Memantine Hydrochloride 10 Mg Film-Coated Tablets.
Memantine Hydrochloride 10/20 mg Leaflet - Front side - 300 x 220 mm
PACKAGE LEAFLET: INFORMATION FOR THE USER Memantine hydrochloride 10 mg film-coated tablets Memantine hydrochloride 20 mg film-coated tablets
Memantine hydrochloride
Read this entire 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
What is in this leaflet
1. What Memantine Tablets are and what are they used for
2. Before you take Memantine Tablets
3. How to take Memantine Tablets
4. Possible side effects
5. How to store Memantine Tablets
6. Contents of the pack and other information
1. WHAT MEMANTINE TABLETS IS AND WHAT IT IS USED FOR How does Memantine Tablets work
Memantine Tablets belongs to a group of medicines known as anti-dementia medicines. Memory loss in Alzheimer's disease is due to a disturbance of message signals in the brain. The brain contains so-called N-methyl-D-aspartate (NMDA)-receptors that are involved in transmitting nerve signals important in learning and memory. Memantine Tablets belongs to a group of medicines called NMDA-receptor antagonists. Memantine Tablets acts on these NMDA-receptors improving the transmission of nerve signals and the memory.
What is Memantine Tablets used for
Memantine Tablets is used for the treatment of patients with moderate to severe Alzheimer's disease.
2. BEFORE YOU TAKE MEMANTINE TABLETS Do not take Memantine Tablets
• if you are allergic (hypersensitive) to memantine or any of the other ingredients of Memantine film-coated tablets (see section 6).
Take special care with Memantine Tablets
• if you have a history of epileptic seizures
• if you have recently experienced a myocardial infarction (heart attack), or if you are suffering from congestive heart failure or from an uncontrolled hypertension (high blood pressure).
In these situations the treatment should be carefully supervised,and the clinical benefit of Memantine Tablets reassessed by your doctor on a regular basis.
If you suffer from renal impairment (kidney problems), your doctor should closely monitor your kidney function and if necessary adapt the memantine doses accordingly.
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.
Memantine Tablets is not recommended for children and adolescents under the age of 18 years.
Using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
In particular, Memantine Tablets may change the effects of the following medicines and their dose may need to be adjusted by your doctor:
• amantadine, ketamine, dextromethorphan
• dantrolene, baclofen
• cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine
• hydrochlorothiazide (or any combination with hydrochlorothiazide)
• anticholinergics (substances generally used to treat movement disorders or intestinal cramps)
• anticonvulsants (substances used to prevent and relieve seizures)
• barbiturates (substances generally used to induce sleep)
• dopaminergic agonists (substances such as L-dopa, bromocriptine)
• neuroleptics (substances used in the treatment of mental disorders)
• oral anticoagulants
If you go into hospital, let your doctor know that you are taking Memantine Tablets.
Taking Memantine Tablets with food and drink
You should inform your doctor if you have recently changed or intend to change your diet substantially (e.g. from normal diet to strict vegetarian diet) 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
Ask your doctor or pharmacist for advice before taking any medicine.
Tell your doctor if you are pregnant or planning to become pregnant. The use of memantine in pregnant women is not recommended.
Women taking Memantine Tablets should not breast-feed.
Driving and using machines
Your doctor will tell you whether your illness allows you to drive and to use machines safely.
Also, Memantine Tablets may change your reactivity, making driving or operating machinery inappropriate.
3. HOW TO TAKE MEMANTINE TABLETS
Always take Memantine Tablets exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.
Dosage
The recommended dose of Memantine Tablets for adults and elderly patients is 20 mg once a day. In order to reduce the risk of side effects this dose is achieved gradually by the following daily treatment scheme:
|
Weekl |
Take half a 10 mg tablet once a day |
|
Week 2 |
Take one 10 mg tablet or half a 20 mg tablet once a day |
|
Week 3 |
Take one and a half 10 mg tablet once a day |
|
Week 4 and beyond |
Take two 10 mg tablets or one 20mg tablet once a day |
Dosage in patients with impaired kidney function
If you have impaired kidney function, your doctor will decide upon a dose that suits your condition. In this case, monitoring of your kidney function should be performed by your doctor at specified intervals.
Administration
Memantine Tablets should be administered orally once a day. To benefit from your medicine you should take it regularly every day at the same time of the day. The tablets should be swallowed with some water. The tablets can be taken with or without food.
Duration of treatment
Continue to take Memantine Tablets as long as it is of benefit to you. Your doctor should assess your treatment on a regular basis.
If you take more Memantine Tablets than you should
• In general, taking too much Memantine Tablets should not result in any harm to you. You may experience increased symptoms as described in section 4. “Possible side effects”.
• If you take a large overdose of Memantine Tablets, contact your doctor or get medical advice, as you may need medical attention.
If you forget to take Memantine Tablets
• If you find you have forgotten to take your dose of Memantine Tablets, wait and take your next dose at the usual time.
• Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Memantine Tablets can cause side effects, although not everybody gets them.
In general, the observed side effects are mild to moderate.
Common: may affect up to 1 in 10 people
• 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 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 Tablets.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE MEMANTINE TABLETS
Keep out of the reach and sight of children.
Do not use Memantine Tablets after the expiry date which is stated on the carton and the blister after EXP. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. CONTENT OF THE PACK AND OTHER INFORMATION
What Memantine Tablets contains
The active substance is memantine hydrochloride.
Memantine hydrochloride 10mg film-coated tablet contains 10 mg memantine hydrochloride equivalent to 8.31 mg memantine.
Memantine hydrochloride 20mg film-coated tablet contains 20 mg memantine hydrochloride equivalent to 16.62 mg memantine.
The other ingredients are Silicified microcrystalline cellulose, Croscarmellose Sodium, Talc and Magnesium stearate, all in the tablet core; and Hypromellose (E464), Titanium dioxide (E171) and Macrogol 400 and Iron oxide red (E172) and Iron oxide yellow (E172) (only in 20 mg film-coated tablet) all in the tablet coating.
What Memantine Tablets looks like and contents of the pack
Memantine hydrochloride 10mg film-coated tablets are white to off white, capsule shape, film coated tablet debossed with 'CL 29' on one side and breakline on both sides (approximate size 12.1 x 5.1mm). This tablet can be divided into equal halves.
Memantine hydrochloride 20 mg film-coated tablets are brown color, capsule shape, film coated tablet debossed with 'CL 30' on one side and plain on the other side (approximate size 14.6 x 7.1 mm).
Memantine Tablets are available in blister packs of 28,56 and 98 tablets. Not all pack sizes may be marketed.
Marketing Authorisation Holder and manufacturer
Wilcare Pharma Limited,
Building 6 Unit 14, Croxley Green Business Park, Watford, England, WD18 8YH
If you would like this leaflet in a different format or register a complaint please contact the Marketing Authorisation Holder listed above or send an email to comDlaints@wilcarepharma.co.uk
This leaflet was last revised in March 2015
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