MEMANTINE STADA 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Memantina Stada 10 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, consult 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 Stada and what is it used for.
2. What you need to know before taking Memantina Stada.
3. How to take Memantina Stada.
4. Possible side effects.
5. Storage of Memantina Stada.
6. Contents of the pack and further information

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

How Memantina Stada works

Memantine belongs to a group of medications called 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. Memantine belongs to the group of medications called NMDA receptor antagonists. Memantine acts on these NMDA receptors, improving the transmission of nerve signals and memory.

What Memantina Stada is used for

Memantine is used in the treatment of patients with moderate to severe Alzheimer's disease.

2. What you need to know before taking Memantina Stada

Do not take Memantina Stada

• 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 memantine.

• if you have a history of epileptic seizures.
• if you have recently suffered 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 reassess the clinical benefit of memantine Stada.

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.

Children and adolescents

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

Taking Memantina Stada 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 memantine 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 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 memantine.

Taking Memantina Stada 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 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 any medication.

Pregnancy

The use of memantine is not recommended in pregnant women.

Breastfeeding

Women taking memantine should discontinue breastfeeding.

Driving and using machines

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

Also, memantine may alter your reaction ability, so driving or operating machines may be inappropriate.

Memantina Stada contains sodium

This medication contains less than 23 mg of sodium (1 mmol) per tablet; this is, essentially "sodium-free".

3. How to take Memantina Stada

Follow the administration instructions of this medication exactly as indicated by your doctor or pharmacist. Consult your doctor or pharmacist if you have any doubts.

Posology:

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

The normal starting dose is half a 10 mg tablet (5 mg) once daily the first week. It is increased to one 10 mg tablet (10 mg) daily the second week and to one and a half tablets once daily in the third week (15 mg). From the fourth week onwards, the normal dose is two 10 mg tablets or one 20 mg tablet administered once daily (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

Memantine should be administered 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 memantine as long as it is beneficial for you. Your doctor should periodically evaluate the effects of your treatment.

If you take more Memantina Stada than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: (91) 5620420, indicating the medication and the amount ingested.

Generally, taking an excessive amount of memantine should not cause you any harm. You may experience an increase in the symptoms described in section 4 "Possible side effects".

If you forget to take Memantina Stada

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

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 gets them.

Generally, 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 medication.

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, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Memantina Stada

Keep this medication out of the sight and reach of children.

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

This medication does not require special storage conditions.

Medications should not be disposed of through wastewater or household waste. Dispose of the packaging and any unused medication in the SIGRE Collection Pointat the pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Contents of the pack and further information

Composition of Memantina Stada

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

The core components are microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, and magnesium stearate. The film-coating components are polyvinyl alcohol, titanium dioxide (E171), macrogol (3350), and talc.

Appearance of the product and contents of the pack

Memantina Stada 10 mg is presented in the form of white, film-coated tablets, more narrow in the center, biconvex, 10 mm - 5.6 mm, with a notch on both sides and engraved with a "10" on one side.

The 10 mg tablet can be divided into equal doses.

The blister packs contain 7, 10, 14, 15, or 20 tablets per blister strip (PVC/PE/PVDC and aluminum).

Memantina STADA 10 mg film-coated tablets are presented in packs of 7, 14, 28, 30, 42, 50, 56, 60, 98, 110, 112, 168, or 180 film-coated tablets.

The blister packs contain 7x1, 10x1, 14x1, 15x1, or 20x1 tablets per blister strip (unit-dose blister PVC/PE/PVDC and aluminum).

Memantina STADA 10 mg film-coated tablets are presented in packs of 7, 14, 28, 30, 42, 50, 56, 60, 98, 110, 112, 168, or 180 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern

(Barcelona)

info@stada.es

Manufacturer

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel

Germany

or

Centrafarm Services B.V.

Van de Reijtstraat 31-E

4814 NE Breda

Netherlands

or

Clonmel Healthcare Ltd.

Waterford Road

Clonmel, Co. Tipperary

Ireland

or

STADA Arzneimittel GmbH

Muthgasse 36

1190 Wien

Austria

This medication is authorized in the EEA member states with the following names:

Germany: Memantinhydrochlorid STADA 10 mg Filmtabletten

Austria: Memantin STADA 10 mg Filmtabletten

Belgium: Memantine EG 10mg filmomhulde tabletten

Bulgaria: Memantine STADA 10 mg film-coated tablets

Spain: Memantina Stada 10 mg comprimidos recubiertos con película EFG

France: MEMANTINE EG 10 mg, comprimé pelliculé

Netherlands: Memantine HCl CF 10 mg, filmomhulde tabletten

Hungary: Memantin Stada 10 mg filmtabletta

Ireland: Memantine Clonmel 10 mg film-coated tablets

Luxembourg: Memantine EG 10mg comprimés pelliculés

Portugal: Memantina Ciclum 10 mg

Czech Republic: MEMANTIN STADA 10mg potahované tablety

Slovakia: Memantin Stada filmom obalené tablety 10 mg

Date of the last revision of this package leaflet:June 2021

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/.