Product Information for the User

Memantina Flas Normon10 mg Buccal Tablets EFG

Memantine Hydrochloride

Read the entire product information carefully before starting to take this medication, as it contains important information for you.

• Keep this product information, as you may need to refer to it again.
• 1. If you have any questions, consult your doctor or pharmacist.

-This medication has been prescribed only to you, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this product information. See section 4.

Memantina Flas Normoncontains the active ingredient memantine hydrochloride. It belongs to a group of medicines known as dementia medicines.

The loss of memory in Alzheimer's disease is due to an alteration in brain signals. The brain contains called N-methyl-D-aspartate (NMDA) receptors that participate in the transmission of important nervous signals in learning and memory. Memantine belongs to the group of medicines called NMDA receptor antagonists. Memantine acts on these receptors by improving the transmission of nervous signals and memory.

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

Do not take Memantina Flas Normon

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take memantine:

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

Under these circumstances, treatment should be closely monitored and your doctor should regularly reevaluate the clinical benefit of memantine.

If you have kidney problems, your doctor should closely monitor your renal function and, if necessary, adjust the dose of memantine.

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

Memantine should be avoided when used with other medications such as amantadine (for Parkinson's treatment), ketamine (a medication generally used as an anesthetic), dextromethorphan (a medication for cough treatment) and other NMDA antagonists.

Children and adolescents

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

Other medications and Memantina Flas Normon

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

Specifically, the administration of Memantina Flas Normon 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),
• dopamine agonists (substances like L-dopa, bromocriptine),
• neuroleptics (substances used in the treatment of mental illnesses),
• oral anticoagulants.

If you are admitted to a 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 change your diet significantly (e.g., from a normal diet to a strict vegetarian diet), as your doctor may need to adjust the dose of the medication.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Memantine is not recommended for use in pregnant women.

Women taking memantine should breastfeed.

Driving and operating machinery

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

Memantina Flas Normon contains aspartame (E-951)

This medication contains 2.50 mg of aspartame in each tablet. Aspartame contains a source of phenylalanine that may be harmful in the case of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates due to the body's inability to eliminate it correctly.

Memantina Flas Normon contains sodiumcontains less than 1 mmol of sodium (23 mg) per tablet; it is essentially "sodium-free".

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

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

The recommended dose ofmemantinein adult patients and elderly patients is 20 mg administered once a day. To reduce the risk of adverse effects, this dose is achieved gradually following the daily treatment schedule:

Memantine Flas Normon tablets cannot be split. For doses not available in Memantine Flas Normon, the patient should use another medication containing memantine whose dose is available.

Dosage 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 must monitor your renal function periodically.

Administration

Memantine Flas Normon must be taken 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 with or without water, as preferred by the patient.The tablets can be taken with or without food.

Treatment duration

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

If you take moreMemantine Flas Normonthan you should

• Generally, taking an excessive amount of Memantine Flas Normon should not cause any harm. You may experience an increase in the symptoms described in section 4 “Possible adverse effects”.
• If you take an overdose ofMemantine Flas Normoncontact your doctor or seek medical advice, as you may need medical attention.

In case of overdose or accidental ingestion, call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Memantine Flas Normon

• If you realize you have forgotten to take your dose ofMemantine Flas Normon, wait and take the next dose at the usual time.
• Do not take a double dose to compensate for the missed dose.

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Generally, adverse effects are classified as mild to moderate.

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

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

Poorly frequent (affects between 1 and 10 of every 1,000 patients):

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

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

• Convulsions.

Unknown frequency (frequency cannot be estimated from available data):

• Pancreatitis, hepatitis (inflammation of the liver), 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 Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, even if it is possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not use this medication after the expiration date that appears on the packaging and on the blister pack after CAD. The expiration date is the last day of the month indicated.

This medication does not require special conditions for conservation.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and medications you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Memantina Flas Normon

The active ingredient is memantine hydrochloride. Each buccal dispersible tablet contains 10 mg of memantine hydrochloride, which is equivalent to 8.31 mg of memantine.

The other components (excipients) are microcrystalline cellulose, potassium polacrilex, sodium croscarmellose, peppermint aroma, aspartame (E-951), a mixture of manitol/cornstarch),sodium saccharin,anhydrous colloidal silica, and magnesium stearate.

Appearance of the product and content of the packaging

Memantina Flas Normon is presented in the form of white or almost white, round, flat, and bisected buccal dispersible tablets, anonymous on both sides with a diameter of 9.1 mm ± 10%.

Memantina Flas Normonis available in Aluminio/Poliamida-Aluminio-PVC blister packaging in containers that contain 112 tablets.

Holder of the marketing authorization and responsible for manufacturing

Laboratorios Normon, S.A.

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

Date of the last review of this leaflet: November 2023

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)(http://www.aemps.gob.es/).