Memantina Tarbis 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Memantina Tarbis 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, 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 must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, talk to your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of this leaflet

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

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

How Memantina Tarbis works

Memantina Tarbis belongs to a group of medicines known as anti-dementia drugs.

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 Tarbis belongs to a group of medicines called NMDA receptor antagonists. Memantina Tarbis acts on these receptors, improving nerve signal transmission and memory.

What Memantina Tarbis is used for

Memantina Tarbis 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 Tarbis

Do not take Memantina Tarbis

• 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 Tarbis.

• if you have a history of epileptic seizures (convulsions).
• 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 should be carefully supervised, and your doctor should regularly re-evaluate the clinical benefit of Memantina Tarbis.

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

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

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

Taking Memantina Tarbis 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 Tarbis may cause changes in the effects of the following medicines, so your doctor may need to adjust the doses:

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 Tarbis.

Taking Memantina Tarbis with food and drink

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 renal dysfunction [kidney problem]) or severe urinary tract infections, as your doctor may need to adjust the dose of the medicine.

Pregnancy, breastfeeding and fertility

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 Tarbis 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 Tarbis may affect your reaction time; therefore, driving or operating machinery may be inappropriate.

3. How to take Memantina Tarbis

Follow exactly the administration instructions for this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Dosage

The recommended dose of Memantina Tarbis in adult and elderly patients is 20 mg taken once daily. To reduce the risk of adverse effects, this dose should be reached gradually according to the following daily schedule:

The usual starting dose is half a tablet once daily (1 x 5 mg) during the first week. This is increased to one tablet 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 tablets administered 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 Tarbis 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 Tarbis for as long as it is beneficial for you. Your doctor should periodically evaluate the effects of your treatment.

If you take more Memantina Tarbis than you should

• In general, taking an excessive amount of Memantina Tarbis 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 Tarbis, contact your doctor or seek medical advice, as you may require medical attention.

If you forget to take Memantina Tarbis

• If you realize you have forgotten to take your dose of Memantina Tarbis, wait and take your next dose at the usual time.
• Do not take a double dose to make up for the missed dose.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

In general, adverse effects are mild to moderate.

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

• Headache, somnolence, constipation, elevated liver function tests, dizziness, loss of balance, shortness of breath, high blood pressure, and hypersensitivity to the medicine.

Uncommon (affects between 1 and 10 out of every 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 in every 10,000 people):

• Seizures.

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

• Pancreatitis, hepatitis (liver inflammation), 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 Tarbis.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

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 Medicinal Products, www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Memantine Tarbis

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to 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 containers at the SIGRE Point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Memantina Tarbis

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 microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica and magnesium stearate in the tablet core; polyvinyl alcohol, titanium dioxide (E 171), talc, macrogol 3350 and yellow iron oxide (E 172) in the tablet coating.

Appearance of the product and contents of the pack

Memantina Tarbis is available as yellow, oval-shaped, film-coated tablets with a break line on one side. The tablet can be divided into equal halves.

Memantina Tarbis film-coated tablets are available in packs containing 30, 56 or 112 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Tarbis Farma, S.L.

Gran Vía Carlos III, 94

08028 Barcelona

Manufacturer

Noucor Health, S.A.

Av. Camí Reial 51-57

08184 Palau-solità i Plegamans (Spain)

This leaflet was approved in: November 2013

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