Product Information for the User

Memantina Cinfa 20 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 by 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 memantine cinfa if:

• 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 of memantine cinfa regularly.

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

Memantine should be avoided when used with other medications such as amantadine (for Parkinson's treatment), ketamine (a medication generally used for anesthesia), dextromethorphan (a medication for cough treatment) and other NMDA antagonists.

Children and adolescents

Memantine Cinfa is not recommended for use in children and adolescents under 18 years old.

Use of memantine 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, memantine cinfa may alter 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 like 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 renal tubular acidosis (ATR, excess of acid-producing substances in the blood due to renal dysfunction or severe urinary tract infections), as your doctor may need to adjust the medication dose.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

If you are pregnant or breastfeeding, or think you may be pregnant or intend to become pregnant, consult your doctor before using this medication. Memantine is not recommended for use in pregnant women.

Women taking Memantina Cinfa should discontinue breastfeeding.

Driving and operating machinery

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 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 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".

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

Dosage

The recommended dose is 20 mg administered once a day. To reduce the risk of adverse effects, this dose is achieved gradually following a daily schedule. There are different dosage containers available 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 achieved at the beginning of the fourth week of treatment.

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

Memantine Cinfa must be taken orally once a day. To get the most out of your medication, you should take it every day 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 taking Memantine Cinfa as long as it is beneficial for you. Your doctor should evaluate the effects of your treatment periodically.

If you take more Memantine Cinfa than you should

Generally, taking an excessive amount of Memantine Cinfa should not cause any harm. You may experience 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 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 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 medication may produce adverse effects, although not all people may 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 the medication.

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):

• Seizures.

Frequency unknown (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 been reports of these events in patients treated with Memantina 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 carton and on 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 the packaging and medications you no longer need at the SIGRE collection pointat the pharmacy. If in doubtask your pharmacist howto dispose of the packaging 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 film-coated tablet contains 20mg of chlorhydrate of memantina which are equivalent to 16.62 mg of memantina.

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

Appearance of the product and content of the packaging

Memantina Cinfa20 mg film-coated tablets are presented in packaging with pink, cylindrical, biconvex tablets marked with “MM2” on one face and with a groove on the other.

Memantina Cinfa20 mg film-coated tablets are presented in packaging that contains 56 tablets.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Cinfa, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) - Spain

Last review date of this leaflet:April 2020

The detailed and updated information of 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 about this medicine by scanning with your mobile phone (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/77540/P_77540.html

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