MEMANTINE TEVA-RATIOPHARM 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Memantina Teva-ratiopharm 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.

even if they have the same symptoms as you, as it may harm them.

• If you experience any side effects, talk to your doctor or pharmacist, even if it is not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Memantina Teva-ratiopharm and what is it used for

How Memantina Teva-ratiopharm works

Memantina Teva-ratiopharm contains the active substance memantine.

Memantina Teva-ratiopharm belongs to a group of medicines known as 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 Teva-ratiopharm belongs to the group of medicines called NMDA receptor antagonists. Memantina Teva-ratiopharm acts on these receptors, improving the transmission of nerve signals and memory.

What Memantina Teva-ratiopharm is used for

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

2. What you need to know before you take Memantina Teva-ratiopharm

Do not take Memantina Teva-ratiopharm:

• 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 Teva-ratiopharm:

• 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 re-evaluate the clinical benefit of Memantina Teva-ratiopharm.

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 generally used as an anesthetic), dextromethorphan (a medicine for the treatment of cough) and other NMDA antagonists should be avoided.

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

Taking Memantina Teva-ratiopharm 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 Teva-ratiopharm 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 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 Teva-ratiopharm.

Taking Memantina Teva-ratiopharm 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 (urinary tract), as your doctor may need to adjust the dose of the medicine.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy: The use of memantine is not recommended in pregnant women.

Breast-feeding: Women taking Memantina Teva-ratiopharm should stop breast-feeding.

Driving and using machines

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

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

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

3. How to take Memantina Teva-ratiopharm

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

Posology

The recommended dose of Memantina Teva-ratiopharm 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 tablets administered once a day (1x 20 mg).

Posology 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 Teva-ratiopharm 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 Teva-ratiopharm as long as it is beneficial for you. Your doctor should periodically evaluate the effects of your treatment.

If you take more Memantina Teva-ratiopharm than you should

• Generally, taking an excessive amount of Memantina Teva-ratiopharm 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 Teva-ratiopharm, contact your doctor or seek medical advice, as you may need medical attention.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount administered.

If you forget to take Memantina Teva-ratiopharm

• If you realize that you have forgotten to take your dose of Memantina Teva-ratiopharm, 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 Teva-ratiopharm can cause side effects, although not everybody gets them.

Generally, the side effects are classified as mild to moderate.

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

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

Uncommon (may affect up to 1 in 100 people):

• Fatigue, fungal infections, confusion, hallucinations, vomiting, gait disturbance, 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, 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, even if it is not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Memantina Teva-ratiopharm

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 shown.

Do not store above 25°C.

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 Teva-ratiopharm

• 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: Tablet core: Microcrystalline cellulose, crospovidone Type A, talc, and magnesium stearate. Coating (Opadry white II 33G28435): Hypromellose 6cP, titanium dioxide E171, lactose monohydrate, macrogol 3350, and triacetin.

Appearance of the product and pack contents

Memantina Teva-ratiopharm tablets are biconvex, white, capsule-shaped (9.8 x 4.9 mm), with a break line on one side and engraved with "M10" on the break line side.

Memantina Teva-ratiopharm is available in packs of 112 film-coated tablets.

Marketing authorisation holder

Teva B.V.

Swensweg 5, 2031 GA Haarlem

Netherlands

Manufacturer

Actavis Ltd

BLB016, Bulebel Industrial Estate

Zejtun, ZTN 3000

Malta

Local representative:

Teva Pharma, S.L.U.

C/ Anabel Segura, 11 Edificio Albatros B, 1ª planta

28108 Alcobendas (Madrid)

Spain

Date of last revision of this leaflet:October 2015

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