MEMANTINE CINFA 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Memantina Cinfa 10 mg Film-Coated 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 Cinfa and what is it used for
2. What you need to know before you take Memantina Cinfa
3. How to take Memantina Cinfa
4. Possible side effects
5. Storage of Memantina Cinfa
6. Contents of the pack and other 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 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 Cinfa belongs to a group of medicines called NMDA receptor antagonists. Memantina Cinfa acts 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 you take Memantina Cinfa

Do not take Memantina Cinfa

• If you are allergic to memantine hydrochloride or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before taking Memantina Cinfa if:

• You have a history of epileptic seizures (convulsions).
• You have recently suffered a myocardial infarction (heart attack), if you suffer from 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 assess 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 medicines such as amantadine (for the treatment of Parkinson's disease), ketamine (a general anesthetic), dextromethorphan (a cough medicine), and other NMDA antagonists should be avoided.

Children and adolescents

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

Using Memantina Cinfa with other medicines

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

In particular, Memantina Cinfa may affect the action 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 used to treat movement disorders or intestinal spasms).
• Anticonvulsants (substances used to prevent and eliminate convulsions).
• Barbiturates (substances 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 intend 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 (urinary tract), 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 have a baby, ask your doctor for advice before taking this medicine. The use of memantine is not recommended in pregnant women.

Women taking Memantina Cinfa should stop breastfeeding.

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. 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 machines.

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

Memantina Cinfa contains sodium.

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

3. How to take Memantina Cinfa

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

Posology

The recommended dose of Memantina Cinfa in adult and elderly patients is 20 mg once daily. To reduce the risk of adverse reactions, this dose is achieved gradually following the daily scheme:

The normal starting dose is half a tablet once daily (1 x 5mg) for the first week. It is increased to one tablet daily (1 x 10 mg) for the second week and to one and a half tablets once daily for the third week. From the fourth week onwards, the normal 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 on the appropriate dose for your condition. In this case, your doctor should regularly monitor your kidney function.

Method of administration

Memantina Cinfashould be administered orally once daily. 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 Cinfa as long as it is beneficial for you. Your doctor should regularly assess the effects of your treatment.

If you take more Memantina Cinfa than you should

Generally, taking too much 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, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 915620420, indicating the medicine 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 further questions on 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.

Side effects are usually mild to moderate.

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

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

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

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

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

• Seizures.

Frequency not known(cannot be estimated from the 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, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) through the website: https://www.notificaram.es/. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Memantina 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 and blister after EXP. The expiry date is 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 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 ingredients are lactose monohydrate, 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 and packaging

Memantina Cinfa 10 mg film-coated tablets are presented in packs containing 28, 56, and 112 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Polígono Industrial Areta

31620 Huarte (Navarra) - Spain

Date of last revision of this leaflet:April 2020

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

You can access detailed and up-to-date information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. 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