Prospecto:information for the user

Memantina Flas Combix 10 mg buccal tablets EFG

memantine hydrochloride

Read this prospect carefullybefore starting to take thismedicine,because it contains important informationfor you.

• Keep this prospect, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you, and you must not give it to others even if they 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 prospect. See section 4.

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

2.What you need to knowbeforestarting totake Memantina Flas Combix

3.How to take Memantina Flas Combix

4.Possible adverse effects

5.Storage of Memantina Flas Combix

6.Contents of the package and additional information

Memantina Flas Combix contains the active ingredient memantine hydrochloride. It belongs to a group of medicines known as dementia medications.

The loss of memory 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. Memantine belongs to the group of medicines called NMDA receptor antagonists. Memantine acts on these receptors by improving the transmission of nervous signals and memory.

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

Do not take Memantina Flas Combix

• if you are allergic to memantine hydrochloride 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 this medication:

• 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 your doctor must reevaluate the clinical benefit of memantine regularly in the above situations.

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

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

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

Children and adolescents

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

Other medications and Memantina Flas Combix

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

Specifically, the administration of memantine may produce changes in the effects of the following medications, so your doctor may need to adjust the dosage:

• 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 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 significantly (for example from a normal diet to a strict vegetarian diet), as your doctor may need to adjust the medication dosage.

Pregnancy and breastfeeding

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

Pregnancy

Memantine is not recommended for use in pregnant women.

Breastfeeding

Women taking memantine should discontinue breastfeeding.

Driving and operating machinery

Your doctor will inform you if your condition allows you to drive and use machinery safely.

Additionally, memantine may affect your reaction time, making driving or operating machinery unsuitable.

Memantina Flas Combix contains sodium

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

Memantina Flas Combix contains Rojo Allura AC

It may cause allergic reactions.

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

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

The normal starting dose is one 5 mg tablet once a day in the first week. It is increased to one 10 mg tablet a 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.

Memantine Flas Combix tablets cannot be split. For doses not available of memantine flas combix, the patient should use another medication containing memantine whose dose is available..

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 periodically.

Administration

Memantine must be taken 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.

Treatment duration

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

Usage instructions

The buccal dispersible tablets of memantine break apart, so they must be handled carefully.

Do not handle the tablets with wet hands because they may disintegrate.

1. Hold the blister pack by the ends and separate one of the cells from the rest, breaking it gently around the perforations that surround it.

2. Remove the back part of the cell gently.

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 adverse effects”.
• If you take a memantine overdose, 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 Toxicological 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 memantine 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 doubts about the use of this medication, ask your doctor or pharmacist.

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

Adverse effects are generally classified as mild to moderate.

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

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

Rare (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, 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 Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on 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 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

Medicines should not be thrown down the drains or in the trash.Deposit the packaging and the medications you no longer need at the SIGRE collection point of the pharmacy.In case of doubt, ask your pharmacist how to dispose ofthe packaging and themedications you no longerneed. By doing so, you will help protect the environment.

Composition of Memantina Flas Combix

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

Appearance of the product and content of the container

Memantina Flas Combix buccal dispersible tablets are pale pink to speckled pink, rounded, flat, beveled-edge tablets, engraved with “M10” on one face and smooth on the other. The tablet diameter is approximately 9 mm.

Memantina Flas Combix is available in blisters of 112 buccal dispersible tablets.

Holder of the marketing authorization

Combix, S.L.U.

C/ Badajoz 2. Edificio 2.

28223 Pozuelo de Alarcón (Madrid)

Spain

Responsible for manufacturing

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

Last review date of this leaflet: February 2024

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/