Patient leaflet - Marixino (previously Maruxa)
B. PACKAGE LEAFLET
Package leaflet: Information for the patient
Marixino 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 Marixino is and what it is used for
-
2. What you need to know before you take Marixino
-
3. How to take Marixino
-
4. Possible side effects
-
5. How to store Marixino
-
6. Contents of the pack and other information
1. What Marixino is and what it is used for
Marixino 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. Marixino belongs to a group of medicines called NMDA-receptor antagonists. Marixino acts on these NMDA-receptors improving the transmission of nerve signals and the memory.
Marixino is used for the treatment of patients with moderate to severe Alzheimer’s disease.
2. What you need to know before you take Marixino
Do not take Marixino
-
– if you are allergic to memantine or any of the other ingredients of this medicine (listed in
section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Marixino:
-
– 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 Marixino 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
Marixino is not recommended for children and adolescents under the age of 18 years.
Other medicines and Marixino
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular, Marixino 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 Marixino.
Marixino 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 Marixino 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, Marixino may change your reactivity, making driving or operating machinery inappropriate.
Marixino contains lactose and sodium
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 less than 1 mmol sodium (23 mg) per tablet, that is to say essentially „sodium-free“.
3. How to take Marixino
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 Marixino 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 | Two 10 mg tablets |
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 two 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
Marixino 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 10 mg film-coated tablet can be divided into equal doses. The tablets can be taken with or without food.
Duration of treatment
Continue to take Marixino as long as it is of benefit to you. Your doctor should assess your treatment on a regular basis.
If you take more Marixino than you should
-
– In general, taking too much Marixino 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 Marixino, contact your doctor or get medical advice, as you may
need medical attention.
If you forget to take Marixino
-
– If you find you have forgotten to take your dose of Marixino, 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 (may affect up to 1 in 10 people):
-
– Headache, sleepiness, constipation, elevated liver function test, dizziness, balance disorders,
shortness of breath, high blood pressure and drug hypersensitivity.
Uncommon (may affect up to 1 in 100 people):
-
– Tiredness, fungal infections, confusion, hallucinations, vomiting, abnormal gait, heart failure
and venous blood clotting (thrombosis/thromboembolism).
Very Rare (may affect up to 1 in 10,000 people ):
-
– 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. 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 Marixino
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 blister and carton after EXP. The expiry date refers to the last day of that month.
This medicine 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 you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Marixino 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 (excipients) are:
Tablet core : lactose monohydrate, microcrystalline cellulose (E460), anhydrous colloidal silica, talc (E553b), magnesium stearate (E470b).
Film coating: methacrylic acid – ethyl acrylate copolymer (1:1), sodium laurilsulfate, polysorbate 80, talc (E553b), triacetin, simeticone.
What Marixino looks like and contents of the pack
White, oval, biconvex film-coated tablets, scored on one side (tablet length: 12.2–12.9 mm, thickness: 3.5–4.5 mm). The tablet can be divided into equal doses.
Marixino film-coated tablets are available in boxes of 14, 28, 30, 42, 50, 56, 60, 70, 84, 90, 98, 100 and 112 film-coated tablets in blisters.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
KRKA, d.d., Novo mesto, Smarjeska cesta 6, 8501 Novo mesto, Slovenia
Manufacturer
KRKA, d.d., Novo mesto, Smarjeska cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-StraBe 5, 27472 Cuxhaven, Germany
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
| Belgie/Belgique/Belgien KRKA Belgium, SA. Tél/Tel: + 32 (0) 487 50 73 62 | Lietuva UAB KRKA Lietuva Tel: + 370 5 236 27 40 |
| Etnrapua KPKA Etnrapua EOOfl Ten.: + 359 (02) 962 34 50 | Luxembourg/Luxemburg KRKA Belgium, SA. Tél/Tel: + 32 (0) 487 50 73 62 (BE) |
| Česká republika KRKA ČR, s.r.o. Tel: + 420 (0) 221 115 150 | Magyarország KRKA Magyarország Kereskedelmi Kft. Tel.: + 36 (1) 355 8490 |
| Danmark KRKA Sverige AB Tlf: + 46 (0)8 643 67 66 (SE) | Malta E. J. Busuttil Ltd. Tel: + 356 21 445 885 |
