Package Insert: Information for the User

Mantinex Flas 10 mg Buccal Tablets EFG

Memantine Hydrochloride

Read this package insert carefully before starting to take this medication,because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you and should not be given to othersalthough they may 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 package insert. See section 4.

How Mantinex Flas works

Mantinex Flasbelongs to a group of medications known as dementia medications.

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 nervous signals in learning and memory. Mantinex Flasbelongs to the group of medications called NMDA receptor antagonists. This medication acts on these receptors by improving the transmission of nervous signals and memory.

What is Mantinex Flas used for

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

Do not take Mantinex Flas

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Mantinex Flas.

• 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 must be closely monitored and your doctor must regularly reevaluate the clinical benefit of memantine.

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

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

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

Taking Mantinex Flas with other medications

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

Specifically, the administration of this medication may produce changes in the effects of the following medications, so your doctor may need to adjust the dosage:

• 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.

Taking Mantinex Flas with food, drinks and alcohol

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) or if you have renal tubular acidosis (ATR, excess of acid-producing substances in the blood due to renal dysfunction) or severe urinary tract infections, as your doctor may need to adjust the medication dosage.

Pregnancy, breastfeeding and fertility

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

Memantine is not recommended for use in pregnant women.

Women taking Mantinex Flas should discontinue breastfeeding.

Driving and operating machinery

Your 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. Mantinex Flas may cause dizziness and drowsiness, mainly at the start of treatment or when increasing the dosage. If you experience these effects, do not drive or operate machinery.

Mantinex Flas contains lactose, aspartame and sodium

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

This medication contains 2.5 mg of aspartame (E-951) in each 10 mg tablet equivalent to 0.04 mg/kg. 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.

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

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist.

In case of doubt, consult your doctor or pharmacist again.

Dosage:

The recommended dose of memantine 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:

Mantinex Flas tablets cannot be split. For doses not available in Mantinex Flas,youshoulduseanother medicationcontaining memantinewhose 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.

How to administer Mantinex Flas:

Mantinex Flas must 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 preferred by the patient. The tablets can be taken with or without food.

Treatment duration:

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

If you take more Mantinex Flas than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: (91) 5620420, indicating the medication and the amount ingested.

• Generally, 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 adverse effects”.
• If you take a memantine overdose, contact your doctor or seek medical advice, as you may need medical attention.

If you forgot to take Mantinex Flas

• If you realize you have forgotten to take your dose of this medication, 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 doubts about the use of this medication, ask your doctor or pharmacist.

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

Adverse effects are generally classified as mild to moderate.

Frequent (may affectup to1 in 10people):

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

Less frequent (may affectup to1 in 100people):

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

Very rare (may affectup to1 in 10,000people):

• Seizures.

Unknown frequency (frequency cannot be estimated from 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 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 directly through the Spanish System for Pharmacovigilance of Medicines for Human Use website:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on 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.

No special storage conditions are required.

Medications should not be disposed of through drains or in the trash. Dispose of the packaging and medications you no longer need at theSIGRE Drop-off Pointat the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. By doing so, you will help protect the environment.

Composition of Mantinex Flas

• The active ingredient is hydrochloride of memantine. (Each buccal dispersible tablet contains 10 mg of hydrochloride of memantine, which are equivalent to 8.31 mg of memantine).
• The other components are: Polycrilin, lactose monohydrate, microcrystalline cellulose (E460), anhydrous colloidal silica, sodium croscarmellose, mannitol (E421), aspartame (E951), iron oxide red (E172), magnesium stearate(E-572), sodium hydroxide (to adjust the pH)and peppermint aroma (modified cornstarch).

Appearance of the product and contents of the packaging

Mantinex Flas 10 mg is presented in the form of buccal dispersible tablets of pink color, round, flat, with beveled edges and marked with "10" on one side.

Mantinex Flas 10 mg is presented in aluminum/Al blister packs of 112 buccal dispersible tablets.

Other presentations:

Mantinex Flas 20 mg buccal dispersible tablets EFG.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

Responsible for manufacturing:

Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 – Sant Joan Despí

(Barcelona)

Spain

Last review date of this leaflet:September 2021