Memantine Hydrochloride 10 mg film-coated tablets

• 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.

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

• if you are allergic to Memantine hydrochloride or any of the other ingredients of this medicine (listed in section 6).

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.

If you suffer from renal impairment (kidney problems), your doctor should closely monitor your kidney function and if necessary adapt the memantine doses accordingly.

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), your doctor may need to adjust the dose of your medicine.

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 hydrochloride 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.

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.

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.

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 hydrochloride may change your reactivity, making driving or operating machinery inappropriate.

This medicine contains less than 1 mmol sodium (23 mg) per film coated tablet, that is to say essentially ‘sodium-free’.

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.

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.

Continue to take Memantine hydrochloride 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 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 Memantine hydrochloride, 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 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 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 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.

• The active substance is memantine hydrochloride. Each film-coated tablet contains 10 mg of memantine hydrochloride equivalent to 8.31 mg memantine.
• The other ingredients are: Cellulose, Microcrystalline (Grade - 200), Silica, Colloidal Anhydrous, Silicified Microcrystalline Cellulose, Sodium Starch Glycolate (Type-A), Talc, Sodium Stearyl Fumarate, Hydroxypropyl cellulose, Titanium Dioxide (E171), Macrogol (6000)

White to off white, centrally tapered oblong, biconvex, film coated tablets with a single break line on both sides and debossed with ‘ME’ and ‘10’ on either side of break line on one side and plain on other side.

Memantine hydrochloride 10 mg film-coated tablets are available in Triple laminated Clear PVC/PE/PVdC-Aluminium foil blister pack

Pack sizes: 28 film coated tablets.

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