| Deutschland TAD Pharma GmbH Tel: + 49 (0) 4721 606–0 | Nederland KRKA Belgium, SA. Tel: + 32 (0) 487 50 73 62 (BE) |
| Eesti KRKA, d.d., Novo mesto Eesti filiaal Tel: + 372 (0) 6 671 658 | Norge KRKA Sverige AB Tlf: + 46 (0)8 643 67 66 (SE) |
| EZZáóa KRKA EAAAS EnE Tni: + 30 2100101613 | Österreich KRKA Pharma GmbH, Wien Tel: + 43 (0)1 66 24 300 |
| España KRKA Farmacéutica, S.L. Tel: + 34 911 61 03 80 | Polska KRKA-POLSKA Sp. z o.o. Tel.: + 48 (0)22 573 7500 |
| France KRKA France Eurl Tél: + 33 (0)1 57 40 82 25 | Portugal KRKA Farmacéutica, Sociedade Unipessoal Lda. Tel: + 351 (0)21 46 43 650 |
| Hrvatska KRKA – FARMA d.o.o. Tel: + 385 1 6312 100 | Romania KRKA Romania S.R.L., Bucharest Tel: + 4 021 310 66 05 |
| Ireland KRKA Pharma Dublin, Ltd. Tel: + 353 1 413 3710 | Slovenija KRKA, d.d., Novo mesto Tel: + 386 (0) 1 47 51 100 |
| Ísland LYFIS ehf. Sími: + 354 534 3500 | Slovenská republika KRKA Slovensko, s.r.o. Tel: + 421 (0) 2 571 04 501 |
| Italia KRKA Farmaceutici Milano S.r.l. Tel: + 39 02 3300 8841 | Suomi/Finland KRKA Finland Oy Puh/Tel: + 358 20 754 5330 |
| Kúnpoc KI.PA. (PHARMACAL) LIMITED Tni: + 357 24 651 882 | Sverige KRKA Sverige AB Tel: + 46 (0)8 643 67 66 (SE) |
| Latvija | United Kingdom (Northern Ireland) |
KRKA Latvija SIA
Tel: + 371 6 733 86 10
Consilient Health Limited Tel: + 353 (0)1 2057760
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
Marixino 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 Marixino is and what it is used for
-
2. What you need to know before you take Marixino
-
3. How to take Marixino
-
4. Possible side effects
-
5. How to store Marixino
-
6. Contents of the pack and other information
1. What Marixino is and what it is used for
Marixino 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. Marixino belongs to a group of medicines called NMDA-receptor antagonists. Marixino acts on these NMDA-receptors improving the transmission of nerve signals and the memory.
Marixino is used for the treatment of patients with moderate to severe Alzheimer’s disease.
2. What you need to know before you take Marixino
Do not take Marixino
-
– if you are allergic to memantine or any of the other ingredients of this medicine (listed in
section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Marixino:
-
– 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 Marixino 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
Marixino is not recommended for children and adolescents under the age of 18 years.
Other medicines and Marixino
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular, Marixino 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 Marixino.
Marixino 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 Marixino 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, Marixino may change your reactivity, making driving or operating machinery inappropriate.
Marixino contains lactose and sodium
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 less than 1 mmol sodium (23 mg) per tablet, that is to say essentially „sodium-free“.
3. How to take Marixino
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 Marixino 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 half a 10 mg tablet once a day (1 × 5 mg). 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
Marixino 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 10 mg film-coated tablet can be divided into equal doses. The tablets can be taken with or without food.
Duration of treatment
Continue to take Marixino as long as it is of benefit to you. Your doctor should assess your treatment on a regular basis.
If you take more Marixino than you should
-
– In general, taking too much Marixino 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 Marixino, contact your doctor or get medical advice, as you may
need medical attention.
If you forget to take Marixino
-
– If you find you have forgotten to take your dose of Marixino, 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 (may affect up to 1 in 10 people):
-
– Headache, sleepiness, constipation, elevated liver function test, dizziness, balance disorders,
shortness of breath, high blood pressure and drug hypersensitivity.
Uncommon (may affect up to 1 in 100 people):
-
– Tiredness, fungal infections, confusion, hallucinations, vomiting, abnormal gait, heart failure
and venous blood clotting (thrombosis/thromboembolism).
Very Rare (may affect up to 1 in 10,000 people ):
-
– 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. 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 Marixino
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 blister and carton after EXP. The expiry date refers to the last day of that month.
This medicine 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 you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Marixino 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 (excipients) are:
What Marixino looks like and contents of the pack
White, oval, biconvex film-coated tablets, scored on one side (tablet length: 12.2–12.9 mm, thickness: 3.5–4.5 mm). The tablet can be divided into equal doses.
