Marixino 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Marixino 20 mg Film-Coated Tablets EFG

Memantine Hydrochloride

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

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

Contents of the Package Leaflet:

1. What is Marixino and what is it used for
2. What you need to know before taking Marixino
3. How to take Marixino
4. Possible side effects
5. Storage of Marixino
6. Package Contents and Additional Information

1. What is Marixino and what is it used for

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

Do not take Marixino

• if you are allergic (hypersensitive) to memantine or any of the other ingredients 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 hypertension (high blood pressure).

In these situations, treatment should be carefully supervised, and your doctor should regularly reassess 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 medications such as amantadine (for the treatment of Parkinson's disease), ketamine (a medication commonly used as an anesthetic), dextromethorphan (a medication for the treatment of cough), and other NMDA antagonists should be avoided.

Children and Adolescents

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

Using Marixino with Other Medications

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

In particular, 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 commonly used to treat movement disorders or intestinal spasms).
• anticonvulsants (substances used to prevent and eliminate seizures).
• barbiturates (substances commonly 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 hospitalized, 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 medication.

Pregnancy and Breastfeeding

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

Pregnancy

The use of memantine is not recommended in pregnant women.

Breastfeeding

Women taking Marixino should stop breastfeeding.

Driving and Using Machines

Your doctor will inform you if your illness allows you to drive and use machines safely. Additionally, Marixino may alter your reaction ability, so driving or operating machines may be inappropriate.

Marixino Contains Lactose and Sodium

If your doctor has told you 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".

3. How to Take Marixino

Follow the administration instructions of this medication exactly 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 daily. To reduce the risk of side effects, this dose is gradually achieved by following the daily scheme. To increase the titration, other doses of film-coated tablets are available.

At the start of treatment, you will begin taking half of a 10 mg film-coated tablet once daily (1 x 5 mg). This dose will be increased weekly by 5 mg until the recommended maintenance dose is reached (20 mg). The recommended maintenance dose is 20 mg once daily, which is achieved at the beginning of the fourth week.

Dosage for Patients with Renal Impairment

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 administered orally once daily. 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 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 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 other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Generally, side 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 disorder, difficulty breathing, high blood pressure, and hypersensitivity to the medication.

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

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

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

• Seizures.

Frequency Not Known (frequency cannot be estimated from 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 Side Effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the national reporting system included in Appendix V. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Marixino

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

Do not use this medication after the expiration date stated on the blister pack and carton 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 via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Marixino

• The active ingredient is memantine hydrochloride.

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

• The other ingredients (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 Package Contents

Marixino film-coated tablets are biconvex, oval, and white (tablet width: 15.7-16.4 mm; 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.

Not all 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

You can obtain more information about this medication by contacting the local representative of the marketing authorization holder.

Date of Last Revision of this Package Leaflet:

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