you suffer from renal impairment (kidney problems), your doctor should closely monitor your kidney function and if necessary adapt the memantine doses accordingly.

The use of medicinal products called amantadine (for the treatment of Parkinson’s di­sease), ketamine (a substance generally used as an anaesthetic), dextromethorphan (generally used to treat cough) and other NMDA-antagonists at the same time should be avoided.

Children and adolescents

Nemdatine is not recommended for children and adolescents under the age of 18 years.

Other medicines and Nemdatine

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular, Nemdatine may change the effects of the following medicines and their dose may need to be adjusted by your doctor:

• – amantadine, ketamine, dextromethorphan

• – dantrolene, baclofen

• – cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine

• – hydrochlorothiazide (or any combination with hydrochlorothi­azide)

• – anticholinergics (substances generally used to treat movement disorders or intestinal cramps)

• – anticonvulsants (substances used to prevent and relieve seizures)

• – barbiturates (substances generally used to induce sleep)

• – dopaminergic agonists (substances such as L-dopa, bromocriptine)

• – neuroleptics (substances used in the treatment of mental disorders)

• – oral anticoagulants

If you go into hospital, let your doctor know that you are taking Nemdatine.

Nemdatine with food and drink

You should inform your doctor if you have recently changed or intend to change your diet substantially (e.g. from normal diet to strict vegetarian diet) or if you are suffering from states of renal tubulary acidosis (RTA, an excess of acid-forming substances in the blood due to renal dysfunction (poor kidney function)) or severe infections of the urinary tract (structure that carries urine), as your doctor may need to adjust the dose of your medicine.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

The use of memantine in pregnant women is not recommended.

Breast-feeding

Women taking Nemdatine should not breast-feed.

Driving and using machines

Your doctor will tell you whether your illness allows you to drive and to use machines safely. Also, Nemdatine may change your reactivity, making driving or operating machinery inappropriate.

Nemdatine contains lactose monohydrate

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Nemdatine

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Dosage

The recommended dose of Nemdatine for adults and older people is 20 mg once a day.

In order to reduce the risk of side effects this dose is achieved gradually by the following daily treatment scheme:

Week 1	Half a 10 mg tablet
Week 2	One 10 mg tablet
Week 3	One and a half 10 mg tablets
Week 4 and beyond	Two 10 mg tablets once a day

The usual starting dose is half a tablet once a day (1× 5 mg) for the first week. This is increased to one tablet once a day (1× 10 mg) in the second week and to 1 and a half tablets once a day (1× 15 mg) in the third week. From the fourth week on, the usual dose is 2 tablets once a day (1× 20 mg).

Dosage in patients with impaired kidney function

If you have impaired kidney function, your doctor will decide upon a dose that suits your condition. In this case, monitoring of your kidney function should be performed by your doctor at specified intervals.

Administration

Nemdatine should be administered orally once a day. To benefit from your medicine you should take it regularly every day at the same time of the day. The tablets should be swallowed with some water.

The tablets can be taken with or without food.

Duration of treatment

Continue to take Nemdatine as long as it is of benefit to you. Your doctor should assess your treatment on a regular basis.

If you take more Nemdatine than you should

• – In general, taking too much Nemdatine should not result in any harm to you. You may experience increased symptoms as described in section 4 ‘Possible side effects’.

• – If you take a large overdose of Nemdatine, contact your doctor or get medical advice, as you may need medical attention.

If you forget to take Nemdatine

• – If you find you have forgotten to take your dose of Nemdatine, wait and take your next dose at the usual time.

• – Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

In general, the observed side effects are mild to moderate.

Common (affects 1 to 10 users in 100)

• – Headache, sleepiness, constipation, elevated liver function test, dizziness, balance disorders, shortness of breath, high blood pressure and drug hypersensitivity

Uncommon (affects 1 to 10 users in 1,000)

• – Tiredness, fungal infections, confusion, hallucinations, vomiting, abnormal gait, heart failure and venous blood clotting (thrombosis/throm­boembolism)

Very Rare (affects less than 1 user in 10,000)

• – Seizures

Not known (frequency cannot be estimated from the available data)

• – Inflammation of the pancreas, inflammation of the liver (hepatitis) and psychotic reactions

Alzheimer’s disease has been associated with depression, suicidal ideation and suicide. These events have been reported in patients treated with memantine.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Nemdatine

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton, blister and bottle label after ‘EXP’. The expiry date refers to the last day of that month.

