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The product code(s) for this leaflet is: PL17780/1036 .
Memantine 10 mg film-coated tablets
Memantine 10 mg film-coated tablets
memantine hydrochloride
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
Memantine contains the active substance memantine hydrochloride. It 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.
Memantine is used for the treatment of patients with moderate to severe Alzheimer's disease.
Talk to your doctor or pharmacist before taking Memantine
Take special care with Memantine:
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.
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.
Memantine is not recommended for children and adolescents under the age of 18 years.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Memantine may change the effects of the following medicines and their dose may need to be adjusted by your doctor:
If you go into hospital, let your doctor know that you are taking Memantine.
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.
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 should not breast-feed.
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.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose of Memantine for adults and elderly 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 recommended dose can also be achieved by using a treatment initiation pack.
The usual starting dose is half a tablet once a day (1 x 5 mg) for the first week. This is increased to one tablet once a day (1x 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 x 20 mg).
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.
Place the tablet with the round side on a hard surface, the score line should face upwards. Press with the forefinger and thumb of the same hand on either side of the score line and push down until the tablet breaks as shown in the illustration.
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 tablets can be taken with or without food.
Continue to take Memantine as long as it is of benefit to you. Your doctor should assess your treatment on a regular basis.
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 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.
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
Uncommon (may affect up to 1 in 100 people)
Tiredness
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
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. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
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 blister and carton 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.
Memantine 10 mg film-coated tablets are presented as white, round, biconvex tablets (8 mm) with a score line on one side and debossed with ‘M9MN’ and ‘10‘ on the other side. The tablet can be divided into equal halves.
Memantine film-coated tablets are available in blister packs of:
blisters containing 10, 14, 20, 28, 30, 42, 50, 56,60, 90, 98, 100, 112 or 120 tablets and a Unit dose blister containing 30x1 tablet
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Manufacturer(s):
This leaflet was last revised in November 2020
1065022703
7643.2001