Patient leaflet - Memantine ratiopharm
B. PACKAGE LEAFLET
Package leaflet: Information for the patient
Memantine ratiopharm 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 Memantine ratiopharm is and what it is used for
-
2. What you need to know before you take Memantine ratiopharm
-
3. How to take Memantine ratiopharm
-
4. Possible side effects
-
5. How to store Memantine ratiopharm
-
6. Contents of the pack and other information
1. What Memantine ratiopharm is and what it is used for
How does Memantine ratiopharm work
Memantine ratiopharm 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 ratiopharm belongs to a group of medicines called NMDA-receptor antagonists. Memantine ratiopharm acts on these NMDA-receptors improving the transmission of nerve signals and the memory.
What is Memantine ratiopharm used for
Memantine ratiopharm is used for the treatment of patients with moderate to severe Alzheimer’s disease.
2. What you need to know before you take Memantine ratiopharm
Do not take Memantine ratiopharm
- if you are allergic to memantine hydrochloride, peanut or soya or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Memantine ratiopharm
- 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 ratiopharm 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
Memantine ratiopharm is not recommended for children and adolescents under the age of 18 years.
Other medicines and Memantine ratiopharm
Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicines.
In particular, Memantine ratiopharm 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 Memantine ratiopharm.
Memantine ratiopharm 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.
The use of memantine in pregnant women is not recommended.
Women taking Memantine ratiopharm 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 ratiopharm may change your reactivity, making driving or operating machinery inappropriate.
Memantine ratiopharm contains lactose and soya lecithin
This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
This medicine contains soya lecithin. If you are allergic to peanut or soya, do not take this medicinal product.
3. How to take Memantine ratiopharm
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 Memantine ratiopharm for adults and older 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:
| 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 one and a half tablets once a day in the third week. From the fourth week on, the usual dose is two tablets once a day (1× 20 mg).
The tablet can be divided into equal doses.
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 ratiopharm 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 ratiopharm as long as it is of benefit to you. Your doctor should assess your treatment on a regular basis.
If you take more Memantine ratiopharm than you should
- In general, taking too much Memantine ratiopharm 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 ratiopharm, contact your doctor or get medical advice, as you may need medical attention.
If you forget to take Memantine ratiopharm
- If you find you have forgotten to take your dose of Memantine ratiopharm, 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 tests, 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 or pharmacist. 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 By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Memantine ratiopharm
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 the blister pack after EXP. The expiry date refers to the last day of that month.
Blister packs
Do not store above 25 °C.
HDPE bottles
This medicinal product does not require any special storage conditions.
Shelf life after first opening of the container: 6 months
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 Memantine ratiopharm 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
Cellulose microcrystalline (E 460), starch pregelatinised (E 1404), lactose, colloidal anhydrous silica (E 551), magnesium stearate (E 470b).
Coating
Polysorbate 80 (E 433), polyvinyl alcohol (E 1203), titanium dioxide (E 171), talc (E 553b), soya lecithin (E 322), xanthan gum (E 415).
What Memantine ratiopharm looks like and contents of the pack
White to off-white, capsule shaped, biconvex tablets with a break score on one side and debossed with “10” on the other side.
Memantine ratiopharm is available in packs of 10, 14, 21, 28, 30, 42, 50, 56, 98, 100 and 112 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
ratiopharm GmbH
Graf-Arco-Straße 3
89079 Ulm
Germany
Manufacturer
Merckle GmbH
Ludwig-Merckle-Straße 3
89143 Blaubeuren
Germany
TEVA Pharmaceutical Works Private Limited Company
Pallagi ut 13, 4042 Debrecen
Hungary
HBM Pharma s.r.o.
