MANTINEX 10 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

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

1. Contents of the pack and further information

1. What is Mantinex and what is it used for

How Mantinex works

Mantinex belongs to a group of medications known as 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. Mantinex belongs to the group of medications called NMDA receptor antagonists. Mantinex acts on these receptors, improving the transmission of nerve signals and memory.

What Mantinex is used for

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

2. What you need to know before taking Mantinex

Do not take Mantinex

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Mantinex.

• if you have a history of epileptic seizures.
• if you have recently suffered a myocardial infarction (heart attack), 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 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 with other 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.

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

Taking Mantinex with other medications

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

In particular, the administration of Mantinex may produce changes in 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 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 hospitalized, inform your doctor that you are taking Mantinex.

Taking Mantinex with food, drinks, and alcohol

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) 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 (urine conduit), 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 any medication.

The use of memantine is not recommended in pregnant women.

Women taking Mantinex should stop breastfeeding.

Driving and using machines

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

Also, Mantinex may alter your reaction ability, so driving or operating machines may be inappropriate.

Mantinex contains lactose

If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

3. How to take Mantinex

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

Posology:

The recommended dose of Mantinex in adult patients and elderly patients is 20 mg administered once daily. To reduce the risk of side effects, this dose is gradually achieved following the daily scheme:

The normal starting dose is half a tablet once daily (5 mg) for the first week. It is increased to one tablet daily (10 mg) for the second week and to one and a half tablets once daily for the third week. From the fourth week onwards, the normal dose is two tablets administered once daily (20 mg).

Posology 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.

How to administer Mantinex:

Mantinex 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.

Duration of treatment:

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

If you take more Mantinex than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: (91) 5620420, indicating the medication and the amount ingested.

• Generally, 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 take an overdose of memantine, contact your doctor or seek medical advice, as you may need medical attention.

If you forget to take Mantinex

• If you realize you have forgotten to take your dose of Mantinex, wait and take the next dose at the usual time.
• Do not take a double dose to make up for the missed 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, Mantinex can cause side effects, although not everyone gets them.

Generally, side effects are classified as mild to moderate.

Frequent (may affect 1 to 10 in every 100 patients):

• Headache, drowsiness, constipation, elevated liver function tests, dizziness, balance disorder, difficult breathing, high blood pressure, and hypersensitivity to the medication.

Uncommon (may affect 1 to 10 in every 1,000 patients):

• Fatigue, fungal infections, confusion, hallucinations, vomiting, gait disturbance, heart failure, and venous thrombosis/thromboembolism.

Rare (may affect less than 1 in every 10,000 patients):

• 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 memantine.

Reporting of 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 directly through the Spanish Pharmacovigilance System for Human Use website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

If you consider any of the side effects you are experiencing to be serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.

5. Storage of Mantinex

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

Do not use this medication after the expiration date stated on the packaging after "EXP". The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of via wastewater or household waste. Place the packaging and any unused medication in the SIGRE Pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Contents of the pack and further information

Composition of Mantinex

• The active ingredient is memantine hydrochloride. (Each film-coated tablet contains 10 mg of memantine hydrochloride, equivalent to 8.31 mg of memantine).
• The other ingredients are:

Core of the tablet:lactose monohydrate, microcrystalline cellulose (E-460i), anhydrous colloidal silica, talc, and magnesium stearate (E-572).

Coating:hypromellose (E-464), titanium dioxide (E-171), and macrogol 400 (E-1521).

Appearance of the product and pack contents

Mantinex 10 mg is presented in the form of white, oblong, biconvex film-coated tablets with a score line.

Mantinex 10 mg film-coated tablets are presented in monodose blister packs (PVDC/Al) of 112 film-coated tablets.

Other presentations:

Mantinex 20 mg film-coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

Manufacturer:

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 – Sant Joan Despí

(Barcelona)

Date of the last revision of this package leaflet:July 2021.

Other sources of information:

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