MEMANTINE CINFA 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Memantina Cinfa 20 mg Film-Coated 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 Cinfa and what is it used for
2. What you need to know before taking Memantina Cinfa
3. How to take Memantina Cinfa
4. Possible side effects
5. Storage of Memantina Cinfa
6. Contents of the pack and further information

1. What is Memantina Cinfa and what is it used for

How Memantina Cinfa works

Memantina Cinfa contains the active substance 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 Cinfabelongs to the group of medications called NMDA receptor antagonists. Memantina Cinfaacts on these receptors, improving the transmission of nerve signals and memory.

What Memantina Cinfa is used for

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

2. What you need to know before taking Memantina Cinfa

Do not take Memantina Cinfa

• 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 Memantina Cinfaif:

• You have a history of epileptic seizures (convulsions).
• You have recently suffered a myocardial infarction (heart attack), if you have 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 re-evaluate the clinical benefit of Memantina Cinfa.

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

The use of memantine with other medications such as amantadine (for the treatment of Parkinson's disease), ketamine (a medication generally used to produce anesthesia), dextromethorphan (a medication for the treatment of cough), and other NMDA antagonists should be avoided.

Children and adolescents

The use of Memantina Cinfais not recommended in children and adolescents under 18 years of age.

Use of Memantina Cinfa with other medications

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

In particular, Memantina Cinfamay affect the effects of the following medications, so your doctor may need to adjust the doses:

• 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 Cinfa.

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

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication. The use of memantine is not recommended in pregnant women.

Women taking Memantina Cinfashould stop breastfeeding.

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. Memantine 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 Cinfa contains lactose.

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

Memantina Cinfa contains sodium.

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

3. How to take Memantina Cinfa

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

Posology

The recommended dose is 20 mg administered once a day. To reduce the risk of side effects, this dose is gradually achieved by following a daily scheme. There are packages of different doses that allow for adjustment in the amount.

At the beginning of treatment, take 5 mg of memantine once a day. Then, this amount is increased by 5 mg per week until the recommended dose (maintenance dose) is reached. The recommended dose is 20 mg once a day and is reached at the beginning of the fourth week of treatment.

Posology 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.

Method of administration

Memantina Cinfashould 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 swallowed with a little water. The tablets can be taken with or without food.

The tablet can be divided into equal doses.

Duration of treatment

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

If you take more Memantina Cinfa than you should

Generally, taking an excessive amount of Memantina Cinfashould 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 Toxicology Information Service, phone: 915620420, indicating the medication and the amount ingested.

If you forget to take Memantina Cinfa

• If you realize you have forgotten to take your dose of Memantina Cinfa, 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 will experience them.

Generally, side effects are classified as mild to moderate.

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

• Headache, somnolence, constipation, elevated liver function tests, dizziness, balance disorder, shortness of breath, 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 (inflammation of the liver), and psychotic reactions.

Alzheimer's disease has been associated with depression, suicidal ideation, and suicide. These events have been reported in patients treated with Memantina Cinfa.

Reporting of 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 Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es/. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Memantina Cinfa

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

Do not use this medication after the expiration date stated on the carton and blister pack after EXP. 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 via wastewater or household waste. Deposit the packaging and any unused medication in the pharmacy's SIGRE collection point. If in doubt, consult your pharmacist on how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Contents of the pack and further information

Composition of Memantina Cinfa

The active substance is memantine hydrochloride. Each film-coated tablet contains 20 mg of memantine hydrochloride, equivalent to 16.62 mg of memantine.

The other ingredients are lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, and magnesium stearate in the tablet core; and hypromellose, titanium dioxide (E-171), macrogol 400, and red iron oxide (E-172) in the tablet coating.

Appearance of the product and pack contents

Memantina Cinfa 20 mg film-coated tablets are presented in packages containing 56 tablets.

Marketing authorization holder and manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

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

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

You can access detailed and updated information on 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/77540/P_77540.html

QR code to: https://cima.aemps.es/cima/dochtml/p/77540/P_77540.html