Marixino 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Marixino 10 mg Film-Coated Tablets EFG

Memantine Hydrochloride

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.

Contents of the pack:

1. What is Marixino and what is it used for
2. What you need to know before you take Marixino
3. How to take Marixino
4. Possible side effects
5. Storing Marixino
6. Contents of the pack and further information

1. What is Marixino and what is it used for

Marixino contains the active substance memantine hydrochloride. It belongs to a group of medicines called 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 the transmission of important nerve signals in learning and memory. Marixino belongs to a group of medicines called NMDA receptor antagonists. Marixino acts on these receptors, improving the transmission of nerve signals and memory.

Marixino is used in the treatment of patients with moderate to severe Alzheimer's disease.

2. What you need to know before you take Marixino

Do not take Marixino

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Marixino:

• if you have a history of epileptic seizures.
• if you have recently suffered a myocardial infarction (heart attack), if you suffer from congestive heart failure or if you have uncontrolled hypertension (high blood pressure).

In these situations, treatment should be carefully supervised and your doctor should regularly re-evaluate the clinical benefit of Marixino.

If you have kidney problems, your doctor should closely monitor your kidney function and, if necessary, adjust the dose of memantine.

The use of memantine with other medicines such as amantadine (for the treatment of Parkinson's disease), ketamine (a medicine usually used as an anaesthetic), dextromethorphan (a medicine for the treatment of cough) and other NMDA antagonists should be avoided.

Children and adolescents

The use of Marixino in children and adolescents under the age of 18 is not recommended.

Using Marixino with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular, the administration of Marixino may produce changes in the effects of the following medicines, so your doctor may need to adjust the dose:

• amantadine, ketamine, dextromethorphan.
• dantrolene, baclofen.
• cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine.
• hydrochlorothiazide (or any combination with hydrochlorothiazide).
• anticholinergics (substances usually used to treat movement disorders or intestinal spasms).
• anticonvulsants (substances used to prevent and eliminate convulsions).
• barbiturates (substances usually used to induce sleep).
• dopaminergic agonists (substances such as L-dopa, bromocriptine).
• neuroleptics (substances used in the treatment of mental illnesses).
• oral anticoagulants.

If you are admitted to hospital, inform your doctor that you are taking Marixino.

Taking Marixino with food and drinks

You should inform your doctor if you have recently changed or intend to change your diet substantially (e.g. from a normal diet to a strict vegetarian diet) or if you have renal tubular acidosis (RTA, excess of acid-producing substances in the blood due to kidney dysfunction or severe urinary tract infections), as your doctor may need to adjust the dose of the 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.

Pregnancy

The use of memantine is not recommended in pregnant women.

Breast-feeding

Women taking Marixino should stop breast-feeding.

Driving and using machines

Your doctor will inform you whether your illness allows you to drive or use machines safely. Also, Marixino may alter your reaction abilities, so driving or operating machinery may be inappropriate.

Marixino contains lactose and sodium

If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, i.e. it is essentially "sodium-free".

3. How to take Marixino

Follow exactly the administration instructions of this medicine given by your doctor. If you are unsure, ask your doctor or pharmacist.

Posology

The recommended dose of Marixino for adults and the elderly is 20 mg once a day. To reduce the risk of side effects, this dose is achieved gradually following the following daily scheme:

The normal starting dose is half a tablet once a day (1 x 5 mg) for the first week. It is increased to one tablet a day (1 x 10 mg) for the second week and to one and a half tablets once a day for the third week. From the fourth week onwards, the normal dose is two tablets once a day (1 x 20 mg).

Dosage for patients with renal insufficiency

If you have kidney problems, your doctor will decide on the appropriate dose for your condition. In this case, your doctor should monitor your kidney function at specific intervals.

Administration

Marixino should be taken orally once a day. To get the most out of your medication, you should take it regularly every day and at the same time. The tablets should be swallowed with a little 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 taking Marixino as long as it is beneficial for you. Your doctor should evaluate the effects of your treatment periodically.

If you take more Marixino than you should

• Generally, taking too much Marixino should not harm you. You may experience an increase in the symptoms described in section 4 "Possible side effects".
• If you take an overdose of Marixino, contact your doctor or seek medical advice, as you may need medical attention.

If you forget to take Marixino

• If you realize you have forgotten to take your dose of Marixino, wait and take the next dose at the usual time.
• Do not take a double dose to make up for the 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, this medicine can cause side effects, although not everybody gets them.

Generally, side effects are mild to moderate.

Common (may affect up to 1 in 10 people):

• Headache, drowsiness, constipation, elevated liver function tests, dizziness, balance disorders, breathing difficulties, high blood pressure and hypersensitivity to the medicine.

Uncommon (may affect up to 1 in 100 people):

• Fatigue, fungal infections, confusion, hallucinations, vomiting, gait disturbances, heart failure and formation of blood clots in the venous system (thrombosis/venous thromboembolism).

Rare (may affect up to 1 in 10,000 people)

• Seizures.

Frequency not known (frequency cannot be estimated from the available data)

• Pancreatitis, 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 experience 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 national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Marixino

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 on the carton after EXP. The expiry date is the last day of the month stated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Marixino

• The active substance is memantine hydrochloride.

Each film-coated tablet contains 10 mg of memantine hydrochloride, equivalent to 8.31 mg of memantine.

• The other ingredients are:

Core of the tablet: lactose monohydrate, microcrystalline cellulose (E460), anhydrous colloidal silica, talc (E553b) and magnesium stearate (E470b).

Coating of the tablet: methacrylic acid-ethyl acrylate copolymer (1:1), sodium lauryl sulphate, polysorbate 80, talc (E553b), triacetin and simethicone.

See section 2 "Marixino contains lactose and sodium":

Appearance and packaging

Marixino film-coated tablets are biconvex, oval and white with a score line on one side (tablet width: 12.2-12.9 mm; thickness: 3.5-4.5 mm). The tablet can be divided into equal doses.

Marixino film-coated tablets are available in packs 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.

Marketing authorisation holder

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

Manufacturer

KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenia

TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany

For further information about this medicine, please contact the local representative of the marketing authorisation holder.

Date of last revision of this leaflet:

Detailed information on this medicine is available on the European Medicines Agency (EMA) website http://www.ema.europa.eu.