Package Leaflet: Information for the User

Memantine Teva-ratiopharm 10 mg Film-Coated Tablets

Memantine, hydrochloride

Read this leaflet carefully before you start taking this medicine because 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. 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. See section 4.

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

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

3. How to take Memantine Teva-ratiopharm

4. Possible side effects

5. Storage of Memantine Teva-ratiopharm

6. Contents of the pack and additional information

How Memantina Teva-ratiopharm works

Memantina Teva-ratiopharmcontains the active ingredient memantina.

Memantina Teva-ratiopharmbelongs to a group of medicines known as dementia medicines.

Anti-dementia medicines.

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 nerve signals in learning and memory. Memantina Teva-ratiopharmbelongs to the group of medicines called NMDA receptor antagonists. Memantina Teva-ratiopharmacts on these receptors by improving the transmission of nerve signals and memory.

What Memantina Teva-ratiopharm is used for

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

Do not take Memantina Teva-ratiopharm:

• if you are allergic to memantine hydrochloride or to 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 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 the above situations, treatment must be closely monitored and your doctor must reevaluate the clinical benefit of Memantina Teva-ratiopharm regularly.

If you have renal insufficiency (kidney problems), your doctor must closely monitor renal function and, if necessary, adapt memantine doses.

The use of memantine should be avoided with other medications such as amantadine (for the treatment of Parkinson's disease), ketamine (a medication generally used as an anesthetic), dextromethorphan (a medication for the treatment of cough), and other NMDA antagonists.

Memantina Teva-ratiopharm is not recommended for use in children and adolescents under 18 years old.

Taking Memantina Teva-ratiopharm with other medications

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

Specifically, the administration of Memantina Teva-ratiopharm 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 such as 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 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 significantly (for example from a normal diet to a strict vegetarian diet) or if you have acidosis tubular renal (ATR, excess of 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.

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.

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

Breastfeeding: Women taking Memantina Teva-ratiopharm should discontinue breastfeeding.

Driving and operating machinery

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

Additionally, Memantina Teva-ratiopharm may alter your reaction time, making driving or operating machinery inappropriate.

This medication contains lactose.If your doctor has indicated that you have a certain sugar intolerance, consult with them before taking this medication.

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 Teva-ratiopharm in adult patients 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:

The normal starting dose is half a tablet once a day (1x 5 mg) in the first week. It is increased by 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 administered 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 Teva-ratiopharm 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 Teva-ratiopharm as long as it is beneficial for you. Your doctor should evaluate the effects of your treatment periodically.

If you take more Memantina Teva-ratiopharm than you should

• In general, taking an excessive amount of Memantina Teva-ratiopharm should not cause any harm. You may experience an increase in the symptoms described in section 4 “Possible adverse 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 Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount administered.

If you forgot to take Memantina Teva-ratiopharm

• If you realize 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 compensate for the missed doses.

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

Like all medications, Memantina Teva-ratiopharmmay cause adverse effects, although not everyone will experience them.

Generally, adverse effects are classified as mild to moderate.

Frequent (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 medication.

Less frequent (may affect up to 1 in 100 people):

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

Very rare (may affect up to 1 in 10,000 people):

• 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. There have been reports of these events in patients treated with memantina.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about 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.

Do not store above 25°C.

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 point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Memantina Teva-ratiopharm

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

Appearance of the product and content of the packaging

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

Memantina Teva-ratiopharm is presented in packaging of 112 film-coated tablets.

Holder of the marketing authorization

Teva B.V.

Swensweg 5, 2031 GA Haarlem

Netherlands

Responsible for manufacturing

Actavis Ltd

BLB016, Bulebel Industrial Estate

Zejtun, ZTN 3000

Malta

Local representative:

Teva Pharma, S.L.U.

C/ Anabel Segura, 11 Edificio Albatros B, 1st floor

28108 Alcobendas (Madrid)

Spain

Last review date of this leaflet:October 2015

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es.