Memantine Hydrochloride 10 Mg Film-Coated Tablets.
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
MEMANTINE Hydrochloride 10 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 is and what it is used for
2. What you need to know before you take Memantine
3. How to take Memantine
4. Possible side effects
5. How to store Memantine
6. Contents of the pack and other information
1. What Memantine is and what it is used for
How does Memantine work
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 belongs to a group of medicines called NMDA-receptor antagonists. Memantine acts on these NMDA-receptors improving the transmission of nerve signals and the memory.
What is Memantine used for
Memantine is used for the treatment of patients with moderate to severe Alzheimer’s disease.
2. What you need to know before you take Memantine Do not take Memantine:
* if you are allergic (hypersensitive) to memantine or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor before taking memantine:
■ 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 uncontrolled hypertension (high blood pressure).
In these situations the treatment should be carefully supervised, and the clinical benefit of Memantine 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 is not recommended for children and adolescents under the age of 18 years. Other medicines and memantine
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
In particular, Memantine 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 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. The use of memantine in pregnant women is not recommended.
Women taking Memantine 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 may change your reactivity, making driving or operating machinery inappropriate.
Memantine Tablets contain lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
3. How to take Memantine
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 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:
CM
O
Q-
|
Week 1 |
half a 10 mg tablet |
|
Week 2 |
one 10 mg tablet |
|
Week 3 |
one and a half 10 mg tablets |
|
Week 4 and beyond |
two 10 mg tablets |
The usual starting dose is half a tablet once a day (1x5 mg) for the first week. This is increased to one tablet once a day (1x10 mg) in the second week and to 1 and a half tablets once a day (1x15 mg) in the third week. From the fourth week on, the usual dose is 2 tablets 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 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 Memantine as long as it is of benefit to you. Your doctor should assess your treatment on a regular basis.
If you take more Memantine than you should
In general, taking too much Memantine 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, contact your doctor or get medical advice, as you may need medical attention.
If you forget to take Memantine
If you find you have forgotten to take your dose of Memantine, 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, Memantine 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.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. 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.
5. How to store Memantine
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 packaging after EXP. The expiry date refers to the last day of that month.
Keep blisters in the outer carton in order to protect from light. This medicine does not require any special temperature 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 to protect the environment.
6. Contents of the pack and other information What Memantine 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 are: lactose monohydrate, microcrystalline cellulose, crospovidone type B, colloidal anhydrous silica, magnesium stearate and film-coating containing hypromellose 6 cP, titanium dioxide (E171), macrogol 400.
What Memantine looks like and contents of the pack
Memantine Hydrochloride film-coated tablets are white, oblong and biconvex with a score line. They are available in packs containing 14, 28, 42, 56, 98, and 112 tablets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Crescent Pharma Limited, Units 3 and 4, Quidhampton Business Units,
Polhampton Lane, Overton, Hampshire, RG25 3ED, United Kingdom
This leaflet was last revised in July 2015