MEMANTINE FLAS CINFA 20 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the User

memantina flas cinfa 20 mg orodispersible 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, 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 package leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is memantina flas cinfa and what is it used for

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

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

2. What you need to know before taking memantina flas cinfa

Do not take memantina flas cinfa

If you are allergic to memantine 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 memantina flas cinfa.

In the above situations, treatment should be carefully supervised, and your doctor should regularly reevaluate 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.

Taking memantina flas cinfa with other medications

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 memantina flas 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),
• 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 memantina flas.

Taking memantina flas cinfa with food and beverages

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.

The use of memantine is not recommended in pregnant women.

Women taking memantine should not breastfeed.

Driving and using machines

Your illness may affect your ability to drive or use machinery, and you should not perform these activities unless your doctor indicates that it is safe to do so. Memantina flas may cause dizziness and somnolence, mainly at the start of treatment or when increasing the dose. If you experience these effects, do not drive or use machinery.

Memantina flas cinfa contains lactose

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

Memantina flas cinfa contains aspartame (E-951)

This medication contains 5 mg of aspartame in each tablet. Aspartame contains a source of phenylalanine that may be harmful in case of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it correctly.

3. How to take memantina flas cinfa

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

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

The tablets of memantina flas cinfa cannot be divided. For doses not available for memantina flas cinfa, you should use another medication that contains memantine with an available dose.

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 should periodically monitor your kidney function.

Administration

Memantina flas cinfa 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.

Take the orodispersible tablet as follows:

1. Do not crush the orodispersible tablet

To avoid crushing the orodispersible tablet, do not press the blister (Figure 1).

1. Separate a blister

Each blister pack contains fourteen blisters, which are separated by perforations. Separate a blister following the perforated lines, where it says "fold" (Figure 2).

1. Remove the foil

Remove the foil carefully, starting from the corner marked with an arrow and where it says "pull here" (Figures 3 and 4).

1. Remove the orodispersible tablet

Remove the orodispersible tablet with dry hands and place it on the tongue (Figure 5).

The tablet will dissolve quickly, and once dissolved, it can be swallowed with or without water, according to your preference.

The tablets can be taken with or without food.

Duration of treatment

Continue taking memantina flas while it is beneficial for you. Your doctor should evaluate the effects of your treatment periodically.

If you take more memantina flas cinfa than you should

In general, 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".

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 ingested.

If you forget to take memantina flas cinfa

If you realize that you have forgotten to take your dose of memantina flas, wait and take the next dose at the usual time.

Do not take a double dose to make up for the missed doses.

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.

In general, side effects are classified as mild to moderate.

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

• 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 patients):

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

Very rare (may affect up to 1 in 10,000 patients):

• Seizures.

Frequency not known (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 Spanish Medication Monitoring System for Human Use: https://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 cinfa

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

Do not use this medication after the expiration date stated on the packaging 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. Place the packaging and any unused medication in the SIGRE collection point at the pharmacy. If in doubt, 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 memantina flas cinfa

• The active ingredient is memantine hydrochloride. Each orodispersible tablet contains 20 mg of memantine hydrochloride, equivalent to 16.62 mg of memantine.
• The other components are: polacrilin, lactose monohydrate, microcrystalline cellulose (E-460), colloidal anhydrous silica, sodium croscarmellose, mannitol (E-421), aspartame (E-951), red iron oxide (E-172), magnesium stearate, sodium hydroxide (for pH adjustment), and peppermint flavor: maltodextrin (corn), modified cornstarch E-1450 (waxy corn), and peppermint oil (Mentha arvensis).

Appearance of the product and package contents

Memantina flas cinfa 20 mg is presented in the form of a pale pink, round, flat, speckled tablet with a beveled edge, with a diameter of 12 mm and marked with the code "20" on one side.

Memantina flas cinfa 20 mg is presented in Al/Al blister packs of 56 orodispersible tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Manufacturer

Genepharm S.A.

18 km Marathon Avenue

15351 Pallini Attikis, Greece.

or

Rontis Hellas S.A.

Industrial Area of Larissa, P.O. Box 3012, GR41004 Larissa

Greece.

or

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of the last revision of this package leaflet:May 2020

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

You can access detailed and updated information about this medication by scanning the QR code included in the package leaflet and packaging with your smartphone. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/83297/P_83297.html

QR code to: https://cima.aemps.es/cima/dochtml/p/83297/P_83297.html