Do not store above 25°C.

<[For HDPE bottle only:]>

Use within 100 days after opening.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Nemdatine contains

• – The active substance is memantine hydrochloride. Each film-coated tablet contains 10 mg memantine hydrochloride equivalent to 8.31 mg memantine.

• – The other ingredients are: Tablet core: Microcrystalline cellulose, crospovidone Type A, talc

and magnesium stearate. Tablet coat (Opadry II White 33G28435): Hypromellose 6cP, titanium dioxide (E171), lactose monohydrate, macrogol 3350 and triacetin.

What Nemdatine looks like and contents of the pack

Nemdatine 10 mg film-coated tablets (tablets) are white, capsule-shaped, biconvex, 9.8 mm x 4.9 mm in size, with score line and the marking “M 10” engraved on the scored side

Pack sizes

Blister packs: 28, 30, 42, 50, 56, 60, 98 and 112 film-coated tablets.

Bottle: 100 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Actavis Group PTC ehf.

Reykjavikurvegi 76–78

220 Hafnarfjöröur

Iceland

Manufacturer

Actavis Group PTC ehf.

Reykjavikurvegur 76–78

220 Hafnarfjordur

Iceland

Actavis Ltd.

BLB 015–016 Bulebel Industrial Estate

Zejtun ZTN 3000

Malta

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgie/Belgiqu­e/Belgien Actavis Group PTC ehf. IJsland/Islan­de/Island Tél/Tel: +354 5503300	Lietuva UAB Teva Baltics Tel: +370 52660203
Etnrapua TeBa OapMa EAfl Ten: +359 24899585	Luxembourg/Lu­xemburg Actavis Group PTC ehf. Islande/Island Tel/Tel: +354 5503300
Česká republika Teva Pharmaceuticals CR, s.r.o. Tel: +420 251007111	Magyarorszag Teva Gyogyszergyar Zrt. Tel: +36 12886400
Danmark Teva Denmark A/S Tlf: +45 44985511	Malta Teva Pharmaceuticals Ireland L-Irlanda Tel: +44 2075407117
Deutschland Actavis Group PTC ehf. Island Tel: +354 5503300	Nederland Actavis Group PTC ehf. IJsland Tel: +354 5503300
Eesti UAB Teva Baltics Eesti filiaal Tel: +372 6610801	Norge Teva Norway AS Tlf: +47 66775590
EMáSa Specifar A.B.E.E. Tql: +30 2118805000	Österreich ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1970070
España Actavis Group PTC ehf. Islandia Tel: +354 5503300	Polska Teva Pharmaceuticals Polska Sp. z o.o. Tel: +48 223459300
France Actavis Group PTC ehf. Islande Tél: +354 5503300	Portugal Actavis Group PTC ehf. Islandia Tel: +354 5503300

Package leaflet: Information for the patient

Nemdatine 15 mg film-coated tablets memantine hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor or pharmacist.

• – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

– If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What Nemdatine is and what it is used for

• 2. What you need to know before you take Nemdatine

• 3. How to take Nemdatine

• 4. Possible side effects

• 5. How to store Nemdatine

• 6. Contents of the pack and other information

1. What Nemdatine is and what it is used for

How does Nemdatine work

Nemdatine contains the active substance memantine hydrochloride. Nemdatine belongs to a group of medicines known as anti-dementia medicines.

Memory loss in Alzheimer’s disease is due to a disturbance of message signals in the brain. The brain contains so-called N-methyl-D-aspartate (NMDA)-receptors that are involved in transmitting nerve signals important in learning and memory. Nemdatine belongs to a group of medicines called NMDA-receptor antagonists. Nemdatine acts on these NMDA-receptors improving the transmission of nerve signals and the memory.

What is Nemdatine used for

Nemdatine is used for the treatment of adult patients with moderate to severe Alzheimer’s di­sease.

2. What you need to know before you take Nemdatine

Do not take Nemdatine

• – if you are allergic to memantine hydrochloride or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before taking Nemdatine

• – if you have a history of epileptic seizures

• – if you have recently experienced a myocardial infarction (heart attack), or if you are suffering from congestive heart failure or from an uncontrolled hypertension (high blood pressure).