Slabinska 30, 03680 Martin
Slovakia
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
| Belgie/Belgique/Belgien Teva Pharma Belgium N.V./S.A./AG Tél/Tel: +32 38207373 | Lietuva UAB Teva Baltics Tel: +370 52660203 |
| Efc^rapufl TeBa OapMa EAfl Tea: +359 24899585 | Luxembourg/Luxemburg ratiopharm GmbH Allemagne/Deutschland Tel/Tel: +49 73140202 |
| 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 ratiopharm GmbH Tel: +49 73140202 | Nederland Teva Nederland B.V. Tel: +31 8000228400 |
| Eesti UAB Teva Baltics Eesti filiaal Tel: +372 6610801 | Norge Teva Norway AS Tlf: +47 66775590 |
| EXXáSa Specifar A.B.E.E. Tql: +30 2118805000 | Österreich ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1970070 |
| España ratiopharm España, S.A. Tel: +34 915672970 | Polska Teva Pharmaceuticals Polska Sp. z o.o. Tel: +48 223459300 |
| France Teva Santé Tél: +33 155917800 | Portugal ratiopharm – Comércio e Indústria de Produtos Farmacêuticos, Lda. Tel: +351 214767550 |
| Hrvatska Pliva Hrvatska d.o.o. Tel: +385 13720000 | România 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 Alvogen ehf. Sími: +354 5222900 | Slovenská republika TEVA Pharmaceuticals Slovakia s.r.o. Tel: +421 257267911 |
| Italia Teva Italia S.r.l. Tel: +39 028917981 | Suomi/Finland Teva Finland Oy Puh/Tel: +358 201805900 |
| Kúnpog Specifar A.B.E.E. EUáSa | Sverige Teva Sweden AB Tel: +46 42121100 |
Tql: +30 2118805000
| Latvija UAB Teva Baltics filiale Latvijä Tel: +371 67323666 | United Kingdom (Northern Ireland) Teva Pharmaceuticals Ireland Ireland Tel: +44 2075407117 |
This leaflet was last revised in
Detailed information on this medicine is available on the European Medicines Agency web site:
Package leaflet: Information for the patient
Memantine ratiopharm 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 ratiopharm is and what it is used for
-
2. What you need to know before you take Memantine ratiopharm
-
3. How to take Memantine ratiopharm
-
4. Possible side effects
-
5. How to store Memantine ratiopharm
-
6. Contents of the pack and other information
1. What Memantine ratiopharm is and what it is used for
How does Memantine ratiopharm work
Memantine ratiopharm 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 ratiopharm belongs to a group of medicines called NMDA-receptor antagonists. Memantine ratiopharm acts on these NMDA-receptors improving the transmission of nerve signals and the memory.
What is Memantine ratiopharm used for
Memantine ratiopharm is used for the treatment of patients with moderate to severe Alzheimer’s disease.
2. What you need to know before you take Memantine ratiopharm
Do not take Memantine ratiopharm
- if you are allergic to memantine hydrochloride, peanut or soya or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Memantine ratiopharm
- 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 ratiopharm 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
Memantine ratiopharm is not recommended for children and adolescents under the age of 18 years.
Other medicines and Memantine ratiopharm
Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicines.
In particular, Memantine ratiopharm 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 Memantine ratiopharm.
Memantine ratiopharm 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.
The use of memantine in pregnant women is not recommended.
Women taking Memantine ratiopharm 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 ratiopharm may change your reactivity, making driving or operating machinery inappropriate.
Memantine ratiopharm contains lactose and soya lecithin
This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
This medicine contains soya lecithin. If you are allergic to peanut or soya, do not take this medicinal product.
3. How to take Memantine ratiopharm
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 Memantine ratiopharm for adults and older 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 5 mg 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.
The tablet can be divided into equal doses.
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 ratiopharm 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 ratiopharm as long as it is of benefit to you. Your doctor should assess your treatment on a regular basis.
If you take more Memantine ratiopharm than you should
- In general, taking too much Memantine ratiopharm 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 ratiopharm, contact your doctor or get medical advice, as you may need medical attention.
If you forget to take Memantine ratiopharm
- If you find you have forgotten to take your dose of Memantine ratiopharm, 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 tests, 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 or pharmacist. 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 By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Memantine ratiopharm
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 the blister pack after EXP. The expiry date refers to the last day of that month.
Blister packs
Do not store above 25 °C.
HDPE bottles
This medicinal product does not require any special storage conditions.
Shelf life after first opening of the container: 6 months
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 Memantine ratiopharm 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
Cellulose microcrystalline (E 460), starch pregelatinised (E 1404), lactose, colloidal anhydrous
silica (E 551), magnesium stearate (E 470b).
Coating
Polysorbate 80 (E 433), polyvinyl alcohol (E 1203), titanium dioxide (E 171), talc (E 553b), soya lecithin (E 322), xanthan gum (E 415).
What Memantine ratiopharm looks like and contents of the pack
White to off-white, capsule shaped, biconvex tablets with a break score on one side and debossed with “20” on the other side.
Memantine ratiopharm is available in packs of 10, 14, 21, 28, 30, 42, 56, 98 and 100 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
ratiopharm GmbH
Graf-Arco-Straße 3
89079 Ulm
Germany
Manufacturer
Merckle GmbH
Ludwig-Merckle-Straße 3
89143 Blaubeuren
Germany
TEVA Pharmaceutical Works Private Limited Company
Pallagi ut 13, 4042 Debrecen
Hungary
HBM Pharma s.r.o.
