Patient leaflet - Memantine Merz
1. What Memantine Merz is and what it is used for
How does Memantine Merz work
Memantine Merz contains the active substance memantine hydrochloride.
Memantine Merz 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 Merz belongs to a group of medicines called NMDA-receptor antagonists. Memantine Merz acts on these NMDA-receptors improving the transmission of nerve signals and the memory.
What is Memantine Merz used for
Memantine Merz is used for the treatment of patients with moderate to severe Alzheimer’s disease.
2. What you need to know before you take Memantine Merz
Do not take Memantine Merz
-
– if you are allergic (hypersensitive) to memantine hydrochloride or any of the other ingredients of Memantine Merz tablets (listed in section 6).
Warning and precautions
Talk to your doctor or pharmacist before taking Memantine Merz
-
– 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 Merz 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 Merz is not recommended for children and adolescents under the age of 18 years.
Other medicines and Memantine Merz
Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular, Memantine Merz 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 Merz.
Memantine Merz 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 Memantine Merz 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 Merz may change your reactivity, making driving or operating machinery inappropriate.
Memantine Merz contains Sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.
3. How to take Memantine Merz
Always take Memantine Merz exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
Dosage
The recommended dose of Memantine Merz 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 tablet |
| week 4 and beyond | two 10 mg tablets once a day |
The usual starting dose is half a tablet once a day (1× 5 mg) for the first week. This is increased to one tablet once a day (1× 10 mg) in the second week and to 1 and a half tablet once a day in the third week. From the fourth week on, the usual dose is 2 tablets once a day (1× 20 mg).
Dosage in patients with impaired kidney function
If you have impaired kidney function, your doctor will decide upon a dose that suits your condition. In this case, monitoring of your kidney function should be performed by your doctor at specified intervals.
Administration
Memantine Merz 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 Merz as long as it is of benefit to you. Your doctor should assess your treatment on a regular basis.
If you take more Memantine Merz than you should
-
– In general, taking too much Memantine Merz 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 Merz, contact your doctor or get medical advice, as
you may need medical attention.
If you forget to take Memantine Merz
-
– If you find you have forgotten to take your dose of Memantine Merz, 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 users):
Headache, sleepiness, constipation, elevated liver function tests, dizziness, balance disorders, shortness of breath, high blood pressure and drug hypersensitivity
Uncommon (may affect up to 1 in 100 users):
- 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 users):
- 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 Merz.
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 inBy reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Memantine Merz
Keep out of the sight and reach of children.
Do not use Memantine Merz after the expiry date which is stated on the carton and the blister after EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
-
6. Content of the pack and other information
What Memantine Merz contains
The active substance is memantine hydrochloride. Each film-coated tablet contains 10 mg of memantine hydrochloride equivalent to 8.31 mg memantine.
The other ingredients are microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, and magnesium stearate, all in the tablet core; and hypromellose, macrogol 400, titanium dioxide (E 171) and iron oxide yellow (E 172) all in the tablet coating.
What Memantine Merz looks like and contents of the pack
Memantine Merz film-coated tablets are presented as pale yellow to yellow, oval shaped film-coated tablet with breaking line and engravings „1–0“ on one side and „M M“ on the other side.
Memantine Merz film-coated tablets are available in blister packs of 14 tablets, 28 tablets, 30 tablets, 42 tablets, 50 tablets, 56 tablets, 98 tablets, 100 tablets, 112 tablets and multipscks of 840 (20 packs of 42) tablets, 980 (10 packs of 98) tablets or 1000 (20 packs of 50) tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Merz Pharmaceuticals GmbH
Eckenheimer Landstr. 100
D-60318 Frankfurt/Main
Germany
Manufacturer
Merz Pharma GmbH + Co. KGaA
Eckenheimer Landstr. 100
D-60318 Frankfurt/Main
Germany
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
| Belgie/Belgique/Belgien Lundbeck S.A./N.V. Tél/Tel: +32 2 340 2828 | Lietuva H. Abbe Pharma GmbH Tel.: +370 52 711710 |
| Et^rapun Merz Pharmaceuticals GmbH Tel.: +49 (0)69 1503 – 0 | Luxembourg/Luxemburg HANFF Global Health Solutions s.a r.l. Tél: +352 45 07 07–1 |
| Česká republika Lundbeck Česká republika s.r.o. Tel: +420 225 275 600 | Magyarország Lundbeck Hungaria Kft. Tel: +36 1 4369980 |
| Danmark Lundbeck Pharma A/S Tlf: +45 4371 4270 | Malta Clinipharm Co. Ltd Tel: +356 21 43 74 15 |
| Deutschland Merz Pharmaceuticals GmbH Tel: +49 (0)69 1503 – 0 | Nederland Lundbeck B.V. Tel: +31 20 697 1901 |
| Eesti H. Abbe Pharma GmbH Tel.: +372 6 460980 | Norge H. Lundbeck AS Tlf: +47 91 300 800 |
| EZ/.áňa Lundbeck Hellas S.A. TnX: +30 210 610 5036 | Österreich Merz Pharma Austria GmbH Tel.: +43 1 865 88 95 |
| España Merz Pharma España S.L. Tel: +34 91 657 47 84 | Polska Centrala Farmaceutyczna CEFARM SA Tel: +48 22 634 02 22 |
| France Lundbeck SAS Tél: + 33 1 79 41 29 00 | Portugal Merz Pharma España S.L. Tel: +34 91 657 47 84 |
| Hrvatska Lundbeck Croatia d.o.o. Tel.: + 385 1 3649 210 | Romania Lundbeck Export A/S Tel: +40 21319 88 26 |
| Ireland Lundbeck (Ireland) Limited Tel: +353 1 468 9800 | Slovenija Lundbeck Pharma d.o.o. Tel.: +386 2 229 4500 |
Ísland
Lundbeck Export A/S, útibú á Íslandi
Sími: +354 414 7070
Italia
Lundbeck Italia S.p.A.
Tel: +39 02 677 4171
Kúnpog
Lundbeck Hellas A.E
TnX.: +357 22490305
Latvija
-
H. Abbe Pharma GmbH