Memantina Sandoz 20 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Memantina Sandoz 20 mg film-coated tablets EFG

memantine hydrochloride

Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

Pack contents and other information

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

How Memantina Sandoz works

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

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

What Memantina Sandoz is used for

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

2. What you need to know before taking Memantina Sandoz

Do not take Memantina Sandoz

• 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 taking Memantina Sandoz:

• if you have a history of epileptic seizures,
• if you have recently had a myocardial infarction (heart attack), or if you have congestive heart disease or uncontrolled hypertension (high blood pressure).

In the above situations, treatment must be carefully monitored and your doctor should regularly reassess the clinical benefit of memantine.

If you have renal impairment (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 together with other medicines such as amantadine (used to treat Parkinson's disease), ketamine (a medicine generally used to induce anaesthesia), dextromethorphan (a medicine used to treat 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 need to take any other medicines.

Specifically, administration of Memantina Sandoz 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 Sandoz.

Taking Memantina Sandoz with food and drink

You should inform your doctor if you have recently changed or intend to substantially change your diet (e.g. 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 kidney dysfunction (kidney problem)) or severe urinary tract infections (urine passage infections), as your doctor may need to adjust the dose of the medicine.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

Memantine is not recommended for use in pregnant women.

Breast-feeding

Women taking memantine should discontinue breast-feeding.

Driving and using machines

Your doctor will advise you whether your condition allows you to drive and use machines safely.

Furthermore, memantine may affect 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 informed you that you have an intolerance to certain sugars, consult him before using this medicine.

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

3. How to take Memantina Sandoz

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

Dosage

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

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

Memantine must be taken 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 a little water. The tablets may be taken with or without food.

The tablets can be divided into four equal doses, as shown in the drawing. If necessary, place the tablet on a flat surface with the score lines facing upwards and press down with your thumb.

Duration of treatment

Continue taking memantine for as long as it is beneficial to you. Your doctor should periodically evaluate the effects of your treatment.

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 at telephone number 91 562 04 20, indicating the medication 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 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 missed doses.

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 can cause adverse effects, although not everyone experiences them.

In general, adverse effects are mild to moderate.

Common: may affect up to 1 in 10 people:

• headache, somnolence, constipation, elevated liver function tests, dizziness, impaired balance, 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).

Very rare: may affect up to 1 in 10,000 people:

• seizures.

Frequency not known: frequency cannot be estimated from the available data:

• inflammation of the pancreas, inflammation of the liver (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 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es.

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

5. Storage of Memantine 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 stated on the blister, label, and packaging after EXP. The expiry date refers to the last day of the month indicated.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of containers and unused medicines. This will help protect the environment.

6. Contents of the pack and other 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 components are monohydrate lactose, sodium carboxymethyl starch (type A) from 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 of the product and contents of the pack

Film-coated, reddish-brown, round tablets (11.1 mm in diameter), with a cross-shaped score line on one side.

The tablet can be divided into equal doses.

The film-coated tablets are packed in transparent PVC-Aclar/aluminum and/or transparent PVC-PVDC/aluminum blisters and/or in HDPE bottles with polypropylene screw caps with child-resistant closure and desiccant, all contained in a cardboard carton.

Pack 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.

Only certain pack sizes may be commercially available.

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

This medicinal product 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 the most recent revision of this leaflet: May 2020

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