Patient leaflet - Memantine Accord
- 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
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1. What Memantine Accord is and what it is used for
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2. What you need to know before you take Memantine Accord
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3. How to take Memantine Accord
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4. Possible side effects
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5. How to store Memantine Accord
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6. Contents of the pack and other information
1. What Memantine Accord is and what it is used for
How does Memantine Accord work
Memantine Accord contains the active substance memantine hydrochloride.
Memantine Accordbelongs 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 Accord belongs to a group of medicines called NMDA-receptor antagonists. Memantine Accord acts on these NMDA-receptors improving the transmission of nerve signals and the memory.
What is Memantine Accord used for
Memantine Accordis used for the treatment of patients with moderate to severe Alzheimer’s disease.
2. What you need to know before you take Memantine Accord
Do not take Memantine Accord:
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– if you are allergic to memantine hydrochloride or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before taking Memantine Accord
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– if you have a history of epileptic seizures
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– if you have recently experienced a myocardial infarction (heart attack), or if you are suffering
rom 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 Accord assessed 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 Accord is not recommended for children and adolescents under the age of 18 years.
Other medicines and Memantine Accord
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular, Memantine Accord 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 Accord.
Memantine Accord 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 Accord 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 Accord may change your reactivity, making driving or operating machinery inappropriate.
Memantine Accord contains lactose
This medicinal product contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, please contact your doctor before taking this medicinal product. Your doctor will advise you.
3. How to take Memantine Accord
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 Accord 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 (1 × 15 mg) in the third week. From the fourth week on, the usual dose is 2tablets 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 Accord 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 a little water. The tablets can be taken with or without food.
Duration of treatment
Continue to take Memantine Accord as long as it is of benefit to you. Your doctor should assess your treatment on a regular basis.
If you take more Memantine Accord than you should
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– In general, taking too much Memantine Accord 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 Memantine Accord, contact your doctor or get medical advice, as you may need medical attention.
If you forget to take Memantine Accord
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– If you find you have forgotten to take your dose of Memantine Accord, 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):
- 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 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.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
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 Accord
Keep this medicine out of the sight and reach of children.
Do not use Memantine Accord 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. Contents of the pack and other information
What Memantine Accord contains
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– The active substance is memantine hydrochloride. Each film-coated tablet contains 10 mg of memantine hydrochloride equivalent to 8.31 mg memantine
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– The other ingredients are lactose monohydrate, microcrystalline cellulose, colloidal anhydrous silica, crospovidone, magnesium stearate, all in the tablet core; hypromellose, polysorbate 80, macrogol 400, titanium dioxide (E 171), all in the tablet coating
What Memantine Accord looks like and contents of the pack
Memantine Accord film-coated tablets are presented as white, oblong, coated and scored tablet,debossed with „MT“ divided by the score on one side and “10” divided by the score on the other side. The tablet can be divided into equal doses.
Memantine Accord film-coated tablets are available in blister packs (PVC/PE/PVDC-aluminium blister) of 14 tablets, 28 tablets, 30 tablets, 42 tablets, 50 tablets, 56 tablets, 98 tablets, 100 tablets and 112 tablets. Memantine Accord film-coated tablets are also available in perforated unit dose calendar blister in pack-sizes of 14×1, 28×1, 56×1 or 98×1 tablet.
Not all pack sizes may be marketed
Marketing Authorisation Holder
Accord Healthcare S.L.U.
World Trade Center, Moll de Barcelona, s/n,
Edifici Est 6a planta,
08039 Barcelona,
Spain
Manufacturer
Delorbis Pharmaceuticals Ltd
17, Athinon Street
Ergates Industrial Area, 2643 Nicosia
Cyprus
Accord Healthcare Polska Sp.z o.o.,
ul. Lutomierska 50,95–200 Pabianice, Poland
This leaflet was last revised in
Detailed information on this medicine is available on the European Medicines Agency web site:.