Slabinska 30, 03680 Martin
Slovakia
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
| Belgie/Belgique/Belgien Teva Pharma Belgium N.V./S.A./AG Tél/Tel: +32 38207373 Et^rapuu TeBa OapMa EAfl Tea: +359 24899585 Česká republika Teva Pharmaceuticals CR, s.r.o. Tel: +420 251007111 Danmark Teva Denmark A/S Tlf: +45 44985511 Deutschland ratiopharm GmbH Tel: +49 73140202 Eesti UAB Teva Baltics Eesti filiaal Tel: +372 6610801 EZZaöa Specifar A.B.E.E. Tql: +30 2118805000 | Lietuva UAB Teva Baltics Tel: +370 52660203 Luxembourg/Luxemburg ratiopharm GmbH Allemagne/Deutschland Tel/Tel: +49 73140202 Magyarorszag Teva Gyogyszergyar Zrt. Tel: +36 12886400 Malta Teva Pharmaceuticals Ireland L-Irlanda Tel: +44 2075407117 Nederland Teva Nederland B.V. Tel: +31 8000228400 Norge Teva Norway AS Tlf: +47 66775590 Österreich ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1970070 |
| España ratiopharm España, S.A. Tel: +34 915672970 | Polska Teva Pharmaceuticals Polska Sp. z o.o. Tel: +48 223459300 |
| France Teva Santé Tél: +33 155917800 | Portugal ratiopharm – Comércio e Indústria de Produtos Farmaceuticos, Lda. Tel: +351 214767550 |
| 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 Alvogen ehf. Sími: +354 5222900 | Slovenská republika TEVA Pharmaceuticals Slovakia s.r.o. Tel: +421 257267911 |
| Italia Teva Italia S.r.l. Tel: +39 028917981 | Suomi/Finland Teva Finland Oy Puh/Tel: +358 201805900 |
| 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
Detailed information on this medicine is available on the European Medicines Agency web site:
Package leaflet: Information for the patient
Memantine ratiopharm 5 mg film-coated tablets
Memantine ratiopharm 10 mg film-coated tablets
Memantine ratiopharm 15 mg film-coated tablets
Memantine ratiopharm 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 ratiopharm is and what it is used for
-
2. What you need to know before you take Memantine ratiopharm
-
3. How to take Memantine ratiopharm
-
4. Possible side effects
-
5. How to store Memantine ratiopharm
-
6. Contents of the pack and other information
1. What Memantine ratiopharm is and what it is used for
How does Memantine ratiopharm work
Memantine ratiopharm 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 ratiopharm belongs to a group of medicines called NMDA-receptor antagonists. Memantine ratiopharm acts on these NMDA-receptors improving the transmission of nerve signals and the memory.
What is Memantine ratiopharm used for
Memantine ratiopharm is used for the treatment of patients with moderate to severe Alzheimer’s disease.
2. What you need to know before you take Memantine ratiopharm
Do not take Memantine ratiopharm
- if you are allergic to memantine hydrochloride, peanut or soya or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Memantine ratiopharm
- 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 ratiopharm 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
Memantine ratiopharm is not recommended for children and adolescents under the age of 18 years.
Other medicines and Memantine ratiopharm
Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicines.
In particular, Memantine ratiopharm 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 Memantine ratiopharm.
Memantine ratiopharm 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.
The use of memantine in pregnant women is not recommended.
Women taking Memantine ratiopharm 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 ratiopharm may change your reactivity, making driving or operating machinery inappropriate.
Memantine ratiopharm contains lactose and soya lecithin
This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
This medicine contains soya lecithin. If you are allergic to peanut or soya, do not take this medicinal product.
3. How to take Memantine ratiopharm
The Memantine ratiopharm treatment initiation pack is only to be used for the beginning of the treatment with Memantine ratiopharm.
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 treatment dose of 20 mg per day is achieved by a gradual increase of the
Memantine ratiopharm dose during the first 3 weeks of treatment. Take one tablet once a day.
Week 1 (day 1–7):
Take one 5 mg tablet once a day (white to off-white, capsule shaped, biconvex, plain on one side and debossed with “5” on the other side) for 7 days.
Week 2 (day 8–14):
Take one 10 mg tablet once a day (white to off-white, capsule shaped, biconvex, with a break score on one side and debossed with “10” on the other side) for 7 days.
Week 3 (day 15–21):
Take one 15 mg tablet once a day (white to off-white, capsule shaped, biconvex, plain on one side and debossed with “15” on the other side) for 7 days.
Week 4 (day 22–28):
Take one 20 mg tablet once day (white to off-white, capsule shaped, biconvex, with a break score on one side and debossed with “20” on the other side) 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
Memantine ratiopharm 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 ratiopharm as long as it is of benefit to you. Your doctor should assess your treatment on a regular basis.
If you take more Memantine ratiopharm than you should
- In general, taking too much Memantine ratiopharm 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 ratiopharm, contact your doctor or get medical advice, as you may need medical attention.
If you forget to take Memantine ratiopharm
- If you find you have forgotten to take your dose of Memantine ratiopharm, 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 tests, 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 or pharmacist. 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 By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Memantine ratiopharm
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 the blister pack 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 Memantine ratiopharm contains
-
– The active substance is memantine hydrochloride.
Each film-coated tablet contains 5 mg memantine hydrochloride equivalent to 4.15 mg memantine.
Each film-coated tablet contains 10 mg memantine hydrochloride equivalent to 8.31 mg memantine.
Each film-coated tablet contains 15 mg memantine hydrochloride equivalent to 12.46 mg memantine.
Each film-coated tablet contains 20 mg memantine hydrochloride equivalent to 16.62 mg memantine.
-
– The other ingredients are:
What Memantine ratiopharm looks like and contents of the pack
White to off-white, capsule shaped, biconvex tablets with a break score on one side and debossed with “10” on the other side.
Memantine ratiopharm is available in packs of 10, 14, 21, 28, 30, 42, 50, 56, 98, 100 and 112 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
ratiopharm GmbH
Graf-Arco-Straße 3
89079 Ulm
Germany
Manufacturer
Merckle GmbH
Ludwig-Merckle-Straße 3
89143 Blaubeuren
Germany
TEVA Pharmaceutical Works Private Limited Company
Pallagi ut 13, 4042 Debrecen
Hungary
HBM Pharma s.r.o.
Slabinska 30, 03680 Martin
Slovakia
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
| Belgie/Belgique/Belgien Teva Pharma Belgium N.V./S.A./AG Tél/Tel: +32 38207373 | Lietuva UAB Teva Baltics Tel: +370 52660203 |
| Efc^rapufl TeBa OapMa EAfl Tea: +359 24899585 | Luxembourg/Luxemburg ratiopharm GmbH Allemagne/Deutschland Tel/Tel: +49 73140202 |
| 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 ratiopharm GmbH Tel: +49 73140202 | Nederland Teva Nederland B.V. Tel: +31 8000228400 |
| Eesti UAB Teva Baltics Eesti filiaal Tel: +372 6610801 | Norge Teva Norway AS Tlf: +47 66775590 |
| EXXáSa Specifar A.B.E.E. Tql: +30 2118805000 | Österreich ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1970070 |
| España ratiopharm España, S.A. Tel: +34 915672970 | Polska Teva Pharmaceuticals Polska Sp. z o.o. Tel: +48 223459300 |
| France Teva Santé Tél: +33 155917800 | Portugal ratiopharm – Comércio e Indústria de Produtos Farmacêuticos, Lda. Tel: +351 214767550 |
| Hrvatska Pliva Hrvatska d.o.o. Tel: +385 13720000 | România 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 Alvogen ehf. Sími: +354 5222900 | Slovenská republika TEVA Pharmaceuticals Slovakia s.r.o. Tel: +421 257267911 |
| Italia Teva Italia S.r.l. Tel: +39 028917981 | Suomi/Finland Teva Finland Oy Puh/Tel: +358 201805900 |
| Kúnpog Specifar A.B.E.E. EUáSa | Sverige Teva Sweden AB Tel: +46 42121100 |
Tql: +30 2118805000
| Latvija UAB Teva Baltics filiale Latvijä Tel: +371 67323666 | United Kingdom (Northern Ireland) Teva Pharmaceuticals Ireland Ireland Tel: +44 2075407117 |
This leaflet was last revised in
Detailed information on this medicine is available on the European Medicines Agency web site:
Package leaflet: Information for the patient
Memantine ratiopharm 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 ratiopharm is and what it is used for
-
2. What you need to know before you take Memantine ratiopharm
-
3. How to take Memantine ratiopharm
-
4. Possible side effects
-
5. How to store Memantine ratiopharm
-
6. Contents of the pack and other information
1. What Memantine ratiopharm is and what it is used for
How does Memantine ratiopharm work
Memantine ratiopharm 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 ratiopharm belongs to a group of medicines called NMDA-receptor antagonists. Memantine ratiopharm acts on these NMDA-receptors improving the transmission of nerve signals and the memory.
