Product Information for the User

Memantina Stada 5 mg Film-Coated Tablets

Memantina Stada 10 mg Film-Coated Tablets

Memantina Stada 15 mg Film-Coated Tablets

Memantina Stada 20 mg Film-Coated Tablets

memantinehydrochloride

Read this 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. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

How Memantina Stada works

Memantina belongs to a group of medicationsdenominatedanti-dementia medications.

The loss of memory in Alzheimer's disease is due to an alteration in brain signals. The brain contains the so-called N-methyl-D-aspartate (NMDA) receptors that participate in the transmission of important nervous signals in learning and memory. Memantina belongs to the group of medications called NMDA receptor antagonists. Memantina acts on these NMDA receptors by improving the transmission of nervous signals and memory.

What Memantina Stada is used for

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

Do not take Memantina Stada

• if you are allergic to hydrochloride of memantine or to any of the other components 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 had a myocardial infarction (heart attack), if you suffer from congestive heart failure or if you have uncontrolled high blood pressure.

The treatment must be closely monitored and the doctor must reevaluate the clinical benefit of memantine regularly in the above situations.

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

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 to induce anesthesia), dextromethorphan (a medication for the treatment of cough), and other NMDA antagonists.

Children and adolescents

Memantine is not recommended for use in children and adolescents under 18 years old.

Taking Memantina Stada 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 memantine may produce changes in the effects of the following medications, so your doctor may need to adjust the dosage:

• 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 memantine.

Taking Memantina Stada with food and drinks

You must inform your doctor if you have recently changed or intend to change your diet significantly (e.g., from a normal diet to a strict vegetarian diet) or if you have kidney tubular acidosis (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 dosage.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant or intend to become pregnantconsult 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 operating machinery

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

Furthermore, memantine may alter your reaction time, making driving or operating machinery inappropriate.

Memantina Stada contains sodium

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

The packaging with the initial treatment of memantine should only be used at the beginning of treatment with memantine.

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

Dosage:

The recommended dose is 20 mg per day, which is achieved through gradual increases in the memantine dose during the first 3 weeks of treatment. The treatment schedule is also indicated on the packaging of the initial treatment. Take one tablet once a day.

Week 1 (days 1-7)

Take one 5 mg tablet once a day (white, oval, biconvex) for 7 days.

Week 2 (days 8-14)

Take one 10 mg tablet once a day (white, biconvex, scored on both sides) for 7 days.

Week 3 (days 15-21)

Take one 15 mg tablet once a day (light brown, oval, biconvex) for 7 days.

Week 4 (days 22-28)

Take one 20 mg tablet once a day (pink, oval, biconvex) for 7 days.

Maintenance dose

The recommended daily dose is 20 mg once a day. To continue treatment, consult your doctor.

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 should monitor your renal function periodically.

Administration

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

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 Toxicological Information Service, phone: (91) 5620420, indicating the medication and the amount ingested.

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

If you forgot to take Memantina Stada

• If you realize you have forgotten to take your memantine dose, 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 doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people may 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 disorder, heart failure, and formation of blood clots in the venous system (venous thromboembolism).

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 memantine.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them 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 on 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 packaging and blister after “CAD”. 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 drains or in the trash. Dispose of the packaging and medications you no longer need atthe SIGRE Collection Pointat 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.

Memantine Stada Composition

The active ingredient is memantine hydrochloride.

Each film-coated tablet of 5 mg contains 5 mg of memantine hydrochloride, equivalent to4.15mg of memantine.

Each film-coated tablet of 10 mg contains 10 mg of memantine hydrochloride, equivalent to8.31mg of memantine.

Each film-coated tablet of 15 mg contains 15 mg of memantine hydrochloride, equivalent to12.46mg of memantine.

Each film-coated tablet of 20 mg contains 20 mg of memantine hydrochloride, equivalent to16.62mg of memantine.

The core components ofmemantine 5/10/15/20 mg film-coated tablets are microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, and magnesium stearate. The components of the film coating are polyvinyl alcohol, titanium dioxide (E171), macrogol (3350), talc, and additionally for memantine 15 mg film-coated tablets, yellow, red, and black iron oxide (E172), and for memantine 20 mg film-coated tablets, yellow and red iron oxide (E172).

Appearance of the product and contents of the package

Memantine Stada 5 mg are presented as white, oval, biconvex film-coated tablets, 8.1 mm x 4.1 mm, engraved with a "5" on one side.

Memantine Stada 10 mg are presented as white, narrow in the center, biconvex film-coated tablets, 10 mm x 5.6 mm, with a groove on both sides and engraved with "10" on one side.

The 10 mg tablet can be divided into equal doses.

Memantine Stada 15 mg are presented as light brown, oval, biconvex film-coated tablets, 12.3 mm x 6.6 mm.

Memantine Stada 20 mg are presented as pink, oval, biconvex film-coated tablets, 13.5 mm x 7.3 mm.

The starter pack contains 28 tablets with 7 tablets of memantine 5 mg, 7 tablets of memantine 10 mg, 7 tablets of memantine 15 mg, and 7 tablets of memantine 20 mg.

The blister packs contain 7 tablets per strip (PVC/PE/PVDC and aluminum).

The blister packs contain 7x1 tablets per strip of memantine 5 mg, 7x1 tablets per strip of memantine 10 mg, 7x1 tablets per strip of memantine 15 mg, and 7x1 tablets per strip of memantine 20 mg (single-dose blister pack PVC/PE/PVDC and aluminum).

Marketing authorization holder and responsible manufacturer

Marketing authorization holder

STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern

(Barcelona)

[email protected]

Responsible 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 Vienna

Austria

This medicinal product is authorized in the Member States of the EEA with the following names:

Germany:Memantine hydrochloride STADA Starter Pack 5 mg /10 mg / 15 mg / 20 mg Film-coated Tablets

Austria:Memantine STADA 5/10/15/20mg Film-coated Tablets

Spain:Memantine Stada 5 mg + 10 mg + 15 mg + 20 mg Film-coated Tablets EFG

Netherlands:Memantine HCl CF 5mg/10 mg/15mg/20mg, film-coated tablets

Portugal:Memantina Ciclum 5mg + 10 mg + 15 mg + 20 mg

Last review date of this leaflet:June 2021

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