MEMANTINE SUN 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Memantina SUN 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 symptoms are the same as yours.
• If you experience 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 Package Leaflet

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

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

How Memantina SUN works

Memantina SUN belongs to a group of medicines called anti-dementia medicines.

Memory loss in Alzheimer's disease is due to an alteration 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. Memantina SUN belongs to a group of medicines called NMDA receptor antagonists. Memantina SUN acts on these receptors, improving the transmission of nerve signals and memory.

What Memantina SUN is used for

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

2. What you need to know before you take Memantina SUN

Do not take Memantina SUN:

• if you are allergic to memantine hydrochloride or 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 SUN:

• if you have a history of epileptic seizures
• 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 reassess the clinical benefit of Memantina SUN.

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 with other medicines such as:

• amantadine (for the treatment of Parkinson's disease),
• ketamine (a medicine usually used as an anesthetic),
• dextromethorphan (a medicine for the treatment of cough) and
• other NMDA antagonists.

should be avoided.

You should inform your doctor if you have renal tubular acidosis (RTA, excess of acid-producing substances in the blood due to kidney dysfunction) or severe urinary tract infections (urinary tract), as your doctor may need to adjust the dose of the medicine.

Children and adolescents

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

Taking Memantina SUN 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 Memantina SUN may produce changes in the effects of the following medicines, so your doctor may need to adjust the dose:

• amantadine, ketamine, dextromethorphan
• dantrolene, baclofen
• cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine
• hydrochlorothiazide (or any combination with hydrochlorothiazide)
• anticholinergics (substances usually used to treat movement disorders or intestinal spasms)
• anticonvulsants (substances used to prevent and eliminate convulsions)
• barbiturates (substances usually 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 SUN.

Taking Memantina SUN 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).

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.

The use of memantine is not recommended in pregnant women.

Women taking Memantina SUN should stop breastfeeding.

Driving and using machines

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

Also, Memantina SUN may alter your reaction ability, so driving or operating machinery may be inappropriate.

3. How to take Memantina SUN

Follow exactly the administration instructions of this medicine indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Posology

The recommended dose of Memantina SUN in adult and elderly patients is 20 mg administered once a day. To reduce the risk of side effects, this dose is gradually achieved following the following daily scheme:

The normal starting dose is half a tablet once a day (1x 5 mg) the first week. It is increased to one tablet a day (1x 10 mg) the second week and to one and a half tablets once a day in the third week. From the fourth week onwards, the normal dose is two 10 mg tablets (2x 10 mg) or one 20 mg tablet once a day (1x 20 mg).

Dosage for patients with renal insufficiency

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

Administration

Memantina SUN should be administered orally once a day. 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 SUN as long as it is beneficial for you. Your doctor should periodically evaluate the effects of your treatment.

If you take more Memantina SUN than you should

• Generally, taking an excessive amount of Memantina SUN should not cause you any harm. You may experience an increase in the symptoms described in section 4 "Possible side effects".
• If you take an overdose of Memantina SUN, contact your doctor or seek medical advice, as you may need medical attention.

If you forget to take Memantina SUN

• If you realize that you have forgotten to take your dose of Memantina SUN, 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 further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Memantina SUN can cause side effects, although not everybody gets them.

Generally, side effects are mild to moderate.

Frequent (affects 1 to 10 users in 100):

• Headache, drowsiness, constipation, elevated liver function tests, dizziness, balance disorder, difficult breathing, high blood pressure, and hypersensitivity to the medicine.

Infrequent (affects 1 to 10 users in 1,000):

• Fatigue, fungal infections, confusion, hallucinations, vomiting, gait disturbance, heart failure, and venous thrombosis/thromboembolism.

Rare (affects less than 1 user in 10,000):

• Seizures.

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

• Pancreatitis, hepatitis, 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 side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Memantina SUN

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 pack 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 SUN

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 ingredients are:

Core of the tablet

Microcrystalline cellulose, anhydrous colloidal silica, sodium croscarmellose, talc, and magnesium stearate.

Coating

Hypromellose, macrogol 400, titanium dioxide (E171), and talc.

Appearance of the product and contents of the pack

White or almost white film-coated tablets, capsule-shaped, approximately 11.00 ± 0.5 mm long, 5.50 ± 0.5 mm wide, and 3.95 ± 0.5 mm thick, scored on one side and smooth on the other. The tablet can be divided into equal doses.

Memantina SUN is available in packs of 28, 30, 42, 50, 56, 60, 98, 100, 112, and 1000 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder

Sun Pharmaceutical Industries Europe B.V.,

Polarisavenue 87,

2132JH Hoofddorp, Netherlands

Manufacturer

Ranbaxy Ireland Limited

Spafield, Cork Road, Cashel, Co. Tipperary

Ireland

or

Terapia SA

Str. Fabricii nr. 124, Cluj Napoca 400 632

Romania

or

Basics GmbH

Hemmelrather Weg 201, 51377 Leverkusen

Germany

or

GALENICA S.A.

Km 3. On "Old National Highway" Chalkida - Athens

Glyfa, Chalkida

34100 Chalkida (GREECE)

You can obtain further information on this medicine from the local representative of the marketing authorisation holder:

Spain

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya 53-55

08007 Barcelona

Spain

Tel: + 34 93 342 78 90

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

Date of last revision of this leaflet:

July 2013

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.