Package Insert: Information for the Patient

Marixino 20 mg Film-Coated Tablets EFG

Memantine Hydrochloride

Read this entire package insert carefully before starting to take this medication, as it contains important information for you.

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

Marixino contains the active ingredient hydrochloride of memantine. It belongs to a group of medications known as dementia medications. Memory loss in Alzheimer's disease is due to an alteration in brain signals. The brain contains called N-methyl-D-aspartate (NMDA) receptors that participate in the transmission of important nervous signals in learning and memory. Marixino belongs to the group of medications called NMDA receptor antagonists. Marixino acts on these receptors by improving the transmission of nervous signals and memory.

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

Do not take Marixino

• if you are allergic (hypersensitive) to memantine or to any of the other components of this medication (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 failure or if you have uncontrolled high blood pressure.

The treatment must be closely monitored and the doctor must reevaluate the clinical benefit of Marixino regularly in the above situations.

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

Memantine should be avoided when used with other medications such as amantadine (for Parkinson's treatment), ketamine (a medication generally used as an anesthetic), dextromethorphan (a medication for cough treatment) and other NMDA antagonists.

Children and adolescents

Marixino is not recommended for use in children and adolescents under 18 years old.

Use of Marixino with other medications

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

Specifically, the administration of Marixino may produce changes in the effects of the following medications, 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 generally used to treat movement disorders or intestinal spasms).
• anticonvulsants (substances used to prevent and eliminate seizures).
• barbiturates (substances generally used to induce sleep).
• dopamine agonists (substances like L-dopa, bromocriptine).
• neuroleptics (substances used in the treatment of mental illnesses).
• oral anticoagulants.

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

Taking Marixino with food and drinks

You must inform your doctor if you have recently changed or intend to change your diet significantly (for example from a normal diet to a strict vegetarian diet) or if you have renal tubular acidosis (ATR, excess acid-producing substances in the blood due to renal dysfunction or severe urinary tract infections), as your doctor may need to adjust the medication dose.

Pregnancy and breastfeeding

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

Pregnancy

Memantine is not recommended for use in pregnant women.

Breastfeeding

Women taking Marixino should discontinue breastfeeding.

Driving and operating machinery

Your doctor will inform you if your condition allows you to drive and use machinery safely. Additionally, Marixino may alter your reaction time, making driving or operating machinery unsuitable.

Marixino contains lactose and sodium

If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication.

This medication contains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, ask your doctor or pharmacist.

Dosage

The recommended dose of Marixino in adults and the elderly is 20 mg administered once a day. To reduce the risk of adverse effects, this dose is achieved gradually following the daily schedule below. Other film-coated tablet doses are available to increase titration.

At the beginning of treatment, you will start taking half of a 10 mg film-coated 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 achieved at the beginning of the fourth week.

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 must monitor your renal function at specific intervals.

Administration

Marixino must be taken orally once a day. To get the most out of your medication, you should take it regularly every day 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.

Treatment duration

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 an excessive amount of Marixino should not cause any harm. You may experience an increase in the symptoms described in section 4 “Possible adverse 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 Marixino dose, wait and take the next dose at the usual time.
• Do not take a double dose to compensate for the missed dose.

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

Like all medications, this medication may produce adverse effects, although not all people may experience them.

Generally, adverse effects are classified as mild to moderate.

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

• Headache, drowsiness, constipation, elevated liver function tests, dizziness, balance alteration, respiratory difficulty, high blood pressure, and hypersensitivity to the medication.

Poorly Frequent (may affect up to 1 in 100 people):

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

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

• Seizures.

Unknown Frequency (frequency cannot be estimated from available data)

• Pancreatitis, hepatitis (inflammation of the liver), 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 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 prospectus. You can also report them directly through the national notification system included in Appendix V.. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the blister pack and on the box after EXP. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.

Marixino Composition

• The active ingredient is memantine hydrochloride.

Each film-coated tablet contains 20 mg of memantine hydrochloride, which is equivalent to 16.62 mg of memantine.

• The other components (excipients) are:

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

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

See section 2 “Marixino contains lactose and sodium”:

Appearance of the product and contents of the pack

Biconvex, oval-shaped, white film-coated tablets (tablet width: 15.7-16.4 mm; tablet thickness: 4.7-5.7 mm).

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.

Only some pack sizes may be marketed.

Marketing Authorization Holder

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

Responsible Person

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

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

For more information about this medicinal product, please contact the local representative of the marketing authorization holder.

Last update of this leaflet:

The detailed information on this medicinal product is available on the website of the European Medicines Agency (EMA)http://www.ema.europa.eu.