Package Insert: Information for the Patient

Memantine SUN 10 mg Film-Coated Tablets

memantine hydrochloride

Read this package insert carefully before you start taking this medicine, because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for 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 any side effects, consult your doctor or pharmacist, even if they are not listed in this package insert.See section 4.

How Memantina SUN works

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

The loss of memory in Alzheimer's disease is due to an alteration in brain signals. The brain contains called N-methyl-D-aspartate (NMDA) receptors that participate in the transmission of important nervous signals in learning and memory. Memantina SUN belongs to the group of medications called NMDA receptor antagonists. Memantina SUN acts on these receptors by improving the transmission of nervous 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.

Do not take Memantina SUN:

• if you are allergic to memantine hydrochloride or any of the other ingredients 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 high blood pressure.

In the above situations, treatment must be closely monitored and your doctor should regularly reevaluate the clinical benefit of Memantina SUN.

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

Memantine should be avoided when used with other medications such as:

• amantadine (for Parkinson's treatment),
• ketamine (a medication generally used as an anesthetic),
• dextromethorphan (a medication for cough treatment) and
• other NMDA antagonists.

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

Children and adolescents

Memantina SUN is not recommended for use in children and adolescents under 18 years old.

Taking Memantina SUN with other medications

Inform your doctor or pharmacist if you are taking/using, have taken/used recently 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 generally used to treat movement disorders or intestinal spasms)
• anticonvulsants (substances used to prevent and eliminate seizures)
• barbiturates (substances generally used to induce sleep)
• dopamine agonists (substances like L-dopa, bromocriptine)
• neuroleptics (substances used in the treatment of mental illnesses)
• oral anticoagulants

If you are admitted to a 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 change your diet significantly (e.g., from a normal diet to a strict vegetarian diet).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Memantine is not recommended for use in pregnant women.

Women taking Memantina SUN should discontinue breastfeeding.

Conducting and using machines

Your doctor will inform you if your condition allows you to drive and use machines safely.

Additionally, Memantina SUN may alter your reaction time, making driving or operating machines inappropriate.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of 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 adverse effects, this dose is achieved gradually following the daily schedule below:

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

Dosage for patients with renal insufficiency

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

Administration

Memantina SUN must 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.

Treatment duration

Continue taking Memantina SUN as long as it is beneficial for you. Your doctor should evaluate the effects of your treatment periodically.

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 adverse effects”.
• If you take a Memantina SUN overdose, contact your doctor or seek medical advice, as you may need medical attention.

If you forgot to take Memantina SUN

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

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

Like all medications, Memantina SUN can produce adverse effects, although not all people will experience them.

Adverse effects are generally classified as mild to moderate.

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

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

Poorly Frequent (affects between 1 and 10 out of 1,000 patients):

• Fatigue, fungal infections, confusion, hallucinations, vomiting, gait alteration, heart failure, and formation of blood clots in the venous system (venous thrombosis/thromboembolism).

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

• Seizures.

Unknown Frequency (frequency cannot be estimated from 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 Adverse Effects

If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medications for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the box and on the blister packaging after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Memantine SUN Composition

The active ingredient is memantine hydrochloride.

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

The other components are:

Core of the tablet

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

Covering

Hydroxypropyl methylcellulose, macrogol 400, titanium dioxide (E171), and talc.

Appearance of the product and contents of the package

White or off-white, capsule-shaped tablets, approximately 11.00 ± 0.5 mm in length, 5.50 ± 0.5 mm in width, and 3.95 ± 0.5 mm in thickness, film-coated, engraved with “M” and “12” on both sides of the break line on one face and smooth on the other face.
The tablet may be divided into equal doses.

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

Only some package sizes may be commercially available.

Marketing Authorization Holder

Sun Pharmaceutical Industries Europe B.V.,

Polarisavenue 87,

2132JH Hoofddorp, Netherlands

Responsible for manufacturing

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)

For more information about this medication, please contact 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 with the following names:

Last review date of this leaflet:

July 2013

For detailed information about this medication, please visit the European Medicines Agency website: http://www.ema.europa.eu.