What is Memantine ratiopharm used for
Memantine ratiopharm is used for the treatment of patients with moderate to severe Alzheimer’s disease.
2. What you need to know before you take Memantine ratiopharm
Do not take Memantine ratiopharm
- if you are allergic to memantine hydrochloride, peanut or soya or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Memantine ratiopharm
- 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 ratiopharm 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
Memantine ratiopharm is not recommended for children and adolescents under the age of 18 years.
Other medicines and Memantine ratiopharm
Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicines.
In particular, Memantine ratiopharm 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 Memantine ratiopharm.
Memantine ratiopharm 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.
The use of memantine in pregnant women is not recommended.
Women taking Memantine ratiopharm 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 ratiopharm may change your reactivity, making driving or operating machinery inappropriate.
Memantine ratiopharm contains lactose and soya lecithin
This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
This medicine contains soya lecithin. If you are allergic to peanut or soya, do not take this medicinal product.
3. How to take Memantine ratiopharm
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 Memantine ratiopharm for adults and older 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 5 mg 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.
The tablet can be divided into equal doses.
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 ratiopharm 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 ratiopharm as long as it is of benefit to you. Your doctor should assess your treatment on a regular basis.
If you take more Memantine ratiopharm than you should
- In general, taking too much Memantine ratiopharm 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 ratiopharm, contact your doctor or get medical advice, as you may need medical attention.
If you forget to take Memantine ratiopharm
- If you find you have forgotten to take your dose of Memantine ratiopharm, 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 tests, 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 or pharmacist. 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 By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Memantine ratiopharm
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 the blister pack after EXP. The expiry date refers to the last day of that month.
Blister packs
Do not store above 25 °C.
HDPE bottles
This medicinal product does not require any special storage conditions.
Shelf life after first opening of the container: 6 months
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 Memantine ratiopharm 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
Cellulose microcrystalline (E 460), starch pregelatinised (E 1404), lactose, colloidal anhydrous
silica (E 551), magnesium stearate (E 470b).
Coating
Polysorbate 80 (E 433), polyvinyl alcohol (E 1203), titanium dioxide (E 171), talc (E 553b), soya lecithin (E 322), xanthan gum (E 415).
What Memantine ratiopharm looks like and contents of the pack
White to off-white, capsule shaped, biconvex tablets with a break score on one side and debossed with “20” on the other side.
Memantine ratiopharm is available in packs of 10, 14, 21, 28, 30, 42, 56, 98 and 100 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
ratiopharm GmbH
Graf-Arco-Straße 3
89079 Ulm
Germany
Manufacturer
Merckle GmbH
Ludwig-Merckle-Straße 3
89143 Blaubeuren
Germany
TEVA Pharmaceutical Works Private Limited Company
Pallagi ut 13, 4042 Debrecen
Hungary
HBM Pharma s.r.o.
Slabinska 30, 03680 Martin
Slovakia
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
| Belgie/Belgique/Belgien Teva Pharma Belgium N.V./S.A./AG Tél/Tel: +32 38207373 Et^rapuu TeBa OapMa EAfl Tea: +359 24899585 Česká republika Teva Pharmaceuticals CR, s.r.o. Tel: +420 251007111 Danmark Teva Denmark A/S Tlf: +45 44985511 Deutschland ratiopharm GmbH Tel: +49 73140202 Eesti UAB Teva Baltics Eesti filiaal Tel: +372 6610801 EZZaöa Specifar A.B.E.E. Tql: +30 2118805000 | Lietuva UAB Teva Baltics Tel: +370 52660203 Luxembourg/Luxemburg ratiopharm GmbH Allemagne/Deutschland Tel/Tel: +49 73140202 Magyarorszag Teva Gyogyszergyar Zrt. Tel: +36 12886400 Malta Teva Pharmaceuticals Ireland L-Irlanda Tel: +44 2075407117 Nederland Teva Nederland B.V. Tel: +31 8000228400 Norge Teva Norway AS Tlf: +47 66775590 Österreich ratiopharm Arzneimittel Vertriebs-GmbH Tel: +43 1970070 |
| España ratiopharm España, S.A. Tel: +34 915672970 | Polska Teva Pharmaceuticals Polska Sp. z o.o. Tel: +48 223459300 |
| France Teva Santé Tél: +33 155917800 | Portugal ratiopharm – Comércio e Indústria de Produtos Farmaceuticos, Lda. Tel: +351 214767550 |
| 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 Alvogen ehf. Sími: +354 5222900 | Slovenská republika TEVA Pharmaceuticals Slovakia s.r.o. Tel: +421 257267911 |
