Memantina Teva-Ratiopharm 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Memantina Teva-ratiopharm 10 mg film-coated tablets EFG

Memantine hydrochloride

Read the entire 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, and you must not give it to other people,

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

• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are

adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Memantina Teva-ratiopharm is and what it is 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 medications.

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 are involved in the transmission of nerve signals important for learning and memory. Memantina Teva-ratiopharm belongs to a group of medicines called NMDA receptor antagonists. Memantina Teva-ratiopharm acts on these receptors, improving nerve signal transmission 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 starting to take Memantina Teva-ratiopharm

Do not take Memantina Teva-ratiopharm:

• if you are allergic to memantine hydrochloride or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to 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 have heart failure, or if you have uncontrolled hypertension (high blood pressure).

In the above situations, treatment must be carefully monitored and your doctor should regularly re-evaluate the clinical benefit of Memantina Teva-ratiopharm.

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

Concomitant use of memantine with other medicines such as amantadine (used to treat Parkinson's disease), ketamine (a drug generally used as an anaesthetic), dextromethorphan (a cough medicine), and other NMDA antagonists should be avoided.

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

Taking Memantina Teva-ratiopharm with other medicines

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

Specifically, administration of Memantina Teva-ratiopharm 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 Teva-ratiopharm.

Taking Memantina Teva-ratiopharm 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), or if you have renal tubular acidosis (RTA, excess acid-producing substances in the blood due to kidney dysfunction) or severe urinary tract infections, as your doctor may need to adjust the dose of the medicine.

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 medicine.

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

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

Driving and use of machinery

Your doctor will advise you whether your condition allows you to drive or operate machinery safely.

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

This medicine contains lactose. If your doctor has informed you that you have an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Memantina Teva-ratiopharm

Follow exactly the instructions for use of this medicine as indicated by your doctor. If in 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 daily. To reduce the risk of adverse effects, this dose is reached gradually according to the following daily schedule:

The usual starting dose is half a tablet once daily (1x 5 mg) in the first week. This is increased to one tablet daily (1x 10 mg) in the second week, and to one and a half tablets once daily in the third week. From the fourth week onwards, the usual dose is two tablets administered once daily (1x 20 mg).

Dosage for patients with renal insufficiency

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 daily. To get 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 Teva-ratiopharm for 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

• In general, 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 adverse effects”.

• If you take an overdose of Memantina Teva-ratiopharm, contact your doctor or seek medical advice, as you may require medical attention.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount taken.

If you forget 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 make up for forgotten 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 Teva-ratiopharm can cause adverse effects, although not everyone experiences them.

In general, adverse effects are classified as mild to moderate.

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

• Headache, somnolence, constipation, elevated liver function tests, dizziness, loss of balance, difficulty 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 formation of blood clots in the venous system (venous thrombosis/venous thromboembolism).

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

• 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 type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Memantine Teva-ratiopharm

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 on the blister pack following EXP. The expiry date refers to the last day of the month indicated.

Do not store above 25°C.

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This 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 components are:
  Tablet core: Microcrystalline cellulose, crospovidone Type A, talc, and magnesium stearate.
  Coating (Opadry white II 33G28435): hypromellose 6 cP, titanium dioxide E171, lactose monohydrate, macrogol 3350, and triacetin.

Nature of the product and pack sizes

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

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

Marketing Authorization Holder

Teva B.V.
Swensweg 5, 2031 GA Haarlem
The 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, 1st floor
28108 Alcobendas (Madrid)
Spain

Date of the most recent revision of this package leaflet: October 2015

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es.