MEMANTINE FLAS NORMON 20 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the User

Memantina Flas Normon20 mg Orodispersible 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.
• 1. 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 Package Leaflet

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

1. What is Memantina Flas Normon and what is it used for

Memantina 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. Memantina belongs to the group of medicines called NMDA receptor antagonists. Memantina acts on these receptors, improving the transmission of nerve signals and memory.

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

2. What you need to know before you take Memantina Flas Normon

Do not take Memantina Flas Normon

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

Warnings and Precautions

Consult your doctor or pharmacist before taking memantine:

• 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 re-evaluate 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.

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

The use of memantine with other medicines such as amantadine (for the treatment of Parkinson's disease), ketamine (a general anesthetic), dextromethorphan (a cough medicine), and other NMDA antagonists should be avoided.

Children and Adolescents

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

Other Medicines and Memantina Flas Normon

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

In particular, the administration of Memantina Flas Normon 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 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 Memantina Flas Normon 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 and Breastfeeding

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.

Memantine is not recommended for use in pregnant women.

Women taking memantine should not breastfeed.

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. Memantina Flas Normon 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.

Memantina Flas Normon contains Aspartame (E-951)

This medicine contains 5.00 mg of aspartame in each tablet. Aspartame is a source of phenylalanine that may be harmful in people with phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

Memantina Flas Normon contains Sodium

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

3. How to take Memantina Flas Normon

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

The recommended dose of memantine in adult and elderly patients is 20 mg once daily. To reduce the risk of adverse effects, this dose should be achieved gradually following the treatment schedule:

Memantina Flas Normon tablets should not be divided. For doses not available with Memantina Flas Normon, the patient should use another medicine containing memantine with an available dose.

Dosage 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.

Administration

Memantina Flas Normon 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 preferred by the patient. The tablets can be taken with or without food.

Duration of Treatment

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

If you take more Memantina Flas Normon than you should

• Generally, taking too much Memantina Flas Normon 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 Memantina Flas Normon, contact your doctor or seek medical advice, as you may need medical attention.

In case of overdose or accidental ingestion, call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you forget to take Memantina Flas Normon

• If you realize you have forgotten to take your dose of Memantina Flas Normon, wait and take the next dose at the usual time.
• Do not take a double dose to make up for the forgotten dose.

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.

Generally, side effects are mild to moderate.

Common (affects 1 to 10 users in 100):

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

Uncommon (affects 1 to 10 users in 1,000):

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

Rare (affects 1 user in 10,000):

• 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, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines and Healthcare Products Agency (AEMPS) website: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Memantina Flas Normon

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 blister after EXP. The expiry date refers to 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 other information

Composition of Memantina Flas Normon

The active substance is memantine hydrochloride. Each orodispersible tablet contains 20 mg of memantine hydrochloride, equivalent to 16.62 mg of memantine.

The other ingredients (excipients) are microcrystalline cellulose, potassium polacrilin, sodium croscarmellose, peppermint flavor, aspartame (E-951), mannitol/corn starch mixture, sodium saccharin, anhydrous colloidal silica, and magnesium stearate.

Appearance of the product and pack contents

Memantina Flas Normon is presented as white or almost white, round, flat, and beveled orodispersible tablets, anonymous on both sides with a diameter of 12.1 ± 10%.

Memantina Flas Normon is available in aluminum/polyamide-aluminum-PVC blisters in packs containing 56 tablets.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 - 28760 Tres Cantos - Madrid (SPAIN)

Date of last revision of this leaflet: November 2023

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

You can access detailed and updated information about this medicine by scanning the QR code included in the leaflet and packaging with your smartphone. You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/89161/P_89161.html