MANTOMED 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Mantomed 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 pack

1. What is Mantomed and what is it used for
2. What you need to know before you take Mantomed
3. How to take Mantomed
4. Possible side effects
5. Storage of Mantomed
6. Contents of the pack and further information

1. What is Mantomed and what is it used for

This medicinal product contains the active substance memantine hydrochloride. It belongs to a group of medicines called anti-dementia medicines.

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 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 NMDA receptors, improving the transmission of nerve signals and memory.

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

2. What you need to know before you take Mantomed

Do not take Mantomed

• 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 this medicine

• 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 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 this medicine.

If you have renal insufficiency (kidney problems), your doctor should closely monitor your kidney function and, if necessary, adjust the dose of memantine.

If you have renal tubular acidosis (RTA, excess of acid-forming substances in the blood due to kidney dysfunction) or severe urinary tract infections (structure that transports urine), your doctor may need to adjust your dose.

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

Children and adolescents

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

Other medicines and Mantomed

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

In particular, this medicine may affect the action of the following medicines, 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 admitted to hospital, inform your doctor that you are taking this medicine.

Taking Mantomed 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) 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.

The use of memantine is not recommended in pregnant women.

Women who take this medicine should stop breastfeeding.

Driving and using machines

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

Also, this medicine may affect your ability to react, so driving or operating machinery may be inappropriate.

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

3. How to take Mantomed

The starter pack of Mantomed should only be used when starting treatment with this medicine.

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

The recommended treatment dose of 20 mg per day is achieved by gradually increasing the dose of this medicine over the first 3 weeks of treatment. The treatment schedule is also indicated on the starter pack. Take one tablet once a day.

Week 1 (day 1-7):

Take one 5 mg tablet once a day for 7 days.

Week 2 (day 8-14):

Take one 10 mg tablet once a day for 7 days.

Week 3 (day 15-21):

Take one 15 mg tablet once a day for 7 days.

Week 4 (day 22-28):

Take one 20 mg tablet per day for 7 days.

Maintenance dose

The recommended daily dose is 20 mg once a day.

For continued treatment, consult your doctor.

Dosage in patients with renal insufficiency

If you have renal insufficiency, your doctor will decide on a dose that suits your condition. In this case, your doctor should regularly monitor your kidney function.

Administration

This medicine should be administered orally once a day. To get the most benefit from your medication, you should take it every day 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 this medicine as long as it is beneficial for you. Your doctor should periodically evaluate the effects of your treatment.

If you take more Mantomed than you should

Generally, taking too much of this medicine should not cause you any harm. You may experience an increase in the symptoms described in section 4.

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.

If you forget to take Mantomed

If you realize that you have forgotten to take your dose of this medicine, 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 further questions on 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.

Side effects are usually 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 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/venous 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. The occurrence of these events has been reported in patients treated with memantine.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Mantomed

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

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

This medicine does not require any special storage conditions.

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 Mantomed

• The active substance is memantine hydrochloride. Each tablet contains 20 mg of memantine hydrochloride, equivalent to 16.62 mg of memantine.
• The other ingredients of Mantomed 20 mg film-coated tablets are: microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate.

Coating material: hypromellose, titanium dioxide (E171), macrogol 400, yellow iron oxide (E172).

Appearance of the product and pack contents

Mantomed 20 mg film-coated tablets are film-coated, biconvex, round, yellow and have a core diameter of 10.3 mm.

This medicine is available in transparent PVC/PE/PVDC-Al or PA/Al/PVC-Al blisters in cardboard boxes of 14, 28, 30, 50, 56, 60, 70, 100, 112 and 1000 tablets.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

Medochemie Limited,

1-10 Constantinoupoleos street,

3011 Limassol,

Cyprus

Manufacturer

Medochemie Limited,

1-10 Constantinoupoleos street,

3011 Limassol,

Cyprus

Or

Medochemie Limited.,

Factory AZ

2 Michali Irakleous Street, Agios Athanassios Industrial Area,

Agios Athanassios, Limassol, 4101,

Cyprus

You can obtain further information on this medicine by contacting the local representative of the marketing authorisation holder:

Local representative:

Medochemie Iberia S.A., Sucursal en España

Avenida de las Águilas, nº 2 B; planta 5 oficina 6,

28044 Madrid

SPAIN

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

Spain: Mantomed 20 mg film-coated tablets EFG

Slovenia: Mantomed 20mg film-coated tablets

Latvia: Mantomed 20mg apvalkotas tabletes

Netherlands: Mantomed 20mg filmomhulde tabletten

Croatia: Mantomed 20mg filmom obložene tablete

Greece: Mantomed 20 mg Επικαλυμμ?να με λεπτ? υμ?νιο δισκ?α

Romania: Mantomed 20 mg comprimate filmate

Slovakia: Mantomed 20 mg

Czech Republic: Mantomed 20 mg

Lithuania: Mantomed 20 mg plevele dengtos tabletes

Estonia: Mantomed

Cyprus: Mantomed 20 mg film-coated tablets

Date of last revision of this leaflet

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