MANTINEX FLAS 10 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the User

Mantinex Flas 10 mg Oral Disintegrating 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 and other information

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

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

How Mantinex Flas works

Mantinex Flas 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. Mantinex Flas belongs to the group of medicines called NMDA receptor antagonists. This medicine works on these receptors, improving the transmission of nerve signals and memory.

What Mantinex Flas is 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 you take Mantinex Flas

Do not take Mantinex Flas

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

Warnings and precautions

Consult your doctor or pharmacist before taking 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 the above 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 medicines such as amantadine (for the treatment of Parkinson's disease), ketamine (a medicine generally used to produce anesthesia), dextromethorphan (a medicine for the treatment of cough) and other NMDA antagonists should be avoided.

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

Taking Mantinex Flas with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

In particular, the administration of this medicine may produce changes in the effects 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 hospitalized, inform your doctor that you are taking memantine.

Taking Mantinex Flas with food, drinks, and alcohol

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) 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 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 during pregnancy.

Women taking Mantinex Flas should stop breastfeeding.

Driving and using machines

Your illness may affect your ability to drive or use machines, and you should not carry out these activities unless your doctor tells you 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 machines.

Mantinex Flas contains lactose, aspartame, and sodium

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

This medicine contains 2.5 mg of aspartame (E-951) per tablet, equivalent to 0.04 mg/kg. Aspartame is a source of phenylalanine, which may be harmful in cases of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it properly.

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

3. How to take Mantinex Flas

Follow exactly the administration instructions of this medicine given 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 a day. To reduce the risk of side effects, this dose is gradually achieved by following the following daily scheme:

Mantinex Flas tablets cannot be divided. For doses not available for Mantinex Flas, you should use another medicine containing memantine whose dose is available.

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 Flas:

Mantinex Flas should be administered orally once a day. 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 them with or without water, as the patient prefers. 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 Mantinex Flas than you should

• 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 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 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.

In general, side effects are classified from 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 venous thrombosis/thromboembolism.

Rare (may affect up to 1 in 1,000 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. These events have 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 Pharmacovigilance System for Human Use website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Mantinex Flas

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 after "EXP". The expiry date is the last day of the month stated.

No special storage conditions are required.

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 Mantinex Flas

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

Appearance and packaging

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 last revision of this leaflet:September 2021