| Italia Teva Italia S.r.l. Tel: +39 028917981 | Suomi/Finland Teva Finland Oy Puh/Tel: +358 201805900 |
| 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
Detailed information on this medicine is available on the European Medicines Agency web site:
Package leaflet: Information for the patient
Memantine ratiopharm 5 mg film-coated tablets
Memantine ratiopharm 10 mg film-coated tablets
Memantine ratiopharm 15 mg film-coated tablets
Memantine ratiopharm 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 ratiopharm is and what it is used for
-
2. What you need to know before you take Memantine ratiopharm
-
3. How to take Memantine ratiopharm
-
4. Possible side effects
-
5. How to store Memantine ratiopharm
-
6. Contents of the pack and other information
1. What Memantine ratiopharm is and what it is used for
How does Memantine ratiopharm work
Memantine ratiopharm 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 ratiopharm belongs to a group of medicines called NMDA-receptor antagonists. Memantine ratiopharm acts on these NMDA-receptors improving the transmission of nerve signals and the memory.
What is Memantine ratiopharm used for
Memantine ratiopharm is used for the treatment of patients with moderate to severe Alzheimer’s disease.
2. What you need to know before you take Memantine ratiopharm
Do not take Memantine ratiopharm
- if you are allergic to memantine hydrochloride, peanut or soya or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Memantine ratiopharm
- 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 ratiopharm 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
Memantine ratiopharm is not recommended for children and adolescents under the age of 18 years.
Other medicines and Memantine ratiopharm
Tell your doctor or pharmacist if you are taking/using, have recently taken/used or might take/use any other medicines.
In particular, Memantine ratiopharm 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 Memantine ratiopharm.
Memantine ratiopharm 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.
The use of memantine in pregnant women is not recommended.
Women taking Memantine ratiopharm 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 ratiopharm may change your reactivity, making driving or operating machinery inappropriate.
Memantine ratiopharm contains lactose and soya lecithin
This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
This medicine contains soya lecithin. If you are allergic to peanut or soya, do not take this medicinal product.
3. How to take Memantine ratiopharm
The Memantine ratiopharm treatment initiation pack is only to be used for the beginning of the treatment with Memantine ratiopharm.
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 treatment dose of 20 mg per day is achieved by a gradual increase of the
Memantine ratiopharm dose during the first 3 weeks of treatment. Take one tablet once a day.
Week 1 (day 1–7):
Take one 5 mg tablet once a day (white to off-white, capsule shaped, biconvex, plain on one side and debossed with “5” on the other side) for 7 days.
Week 2 (day 8–14):
Take one 10 mg tablet once a day (white to off-white, capsule shaped, biconvex, with a break score on one side and debossed with “10” on the other side) for 7 days.
Week 3 (day 15–21):
Take one 15 mg tablet once a day (white to off-white, capsule shaped, biconvex, plain on one side and debossed with “15” on the other side) for 7 days.
Week 4 (day 22–28):
Take one 20 mg tablet once day (white to off-white, capsule shaped, biconvex, with a break score on one side and debossed with “20” on the other side) 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
Memantine ratiopharm 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 ratiopharm as long as it is of benefit to you. Your doctor should assess your treatment on a regular basis.
If you take more Memantine ratiopharm than you should
- In general, taking too much Memantine ratiopharm 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 ratiopharm, contact your doctor or get medical advice, as you may need medical attention.
If you forget to take Memantine ratiopharm
- If you find you have forgotten to take your dose of Memantine ratiopharm, 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 tests, 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 or pharmacist. 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 By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Memantine ratiopharm
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 the blister pack 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 Memantine ratiopharm contains
-
– The active substance is memantine hydrochloride.
Each film-coated tablet contains 5 mg memantine hydrochloride equivalent to 4.15 mg memantine.
Each film-coated tablet contains 10 mg memantine hydrochloride equivalent to 8.31 mg memantine.
Each film-coated tablet contains 15 mg memantine hydrochloride equivalent to 12.46 mg memantine.
Each film-coated tablet contains 20 mg memantine hydrochloride equivalent to 16.62 mg memantine.
-
– The other ingredients are: