MEMANTINE TARBIS 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Memantina Tarbis10 mg film-coated tablets EFG

Memantine, hydrochloride

Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.

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

Contents of the package leaflet

1. What is Memantina Tarbis and what is it used for
2. What you need to know before taking Memantina Tarbis
3. How to take Memantina Tarbis
4. Possible side effects
5. Storage of Memantina Tarbis
6. Package contents and additional information

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

How Memantina Tarbis works

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

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 participate in the transmission of important nerve signals in learning and memory. Memantina Tarbis belongs to the group of medications called NMDA receptor antagonists. Memantina Tarbis acts on these receptors, improving the transmission of nerve signals 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 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 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 failure or if you have uncontrolled hypertension (high blood pressure).

In these situations, treatment should be carefully supervised, and your doctor should regularly reevaluate the clinical benefit of Memantina Tarbis.

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 medications such as amantadine (for the treatment of Parkinson's disease), ketamine (a medication generally used to produce anesthesia), dextromethorphan (a medication for the treatment of cough), and other NMDA antagonists should be avoided.

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

Using Memantina Tarbis with other medications

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

In particular, the administration of Memantina Tarbis may produce changes in the effects of the following medications, so your doctor may need to adjust the doses:

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 Tarbis.

Taking Memantina Tarbis with food and drinks

You should inform your doctor if you have recently changed or plan 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 medication.

Pregnancy, breastfeeding, and fertility

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

The use of memantine is not recommended in pregnant women.

Women taking Memantina Tarbis should stop breastfeeding.

Driving and using machines

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

Additionally, Memantina Tarbis may alter your reaction ability, so driving or operating machines may be inappropriate.

3. How to take Memantina Tarbis

Follow your doctor's instructions for taking this medication exactly. If you are unsure, consult your doctor or pharmacist again.

Dosage

The recommended dose of Memantina Tarbis in adult and elderly patients is 20 mg administered once daily. To reduce the risk of side effects, this dose is gradually achieved by following the daily scheme:

The normal starting dose is half a tablet once daily (1 x 5mg) for the first week. It is increased to one tablet daily (1 x 10 mg) for the second week and to one and a half tablets once daily for the third week. From the fourth week onwards, the normal 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 on the appropriate dose for your condition. In this case, your doctor should periodically monitor your kidney function.

Administration

Memantina Tarbis should be taken orally once daily. 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 Tarbis 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

• Generally, 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 need 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 the next dose at the usual time.
• Do not take a double dose to make up for the forgotten dose.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Generally, side effects are classified as mild to moderate.

Frequent (affecting 1 to 10 in 100 patients):

• Headache, drowsiness, constipation, elevated liver function tests, dizziness, balance disorder, shortness of breath, high blood pressure, and hypersensitivity to the medication.

Uncommon (affecting 1 to 10 in 1,000 patients):

• Fatigue, fungal infections, confusion, hallucinations, vomiting, gait disturbance, heart failure, and venous thrombosis/thromboembolism.

Rare (affecting less than 1 in 10,000 patients):

• Seizures.

Frequency not known (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 Tarbis.

If you consider any of the side effects you are experiencing to be serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications, www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Memantina Tarbis

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date stated on the carton and blister after EXP. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of via wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If you have any questions, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Memantina Tarbis

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

The other ingredients 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 package contents

Memantina Tarbis is presented in the form of yellow, oval-shaped film-coated tablets with a score line on one side. The tablet can be divided into two equal halves.

Memantina Tarbis film-coated tablets are presented in packs of 30, 56, or 112 tablets.

Not all 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 package leaflet was approved in: November 2013

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