• 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 Marixino is and what it is used for
2. What you need to know before you take Marixino
3. How to take Marixino
4. Possible side effects
5. How to store Marixino
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 Marixino:

• 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 Marixino 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.

Marixino 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, Marixino 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 Marixino.

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 Marixino should not breast-feed.

Your doctor will tell you whether your illness allows you to drive and to use machines safely. Also, Marixino 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.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially “sodium-free”.

The recommended dose of Marixino 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. For up-titration other tablet strengths are available.

At the beginning of treatment you will start by using half a 10 mg tablet once a day (1 x 5 mg). This dose will be increased weekly by 5 mg until the recommended (maintenance) dose is reached. The recommended maintenance dose is 20 mg once a day, which is reached at the beginning of the 4^th week.

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.

Marixino 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.

Continue to take Marixino as long as it is of benefit to you. Your doctor should assess your treatment on a regular basis.

• In general, taking too much Marixino 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 Marixino, contact your doctor or get medical advice, as you may need medical attention.

• If you find you have forgotten to take your dose of Marixino, 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

United Kingdom (Northern Ireland)

or search for MHRA Yellow Card in the Google Play or Apple App Store.

United Kingdom (Great Britain)

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 20 mg memantine hydrochloride equivalent to 16.62 mg memantine.
• The other ingredients (excipients) are:
  Tablet core: lactose monohydrate, microcrystalline cellulose (E460), anhydrous colloidal silica, talc (E553b), magnesium stearate (E470b).
  Film coating: methacrylic acid - ethyl acrylate copolymer (1:1), sodium laurilsulfate, polysorbate 80, talc (E553b), triacetin, simeticone.
  See section 2 “Marixino contains lactose and sodium”.

White, oval, biconvex film-coated tablet (tablet length: 15.7–16.4 mm, thickness: 4.7–5.7 mm).

Marixino film-coated tablets are available in boxes of 14, 28, 30, 42, 50, 56, 60, 70, 84, 90, 98, 100 and 112 film-coated tablets in blisters.

Not all pack sizes may be marketed.

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: