MEMANTINE COMBIX 20 mg ORALLY DISINTEGRATING TABLETS

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 ingredients of this medicine (listed in section 6).

Warnings and precautions

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

• 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 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 medicine.

The use of memantine with other medicines such as amantadine (for the treatment of Parkinson's disease), ketamine (a general anesthetic), dextromethorphan (a cough medicine), 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 medicines and Memantina Flas Combix

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

In particular, the administration of memantine may affect 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 used to treat movement disorders or intestinal spasms),
• anticonvulsants (substances used to prevent and eliminate seizures),
• barbiturates (substances 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 intend 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 medicine.

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 medicine.

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 affect your reaction ability, so driving or operating machines may be inappropriate.

Memantina Flas Combix contains sodium

This medicine 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 for this medicine 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 daily. To reduce the risk of side effects, this dose is gradually achieved by following the daily treatment scheme:

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

The tablets of Memantina Flas Combix cannot be divided. For doses not available for Memantina Flas Combix, the patient should use another medicine containing memantine whose dose is available.

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 daily. 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 the patient prefers. 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 memantine 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, breaking it gently 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 medicine 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 medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

Side effects are generally classified as mild to moderate.

Common (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 medicine.

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

• Fatigue, fungal infections, confusion, hallucinations, vomiting, gait disturbance, heart failure, and venous thrombosis/thromboembolism.

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 Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Memantina Flas Combix

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

Do not use this medicine after the expiration date stated on the packaging and blister pack after EXP. The expiration date is the last day of the month indicated.

This medicine does not require special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines 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 20 mg of memantine hydrochloride, equivalent to 16.62 mg of memantine.
• The other ingredients 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 "M20" on one side and smooth on the other. The diameter of the tablet is approximately 12 mm.

Memantina Flas Combix is available in blister packs of 56 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 medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/