MANTOMED 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Mantomed 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 Mantomed and what is it used for
2. What you need to know before taking Mantomed
3. How to take Mantomed
4. Possible side effects
5. Storage of Mantomed
6. Package contents and additional information

1. What is Mantomed and what is it used for

This medication contains the active ingredient memantine hydrochloride. It 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.

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

2. What you need to know before taking Mantomed

Do not take Mantomed

• 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 this medication

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

In these situations, treatment should be carefully supervised, and your doctor should regularly reassess the clinical benefit of this medication.

If you have 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, your doctor may need to adjust your dose.

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

Other Medications and Mantomed

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

In particular, this medication may affect 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 this medication.

Taking Mantomed 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), as your doctor may need to adjust the dose of the medication.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.

The use of memantine is not recommended in pregnant women.

Women taking this medication should stop breastfeeding.

Driving and Using Machines

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

Additionally, this medication may affect your reaction ability, so driving or operating machines may be inappropriate.

This medication 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 medication.

Follow the administration instructions for this medication exactly as 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 medication 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 (days 1-7):

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

Week 2 (days 8-14):

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

Week 3 (days 15-21):

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

Week 4 (days 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 Impairment

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

Administration

This medication should be taken 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 medication 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 an excessive amount of this medication 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 medication and the amount ingested.

If You Forget to Take Mantomed

If you realize you have forgotten to take your dose of this medication, 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 medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Side effects are generally 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 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 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 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 Mantomed

Keep this medication out of sight and reach of children.

Do not use this medication after the expiration date stated on the carton and blister pack 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 pharmacy's SIGRE collection point. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Mantomed

• The active ingredient is memantine hydrochloride. Each tablet contains 10 mg of memantine hydrochloride, equivalent to 8.31 mg of memantine.
• The other ingredients of Mantomed 10 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 Package Contents

Mantomed 10 mg film-coated tablets are yellow, oblong, biconvex, scored on both sides, and have a core size of 5.6 x 11.1 mm. The tablet can be divided into equal doses.

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

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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 request more information about this medication from the local representative of the marketing authorization 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 medication is authorized in the Member States of the European Economic Area under the following names:

Spain: Mantomed 10 mg film-coated tablets EFG

Slovenia: Mantomed 10mg filmsko obložene tablete

Latvia: Mantomed 10mg apvalkotas tabletes

Netherlands: Mantomed 10mg Filmomhulde tabletten

Croatia: Mantomed 10mg filmom obložene tablete

Greece: Mantomed 10 mg Επικαλυμμ?να με λεπτ? υμ?νιο δισκ?α

Romania: Mantomed 10 mg comprimate filmate

Slovakia: Mantomed 10 mg

Czech Republic: Mantomed 10 mg

Lithuania: Mantomed 10 mg plevele dengtos tabletes

Estonia: Mantomed

Cyprus: Mantomed 10 mg film-coated tablets

Date of Last Revision of this Package Leaflet

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