Memantina Aristo 20 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Memantina Aristo 20 mg film-coated tablets EFG

Memantine hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. 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 pass it on to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, talk to your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

How Memantina Aristo works

Memantina Aristo contains the active substance memantina hydrochloride. This 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 so-called N-methyl-D-aspartate (NMDA) receptors, which are involved in the transmission of nerve signals important for learning and memory. Memantina belongs to a group of medicines called NMDA receptor antagonists. Memantina acts on these receptors, improving nerve signal transmission and memory.

What Memantina Aristo is used for:

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

2. What you need to know before taking Memantina Aristo

Do not take Memantina Aristo

• if you are allergic to 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 Aristo,

• if you have a history of epileptic seizures (convulsions).
• 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 must be carefully supervised and your doctor should regularly re-evaluate the clinical benefit of Memantina Aristo.

If you have renal impairment (kidney problems), your doctor must closely monitor your kidney function and, if necessary, adjust the dose 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 produce anaesthesia), dextromethorphan (a cough medicine), and other NMDA antagonists.

Children and adolescents

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

Taking Memantina Aristo 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 memantine may cause changes in the effects of the following medicines, so your doctor may need to adjust their 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 stop 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 Aristo.

Taking Memantina Aristo 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), 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.

Pregnancy
Memantine is not recommended for use in pregnant women.
Breastfeeding
Women taking Memantina Aristo should discontinue breastfeeding.

Driving and using machines

Your doctor will advise you whether your condition allows you to drive and use machines safely.

Your medical 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.

Memantina Aristo may cause dizziness and somnolence, mainly at the beginning of treatment or when the dose is increased. If you experience these effects, you must not drive or operate machinery.

Furthermore, Memantina Aristo may impair your reaction ability, so driving or operating machinery may be inappropriate.

Memantina Aristo contains lactose

If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine.

3. How to take Memantina Aristo

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

Dosage

The recommended dose of Memantina Aristo 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:

Treatment is initiated at a dose of 5 mg once daily. This dose is increased weekly by 5 mg per week until the recommended dose (maintenance dose) is reached. The recommended maintenance dose of 20 mg once daily will be reached at the beginning of the fourth week following this schedule.

Different dosage strengths of tablets are available to allow dose adjustment.

Dosage for patients with reduced renal function

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

Administration

Memantina Aristo 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.

Duration of treatment

Continue taking Memantina Aristo for as long as it benefits you. Your doctor should periodically evaluate your treatment.

If you take more Memantina Aristo than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone: (91) 5620420, indicating the medication and the amount ingested.

In general, taking an excessive amount of Memantina Aristo should not cause you any harm. You may experience an increase in the symptoms described in section 4 "Possible side effects".

If you forget to take Memantina Aristo

• If you realize you have forgotten to take your dose of Memantina Aristo, wait and take the next dose at the usual time.
• Do not take a double dose to make up for missed doses.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

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

Frequent (may affect up to 1 in 10 people):

• Headache, somnolence, constipation, increased 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 (frequency cannot be estimated from available data):

• Inflammation of the pancreas, hepatitis (inflammation of the liver), 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 or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system: Spanish System for Pharmacovigilance of Human Medicines: Website: www.notificaRAM.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Memantine Aristo

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

Do not use this medicine after the expiry date stated on the carton and on the blister after EXP. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Memantina Aristo

The active substance is Memantine hydrochloride.

Each 20 mg coated tablet contains 20 mg of memantine hydrochloride, equivalent to 16.62 mg of memantine.

The other components are: lactose monohydrate, magnesium stearate, microcrystalline cellulose, talc, colloidal anhydrous silica, hypromellose, Macrogol 4000, titanium dioxide (E 171).

Appearance of the medicinal product and content of the container

Memantina Aristo 20 mg coated tablets are oval-shaped, white or almost white tablets. Each tablet has three break lines on both sides, allowing it to be divided into four equal parts.

Memantina Aristo 20 mg coated tablets:

Memantina Aristo coated tablets are presented in blisters containing the tablets. Memantina Aristo coated tablets are available in pack sizes of 7, 28, 30, 42, 50, 56, 98 and 100.

Hospital pack of 420 film-coated tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Aristo Pharma Iberia S.L.
C/ Solana 26
28850 – Torrejón de Ardoz, Madrid
Spain

Manufacturer

Laboratorios Medicamentos Internacionales, S.A. (Medinsa)
C/ Solana 26
28850 – Torrejón de Ardoz, Madrid
Spain

ARISTO PHARMA GMBH
Wallenroder Strasse 8-10
13435 Berlin, Germany

NEURAXPHARM ARZNEIMITTEL GMBH U CO.KG
Elisabethselbert Strasse, 23
Langenfeld – 40764, Germany

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

Germany: Memantin Aristo 20 mg Filmtabletten
Poland: Memantin NeuroPharma 20 mg
Portugal: Memantina Aristo / 20 mg comprimidos revestidos por película
Spain: Memantina Aristo 20 mg comprimidos recubiertos con película EFG

Date of the most recent revision of this leaflet: September 2017

Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products: http://www.aemps.gob.es/