MEMANTINE FLAS CINFA 10 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the User

memantina flas cinfa 10 mg orodispersible tablets EFG

Memantine Hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is memantina flas cinfa and what is it used for
2. What you need to know before you take memantina flas cinfa
3. How to take memantina flas cinfa
4. Possible side effects
5. Storage of memantina flas cinfa
6. Contents of the pack and other information

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

Memantina flas cinfa contains the active substance memantine hydrochloride. It belongs to a group of medicines called anti-dementia medicines. 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 are involved in the transmission of important nerve signals in learning and memory. Memantina flas cinfa belongs to a group of medicines 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 you take memantina flas cinfa

Do not take memantina flas cinfa

If you are allergic to memantine 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 memantina flas cinfa.

In the above situations, treatment should be carefully supervised and your doctor should regularly re-evaluate 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 medicine generally used as an anesthetic), dextromethorphan (a medicine 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 medicines

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

In particular, the administration of memantina flas may produce changes in 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 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 memantina flas.

Taking memantina flas cinfa 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

The use of memantine is not recommended in pregnant women.

Women who take memantine should not breastfeed.

Driving and using machines

Your illness may affect your ability to drive or use machines and you should not carry out these activities unless your doctor tells you it is safe to do so. Memantina flas can 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 machines.

Memantina flas cinfa contains lactose

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

Memantina flas cinfa contains aspartame (E-951)

This medicine contains 2.5 mg of aspartame in each tablet. Aspartame is a source of phenylalanine that may be harmful in cases 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 exactly the administration instructions of this medicine indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

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

Dosage for patients with renal impairment

If you have kidney problems, your doctor will decide 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 is indicated "fold" (Figure 2).

1. Remove the foil

Remove the foil carefully, starting from the corner marked with an arrow and where it is indicated "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 medicine 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 forgotten doses.

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 everybody gets them.

In general, side effects are classified from 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 medicine.

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

• 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 patients):

• Seizures.

Frequency not known (cannot be estimated from the 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 of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of memantina flas cinfa

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of memantina flas cinfa

• The active substance is memantine hydrochloride. Each orodispersible tablet contains 10 mg of memantine hydrochloride, equivalent to 8.31 mg of memantine.
• The other ingredients 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 starch E-1450 (corn starch), and peppermint oil (Mentha arvensis).

Appearance of the product and pack contents

Memantina flas cinfa 10 mg is presented in the form of a pale pink, round, flat, speckled tablet with a beveled edge, with a diameter of 9 mm and marked with the code "10" on one face.

Memantina flas cinfa 10 mg is presented in Al/Al blister packs of 112 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 last revision of this leaflet:May 2020

Detailed information on this medicine 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 medicine by scanning the QR code included in the leaflet and carton with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/83298/P_83298.html

QR code to: https://cima.aemps.es/cima/dochtml/p/83298/P_83298.html