Memantina Pensa 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Memantina Pensa 10 mg film-coated tablets EFG Memantine hydrochloride

Read the 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

1. What Memantina Pensa is and what it is used for
2. What you need to know before taking Memantina Pensa
3. How to take Memantina Pensa
4. Possible side effects
5. How to store Memantina Pensa
6. Contents of the pack and other information

1. What Memantina Pensa is and what it is used for

How Memantina Pensa works

Memantina Pensa belongs to a group of medicines known as anti-dementia medications. Memory loss in Alzheimer's disease is due to disturbances in brain signaling. The brain contains so-called N-methyl-D-aspartate (NMDA) receptors, which are involved in the transmission of nerve signals important for learning and memory. Memantina Pensa belongs to a group of medicines called NMDA receptor antagonists. Memantina Pensa acts on these receptors, improving nerve signal transmission and memory.

What Memantina Pensa is used for:

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

2. What you need to know before starting to take Memantina Pensa

Do not take Memantina Pensa:

• if you are allergic to the active substance, memantine hydrochloride, or to any of the other ingredients of this medicine (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 disease, or if you have uncontrolled hypertension (high blood pressure).

In the above situations, treatment should be carefully monitored, and your doctor should regularly re-evaluate the clinical benefit of Memantina Pensa.

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

Concomitant use of memantine with other medicines such as amantadine (used to treat Parkinson's disease), ketamine (a drug generally used to induce anesthesia), dextromethorphan (a cough medication), and other NMDA antagonists should be avoided.

Children and adolescents

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

Taking Memantina Pensa with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Specifically, administration of Memantina Pensa 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 Pensa.

Taking Memantina Pensa 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 (urine passage infections), as your doctor may need to adjust the dose of the medicine.

Pregnancy and breastfeeding

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

The use of memantine is not recommended in pregnant women.

Women taking Memantina Pensa should discontinue breastfeeding.

Driving and using machines

Your doctor will advise you whether your condition allows you to drive and operate machinery safely.

Furthermore, Memantina Pensa may affect your reaction capability, so driving or operating machinery may be inappropriate.

3. How to take Memantina Pensa

Follow exactly the instructions for use of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Dosage

The recommended dose of Memantina Pensa in adult patients and elderly patients is 20 mg administered once daily. To reduce the risk of adverse effects, this dose should be reached gradually according to the following daily schedule:

The usual starting dose is half a 10 mg tablet once daily (5 mg) during the first week. This is increased to one 10 mg tablet once daily (10 mg) during the second week, and to one and a half tablets once daily (15 mg) during the third week. From the fourth week onwards, the usual dose is two 10 mg tablets administered once daily (20 mg).

Dosage for patients with renal impairment

If you have kidney problems, your doctor will decide the appropriate dose according to your condition. In this case, your doctor should periodically monitor your kidney function.

Administration

Memantina Pensa 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 some water. The tablets may be taken with or without food.

Duration of treatment

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

If you take more Memantina Pensa than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount ingested. In general, taking an excessive amount of Memantina Pensa should not cause you 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 make up for the missed dose.

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

In general, adverse effects are classified as mild to moderate.

Common (may affect between 1 and 10 out of 100 patients):

• 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 between 1 and 10 out of 1,000 patients):

• 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 less than 1 out of 10,000 people):

• Seizures.

Frequency not known (frequency cannot be estimated from the available data):

• Inflammation of the pancreas, 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 memantine.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via 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 Memantina Pensa

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. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

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 in doubt, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Memantina Pensa

• 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 components are sodium croscarmellose, colloidal anhydrous silica, microcrystalline cellulose, magnesium stearate, polyvinyl alcohol, titanium dioxide (E171), talc, macrogol 3350, yellow iron oxide (E172).

Appearance of the product and contents of the pack

Memantina Pensa 10 mg is available as yellow, oval, film-coated tablets, scored on one side. They are supplied in PVC-PVDC/aluminum blisters containing 28, 56, and 112 tablets.

The tablets can be divided into equal doses.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

NOUCOR HEALTH, S.A.

Av. Camí Reial, 51-57

08184 – Palau-solità i Plegamans, Barcelona

Spain

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

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

ES: Memantina Pensa 10 mg film-coated tablets EFG

Date of the most recent review of this leaflet: January 2018

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