Package Leaflet: Information for the User

Mantinex 10 mg Film-Coated Tablets EFG

Memantine Hydrochloride

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

• Keep this package 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 pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

6. Contents of the pack and additional information

How Mantinex works

Mantinex belongs 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 nerve signals in learning and memory. Mantinex belongs to the group of medications called NMDA receptor antagonists. Mantinex acts on these receptors by improving the transmission of nerve signals and memory.

What is Mantinex used for

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

Do not take Mantinex

• 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.

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

The treatment must be carefully supervised and the doctor must reevaluate the clinical benefit of memantine regularly in the above situations.

If you have 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 to induce anesthesia), dextromethorphan (a medication for cough treatment) and other NMDA antagonists.

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

Taking Mantinex with other medications

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

In particular, the administration of Mantinex 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 such as 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 Mantinex.

Taking Mantinex 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 acidosis tubular renal (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 should discontinue breastfeeding.

Driving and operating machinery

Your doctor will inform you if your condition allows you to drive and use machinery safely.

Mantinex may also alter your reaction time, making driving or operating machinery unsuitable.

Mantinex contains lactose

If your doctor has indicated that you have an intolerance to certain sugars, consult with him before taking this medication.

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 Mantinex 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:

The initial normal dose is half a tablet once a day (5 mg) in the first week. It is increased to one tablet a day (10 mg) in the second week and to one and a half tablets once a day in the third week. From the fourth week onwards, the normal dose is two tablets administered once a day (20 mg).

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.

How to administer Mantinex:

Mantinex should 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 swallowed with a little water. The tablets can be taken with or without food.

Treatment duration:

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

If you take more Mantinex 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:

• If you realize you have forgotten to take your Mantinex 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, Mantinex may produce adverse effects, although not all people will experience them.

Adverse effects are generally classified as mild to moderate.

Frequent (may affect 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 (may affect 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 thromboembolism).

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

• Seizures.

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

• Pancreatitis, hepatitis, and psychotic reactions.

Alzheimer's disease has been linked to 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 about the safety of this medication.

If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

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 packaging and medications you no longer need at theSIGRE Collection Pointof the pharmacy. If in doubt, 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 Mantinex

• The active ingredient is hydrochloride of memantine. (Each film-coated tablet contains 10 mg of hydrochloride of memantine, which are equivalent to 8.31 mg of memantine).
• The other components are:

Tablet core:monohydrate lactose, microcrystalline cellulose (E-460i), anhydrous colloidal silica, talc, and magnesium stearate (E-572).

Coating: hypromellose (E-464), titanium dioxide (E-171), and macrogol 400 (E-1521).

Appearance of the product and contents of the packaging

Mantinex 10 mg is presented in the form of film-coated tablets, white in color, oblong, biconvex, and with a notch.

Mantinex 10 mg tablets are presented in monodose blister packaging of PVDC/Al of 112 film-coated tablets.

Other presentations:

Mantinex 20 mg film-coated tablets.

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)

Last review date of this leaflet:July 2021.

Other sources of information:

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