Memantina Sun 20 mg film-coated tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Memantina SUN 20 mg film-coated tablets EFG

memantine hydrochloride

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

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

Leaflet Contents

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

2. What you need to know before taking Memantina SUN

3. How to take Memantina SUN

4. Possible side effects

5. How to store Memantina SUN

6. Contents of the pack and other information

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

How Memantina SUN works

Memantina SUN belongs to a group of medicines known as antidementia agents.

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 play a role in the transmission of nerve signals important for 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 taking Memantina SUN

Do not take Memantina SUN:

• 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 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 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 SUN.

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

The use of memantine should be avoided concomitantly with other medicines such as:

• amantadine (used to treat Parkinson's disease),
• ketamine (a drug generally used as an anesthetic),
• dextromethorphan (a medicine used to treat cough), and
• other NMDA antagonists.

You should inform your doctor if you have renal tubular acidosis (RTA, excess acid-producing substances in the blood due to renal dysfunction (kidney problem)) or severe urinary tract infections (urine passage infections), 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

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

Specifically, administration of Memantina SUN may cause changes in the effects of the following medicines, so your doctor may need to adjust the dosage:

• 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 SUN.

Taking Memantina SUN 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).

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 SUN should discontinue breastfeeding.

Driving and using machines

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

Furthermore, Memantina SUN may affect your reaction capabilities, so driving or operating machinery may be inappropriate.

3. How to take Memantina SUN

Follow exactly the administration instructions for this medicine 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 daily. To reduce the risk of adverse effects, this dose should be reached gradually according to the following daily regimen:

The usual starting dose is half a tablet once daily (1 x 5 mg) during the first week. This is increased to one tablet once daily (1 x 10 mg) during the second week, and to one and a half tablets once daily during 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 daily (1 x 20 mg).

Dosage for patients with renal impairment

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 daily. To obtain 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 SUN for 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

• In general, 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 require 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 missed doses.

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

4. Possible adverse effects

Like all medicines, Memantina SUN may cause adverse effects, although not everyone experiences them.

In general, adverse effects are mild to moderate in severity.

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

• Headache, somnolence, constipation, elevated liver function tests, dizziness, balance disorder, dyspnoea, high blood pressure, and drug hypersensitivity.

Uncommon (affects 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 (affects less than 1 out of 10,000 patients):

• Seizures.

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

• Inflammation of the pancreas, inflammation of the liver (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 adverse effects

If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse 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 stated on the carton and blister pack following EXP. The expiry date is 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 unused medicines and their packaging at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This 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 20 mg of memantine hydrochloride, equivalent to 16.62 mg of memantine.

The other components are:

Tablet core

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

Coating

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

Appearance of the product and contents of the pack

Reddish-pink, oval film-coated tablets, approximately 13.70 ± 0.5 mm in length, 7.50 ± 0.5 mm in width and 4.80 ± 0.5 mm in thickness, engraved with "M14" on one side and smooth on the other.

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Sun Pharmaceutical Industries Europe B.V.,

Polarisavenue 87,

2132JH Hoofddorp, The Netherlands

Manufacturer

Terapia SA

Str. Fabricii nr. 124, Cluj Napoca 400 632

Romania

Or

Sun Pharmaceutical Industries Europe B.V.

Polarisavenue 87

2132JH Hoofddorp

The Netherlands

Further information about this medicinal product is available 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 medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the most recent review of this summary:

July 2013

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