MEMANTINE SUN 20 mg FILM-COATED TABLETS

Introduction

Patient Information Leaflet

Memantina SUN 20 mg film-coated tablets EFG

memantine hydrochloride

Read the entire leaflet carefully before starting to take this medication, as 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 medication has been prescribed to 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 side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What is Memantina SUN and what is it used for
2. What you need to know before taking Memantina SUN
3. How to take Memantina SUN
4. Possible side effects
5. Storage of Memantina SUN

1. Package contents and additional information

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

How Memantina SUN works

Memantina SUN belongs to a group of medications known as anti-dementia medications.

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 participate in the transmission of important nerve signals in learning and memory. Memantina SUN belongs to the group of medications 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 taking Memantina SUN

Do not take Memantina SUN:

• if you are allergic to memantine hydrochloride or 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 SUN:

• if you have a history of epileptic seizures
• if you have recently had 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 will decide on the appropriate dose for your condition. In this case, your doctor should periodically monitor your kidney function.

The use of memantine with other medications such as:

• amantadine (for the treatment of Parkinson's disease),
• ketamine (a medication commonly used as an anesthetic),
• dextromethorphan (a medication 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 medication.

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 medications

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

In particular, the administration of Memantina SUN may produce changes in the effects of the following medications, 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 commonly used to treat movement disorders or intestinal spasms)
• anticonvulsants (substances used to prevent and eliminate seizures)
• barbiturates (substances commonly 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 beverages

You should inform your doctor if you have recently changed or plan 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 plan to become pregnant, consult your doctor or pharmacist before using this medication.

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 if your condition allows you to drive and use machines safely.

Additionally, Memantina SUN may affect your reaction ability, so driving or operating machines may be inappropriate.

3. How to take Memantina SUN

Follow the administration instructions of this medication exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Dosage

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 reached by following the daily scheme:

The usual 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 usual dose is two 10 mg tablets (2 x 10 mg) or one 20 mg tablet once a day (1x 20 mg).

Dosage for patients with renal impairment

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 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 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 the missed doses.

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

4. Possible side effects

Like all medications, Memantina SUN can cause side effects, although not everyone will experience them.

Generally, side effects are classified as mild to moderate.

Frequent (affecting 1 to 10 in every 100 patients):

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

Infrequent (affecting 1 to 10 in every 1,000 patients):

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

Very rare (affecting less than 1 in every 10,000 patients):

• 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 side effects

If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medication Pharmacovigilance System: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Memantina SUN

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

Do not use this medication after the expiration date shown on the carton and blister pack after EXP. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of through wastewater or household waste. Place the packaging and any unused medications in the pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medications. This will help protect the environment.

6. Package contents and additional information

Composition of Memantina SUN

The active ingredient is memantine hydrochloride.

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

The other components are:

Core of the tablet

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

Coating

hypromellose, macrogol 400, titanium dioxide (E171), red iron oxide (E172), yellow iron oxide (E172), and talc.

Appearance of the product and package contents

Reddish-pink, oval, film-coated tablets, approximately 13.70 ± 0.5 mm long, 7.50 ± 0.5 mm wide, and 4.80 ± 0.5 mm thick, engraved with "M14" on one side and smooth on the other side.

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

Not all pack sizes may be marketed.

Marketing authorization holder

Sun Pharmaceutical Industries Europe B.V.,

Polarisavenue 87,

2132JH Hoofddorp, Netherlands

Manufacturer

Terapia SA

Str. Fabricii nr. 124, Cluj Napoca 400 632

Romania

or

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH Hoofddorp

Netherlands

You can request more information about this medication from the local representative of the marketing authorization holder:

Spain

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya 53-55

08007 Barcelona

Spain

Tel: + 34 93 342 78 90

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

Date of the last revision of this leaflet:

July 2013

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