Package Insert: Information for the Patient User

Memantine MABO 20 mg Film-Coated Tablets

Memantine Hydrochloride

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

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to otherseven if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult yourdoctor or pharmacist, even if they are not listed in this package insert. See section 4.

How Memantina MABO works

Memantina MABO belongs to a group of medications known as dementia medications.

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 nerve signals in learning and memory.

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

What Memantina MABO is used for

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

Do not take Memantina MABO

• 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 Memantina MABO:

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

In the above situations, treatment must be closely monitored and your doctor should regularly reevaluate the clinical benefit of Memantina MABO.

If you have kidney insufficiency (kidney problem), your doctor should closely monitor 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.

Children and adolescents

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

Taking Memantina MABO 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 Memantina MABO 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, nicotinamide,
• 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 MABO.

Taking Memantina MABO 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 kidney tubular acidosis (ATR, excess acid-producing substances in the blood due to renal dysfunction [kidney problem]) 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 this medication.

Pregnancy

Memantine is not recommended for use in pregnant women.

Breastfeeding

Women taking Memantina MABO should discontinue breastfeeding.

Driving and operating machinery

Your doctor will inform you if your condition allows you to drive and use machinery safely. Additionally, Memantina MABO may alter your reaction time, making driving or operating machinery unsuitable.

Memantina MABO contains sodium

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

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

Dosage

The recommended dose of memantine for adults and elderly patients is 20 mg administered once a day.

To reduce the risk of adverse effects, this dose should be achieved gradually following a daily treatment schedule. There are tablets with different doses available to adjust the dose.

At the beginning of treatment, you will start taking half a tablet of Memantina MABO 10 mg film-coated tablets once a day. This dose will be increased weekly by 5 mg to reach the recommended maintenance dose. The recommended maintenance dose is 20 mg once a day, which is achieved at the beginning of the fourth week.

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

Memantina MABO should be taken orally once a day. To get the most out of your medication, you should take it every day 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 Memantina MABO as long as it is beneficial for you. Your doctor should evaluate the effects of your treatment periodically.

If you take more Memantina MABO than you should

Generally, taking an excessive amount of Memantina MABO should not cause any harm. You may experience an increase in the symptoms described in section 4 "Possible adverse effects".

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

If you forgot to take Memantina MABO

If you realize you have forgotten to take your dose of Memantina MABO, 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, Memantina MABO can produce adverse effects, although not all people will experience them.

Generally, adverse effects are classified as mild to moderate.

Frequent (mayaffectbetween 1 and 10 in every 100 patients):

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

Poorly frequent (mayaffectbetween 1 and 10 in 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 (mayaffectless than 1 in every 10,000 patients):

• Seizures

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

• Pancreatitis,hepatitis(liver inflammation)and psychotic reactions.

Alzheimer's disease has been associated with depression, suicidal ideation, and suicide. These events have been reported in patients treated with Memantina MABO.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect not listed in this prospectus. You can also report them 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.

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 after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Do not dispose of medications through drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE collection point at the pharmacy. If in doubt, ask your doctor or pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Memantina MABO

• The active ingredient ishydrochlorideof memantine. Each film-coated tablet contains 20 mg ofhydrochlorideof memantine equivalent to 16.62 mg of memantine.
• The other components are:Core: microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate;Coating:polyvinyl alcohol, macrogol 3350, talc, titanium dioxide (E-171), yellow iron oxide (E-172) and red iron oxide (E-172).

Appearance of the product and content of the container

Memantina MABO 20 mg film-coated tablets have a pale red color, oval shape with a breaking line on one face.

Memantina MABO film-coated tablets are presented in aPVC-PVDC/Aluminumblister pack in containers of 56 tablets.

Only some container sizes may be commercially marketed.

Marketing authorization holder title

MABO-FARMA S.A.

Calle Rejas 2, 1st floor

28821, Coslada, Madrid

Spain

Responsible manufacturer

NOUCOR HEALTH, S.A.

Avda.Camí Reial, 51-57

08184 Palau-solità i Plegamans

Barcelona, Spain

Last review date of this leaflet:March 2023

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/