MANTINEX FLAS 20 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the User

Mantinex Flas 20 mg Oral Disintegrating 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 Flas and what is it used for.
2. What you need to know before taking Mantinex Flas.
3. How to take Mantinex Flas.
4. Possible side effects.
5. Storage of Mantinex Flas.
6. Package Contents and Additional Information.

1. What is Mantinex Flas and what is it used for

How Mantinex Flas Works

Mantinex Flas 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 Flas belongs to the group of medications called NMDA receptor antagonists. This medication acts on these receptors, improving the transmission of nerve signals and memory.

What is Mantinex Flas used for

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

2. What you need to know before taking Mantinex Flas

Do not take Mantinex Flas

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

Warnings and Precautions

Consult your doctor or pharmacist before starting to take Mantinex Flas.

• 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 renal insufficiency (kidney problems), your doctor should closely monitor your renal 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 Flas is not recommended in children and adolescents under 18 years of age.

Taking Mantinex Flas 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 this medication 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 memantine.

Taking Mantinex Flas with food, beverages, 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 (urinary tract), 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 Flas should stop breastfeeding.

Driving and Using Machines

Your illness may affect your ability to drive or use machinery, and you should not perform these activities unless your doctor indicates that it is safe to do so. Mantinex Flas may cause dizziness and somnolence, mainly at the start of treatment or when increasing the dose. If you experience these effects, do not drive or use machinery.

Mantinex Flas contains lactose, aspartame, and sodium

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

This medication contains 5 mg of aspartame (E-951) per tablet, equivalent to 0.07 mg/kg. Aspartame contains a source of phenylalanine, which may be harmful in case of phenylketonuria (PKU), a rare genetic disease in which phenylalanine accumulates because the body is unable to eliminate it properly.

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

3. How to take Mantinex Flas

Follow the exact administration instructions for this medication as indicated by your doctor or pharmacist.

In case of doubt, consult your doctor or pharmacist again.

Posology:

The recommended dose of memantine in adult 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 tablets of Mantinex Flas cannot be divided. For doses not available for Mantinex Flas, you should use another medication containing memantine with an available dose.

Posology for patients with renal insufficiency:

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 renal function.

How to administer Mantinex Flas:

Mantinex Flas 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 placed on the tongue and allowed to dissolve before swallowing with or without water, as the patient prefers. 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 Mantinex Flas 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 Flas

• 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 experiences them.

Generally, side effects are classified as mild to moderate.

Frequent (may affect up to 1 in 10 people):

• Headache, drowsiness, constipation, elevated liver function tests, dizziness, balance disorder, difficulty 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 venous thrombosis/thromboembolism.

Rare (may affect up to 1 in 1,000 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 directly through the Spanish Pharmacovigilance System for Human Use website: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Mantinex Flas

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 through wastewater or household waste. Deposit the packaging and unused medications in the SIGRE Pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Mantinex Flas

• The active ingredient is memantine hydrochloride. (Each oral disintegrating tablet contains 10 mg of memantine hydrochloride, equivalent to 8.31 mg of memantine).
• The other components are: Polacrilin, lactose monohydrate, microcrystalline cellulose (E460), anhydrous colloidal silica, sodium croscarmellose, mannitol (E421), aspartame (E951), red iron oxide (E172), magnesium stearate (E-572), sodium hydroxide (for pH adjustment), and peppermint flavor (modified cornstarch).

Appearance of the product and package contents

Mantinex Flas 10 mg is presented in the form of oral disintegrating tablets, pink, round, flat, with beveled edges, and marked with "10" on one face.

Mantinex Flas 10 mg is presented in Al/Al blister packs of 112 oral disintegrating tablets.

Other presentations:

Mantinex Flas 20 mg oral disintegrating tablets EFG.

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)

Spain

Date of the last revision of this package leaflet:September 2021