Memantina Flas Normon 10 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Memantina Flas Normon 10 mg orodispersible tablets EFG

Memantine hydrochloride

Read the entire package leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.

  1. If you have any questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.

  • If you experience any adverse effects, consult your doctor or pharmacist, even if these effects are not listed in this leaflet. See section 4.

Contents of the package leaflet

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

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

Memantina Flas Normon contains the active substance memantina hydrochloride. It belongs to a group of medicines known as anti-dementia drugs.

Memory loss in Alzheimer's disease is due to disturbances in brain signaling. The brain contains so-called N-methyl-D-aspartate (NMDA) receptors, which are involved in the transmission of nerve signals important for learning and memory. Memantina belongs to a 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 taking Memantina Flas Normon

Do not take Memantina Flas Normon

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

Warnings and precautions

Consult your doctor or pharmacist before starting memantine:

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

In the above situations, treatment should be carefully monitored and your doctor should regularly re-evaluate the clinical benefit of memantine.

If you have renal impairment (kidney problems), your doctor must closely monitor your kidney function and, if necessary, adjust the doses of memantine.

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

The use of memantine should be avoided together with other medicines such as amantadine (used to treat Parkinson's disease), ketamine (a drug generally used as an anesthetic), dextromethorphan (a medicine used to treat cough), and other NMDA antagonists.

Children and adolescents

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

Other medicines and Memantina Flas Normon

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

Specifically, the administration of Memantina Flas Normon may cause changes in the effects of the following medicines, so your doctor may need to adjust the dosage:

• amantadine, ketamine, dextromethorphan,
• dantrolene, baclofen,
• cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine,
• hydrochlorothiazide (or any combination containing hydrochlorothiazide),
• anticholinergics (substances generally used to treat movement disorders or intestinal spasms),
• anticonvulsants (substances used to prevent and stop 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 admitted to hospital, inform your doctor that you are taking Memantina Flas Normon.

Taking Memantina Flas Normon with food and drinks

You should inform your doctor if you have recently changed or intend to substantially change your diet (for example, 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 become pregnant, consult your doctor or pharmacist before using this medicine.

The use of memantine is not recommended in pregnant women.

Women who take memantine must not breastfeed.

Driving and using machines

Your medical condition may affect your ability to drive or operate machinery, and you should not perform these activities unless your doctor tells you it is safe to do so. Memantina Flas Normon may cause dizziness and drowsiness, especially at the beginning of treatment or when the dose is increased. If you experience these effects, you must not drive or operate machinery.

Memantina Flas Normon contains aspartame (E-951)

This medicine contains 2.50 mg of aspartame per tablet. Aspartame is a source of phenylalanine, which may be harmful in individuals 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; therefore, it is essentially “sodium-free”.

3. How to take Memantina Flas Normon

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

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

Memantina Flas Normon tablets cannot be split. For doses not available of Memantina Flas Normon, the patient should use another medication containing memantine for which the required dose is available.

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 maximum benefit from your medication, you must take it every day at the same time. The tablets should be placed on the tongue and allowed to dissolve before swallowing with or without water, according to the patient's preference. The tablets may be taken with or without food.

Duration of treatment

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

If you take more Memantina Flas Normon than you should

• In general, taking an excessive amount of Memantina Flas Normon should not cause you any harm. You may experience an increase in the symptoms described in section 4, "Possible adverse effects".
• If you take an overdose of Memantina Flas Normon, contact your doctor or seek medical advice, as you may require medical attention.

In case of overdose or accidental ingestion, call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount ingested.

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 missed dose.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

In general, adverse effects are classified as mild to moderate.

Common (affects between 1 and 10 out of every 100 patients):

• Headache, drowsiness, constipation, elevated liver function tests, dizziness, loss of coordination, difficulty breathing, high blood pressure, and hypersensitivity to the medicine.

Uncommon (affects between 1 and 10 out of every 1,000 patients):

• Fatigue, fungal infections, confusion, hallucinations, vomiting, gait disturbance, heart failure, and formation of blood clots in the venous system (venous thrombosis/venous thromboembolism).

Very rare (affects less than 1 out of every 10,000 patients):

• Seizures.

Frequency not known (frequency cannot be estimated from available data):

• Inflammation of the pancreas, inflammation of the liver (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 adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Memantine Flas Normon

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

Do not use this medicine after the expiry date stated on the packaging and on the blister after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This 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 10 mg of memantine hydrochloride, equivalent to 8.31 mg of memantine.

The other components (excipients) are microcrystalline cellulose, polacriline potassium, sodium croscarmellose, mint flavoring, aspartame (E-951), a mixture of mannitol/corn starch, sodium saccharin, anhydrous colloidal silica, and magnesium stearate.

Appearance of the product and contents of the pack

Memantina Flas Normon is presented as white or almost white, round, flat, bevelled orodispersible tablets, marked with "10" on one side and unmarked on the other, with a diameter of 9.1 mm ± 10%.

Memantina Flas Normon is available in aluminum/polyamide-aluminum-PVC blisters, in packs containing 112 tablets.

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 - 28760 Tres Cantos - Madrid (SPAIN)

Date of the most recent review of this leaflet: November 2023

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

You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the package leaflet and outer packaging. You can also access this information at the following internet address:

https://cima.aemps.es/cima/dochtml/p/89160/P_89160.html