Memantin CINFA 20 mg film-coated tablets EFG
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Memantina Cinfa 20 mg film-coated tablets EFG
Memantine hydrochloride
Read this entire leaflet carefully before you start taking this medicine, as 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, since it could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
Leaflet Contents
- What Memantina Cinfa is and what it is used for
- What you need to know before taking Memantina Cinfa
- How to take Memantina Cinfa
- Possible side effects
- How to store Memantina Cinfa
- 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 anti-dementia drugs.
Memory loss in Alzheimer's disease is due to disturbances in brain signaling. The brain contains receptors known as 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 the transmission of nerve signals 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 must be carefully supervised, and your doctor should regularly reassess the clinical benefit of memantina cinfa.
If you have renal impairment (kidney problems), your doctor must closely monitor your kidney function and, if necessary, adjust the doses of memantine.
The use of memantine should be avoided together with other medicines such as amantadine (used to treat Parkinson's disease), ketamine (a drug generally used to induce anesthesia), dextromethorphan (a cough medicine), 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 taking, have recently taken, or might need to take any other medicines.
Specifically, Memantina Cinfa may cause changes in the effects of the following medicines, so your doctor may need to adjust the 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 intend to substantially change your diet (for example, 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 kidney 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 plan 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 condition may affect your ability to drive or operate machinery, and you should not perform these activities unless your doctor tells you it is safe. Memantina may cause dizziness and drowsiness, 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 memantine Cinfa
Follow exactly the administration instructions for this medicine given by your doctor. If in doubt, consult your doctor again.
Dosage
The recommended dose is 20 mg administered once daily. To reduce the risk of adverse effects, this dose should be reached gradually according to a daily schedule. Packaging is available in different strengths to allow dose adjustment.
At the beginning of treatment, take 5 mg of memantine once daily. The dose is then increased by 5 mg per week until the recommended dose (maintenance dose) is reached. The recommended dose of 20 mg once daily is reached at the beginning of the fourth week of treatment.
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
Memantine Cinfa should be administered orally once daily. To get 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 Memantine Cinfa for as long as it is beneficial for you. Your doctor should periodically evaluate the effects of your treatment.
If you take more Memantine Cinfa than you should
In general, taking an excessive amount of Memantine 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 Toxicology Information Service at telephone number: 915620420, indicating the medication and the amount ingested.
If you forget to take Memantine Cinfa
- If you realize you have forgotten to take your dose of Memantine 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 will experience them.
In general, adverse effects are classified as mild to moderate.
Frequent (may affect up to 1 in 10 people):
- Headache, somnolence, 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 people):
- Fatigue, fungal infections, confusion, hallucinations, vomiting, gait disturbance, 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):
- Pancreatitis, 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 may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: 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 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 is the last day of the month indicated.
This medicine does not require any special storage conditions.
Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE Point at your pharmacy. If you have any doubts, 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 other 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 components are lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous 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 medicinal product and contents of the container
Memantina Cinfa 20 mg film-coated tablets are presented as pink, cylindrical, biconvex tablets marked “MM2” on one side and with a score line on the other.
Memantina Cinfa 20 mg film-coated tablets are available in packs 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 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 Medical Devices (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 carton. You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/77540/P_77540.html
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