In these situations the treatment should be carefully supervised, and the clinical benefit of Nemdatine reassessed by your doctor on a regular basis.

If you suffer from renal impairment (kidney problems), your doctor should closely monitor your kidney function and if necessary adapt the memantine doses accordingly.

The use of medicinal products called amantadine (for the treatment of Parkinson’s di­sease), ketamine (a substance generally used as an anaesthetic), dextromethorphan (generally used to treat cough) and other NMDA-antagonists at the same time should be avoided.

Children and adolescents

Nemdatine is not recommended for children and adolescents under the age of 18 years.

Other medicines and Nemdatine

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular, Nemdatine may change the effects of the following medicines and their dose may need to be adjusted by your doctor:

• – amantadine, ketamine, dextromethorphan

• – dantrolene, baclofen

• – cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine

• – hydrochlorothiazide (or any combination with hydrochlorothi­azide)

• – anticholinergics (substances generally used to treat movement disorders or intestinal cramps)

• – anticonvulsants (substances used to prevent and relieve seizures)

• – barbiturates (substances generally used to induce sleep)

• – dopaminergic agonists (substances such as L-dopa, bromocriptine)

• – neuroleptics (substances used in the treatment of mental disorders)

• – oral anticoagulants

If you go into hospital, let your doctor know that you are taking Nemdatine.

Nemdatine with food and drink

You should inform your doctor if you have recently changed or intend to change your diet substantially (e.g. from normal diet to strict vegetarian diet) or if you are suffering from states of renal tubulary acidosis (RTA, an excess of acid-forming substances in the blood due to renal dysfunction (poor kidney function)) or severe infections of the urinary tract (structure that carries urine), as your doctor may need to adjust the dose of your medicine.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

The use of memantine in pregnant women is not recommended.

Breast-feeding

Women taking Nemdatine should not breast-feed.

Driving and using machines

Your doctor will tell you whether your illness allows you to drive and to use machines safely. Also, Nemdatine may change your reactivity, making driving or operating machinery inappropriate.

Nemdatine contains lactose monohydrate

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Nemdatine

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Dosage

The recommended dose of Nemdatine for adults and older people is 20 mg once a day.

In order to reduce the risk of side effects this dose is achieved gradually by the following daily treatment scheme:

Week 1	One 5 mg tablet
Week 2	One 10 mg tablet
Week 3	One 15 mg tablet
Week 4 and beyond	One 20 mg tablet once a day

The usual starting dose is 5 mg memantine once a day for the first week. This is increased to 10 mg memantine in the second week and to 15 mg memantine once a day in the third week. From the fourth week on, the usual dose is 20 mg memantine once a day.

Dosage in patients with impaired kidney function

If you have impaired kidney function, your doctor will decide upon a dose that suits your condition. In this case, monitoring of your kidney function should be performed by your doctor at specified intervals.

Administration

Nemdatine should be administered orally once a day. To benefit from your medicine you should take it regularly every day at the same time of the day. The tablets should be swallowed with some water.

The tablets can be taken with or without food.

Duration of treatment

Continue to take Nemdatine as long as it is of benefit to you. Your doctor should assess your treatment on a regular basis.

If you take more Nemdatine than you should

• – In general, taking too much Nemdatine should not result in any harm to you. You may experience increased symptoms as described in section 4 ‘Possible side effects’.

• – If you take a large overdose of Nemdatine, contact your doctor or get medical advice, as you may need medical attention.

If you forget to take Nemdatine

• – If you find you have forgotten to take your dose of Nemdatine, wait and take your next dose at the usual time.

• – Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

In general, the observed side effects are mild to moderate.

Common (affects 1 to 10 users in 100)

• – Headache, sleepiness, constipation, elevated liver function test, dizziness, balance disorders, shortness of breath, high blood pressure and drug hypersensitivity

Uncommon (affects 1 to 10 users in 1,000)

• – Tiredness, fungal infections, confusion, hallucinations, vomiting, abnormal gait, heart failure and venous blood clotting (thrombosis/throm­boembolism)

Very Rare (affects less than 1 user in 10,000)

• – Seizures

Not known (frequency cannot be estimated from the available data)

• – Inflammation of the pancreas, inflammation of the liver (hepatitis) and psychotic reactions

Alzheimer’s disease has been associated with depression, suicidal ideation and suicide. These events have been reported in patients treated with memantine.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Nemdatine

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after ‘EXP’. The expiry date refers to the last day of that month.

