Package Insert: Information for the Patient

MemantinePensa 10 mg Film-Coated Tablets
Hidroclorurodememantina

Read this package insert carefully before starting to take this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

How Memantina Pensa works

Memantina Pensa belongs to a group of medicationsdenominatedanti-dementia medications. Memory loss 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 Pensa belongs to the group of medications called NMDA receptor antagonists. Memantina Pensa acts on these receptors by improving the transmission of nervous signals and memory.

What Memantina Pensa is used for:

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

Do not takeMemantina Pensa:

• if you are allergic to the active ingredienthydrochlorideofmemantinaor to 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 Pensa:

• if you have a history of epileptic seizures.
• if 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 must be closely monitored and your doctor must regularly reevaluate the clinical benefit of Memantina Pensa.

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

Memantina 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

Memantina Pensa is not recommended for use in children and adolescents under 18 years old.

Taking Memantina Pensa with other medications

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

In particular, the administration of Memantina Pensa may 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 Pensa.

Taking Memantina Pensa with food and drinks

You must inform your doctor if you have recently changed or intend to change your diet significantly (for example from a normal diet to a strict vegetarian diet) or if you have renal tubular acidosis (ATR, excess 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

If you are pregnant or breastfeeding, or if you think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Memantina is not recommended for use in pregnant women.

Women taking Memantina Pensa should discontinue breastfeeding.

Driving and operating machinery

Your doctor will inform you if your condition allows you to drive and use machinery safely.

Furthermore, Memantina Pensa may alter your reaction time, making driving or operating machinery inappropriate.

Follow exactly the administration instructions of this medication as indicated by your doctor.This medicationindicated by your doctor.Consult your doctor or pharmacist again in case of doubt.

Dosage

The recommended dose of Memantina Pensa in 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 initial normal dose is half a tablet of 10 mg once a day (5 mg) in the first week. It is increased to one tablet of 10 mg once a day (10 mg) in the second week and to one and a half tablets once a day (15 mg) in the third week. From the fourth week onwards, the normal dose is two tablets of 10 mg administered once a day (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 should monitor your renal function periodically.

Administration

Memantina Pensa should be administered 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.

Treatment duration

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

If you take more Memantina Pensa than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

Generally, taking an excessive amount of Memantina Pensa should not cause any harm. You may experience an increase in the symptoms described in section 4.

If you forget to take Memantina Pensa

If you realize you have forgotten to take your dose of Memantina Pensa, 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, pharmacist, or nurse.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Generally, adverse effects are classified as mild to moderate.

Frequent (may affect between 1 and 10 of every 100 patients):

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

Poorly Frequent (may affect between 1 and 10 of every 1000 patients):

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

Very Rare (may affect fewer than 1 of every 10,000 people):

• Seizures.

Unknown Frequency (the frequency cannot be estimated from the 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 memantine.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthe box and blister pack. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

Composition of Memantina Pensa

• The active ingredient is hydrochloride of memantine. Each film-coated tablet contains 10 mg of hydrochloride of memantine equivalent to 8.31 mg of memantine.
• The other components are or croscarmelosa sodium, anhydrous colloidal silica, microcrystalline cellulose, magnesium stearate, polyvinyl alcohol, titanium dioxide (E171), talc, macrogol 3350, yellow iron oxide (E172)

Appearance of the product and content of the packaging

Memantina Pensa 10 mg is presented in the form of yellow film-coated, oval, and scored tablets on one side. It is presented in a PVC-PVDC/Aluminum blister containing 28, 56, and 112 tablets.

The tablets can be divided into equal doses.

Only some package sizes may be commercially marketed.

Holder of the marketing authorization

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Responsible for manufacturing

NOUCOR HEALTH, S.A.

Av. Camí Reial, 51-57

08184 – Palau-solità i Plegamans, Barcelona

Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

PT: Memantina Pensa, 10 mg, Film-coated tablets.

ES: Memantina pensa 10 mg film-coated tablets EFG

Date of the last review of this leaflet: January 2018

The 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/