• 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 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 hydrochloride 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 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) 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 hydrochloride in pregnant women is not recommended.

Breast-feeding

Women taking Memantine hydrochloride 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.

The recommended dose of Memantine hydrochloride for adults and older people 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 tablets

week 4 and beyond two 10 mg tablets once a day

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 (1 x 10 mg) in the second week and to 1 and a half tablets 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.

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 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 in formation on the safety of this medicine.

The active substance is memantine hydrochloride.

Memantine hydrochloride 10 mg film-coated tablets contain 10 mg memantine hydrochloride equivalent to 8.31 mg memantine.

Memantine hydrochloride 20 mg film-coated tablets contain 20 mg memantine hydrochloride equivalent to 16.62 mg memantine.

The other ingredients are microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica and magnesium stearate, povidone (K-30), all in the tablet core; and hypromellose, macrogol 400, titanium dioxide (E171) and iron oxide yellow (E172) and red iron oxide (only in 20 mg film-coated tablet), all in the tablet coating.

Memantine hydrochloride 10 mg film-coated tablets are pale yellow to yellow, oval shaped film-coated tablets with breaking line and engravings “1 0” on one side and “R R” on the other side.

The tablet can be divided into equal doses.

Memantine hydrochloride 20 mg film-coated tablets are pale red to grey red, oval shaped film-coated tablets with breaking line and engravings “2 0” on one side and “R R” on the other side.

The tablet can be divided into equal doses.

Memantine hydrochloride film-coated tablets are available in blister packs of 7, 28, 42, 56, 98 and 112 tablets.

Not all pack sizes may be marketed.