Product Information for the User

Memantina Cinfa 10 mg Film-Coated Tablets

Memantine Hydrochloride

Read this 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. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.See section 4.

How Memantina Cinfa works

Memantina Cinfa contains the active ingredient memantine hydrochloride. Itbelongs to a group of medicines known as dementia medicines.

The loss of memory in Alzheimer's disease is due to an alteration in brain signals. The brain contains called N-methyl-D-aspartate (NMDA) receptors that participate in the transmission of important nervous signals in learning and memory. Memantina Cinfabelongs to the group of medicines called NMDA receptor antagonists. Memantina Cinfaacts on these receptors, improving the transmission of nervous signals and memory.

What is memantina cinfa used for

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

Do not take Memantina Cinfa

• If you are allergic to memantine hydrochloride or any of the other components 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 had a myocardial infarction (heart attack), if you have congestive heart failure or if you have uncontrolled hypertension (high blood pressure).

In the above situations, treatment should be closely monitored and your doctor should re-evaluate the clinical benefit ofmemantina cinfaregularly.

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

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

Children and adolescents

The use ofMemantina Cinfais not recommended in children and adolescents under 18 years old.

Use of Memantina Cinfa with other medications

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

Specifically,Memantina Cinfamay produce changes in 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 seizures).
• Barbiturates (substances generally used to induce sleep).
• Dopamine agonists (substances such as L-dopa, bromocriptine).
• Neuroleptics (substances used in the treatment of mental illnesses).
• Oral anticoagulants.

If you are admitted to a 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 (for example, from a normal diet to a strict vegetarian diet) or if you have acidosis tubular renal (ATR, excess of 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 medication.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

If you are pregnantor in the lactation period, believe you may be pregnantor intend to become pregnant, consult your doctor before using this medication. The use of memantine is not recommended in pregnant women.

Women takingMemantina Cinfashould discontinue breastfeeding.

Driving and operating machinery

Your condition may affect your ability to drive or operate machinery and you should not engage in these activities unless your doctor tells you it is safe to do so. Memantine may cause dizziness and somnolence, mainly at the beginning of treatment or when increasing the dose. If you experience these effects, do not drive or operate machinery.

Memantina Cinfa contains lactose. If your doctor hastoldyou that you have an intolerance to certain sugars, consult with him before taking this medication.

Memantina Cinfa contains sodium.

This medication contains less than 23 mg of sodium (1 mmol) per tablet; this is, essentially “sodium-free”.

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

Dosage

The recommended dose of Memantina Cinfain adult patients and elderly patients is 20 mg administered once a day. To reduce the risk of adverse effects, this dose is achieved gradually following the daily schedule below:

The normal starting dose is half a tablet once a day (1 x 5mg) in the first week. Itincreases to one tablet a day (1 x 10 mg) in the second week and to one and a half tablets once aday in the third week. From the fourth week onwards, the normal dose is two tablets administered once aday (1 x 20 mg).

Dosage 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 must monitor your renal function periodically.

Administration form

Memantina cinfamust be administered orally once a day. To get the most out of yourmedication, 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.

Treatment duration

Continue takingMemantina Cinfaas long as it is beneficial for you. Your doctor should evaluate the effects ofyour treatment periodically.

If you take more Memantina Cinfa than you should

Generally, taking an excessive amount ofMemantina Cinfashould not cause you any harm. You mayexperience an increase in the symptoms described in section 4 “Possible adverse effects”.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 915620420, indicating the medication and the amount ingested.

If you forgot to take Memantina Cinfa

• If you realize you have forgotten to take your dose ofMemantina Cinfa, wait and take the next dose at theusual time.
• Do not take a double dose to compensate for the missed dose.

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

Like all medications,this medicationcan produce adverse effects, although not allpeople experience them.

Generally, 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, balance disorder, shortness of breath, high blood pressure, and hypersensitivity to themedication.

Rare(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 (venous thromboembolism).

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

• Convulsions.

Unknown frequency (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. There have beenreports of these events in patients treated withMemantina Cinfa.

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es/.By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the packaging and in the blister pack afterCAD. 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 through drains or in the trash.Deposit containers and medications you no longer need at the SIGRE collection point at the pharmacy.In case of doubtask your pharmacist howto dispose of containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Memantina Cinfa

The active ingredient is chlorhydrate of memantina. Each coated tablet contains 10 mg of chlorhydrate of memantina which is equivalent to 8.31 mg of memantina.

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

Appearance of the product and contents of the packaging

Memantina Cinfa 10 mg coated tablets are presented in packaging with white, cylindrical, biconvex tablets marked with “MM1” on one face and with a groove on the other.

Memantina Cinfa10 mg coated tablets are presented in packaging that contains 28, 56 and 112 tablets.

Only some packaging sizes may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Park Areta

31620 Huarte (Navarra) - Spain

Last review date of this leaflet:April 2020

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

You can access detailed and updated information on this medicine by scanning with your smartphone the QR code included in the leaflet and 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