Summary of Product Characteristics: Information for the User

Memantine Hydrochloride 20 mg Buccodispersible Tablets EFG

Memantine Hydrochloride

Read this 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.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Memantine flas cinfa contains the active ingredient hydrochloride of memantine. It belongs to a group of medicines known as anti-dementia medicines. Memory loss 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 nerve signals in learning and memory. Memantine flas cinfa belongs to the group of medicines called NMDA receptor antagonists. Memantine flas cinfa acts on these receptors by improving the transmission of nerve signals and memory.

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

Do not take memantine flas cinfa

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 starting to take memantine flas cinfa.

• 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.

In the above situations, 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 memantine dose.

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 medication dose.

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

Children and adolescents

Memantine is not recommended for use in children and adolescents under 18 years old.

Taking memantine flas cinfa with other medicines

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

Specifically, the administration of memantine flas 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 memantine flas.

Taking memantine flas cinfa with food and drinks

You should inform your doctor if you have recently changed or intend to change your diet significantly (for example from a normal diet to a strict vegetarian diet), as your doctor may need to adjust the medication dose.

Pregnancy and breastfeeding

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

Memantine is not recommended for use in pregnant women.

Women taking memantine should not 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. Memantine flas 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.

Memantine flas cinfa contains lactose

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

Memantine flas cinfa contains aspartame (E-951)

This medicine contains 5 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.

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

The recommended dose of memantine flas in 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 schedule below:

Memantine flas cinfa tablets cannot be split. For doses not available of memantine flas cinfa, you 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 should monitor your renal function periodically.

Administration

Memantine flas cinfa should 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.

Take the buccal dispersible tablet as follows:

1. Do not crush the buccal dispersible tablet

To avoid crushing the buccal dispersible tablet, do not press the blister (Figure 1).

1. Separate a blister

Each blister contains 14 blisters, which are separated by perforations. Separate a blister following the perforated lines, where it is indicated “fold” (Figure 2).

3.Remove the foil

Remove the foil carefully, starting from the corner marked with an arrow and where it is indicated “pull here” (Figures 3 and 4).

4.Take the buccal dispersible tablet

Take the buccal dispersible tablet with dry hands and place it on the tongue (Figure 5).

The tablet will dissolve quickly, and once dissolved, you can swallow it with or without water, as you prefer.

The tablets can be taken with or without food.

Treatment duration

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

If you take more memantine flas cinfa than you should

Generally, taking an excessive amount of memantine should not cause you any harm. You may experience an increase in the symptoms described in the section 4 “Possible adverse effects”.

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

If you forget to take memantine flas cinfa

If you realize you have forgotten to take your memantine flas dose, wait and take the next dose at the usual time.

Do not take a double dose to compensate for the missed doses.

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 (may affect up to 1 in 10 patients):

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

Poorly frequent (may affect up to 1 in 100 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 (may affect up to 1 in 10,000 patients):

• Seizures.

Unknown 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 or pharmacist, even if it is a possible adverse effect not listed in this prospectus.You can also report themdirectly through the Spanish System for Pharmacovigilance of Medications 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 after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

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

Composition ofmemantina flas cinfa

• The active ingredient is hydrochloride of memantine. Each buccal dispersible tablet contains 20 mg of hydrochloride of memantine, which is equivalent to 16.62 mg of memantine.
• The other components are: polacrilin, lactose monohydrate, microcrystalline cellulose (E-460), anhydrous colloidal silica, croscarmellose sodium, mannitol (E-421), aspartame (E-951), iron oxide red (E-172), magnesium stearate, sodium hydroxide (to adjust the pH), and peppermint aroma: corn maltodextrin, modified corn starch (E-1450) and peppermint oil (menta arvensis).

Appearance of the product and contents of the package

memantina flas cinfa 20 mg is presented in the form of a pale pink, rounded, flat, speckled, beveled-edge tablet, with a diameter of 12 mm and marked with the code "20" on one side.

memantina flas cinfa 20 mg is presented in aluminum/Al blister packs of 56 buccal dispersible tablets.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) - Spain

Responsible for manufacturing

Genepharm S.A.

18 km Marathon Avenue

15351 Pallini Attikis, Greece.

or

Rontis Hellas S.A.

Industrial Area of Larissa, P.O. Box 3012, GR41004 Larissa

Greece.

or

Cinfa Laboratories, S.A.

Carretera Olaz-Chipi, 10. Industrial Estate Areta

31620 Huarte (Navarra) - Spain

Last review date of this leaflet:May 2020

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (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/83297/P_83297.html

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