Memantina CINFA 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Memantina Cinfa 10 mg film-coated tablets EFG

Memantine hydrochloride

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Memantina Cinfa is and what it is used for
2. What you need to know before taking Memantina Cinfa
3. How to take Memantina Cinfa
4. Possible adverse effects
5. How to store Memantina Cinfa
6. Contents of the pack and other information

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

How Memantina Cinfa works

Memantina Cinfa contains the active substance memantine hydrochloride. It belongs to a group of medicines known as antidementia drugs.

Memory loss in Alzheimer's disease is due to disturbances in brain signaling. The brain contains so-called N-methyl-D-aspartate (NMDA) receptors, which are involved in the transmission of nerve signals important for learning and memory. Memantina Cinfa belongs to a group of medicines called NMDA receptor antagonists. Memantina Cinfa acts on these receptors, improving nerve signal transmission and memory.

What Memantina Cinfa is used for

Memantina Cinfa is 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 to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before starting Memantina Cinfa if:

• You have a history of epileptic seizures (convulsions).
• You have recently had a myocardial infarction (heart attack), suffer from congestive heart disease, or have uncontrolled hypertension (high blood pressure).

In the above situations, treatment should be carefully monitored, and your doctor should regularly reassess the clinical benefit of Memantina Cinfa.

If you have renal impairment (kidney problems), your doctor should closely monitor kidney function and, if necessary, adjust the dosage of memantine.

The use of memantine should be avoided concomitantly with other medicines such as amantadine (used to treat Parkinson’s disease), ketamine (a drug generally used to induce anesthesia), dextromethorphan (a cough medication), and other NMDA antagonists.

Children and adolescents

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

Taking Memantina Cinfa with other medicines

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

Specifically, Memantina Cinfa may cause changes in the effects of the following medicines, so your doctor may need to adjust their doses:

• Amantadine, ketamine, dextromethorphan.
• Dantrolene, baclofen.
• Cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine.
• Hydrochlorothiazide (or any combination containing hydrochlorothiazide).
• Anticholinergics (substances generally used to treat movement disorders or intestinal spasms).
• Anticonvulsants (substances used to prevent and control 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 admitted to hospital, 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 substantially change your diet (e.g., from a normal diet to a strict vegetarian diet), or if you have renal tubular acidosis (RTA, excess acid-producing substances in the blood due to renal dysfunction [kidney problem]) or severe urinary tract infections, as your doctor may need to adjust the dose of the medicine.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

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

Women taking Memantina Cinfa should discontinue breastfeeding.

Driving and using machines

Your medical condition may affect your ability to drive or operate machinery, and you should not perform these activities unless your doctor advises it is safe to do so. Memantine may cause dizziness and somnolence, especially at the beginning of treatment or when the dose is increased. If you experience these effects, you must not drive or operate machinery.

Memantina Cinfa contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with them before taking this medicine.

Memantina Cinfa contains sodium.

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

3. How to take Memantina Cinfa

Follow exactly the administration instructions for this medicine given by your doctor. If in doubt, consult your doctor again.

Dosage

The recommended dose of Memantina Cinfa in adult and elderly patients is 20 mg administered once daily. To reduce the risk of adverse effects, this dose is reached gradually according to the following daily regimen:

The usual starting dose is half a tablet once daily (1 x 5 mg) during the first week. This is increased to one tablet daily (1 x 10 mg) during the second week, and to one and a half tablets once daily during the third week. From the fourth week onwards, the usual dose is two tablets administered once daily (1 x 20 mg).

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.

Method of administration

Memantina cinfa should be administered orally once daily. To obtain the maximum benefit from your medication, you must take it every day at the same time. The tablets should be swallowed with a little water. The tablets may be taken with or without food.

The tablet may be divided into equal doses.

Duration of treatment

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

If you take more Memantina Cinfa than you should

In general, taking an excessive amount of Memantina Cinfa 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, contact your doctor or pharmacist immediately or call the Poison Information Service at telephone number: 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 missed dose.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

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

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

• Headache, drowsiness, constipation, elevated liver function tests, dizziness, loss of balance, shortness of breath, high blood pressure, and hypersensitivity to the medicine.

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

• Fatigue, fungal infections, confusion, hallucinations, vomiting, impaired gait, heart failure, and formation of blood clots in the venous system (venous thrombosis/venous thromboembolism).

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

• Seizures.

Frequency not known (cannot be estimated from available data):

• Inflammation of the pancreas, hepatitis (liver inflammation), 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 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 leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es/. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Memantine Cinfa

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

Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the container and additional information

Composition of Memantina Cinfa

The active substance is memantine hydrochloride. Each film-coated tablet contains 10 mg of memantine hydrochloride, equivalent to 8.31 mg of memantine.

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

Appearance of the product and contents of the container

Memantina Cinfa 10 mg film-coated tablets are presented in packs containing white, cylindrical, biconvex tablets, marked with "MM1" on one side and a score line on the other.

Memantina Cinfa 10 mg film-coated tablets are available in pack sizes containing 28, 56, and 112 tablets.

Only certain pack sizes may be commercially available.

Marketing Authorization Holder and Manufacturer

Laboratorios Cinfa, S.A.
Carretera Olaz-Chipi, 10. Polígono Industrial Areta
31620 Huarte (Navarra) - Spain

Date of the most recent review of this leaflet: April 2020

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/77539/P_77539.html

QR code to: https://cima.aemps.es/cima/dochtml/p/77539/P_77539.html