Memantine hydrochloride 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 Memantine Tablets are and what are they used for

• 2. What you need to know before you take Memantine Tablets

• 3. How to take Memantine Tablets

• 4. Possible side effects

• 5. How to store Memantine Tablets

• 6. Contents of the pack and other information

1. what memantine tablets is and what it is used for

Memantine Tablets contains the active substance memantine hydrochloride. It 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. Memantine Tablets belongs to a group of medicines called NMDA-receptor antagonists. Memantine Tablets acts on these NMDA-receptors improving the transmission of nerve signals and the memory.

Memantine Tablets is used for the treatment of patients with moderate to severe Alzheimer's di­sease.

2. what you need to know before you

__ TAKE MEMANTINE TABLETS llllllllllllll Do not take Memantine Tablets – if you are allergic (hypersensitive) to memantine or any of the other ingredients of Memantine film-coated tablets (see section 6).

Warning and precautions

Talk to your doctor or pharmacist T /

before taking Memantine Tablets

• – 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 Memantine Tablets 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.

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), your doctor may need to adjust the dose of your medicine.

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

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

Other medicines and Memantine Tablets

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

In particular, Memantine Tablets 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, * S

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 Memantine Tablets.

Memantine Tablets 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) 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 any medicine.

Pregnancy

The use of memantine in pregnant women is not recommended.

Breast-feeding

Women taking Memantine Tablets 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, Memantine Tablets may change your reactivity, making driving or operating machinery inappropriate.

3. how to take memantine tablets

Always take Memantine Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The recommended dose of Memantine Tablets for adults and elderly patients 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 Memantine Tablets 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

Memantine Tablets 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 Memantine Tablets as long as it is of benefit to you. Your doctor should assess your treatment on a regular basis.

If you take more Memantine Tablets than you should

• – In general, taking too much Memantine Tablets 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 Memantine Tablets, contact your doctor or get medical advice, as you may need medical attention.

If you forget to take Memantine Tablets

• – If you find you have forgotten to take your dose of Memantine Tablets, 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 product, ask your doctor or pharmacist.

4. possible side effects

Like all medicines, Memantine Tablets can cause side effects, although not everybody gets them.

In general, the observed side effects are mild to moderate. Common: (affect 1to 110 users in 100)

Illi I LlHttl Headache, sleepiness, constipation, elevated liver

IwiilTI 111111 function tests, dizziness, balance disorders, shortness of

breath, high blood pressure and drug hypersensitivity

Uncommon: ( affect 1to 10 user in 1000)

Tiredness, fungal infections, confusion, hallucinations, vomiting, abnormal gait, heart failure and venous blood

clotting

(thrombosis/throm­boembolism)

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

* Seizures

Not known: frequency cannot be estimatedfrom 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 Tablets.

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 Yellow Card Scheme at:. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store memantine tablets

Keep this medicine out of the sight and reach of children

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

This medicinal product does not require any special storage conditions.

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

6. contents of the pack and other information

What Memantine Tablets 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 Silicified microcrystalline cellulose, Croscarmellose Sodium, Talc and Magnesium stearate, all in the tablet core; and Hypromellose (E464), Titanium dioxide (E171) and Macrogol 400, Iron oxide red (E172) and Iron oxide yellow (E172) all in the tablet coating.

What Memantine Tablets looks like and contents of the pack

Memantine hydrochloride 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 Memantine Tablets are and what are they used for

• 2. What you need to know before you take Memantine Tablets

• 3. How to take Memantine Tablets

• 4. Possible side effects

• 5. How to store Memantine Tablets

• 6. Contents of the pack and other information

1. what memantine tablets is and what it is used for

Memantine Tablets contains the active substance memantine hydrochloride. It 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. Memantine Tablets belongs to a group of medicines called NMDA-receptor antagonists. Memantine Tablets acts on these NMDA-receptors improving the transmission of nerve signals and the memory.

Memantine Tablets is used for the treatment of patients with moderate to severe Alzheimer's di­sease.

2. what you need to know before you

__ TAKE MEMANTINE TABLETS llllllllllllll Do not take Memantine Tablets – if you are allergic (hypersensitive) to memantine or any of the other ingredients of Memantine film-coated tablets (see section 6).

Warning and precautions

Talk to your doctor or pharmacist T /

before taking Memantine Tablets

• – 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 Memantine Tablets 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.

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), your doctor may need to adjust the dose of your medicine.

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

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

Other medicines and Memantine Tablets

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

In particular, Memantine Tablets 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, * S

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 Memantine Tablets.

Memantine Tablets 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) 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 any medicine.

Pregnancy

The use of memantine in pregnant women is not recommended.

Breast-feeding

Women taking Memantine Tablets 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, Memantine Tablets may change your reactivity, making driving or operating machinery inappropriate.

3. how to take memantine tablets

Always take Memantine Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The recommended dose of Memantine Tablets for adults and elderly patients 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 Memantine Tablets 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

Memantine Tablets 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 Memantine Tablets as long as it is of benefit to you. Your doctor should assess your treatment on a regular basis.