Do not store above 25°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the pack and other information

What Nemdatine contains

• – The active substance is memantine hydrochloride. Each film-coated tablet contains 15 mg

memantine hydrochloride equivalent to 12.46 mg memantine.

• – The other ingredients are: Tablet core: Microcrystalline cellulose, crospovidone Type A, talc and magnesium stearate. Tablet coat (Opadry II Orange 33G230001): Hypromellose 6cP, titanium dioxide (E171), lactose monohydrate, macrogol 3350, triacetin and iron oxide yellow, red and black (E172).

What Nemdatine looks like and contents of the pack

Nemdatine 15 mg film-coated tablets (tablets) are orange, oval shaped, biconvex, 11.4 mm x 6.4 mm in size, with the marking “M15” engraved on one side.

Pack sizes

Blister packs: 7, 42 and 98 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Actavis Group PTC ehf.

Reykjavikurvegi 76–78

220 Hafnarfjöröur

Iceland

Manufacturer

Actavis Group PTC ehf.

Reykjavikurvegur 76–78

220 Hafnarfjordur

Iceland

Actavis Ltd.

BLB 015–016 Bulebel Industrial Estate

Zejtun ZTN 3000

Malta

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgie/Belgiqu­e/Belgien Actavis Group PTC ehf. IJsland/Islan­de/Island Tél/Tel: +354 5503300	Lietuva UAB Teva Baltics Tel: +370 52660203
Etnrapua TeBa OapMa EAfl Ten: +359 24899585	Luxembourg/Lu­xemburg Actavis Group PTC ehf. Islande/Island Tel/Tel: +354 5503300
Česká republika Teva Pharmaceuticals CR, s.r.o. Tel: +420 251007111	Magyarorszag Teva Gyogyszergyar Zrt. Tel: +36 12886400
Danmark Teva Denmark A/S Tlf: +45 44985511	Malta Teva Pharmaceuticals Ireland L-Irlanda Tel: +44 2075407117
Deutschland Actavis Group PTC ehf. Island Tel: +354 5503300	Nederland Actavis Group PTC ehf. IJsland Tel: +354 5503300
Eesti UAB Teva Baltics Eesti filiaal Tel: +372 6610801	Norge Teva Norway AS Tlf: +47 66775590
EMáSa Specifar A.B.E.E. Tql: +30 2118805000	Österreich ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1970070
España Actavis Group PTC ehf. Islandia Tel: +354 5503300	Polska Teva Pharmaceuticals Polska Sp. z o.o. Tel: +48 223459300
France Actavis Group PTC ehf. Islande Tél: +354 5503300	Portugal Actavis Group PTC ehf. Islandia Tel: +354 5503300
Hrvatska Pliva Hrvatska d.o.o. Tel: +385 13720000	Romania Teva Pharmaceuticals S.R.L. Tel: +40 212306524

Package leaflet: Information for the patient

Nemdatine 5 mg film-coated tablets

Nemdatine 10 mg film-coated tablets

Nemdatine 15 mg film-coated tablets

Nemdatine 20 mg film-coated tablets memantine hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor or pharmacist.

• – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

– If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What Nemdatine is and what it is used for

• 2. What you need to know before you take Nemdatine

• 3. How to take Nemdatine

• 4. Possible side effects

• 5. How to store Nemdatine

• 6. Contents of the pack and other information

1. What Nemdatine is and what it is used for

How does Nemdatine work

Nemdatine contains the active substance memantine hydrochloride. Nemdatine belongs to a group of medicines known as anti-dementia medicines.

Memory loss in Alzheimer’s disease is due to a disturbance of message signals in the brain. The brain contains so-called N-methyl-D-aspartate (NMDA)-receptors that are involved in transmitting nerve signals important in learning and memory. Nemdatine belongs to a group of medicines called NMDA-receptor antagonists. Nemdatine acts on these NMDA-receptors improving the transmission of nerve signals and the memory.

