Memantine Hydrochloride Zentiva 20mg Film-Coated Tablets
Memantine hydrochloride 10 mg film-coated tablets Memantine hydrochloride 20 mg film-coated tablets
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 hydrochloride is and what it is used for
2. What you need to know before you take memantine hydrochloride
3. How to take memantine hydrochloride
4. Possible side effects
5. How to store memantine hydrochloride
6. Contents of the pack and other information
The name of your medicine is Memantine Hydrochloride Film-Coated Tablets (referred to as memantine hydrchloride throughout this leaflet). Memantine hydrochloride is used for the treatment of patients with moderate to severe Alzheimer's disease. Memantine hydrochloride 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 hydrochloride belongs to a group of medicines called (NMDA)-receptor antagonists. Memantine hydrochloride acts on these (NMDA)-receptors improving the transmission of nerve signals and the memory.
Do not take memantine hydrochloride
- 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 hydrochloride
- 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 hydrochloride reassessed by your doctor on a regular basis.
You should inform your doctor 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.
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 hydrochloride is not recommended for children and adolescents under the age of 18 years.
Other medicines and memantine hydrochloride
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular, memantine hydrochloride 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 hydrochloride.
Memantine hydrochloride with food, drink and alcohol
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), as your doctor may need to adjust the dose of your medicine.
Pregnancy, breast-feeding and fertility
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 hydrochloride in pregnant women is not recommended.
Women taking this medicine 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 hydrochloride may change your reactivity, making driving or operating machinery inappropriate.
Memantine Hydrochloride Film-Coated Tablets contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Dosage
The recommended dose of memantine hydrochloride 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:
|
week 1 |
half a 10 mg tablet (5 mg) |
|
week 2 |
one 10 mg tablet (10 mg) |
|
week 3 |
one and a half 10 mg tablet (15 mg) |
|
week 4 and beyond |
two 10 mg tablets once a day or one 20 mg tablet (20 mg) |
The usual starting dose is a half of 10 mg tablet once a day (1 x 5 mg) for the first week. This is increased to one 10 mg tablet once a day (1 x 10 mg) in the second week and to one and a half 10 mg tablet once a day (1 x 15 mg) in the third week. From the fourth week on, the usual dose is two 10 mg tablets or one 20 mg tablet once a day (1 x 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 hydrochloride 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 hydrochloride as long as it is of benefit to you. Your doctor should assess your treatment on a regular basis.
If you take more memantine hydrochloride than you should
- In general, taking too much memantine hydrochloride 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 this medicine contact your doctor or get medical advice, as you may need medical attention.
If you forget to take memantine hydrochloride
- If you find you have forgotten to take your dose of memantine hydrochloride, 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.
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 hydrochloride.
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 Yellow card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
This medicinal product does not require any special storage conditions.
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 after (EXP). The expiry date refers to the last day of that month.
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.
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 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).
What Memantine Hydrochloride Film-Coated Tablets contains
The active substance is memantine hydrochloride.
The other ingredients are:
Tablet core: lactose monohydrate, microcrystalline cellulose, silica colloidal anhydrous, talc, magnesium stearate.
Tablet film-coating: hypromellose (E464), titanium dioxide (E171), macrogol 400 (E1521).
What Memantine Hydrochloride Film-Coated Tablets
looks like and contents of the pack
Memantine hydrochloride 10mg film-coated tablets:
10 mg breakable film-coated tablets.
White to off-white, capsule shaped film coated tablets with length approx. 11.1±0.2 mm and width approx.5.1±0.2 mm, with break line on both sides. Memantine hydrochloride 20mg film-coated tablets: 20mg breakable film-coated tablets.
White to off-white, capsule shaped film-coated tablets with length approx.13.30±0.2 mm and width approx. 7.2±0.2 mm, having "SNAP TAB" score line on one side and break line on the other side.
The tablet can be divided into equal doses.
Memantine hydrochloride 10 mg film-coated tablets:
PVC/Aluminium blister tablet container containing 14, 28, 30, 42, 45, 50, 56, 60, 84, 90, 98, 100 and 112 film coated tablets.
Memantine hydrochloride 20 mg film-coated tablets:
PVC/Aluminium blister tablet container containing 14, 28, 30, 42, 45, 50, 56, 60, 84, 90, 98, 100 and 112 film coated tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Zentiva, One Onslow Street, Guildford, Surrey, GU1 4YS, UK
Manufacturer
Zentiva S.A., 50 Theodor Pallady Blvd., 032266, § ^ § Bucharest, Romania
This leaflet was last revised in October 2013.
MO)