MEMANTINE ARISTO 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Memantina Aristo 10 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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Memantina Aristo is and what it is used for.
2. What you need to know before you take Memantina Aristo.
3. How to take Memantina Aristo.
4. Possible side effects.
5. Storage of 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 memantine hydrochloride. This belongs to a group of medicines called anti-dementia medicines.

Memory loss in Alzheimer's disease is due to a disturbance in brain signals. The brain contains so-called N-methyl-D-aspartate (NMDA) receptors that are involved in the transmission of important nerve signals in learning and memory. Memantine belongs to a group of medicines called NMDA receptor antagonists. Memantine acts on these receptors, improving the transmission of nerve signals 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 you take Memantina Aristo

Do not take Memantina Aristo

• if you are allergic to memantine hydrochloride or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before taking Memantina Aristo,

• if you have a history of epileptic seizures (convulsions).
• if you have recently suffered a myocardial infarction (heart attack), if you suffer from congestive heart failure or if you have uncontrolled hypertension (high blood pressure).

In these situations, treatment should be carefully supervised and your doctor should regularly re-evaluate the clinical benefit of Memantina Aristo.

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

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

Children and adolescents.

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

Using Memantina Aristo with other medicines

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

In particular, the administration of memantine may produce 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 with hydrochlorothiazide).
• anticholinergics (substances generally used to treat movement disorders or intestinal spasms).
• anticonvulsants (substances used to prevent and eliminate convulsions).
• 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 hospitalized, 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 change your diet substantially (e.g., from a normal diet to a strict vegetarian diet) or if you have renal tubular acidosis (RTA, excess of acid-producing substances in the blood due to kidney dysfunction) or severe urinary tract infections (urine conduit), 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 have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy: Memantine is not recommended during pregnancy. Breastfeeding: Women taking Memantina Aristo should stop breastfeeding.

Driving and using machines

Your doctor will inform you whether your illness allows you to drive and use machines safely.

Your illness may affect your ability to drive or use machinery, and you should not carry out these activities unless your doctor tells you it is safe to do so.

Memantina Aristo may cause dizziness and somnolence, mainly at the start of treatment or when increasing the dose. If you experience these effects, do not drive or use machinery.

Memantina Aristo may also alter your reaction ability, so driving or operating machinery may be inappropriate.

Memantina Aristo contains lactose

If your doctor has told you that you have an intolerance to some sugars, consult with them before taking this medicine.

3. How to take Memantina Aristo

Follow exactly the administration instructions of this medicine given by your doctor. If you are unsure, consult your doctor or pharmacist again.

Posology

The recommended dose of Memantina Aristo in adult and elderly patients is 20 mg once daily. To reduce the risk of side effects, this dose is gradually achieved by following the daily scheme below.

Treatment is started with 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 is 20 mg once daily and will be reached at the start of the fourth week following the scheme mentioned.

The 10 mg tablet can be divided into two equal halves.

To adjust the dose, there are tablets with different doses.

Posology for patients with reduced renal function

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

Administration

Memantina Aristo should be taken orally once daily. To get the most out of your medication, 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.

Duration of treatment

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

If you take more Memantina Aristo than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: (91) 5620420, indicating the medicine and the amount ingested.

Generally, 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 forgotten doses.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Side effects are usually mild to moderate.

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

• Headache, somnolence, constipation, elevated liver function tests, dizziness, balance disorders, 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 disturbances, heart failure, and venous thrombosis/thromboembolism.

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

• Seizures.

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

• Pancreatitis, 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 Memantina.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Memantina Aristo

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

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

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Memantina Aristo

The active substance is Memantine hydrochloride.

Each 10 mg film-coated tablet contains 10 mg of Memantine hydrochloride, equivalent to 8.31 mg of memantine.

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

Appearance and packaging

Memantina Aristo 10 mg film-coated tablets are presented in the form of oval-shaped, white or almost white film-coated tablets. Each tablet has a score line on both sides by which it can be divided into two equal halves.

Memantina Aristo 10 mg film-coated tablets:

Memantina Aristo film-coated tablets are presented in blisters containing the tablets. Memantina Aristo film-coated tablets are available in packs of 7, 28, 30, 42, 50, 56, 98, 100, and 112 film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Aristo Pharma Iberia S.L.

C/ Solana 26

28850 – Torrejón de Ardoz, Madrid

Manufacturer

Laboratorios Medicamentos Internacionales, S.A. (Medinsa)

C/ Solana 26

28850 – Torrejón de Ardoz, Madrid

ARISTO PHARMA GMBH

Wallenroder Strasse 8-10

13435 Berlin, Germany

NEURAXPHARM ARZNEIMITTEL GMBH U CO.KG

Elisabethselbert Strasse, 23

Langenfeld – 40764, Germany

This medicine is authorised in the Member States of the European Economic Area under the following names:

Germany: Memantin Aristo 10 mg Filmtabletten

Poland: Memantin NeuroPharma 10 mg

Portugal: Memantina Aristo 10 mg comprimidos revestidos por película

Spain: Memantina Aristo 10 mg comprimidos recubiertos con película EFG

Date of last revision of this leaflet: September 2017

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