If you take more Memantine Tablets than you should

• – In general, taking too much Memantine Tablets 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 Memantine Tablets, contact your doctor or get medical advice, as you may need medical attention.

If you forget to take Memantine Tablets

• – If you find you have forgotten to take your dose of Memantine Tablets, 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 product, ask your doctor or pharmacist.

4. possible side effects

Like all medicines, Memantine Tablets can cause side effects, although not everybody gets them.

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

Common: (affect 1to 110 users in 100)

Illi I LlHttl Headache, sleepiness, constipation, elevated liver

IwiilTI 111111 function tests, dizziness, balance disorders, shortness of breath, high blood pressure and drug hypersensitivity

Uncommon: ( affect 1to 10 user in 1000)

Tiredness, fungal infections, confusion, hallucinations, vomiting, abnormal gait, heart failure and venous blood

clotting

(thrombosis/throm­boembolism)

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

* Seizures

Not known: frequency cannot be estimatedfrom the available data

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

5. how to store memantine tablets

Keep this medicine out of the sight and reach of children

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

This medicinal product does not require any special storage conditions.

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

6. contents of the pack and other information

What Memantine Tablets 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 Silicified microcrystalline cellulose, Croscarmellose Sodium, Talc and Magnesium stearate, all in the tablet core; and Hypromellose (E464), Titanium dioxide (E171) and Macrogol 400, Iron oxide red (E172) and Iron oxide yellow (E172) all in the tablet coating.

What Memantine Tablets looks like and contents of the pack

Memantine Tablets are available in blister packs of 28 tablets, 56 tablets, 98 tablets and 112 tablets.

Not all pack sizes may be marketed.

filACLEODb

lllllllllllll­lllllllllllllll

Marketing Authorisation Holder and Manufacturer

Macleods Pharma UK Limited

Wynyard Park House,

Wynyard Avenue,

Wynyard, Billingham,

TS22 5TB,

United Kingdom

This medicinal product is authorized in the member states of the EEA under the following names:

Germany: Memantin hydrochlorid Macleods 20 mg filmtabletten

Spain: Memantina clorhidrato Macleods 20 mg comprimidos

recubiertos con peHcula

United Kingdom: Memantine hydrochloride 20 mg film-coated tablets

This leaflet was last revised in {07/2020}.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Memantine hydrochloride 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 Memantine Tablets are and what are they used for

• 2. What you need to know before you take Memantine Tablets

• 3. How to take Memantine Tablets

• 4. Possible side effects

• 5. How to store Memantine Tablets

• 6. Contents of the pack and other information

1. what memantine tablets is and what it is used for

Memantine Tablets contains the active substance memantine hydrochloride. It 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. Memantine Tablets belongs to a group of medicines called NMDA-receptor antagonists. Memantine Tablets acts on these NMDA-receptors improving the transmission of nerve signals and the memory.

Memantine Tablets is used for the treatment of patients with moderate to severe Alzheimer's di­sease.

2. what you need to know before you

__ TAKE MEMANTINE TABLETS llllllllllllll Do not take Memantine Tablets – if you are allergic (hypersensitive) to memantine or any of the other ingredients of Memantine film-coated tablets (see section 6).

Warning and precautions

Talk to your doctor or pharmacist T /

before taking Memantine Tablets

• – 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 Memantine Tablets 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.

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), your doctor may need to adjust the dose of your medicine.

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

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

Other medicines and Memantine Tablets

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

In particular, Memantine Tablets 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, * S

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 Memantine Tablets.

Memantine Tablets 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) 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 any medicine.

Pregnancy

The use of memantine in pregnant women is not recommended.

Breast-feeding

Women taking Memantine Tablets 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, Memantine Tablets may change your reactivity, making driving or operating machinery inappropriate.

3. how to take memantine tablets

Always take Memantine Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

The recommended dose of Memantine Tablets for adults and elderly patients 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 Memantine Tablets 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

Memantine Tablets 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 Memantine Tablets as long as it is of benefit to you. Your doctor should assess your treatment on a regular basis.

If you take more Memantine Tablets than you should

• – In general, taking too much Memantine Tablets 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 Memantine Tablets, contact your doctor or get medical advice, as you may need medical attention.

If you forget to take Memantine Tablets

• – If you find you have forgotten to take your dose of Memantine Tablets, 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 product, ask your doctor or pharmacist.

4. possible side effects

Like all medicines, Memantine Tablets can cause side effects, although not everybody gets them.

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

Common: (affect 1to 110 users in 100)

Illi I LlHttl Headache, sleepiness, constipation, elevated liver

IwiilTI 111111 function tests, dizziness, balance disorders, shortness of breath, high blood pressure and drug hypersensitivity

Uncommon: ( affect 1to 10 user in 1000)

Tiredness, fungal infections, confusion, hallucinations, vomiting, abnormal gait, heart failure and venous blood

clotting

(thrombosis/throm­boembolism)

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

* Seizures

Not known: frequency cannot be estimatedfrom the available data

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