MEMANTINE SANDOZ 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the Patient

Memantina Sandoz 20 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, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Memantina Sandoz and what is it used for
2. What you need to know before you take Memantina Sandoz
3. How to take Memantina Sandoz
4. Possible side effects
5. Storage of Memantina Sandoz

Contents of the pack and further information

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

How Memantina Sandoz works

Memantine belongs to a group of medicines called anti-dementia medicines.

Memory loss in Alzheimer's disease is due to a disturbance in brain signals. The brain contains so-called N-methyl-D-aspartate (NMDA) receptors that are involved in the transmission of important nerve signals in learning and memory. Memantine belongs to a group of medicines called NMDA receptor antagonists. Memantine acts on these receptors, improving the transmission of nerve signals and memory.

What Memantina Sandoz 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 you take Memantina Sandoz

Do not take Memantina Sandoz

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Memantina Sandoz:

• if you have a history of epileptic seizures,
• if you have recently suffered a myocardial infarction (heart attack), or if you suffer from congestive heart failure or 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 memantine.

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

Children and adolescents

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

Taking Memantina Sandoz with other medicines

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

In particular, the administration of Memantina Sandoz may produce 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 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 Sandoz.

Taking Memantina Sandoz with food and drinks

You should inform your doctor if you have recently changed or intend 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 medicine.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Memantine is not recommendedfor use in pregnant women.

Breastfeeding

Women who take memantine should stop 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 machinery may be inappropriate.

Memantina Sandoz contains lactose and sodium

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, consult with them before using this medicine.

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

3. How to take Memantina Sandoz

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

Posology

The recommended doseof memantine 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:

Posology 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

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.

The tablets can be divided into equal doses, as described in the drawing. If necessary, place the tablet on a flat surface with the dividing lines facing up, press the tablet with your thumb.

Duration of treatment

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 Sandoz than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount ingested.

In general, 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 Sandoz

• If you realize that 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 forgotten doses.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

In general, side effects are mild to moderate.

Common,may affect up to 1 in 10 people:

• headache, drowsiness, constipation, elevated liver function tests, dizziness, balance disorder, shortness of breath, 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 (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 this medicine.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Memantina Sandoz

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

This medicine does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the blister or label and carton after EXP. The expiry date is the last day of the month shown.

After first opening, use the contents of the bottle within 6 months.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and further information

Composition of Memantina Sandoz

• The active substance is memantine. Each tablet contains 20 mg of memantine hydrochloride equivalent to 16.62 mg of memantine.
• The other ingredients are lactose monohydrate, sodium carboxymethyl starch (type A) potato, microcrystalline cellulose, colloidal anhydrous silica, and magnesium stearate in the core;

polyvinyl alcohol, macrogol, titanium dioxide (E 171), talc, red iron oxide (E 172), and yellow iron oxide (E 172) in the coating.

Appearance and packaging of the product

Film-coated tablets of brown-red color, round (11.1 mm in diameter) with two dividing lines in the shape of a cross on one side.

The tablet can be divided into equal doses.

The film-coated tablets are packaged in transparent PVC-Aclar/Aluminum and/or transparent PVC-PVDC/Aluminum blisters or in HDPE bottles with a screw cap of PP with a safety closure and desiccant inserted in a cardboard box.

Package sizes:

Blister: 7, 10, 14, 18, 20, 22, 28, 30, 40, 42, 45, 48, 49, 49x1, 50, 56, 56x1, 60, 70, 84, 90, 96, 98, 98x1, 100, 100x1, 112, 980 (10x98) or 1000 (20x50) film-coated tablets.

Bottle: 28, 30, 56, 98, 100 or 112 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Lek Pharmaceuticals d.d.

Verovškova 57,

1526 Ljubljana

Slovenia

or

Lek S.A

ul. Domaniewska 50 C,

02-672 Warszawa

Poland

or

Salutas Pharma GmbH

Otto-von-Guericke-Allee 1,

39179

Barleben

Germany

or

S.C. Sandoz, S.R.L.

Str. Livezeni nr. 7A,

RO-540472 Targu-Mures

Romania

This medicine is authorized in the Member States of the European Economic Area under the following names:

Netherlands:Memantine Sandoz 20 mg, filmomhulde tabletten

Austria:Memantin Sandoz 20 mg – Filmtabletten

Belgium:Memantine Sandoz 20 mg filmomhulde tabletten

Cyprus:Memantine Sandoz 20 mg tabs

Czech Republic:Memantin Sandoz 20 mg

Germany:Memantin HEXAL 20 mg Filmtabletten

Denmark:Memantine Sandoz

Greece:Memantine/Sandoz

Finland:Memantine Sandoz 20 mg tabletti, kalvopäällysteinen

France:Memantine Sandoz 20 mg, comprimé pelliculé sécable

Iceland:Memantine Sandoz

Luxembourg:Memantine Sandoz 20 mg comprimés pelliculés

Malta:Memantine 20 mg Film-coated Tablets

Norway:Memantine Sandoz

Portugal:Memantina Sandoz

Sweden:Memantine Sandoz

United Kingdom:Memantine 20 mg Film-coated Tablets

Date of last revision of this leaflet: May 2020

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