What is Nemdatine used for

Nemdatine is used for the treatment of adult patients with moderate to severe Alzheimer’s di­sease.

2. What you need to know before you take Nemdatine

Do not take Nemdatine

• – if you are allergic to memantine hydrochloride or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before taking Nemdatine

• – if you have a history of epileptic seizures

• – if you have recently experienced a myocardial infarction (heart attack), or if you are suffering

from congestive heart failure or from an uncontrolled hypertension (high blood pressure).

In these situations the treatment should be carefully supervised, and the clinical benefit of Nemdatine reassessed by your doctor on a regular basis.

If you suffer from renal impairment (kidney problems), your doctor should closely monitor your kidney function and if necessary adapt the memantine doses accordingly.

The use of medicinal products called amantadine (for the treatment of Parkinson’s di­sease), ketamine (a substance generally used as an anaesthetic), dextromethorphan (generally used to treat cough) and other NMDA-antagonists at the same time should be avoided.

Children and adolescents

Nemdatine is not recommended for children and adolescents under the age of 18 years.

Other medicines and Nemdatine

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular, Nemdatine may change the effects of the following medicines and their dose may need to be adjusted by your doctor:

• – amantadine, ketamine, dextromethorphan

• – dantrolene, baclofen

• – cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine

• – hydrochlorothiazide (or any combination with hydrochlorothi­azide)

• – anticholinergics (substances generally used to treat movement disorders or intestinal cramps)

• – anticonvulsants (substances used to prevent and relieve seizures)

• – barbiturates (substances generally used to induce sleep)

• – dopaminergic agonists (substances such as L-dopa, bromocriptine)

• – neuroleptics (substances used in the treatment of mental disorders)

• – oral anticoagulants

If you go into hospital, let your doctor know that you are taking Nemdatine.

Nemdatine with food and drink

You should inform your doctor if you have recently changed or intend to change your diet substantially (e.g. from normal diet to strict vegetarian diet) or if you are suffering from states of renal tubulary acidosis (RTA, an excess of acid-forming substances in the blood due to renal dysfunction (poor kidney function)) or severe infections of the urinary tract (structure that carries urine), as your doctor may need to adjust the dose of your medicine.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

The use of memantine in pregnant women is not recommended.

Breast-feeding

Women taking Nemdatine should not breast-feed.

Driving and using machines

Your doctor will tell you whether your illness allows you to drive and to use machines safely. Also, Nemdatine may change your reactivity, making driving or operating machinery inappropriate.

Nemdatine contains lactose monohydrate

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Nemdatine

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

The Nemdatine treatment initiation pack is only to be used for the beginning of the treatment with Nemdatine.

Dosage

The recommended treatment dose of 20 mg per day is achieved by a gradual increase of the Nemdatine dose during the first 3 weeks of treatment. The treatment scheme is also indicated on the treatment initiation pack. Take one tablet once a day.

Week 1 (day 1–7):

Take one 5 mg tablet once a day (white, oval-shaped) for 7 days.

Week 2 (day 8–14):

Take one 10 mg tablet once a day (white, capsule shaped) for 7 days.

Week 3 (day 15–21):

Take one 15 mg tablet once a day (orange, oval shaped) for 7 days.

Week 4 (day 22–28):

Take one 20 mg tablet per day (dark pink, oval shaped) for 7 days.

Week 1	5 mg tablet
Week 2	10 mg tablet
Week 3	15 mg tablet
Week 4 and beyond	20 mg tablets once a day

Maintenance dose

The recommended daily dose is 20 mg once a day.

For continuation of the treatment please consult your doctor.

Dosage in patients with impaired kidney function

If you have impaired kidney function, your doctor will decide upon a dose that suits your condition. In this case, monitoring of your kidney function should be performed by your doctor at specified intervals.

Administration

Nemdatine should be administered orally once a day. To benefit from your medicine you should take it regularly every day at the same time of the day. The tablets should be swallowed with some water.

The tablets can be taken with or without food.

Duration of treatment

Continue to take Nemdatine as long as it is of benefit to you. Your doctor should assess your treatment on a regular basis.

If you take more Nemdatine than you should

• – In general, taking too much Nemdatine should not result in any harm to you. You may experience increased symptoms as described in section 4 ‘Possible side effects’.

• – If you take a large overdose of Nemdatine, contact your doctor or get medical advice, as you may need medical attention.

If you forget to take Nemdatine

• – If you find you have forgotten to take your dose of Nemdatine, wait and take your next dose at the usual time.

• – Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

In general, the observed side effects are mild to moderate.

Common (affects 1 to 10 users in 100)

• – Headache, sleepiness, constipation, elevated liver function test, dizziness, balance disorders, shortness of breath, high blood pressure and drug hypersensitivity

Uncommon (affects 1 to 10 users in 1,000)

• – Tiredness, fungal infections, confusion, hallucinations, vomiting, abnormal gait, heart failure and venous blood clotting (thrombosis/throm­boembolism)

Very Rare (affects less than 1 user in 10,000)

• – Seizures

Not known (frequency cannot be estimated from the available data)

• – Inflammation of the pancreas, inflammation of the liver (hepatitis) and psychotic reactions

Alzheimer’s disease has been associated with depression, suicidal ideation and suicide. These events have been reported in patients treated with memantine.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. Y ou can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Nemdatine

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister after ‘EXP’. The expiry date refers to the last day of that month.

Do not store above 25°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Nemdatine contains

• – The active substance is memantine hydrochloride. Each film-coated tablet contains 5, 10, 15, or 20 mg memantine hydrochloride equivalent to 4.15, 8.31, 12.46 or 16.62 mg memantine.

• – The other ingredients for Nemdatine 5, 10, 15 and 20 mg film-coated tablets are: Tablet core: Microcrystalline cellulose, crospovidone Type A, talc and magnesium stearate. Tablet coat: Hypromellose 6cP, titanium dioxide (E171), lactose monohydrate, macrogol 3350 and triacetin. The 15 mg tablets furthermore contain iron oxide yellow, red and black (E172). The 20 mg tablets furthermore contain iron oxide red and yellow (E172).

What Nemdatine looks like and contents of the pack

Nemdatine 5 mg film-coated tablets (tablets) are white, oval shaped, biconvex, 8 mm x 4.5 mm in size, with the marking “M5” engraved on one side.

Nemdatine 10 mg film-coated tablets (tablets) are white, capsule-shaped, biconvex, 9.8 mm x 4.9 mm in size, with score line and the marking “M 10” engraved on the scored side.

Nemdatine 15 mg film-coated tablets (tablets) are orange, oval shaped, biconvex, 11.4 mm x 6.4 mm in size, with the marking “M15” engraved on one side.

Nemdatine 20 mg film-coated tablets (tablets) are dark pink, oval shaped, biconvex, 12.6 mm x 7 mm in size, with the marking “M20” engraved on one side.

One treatment initiation pack contains 28 tablets in 4 blisters in a wallet pack or a multipack of 4 blisters in 4 separate immediate cartons and one outer carton with 7 tablets of Nemdatine 5 mg, 7 tablets of Nemdatine 10 mg, 7 tablets of Nemdatine 15 mg and 7 tablets of Nemdatine 20 mg.

Marketing Authorisation Holder

Actavis Group PTC ehf.

Reykjavikurvegi 76–78

220 Hafnarfjordur

Iceland

Manufacturer

Actavis Group PTC ehf.

Reykjavikurvegur 76–78

220 Hafnarfjordur

Iceland

Actavis Ltd.

BLB 015–016 Bulebel Industrial Estate

Zejtun ZTN 3000

Malta

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

Belgie/Belgiqu­e/Belgien Actavis Group PTC ehf. IJsland/Islan­de/Island Tél/Tel: +354 5503300	Lietuva UAB Teva Baltics Tel: +370 52660203
Efcnrapua TeBa OapMa EAfl Ten: +359 24899585	Luxembourg/Lu­xemburg Actavis Group PTC ehf. Islande/Island Tel/Tel: +354 5503300
Česká republika Teva Pharmaceuticals CR, s.r.o. Tel: +420 251007111	Magyarorszag Teva Gyogyszergyar Zrt. Tel: +36 12886400
Danmark Teva Denmark A/S Tlf: +45 44985511	Malta Teva Pharmaceuticals Ireland L-Irlanda Tel: +44 2075407117
Deutschland Actavis Group PTC ehf. Island Tel: +354 5503300	Nederland Actavis Group PTC ehf. IJsland Tel: +354 5503300

Eesti UAB Teva Baltics Eesti filiaal Tel: +372 6610801	Norge Teva Norway AS Tlf: +47 66775590
EMáSa Specifar A.B.E.E. Tql: +30 2118805000	Österreich ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1970070
España Actavis Group PTC ehf. Islandia	Polska Teva Pharmaceuticals Polska Sp. z o.o. Tel: +48 223459300

Tel: +354 5503300

France Actavis Group PTC ehf. Islande Tél: +354 5503300	Portugal Actavis Group PTC ehf. Islandia Tel: +354 5503300
Hrvatska Pliva Hrvatska d.o.o. Tel: +385 13720000	Romania Teva Pharmaceuticals S.R.L. Tel: +40 212306524
Ireland Teva Pharmaceuticals Ireland Tel: +44 2075407117	Slovenija Pliva Ljubljana d.o.o. Tel: +386 15890390
Ísland Actavis Group PTC ehf. Sími: +354 5503300	Slovenská republika TEVA Pharmaceuticals Slovakia s.r.o. Tel: +421 257267911
Italia Actavis Group PTC ehf. Islanda	Suomi/Finland Teva Finland Oy Puh/Tel: +358 201805900

Tel: +354 5503300

Kùnpoç Specifar A.B.E.E. EUáSa

Sverige Teva Sweden AB Tel: +46 42121100

Tql: +30 2118805000

Latvija UAB Teva Baltics filiäle Latvijä Tel: +371 67323666

United Kingdom (Northern Ireland) Teva Pharmaceuticals Ireland Ireland Tel: +44 2075407117

This leaflet was last revised in {MM/YYYY}

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site:

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Package leaflet: Information for the patient

Nemdatine 20 mg film-coated tablets memantine hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• – Keep this leaflet. You may need to read it again.

• – If you have any further questions, ask your doctor or pharmacist.

• – This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,

even if their signs of illness are the same as yours.

– If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

• 1. What Nemdatine is and what it is used for

• 2. What you need to know before you take Nemdatine

• 3. How to take Nemdatine

• 4. Possible side effects

• 5. How to store Nemdatine

• 6. Contents of the pack and other information

1. What Nemdatine is and what it is used for

How does Nemdatine work

Nemdatine contains the active substance memantine hydrochloride. Nemdatine belongs to a group of medicines known as anti-dementia medicines.

Memory loss in Alzheimer’s disease is due to a disturbance of message signals in the brain. The brain contains so-called N-methyl-D-aspartate (NMDA)-receptors that are involved in transmitting nerve signals important in learning and memory. Nemdatine belongs to a group of medicines called NMDA-receptor antagonists. Nemdatine acts on these NMDA-receptors improving the transmission of nerve signals and the memory.

What is Nemdatine used for

Nemdatine is used for the treatment of adult patients with moderate to severe Alzheimer’s di­sease.

2. What you need to know before you before you take Nemdatine

Do not take Nemdatine

• – if you are allergic to memantine hydrochloride or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before taking Nemdatine

• – if you have a history of epileptic seizures

• – if you have recently experienced a myocardial infarction (heart attack), or if you are suffering from congestive heart failure or from an uncontrolled hypertension (high blood pressure).

In these situations the treatment should be carefully supervised, and the clinical benefit of Nemdatine reassessed by your doctor on a regular basis.

If you suffer from renal impairment (kidney problems), your doctor should closely monitor your kidney function and if necessary adapt the memantine doses accordingly.

The use of medicinal products called amantadine (for the treatment of Parkinson’s di­sease), ketamine (a substance generally used as an anaesthetic), dextromethorphan (generally used to treat cough) and other NMDA-antagonists at the same time should be avoided.

Children and adolescents

Nemdatine is not recommended for children and adolescents under the age of 18 years.

Other medicines and Nemdatine

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular, Nemdatine may change the effects of the following medicines and their dose may need to be adjusted by your doctor:

• – amantadine, ketamine, dextromethorphan

• – dantrolene, baclofen

• – cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine

• – hydrochlorothiazide (or any combination with hydrochlorothi­azide)

• – anticholinergics (substances generally used to treat movement disorders or intestinal cramps)

• – anticonvulsants (substances used to prevent and relieve seizures)

• – barbiturates (substances generally used to induce sleep)

• – dopaminergic agonists (substances such as L-dopa, bromocriptine)

• – neuroleptics (substances used in the treatment of mental disorders)

• – oral anticoagulants

If you go into hospital, let your doctor know that you are taking Nemdatine.

Nemdatine with food and drink

You should inform your doctor if you have recently changed or intend to change your diet substantially (e.g. from normal diet to strict vegetarian diet) or if you are suffering from states of renal tubulary acidosis (RTA, an excess of acid-forming substances in the blood due to renal dysfunction (poor kidney function)) or severe infections of the urinary tract (structure that carries urine), as your doctor may need to adjust the dose of your medicine.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

The use of memantine in pregnant women is not recommended.

Breast-feeding

Women taking Nemdatine should not breast-feed.

Driving and using machines

Your doctor will tell you whether your illness allows you to drive and to use machines safely. Also, Nemdatine may change your reactivity, making driving or operating machinery inappropriate.

Nemdatine contains lactose monohydrate

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take Nemdatine

Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

Dosage

The recommended dose of Nemdatine for adults and older people is 20 mg once a day.

In order to reduce the risk of side effects this dose is achieved gradually by the following daily treatment scheme. For up-titration other tablet strengths are available.

At the beginning of treatment you will start by using Nemdatine 5 mg film-coated tablets once a day. This dose will be increased weekly by 5 mg until the recommended (maintenance) dose is reached. The recommended maintenance dose is 20 mg once a day, which is reached at the beginning of the 4th week.

Dosage in patients with impaired kidney function

If you have impaired kidney function, your doctor will decide upon a dose that suits your condition. In this case, monitoring of your kidney function should be performed by your doctor at specified intervals.

Administration

Nemdatine should be administered orally once a day. To benefit from your medicine you should take it regularly every day at the same time of the day. The tablets should be swallowed with some water.

The tablets can be taken with or without food.

Duration of treatment

Continue to take Nemdatine as long as it is of benefit to you. Your doctor should assess your treatment on a regular basis.

If you take more Nemdatine than you should

• – In general, taking too much Nemdatine should not result in any harm to you. You may experience increased symptoms as described in section 4 ‘Possible side effects’.

• – If you take a large overdose of Nemdatine, contact your doctor or get medical advice, as you may need medical attention.

If you forget to take Nemdatine

• – If you find you have forgotten to take your dose of Nemdatine, wait and take your next dose at the usual time.

• – Do not take a double dose to make up for a forgotten dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

In general, the observed side effects are mild to moderate.

Common (affects 1 to 10 users in 100)

• – Headache, sleepiness, constipation, elevated liver function test, dizziness, balance disorders, shortness of breath, high blood pressure and drug hypersensitivity

Uncommon (affects 1 to 10 users in 1,000)

• – Tiredness, fungal infections, confusion, hallucinations, vomiting, abnormal gait, heart failure and venous blood clotting (thrombosis/throm­boembolism)

Very Rare (affects less than 1 user in 10,000)

• – Seizures

Not known (frequency cannot be estimated from the available data)

• – Inflammation of the pancreas, inflammation of the liver (hepatitis) and psychotic reactions

Alzheimer’s disease has been associated with depression, suicidal ideation and suicide. These events have been reported in patients treated with memantine.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Nemdatine

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton, blister and bottle label after ‘EXP’. The expiry date refers to the last day of that month.

Do not store above 25°C.

<[For HDPE bottle only:]>

Use within 100 days after opening.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Nemdatine contains

• – The active substance is memantine hydrochloride. Each film-coated tablet contains 20 mg memantine hydrochloride equivalent to 16.62 mg memantine.

• – The other ingredients are: Tablet core: Microcrystalline cellulose, crospovidone Type A, talc and magnesium stearate. Tablet coat (Opadry II Pink 33G240000): Hypromellose 6cP, titanium dioxide (E171), lactose monohydrate, macrogol 3350, triacetin and iron oxide red and yellow (E172).