Marixino film-coated tablets are available in boxes of 14, 28, 30, 42, 50, 56, 60, 70, 84, 90, 98, 100 and 112 film-coated tablets in blisters.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
KRKA, d.d., Novo mesto, Smarjeska cesta 6, 8501 Novo mesto, Slovenia
Manufacturer
KRKA, d.d., Novo mesto, Smarjeska cesta 6, 8501 Novo mesto, Slovenia
TAD Pharma GmbH, Heinz-Lohmann-StraBe 5, 27472 Cuxhaven, Germany
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
| Belgie/Belgique/Belgien KRKA Belgium, SA. Tél/Tel: + 32 (0) 487 50 73 62 | Lietuva UAB KRKA Lietuva Tel: + 370 5 236 27 40 |
| Etnrapua KPKA Etnrapua EOOfl Ten.: + 359 (02) 962 34 50 | Luxembourg/Luxemburg KRKA Belgium, SA. Tél/Tel: + 32 (0) 487 50 73 62 (BE) |
| Česká republika KRKA ČR, s.r.o. Tel: + 420 (0) 221 115 150 | Magyarország KRKA Magyarország Kereskedelmi Kft. Tel.: + 36 (1) 355 8490 |
| Danmark KRKA Sverige AB Tlf: + 46 (0)8 643 67 66 (SE) | Malta E. J. Busuttil Ltd. Tel: + 356 21 445 885 |
| Deutschland TAD Pharma GmbH Tel: + 49 (0) 4721 606–0 | Nederland KRKA Belgium, SA. Tel: + 32 (0) 487 50 73 62 (BE) |
| Eesti KRKA, d.d., Novo mesto Eesti filiaal Tel: + 372 (0) 6 671 658 | Norge KRKA Sverige AB Tlf: + 46 (0)8 643 67 66 (SE) |
| EZZáóa KRKA EAAAS EnE Tni: + 30 2100101613 | Österreich KRKA Pharma GmbH, Wien Tel: + 43 (0)1 66 24 300 |
| España KRKA Farmacéutica, S.L. Tel: + 34 911 61 03 80 | Polska KRKA-POLSKA Sp. z o.o. Tel.: + 48 (0)22 573 7500 |
| France KRKA France Eurl Tél: + 33 (0)1 57 40 82 25 | Portugal KRKA Farmacéutica, Sociedade Unipessoal Lda. Tel: + 351 (0)21 46 43 650 |
| Hrvatska KRKA – FARMA d.o.o. Tel: + 385 1 6312 100 | Romania KRKA Romania S.R.L., Bucharest Tel: + 4 021 310 66 05 |
| Ireland KRKA Pharma Dublin, Ltd. Tel: + 353 1 413 3710 | Slovenija KRKA, d.d., Novo mesto Tel: + 386 (0) 1 47 51 100 |
| Ísland LYFIS ehf. Sími: + 354 534 3500 | Slovenská republika KRKA Slovensko, s.r.o. Tel: + 421 (0) 2 571 04 501 |
| Italia KRKA Farmaceutici Milano S.r.l. Tel: + 39 02 3300 8841 | Suomi/Finland KRKA Finland Oy Puh/Tel: + 358 20 754 5330 |
| Kúnpoc KI.PA. (PHARMACAL) LIMITED Tni: + 357 24 651 882 | Sverige KRKA Sverige AB Tel: + 46 (0)8 643 67 66 (SE) |
| Latvija | United Kingdom (Northern Ireland) |
KRKA Latvija SIA
Tel: + 371 6 733 86 10
Consilient Health Limited Tel: + 353 (0)1 2057760
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
Marixino 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 Marixino is and what it is used for
-
2. What you need to know before you take Marixino
-
3. How to take Marixino
-
4. Possible side effects
-
5. How to store Marixino
-
6. Contents of the pack and other information
1. What Marixino is and what it is used for
Marixino 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. Marixino belongs to a group of medicines called NMDA-receptor antagonists. Marixino acts on these NMDA-receptors improving the transmission of nerve signals and the memory.
Marixino is used for the treatment of patients with moderate to severe Alzheimer’s disease.
2. What you need to know before you take Marixino
Do not take Marixino
-
– if you are allergic to memantine or any of the other ingredients of this medicine (listed in
section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Marixino:
-
– 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 Marixino 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
Marixino is not recommended for children and adolescents under the age of 18 years.
Other medicines and Marixino
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular, Marixino 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 Marixino.
Marixino 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 Marixino 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, Marixino may change your reactivity, making driving or operating machinery inappropriate.
Marixino contains lactose and sodium
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 less than 1 mmol sodium (23 mg) per tablet, that is to say essentially „sodium-free“.
3. How to take Marixino
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 Marixino 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 half a 10 mg tablet once a day (1 × 5 mg). 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
Marixino 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 10 mg film-coated tablet can be divided into equal doses. The tablets can be taken with or without food.
Duration of treatment
Continue to take Marixino as long as it is of benefit to you. Your doctor should assess your treatment on a regular basis.
If you take more Marixino than you should
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– In general, taking too much Marixino should not result in any harm to you. You may experience
increased symptoms as described in section 4. „Possible side effects“.
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– If you take a large overdose of Marixino, contact your doctor or get medical advice, as you may
need medical attention.
If you forget to take Marixino
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– If you find you have forgotten to take your dose of Marixino, wait and take your next dose at
the usual time.
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– 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 (may affect up to 1 in 10 people):
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– Headache, sleepiness, constipation, elevated liver function test, dizziness, balance disorders,
shortness of breath, high blood pressure and drug hypersensitivity.
Uncommon (may affect up to 1 in 100 people):
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– Tiredness, fungal infections, confusion, hallucinations, vomiting, abnormal gait, heart failure
and venous blood clotting (thrombosis/thromboembolism).
Very Rare (may affect up to 1 in 10,000 people ):
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– Seizures.
Not known (frequency cannot be estimated from the available data):
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– 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. 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 Marixino
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 blister and carton after EXP. The expiry date refers to the last day of that month.
This medicine 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 you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Marixino contains
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– The active substance is memantine hydrochloride.
Each film-coated tablet contains 20 mg memantine hydrochloride equivalent to 16.62 mg memantine.
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– The other ingredients (excipients) are: