Marixino 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Marixino 10 mg film-coated tablets EFG

memantine hydrochloride

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Marixino is and what it is used for

Marixino contains the active substance memantine hydrochloride. It belongs to a group of medicines known as antidementia agents. Memory loss in Alzheimer's disease is due to disturbances in brain signaling. The brain contains so-called N-methyl-D-aspartate (NMDA) receptors, which are involved in the transmission of nerve signals important for learning and memory. Marixino belongs to the group of medicines called NMDA receptor antagonists. Marixino acts on these receptors, improving nerve signal transmission and memory.

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

2. What you need to know before taking Marixino

Do not take Marixino

• if you are allergic (hypersensitive) to memantine or to 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 had a myocardial infarction (heart attack), if you suffer from congestive heart disease, or if you have uncontrolled high blood pressure (hypertension).

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

If you have renal impairment (kidney problems), your doctor must closely monitor your kidney function and, if necessary, adjust the dose of memantine.

The use of memantine should be avoided together with other medicines such as amantadine (used to treat Parkinson’s disease), ketamine (a drug generally used as an anesthetic), dextromethorphan (a cough medicine), and other NMDA antagonists.

Children and adolescents

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

Taking Marixino with other medicines

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

Specifically, the administration of Marixino may cause changes in the effects of the following medicines, so your doctor may need to adjust the dosage:

• amantadine, ketamine, dextromethorphan.
• dantrolene, baclofen.
• cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine.
• hydrochlorothiazide (or any combination containing hydrochlorothiazide).
• anticholinergics (substances generally used to treat movement disorders or intestinal spasms).
• anticonvulsants (substances used to prevent and stop seizures).
• barbiturates (substances generally 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 drink

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

The use of memantine is not recommended in pregnant women.

Breastfeeding

Women taking Marixino should discontinue breastfeeding.

Driving and using machines

Your doctor will advise you whether your condition allows you to drive and use machines safely. Furthermore, Marixino may affect your reaction ability, so driving or operating machinery may be inappropriate.

Marixino contains lactose and sodium

If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; thus, it is essentially “sodium-free”.

3. How to take Marixino

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist.

Dosage

The recommended dose of Marixino in adults and elderly patients is 20 mg administered once daily. To reduce the risk of adverse effects, this dose should be reached gradually according to the following daily regimen:

The usual starting dose is half a tablet once daily (1 x 5 mg) during the first week. This is increased to one tablet once daily (1 x 10 mg) in the second week, and to one and a half tablets once daily in the third week. From the fourth week onwards, the usual dose is two tablets once daily (1 x 20 mg).

Dosage for patients with renal impairment

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

Administration

Marixino should be administered orally once daily. To get the maximum benefit from your medication, you must take it regularly every day and at the same time each day. The tablets should be swallowed with some water. The 10 mg film-coated tablet may be divided into equal doses. Tablets may be taken with or without food.

Duration of treatment

Continue taking Marixino for as long as it is beneficial for you. Your doctor should periodically evaluate the effects of your treatment.

If you take more Marixino than you should

• In general, taking an excessive amount of Marixino should not cause you any harm. 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 require 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 missed dose.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

In general, adverse effects are classified as mild to moderate.

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

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

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

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

Very rare (may affect up to 1 in 10,000 people):

• Seizures.

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

• Inflammation of the pancreas, inflammation of the liver (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 adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Marixino

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the blister and carton after EXP. The expiry date refers to the last day of the month indicated.

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 and packaging you no longer need. This helps protect the environment.

6. Package contents and additional 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 components (excipients) are:

Tablet core: lactose monohydrate, microcrystalline cellulose (E460), colloidal anhydrous silica, talc (E553b) and magnesium stearate (E470b).

Tablet coating: polymethacrylic acid-ethyl acrylate copolymer (1:1), sodium lauryl sulfate, polysorbate 80, talc (E553b), triacetin and simethicone.

See section 2 “Marixino contains lactose and sodium”:

Presentation of the product and contents of the pack

Film-coated, biconvex, oval white tablets with a score line on one side (tablet length: 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 boxes containing 14, 28, 30, 42, 50, 56, 60, 70, 84, 90, 98, 100 and 112 film-coated tablets in blisters.

Only certain pack sizes may be marketed.

Marketing Authorization 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

Further information on this medicinal product is available upon request by contacting the local representative of the Marketing Authorization Holder.

Date of the most recent review of this leaflet:

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