MEMANTINE COMBIX 10 mg ORALLY DISINTEGRATING TABLETS

Introduction

Leaflet: information for the user

Memantina Flas Combix 10 mg oral dispersible tablets EFG

memantine hydrochloride

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult 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 leaflet. See section 4.

Contents of the leaflet:

1. What is Memantina Flas Combix and what is it used for
2. What you need to know before taking Memantina Flas Combix
3. How to take Memantina Flas Combix
4. Possible side effects
5. Storage of Memantina Flas Combix
6. Package contents and additional information

1. What is Memantina Flas Combix and what is it used for

Memantina Flas Combix 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. Memantine belongs to the group of medications called NMDA receptor antagonists. Memantine acts on these receptors, improving the transmission of nerve signals and memory.

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

2. What you need to know before taking Memantina Flas Combix

Do not take Memantina Flas Combix

• if you are allergic to memantine hydrochloride or any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to take this medication:

• 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 the above situations, treatment should be carefully monitored and your doctor should regularly reassess the clinical benefit of memantine.

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

If you have renal tubular acidosis (RTA, excess of acid-producing substances in the blood due to kidney dysfunction) or severe urinary tract infections, your doctor may need to adjust the dose of the medication.

The use of memantine with other medications such as amantadine (for the treatment of Parkinson's disease), ketamine (a medication generally 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 memantine is not recommended in children and adolescents under 18 years of age.

Other medications and Memantina Flas Combix

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

In particular, the administration of memantine 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 convulsions),
• 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 hospitalized, inform your doctor that you are taking memantine.

Taking Memantina Flas Combix with food and drinks

You should inform your doctor if you have recently changed or plan to change your diet substantially (e.g., from a normal diet to a strict vegetarian diet), 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 memantine should stop breastfeeding.

Driving and using machines

Your doctor will inform you if your illness allows you to drive and use machines safely.

Additionally, memantine may alter your reaction ability, so driving or operating machines may be inappropriate.

Memantina Flas Combix contains sodium

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

Memantina Flas Combix contains Red Allura AC

It may cause allergic reactions.

3. How to take Memantina Flas Combix

Follow the administration instructions of this medication exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose of memantine in adult and elderly patients is 20 mg administered once a day. To reduce the risk of side effects, this dose is gradually achieved by following the following daily treatment scheme:

The normal starting dose is one 5 mg tablet once a day for the first week. It is increased to one 10 mg tablet per day in the second week and to 15 mg once a day in the third week. From the fourth week onwards, the normal dose is two 10 mg tablets or one 20 mg tablet administered once a day.

The tablets of Memantina Flas Combix cannot be divided. For unavailable doses of memantina flas combix, the patient should use another medication that contains memantine with an available dose

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 periodically monitor your kidney function.

Administration

Memantine should be administered orally once a day. To get the most out of your medication, you should take it every day and at the same time. The tablets should be placed on the tongue and allowed to dissolve before swallowing them with or without water, as preferred by the patient. The tablets can be taken with or without food.

Duration of treatment

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

Instructions for use

The oral dispersible tablets of memantina are fragile, so they should be handled with care.

Do not handle the tablets with wet hands, as they may break.

1. Hold the blister pack by the ends and separate one of the cells from the rest, gently breaking it along the perforations that surround it.
2. Gently remove the back of the cell.

Place the tablet on your tongue. It will dissolve directly in the mouth, so it can be swallowed without water.

If you take more Memantina Flas Combix than you should

• Generally, taking an excessive amount of memantine 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 memantine, contact your doctor or seek medical advice, as you may need medical attention.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount administered.

If you forget to take Memantina Flas Combix

• If you realize you have forgotten to take your dose of memantine, 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 experiences 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, difficult 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 venous thrombosis/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 leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Memantina Flas Combix

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

Do not use this medication after the expiration date shown on the packaging and on the blister pack after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Memantina Flas Combix

• The active ingredient is memantine hydrochloride. Each oral dispersible tablet contains 10 mg of memantine hydrochloride, equivalent to 8.31 mg of memantine.
• The other components are: microcrystalline cellulose, mannitol (E421), sodium croscarmellose, sucralose, peppermint flavor, magnesium stearate, anhydrous colloidal silica, and Red Allura AC (E129).

Appearance of the product and package contents

The oral dispersible tablets of Memantina Flas Combix are pale pink to pink mottled, round, flat, with beveled edges, engraved with "M10" on one face and smooth on the other. The diameter of the tablet is approximately 9 mm.

Memantina Flas Combix is available in blister packs of 112 oral dispersible tablets.

Marketing authorization holder

Laboratorios Combix, S.L.U.

C/ Badajoz 2. Edificio 2.

28223 Pozuelo de Alarcón (Madrid)

Spain

Manufacturer

Zydus France

ZAC Les Hautes Patures

Parc d'activités des Peupliers

25 Rue des Peupliers

92000 Nanterre

France

or

Centre Spécialités Pharmaceutiques

ZAC des Suzots

35 rue de la Chapelle

63450 Saint Amant Tallende

France

or

Netpharmalab Consulting Services S.L.

Carretera de Fuencarral 22

28108 Alcobendas, Madrid

Spain

or

Laboratori Fundacio DAU

C/De la letra C, 12-14,

Polígono Industrial de la Zona Franca,

08040 Barcelona,

Spain

or

Flavine Pharma France

3 Voie d’Allemagne

13127 Vitrolles

France

Date of the last revision of this leaflet: February 2024

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/