MEMANTINE QUALIGEN 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

MemantineQualigen20 mg Film-Coated Tablets EFG

Memantine, Hydrochloride

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

1. What is Memantine Qualigen and what is it used for
2. What you need to know before you take Memantine Qualigen
3. How to take Memantine Qualigen
4. Possible side effects
5. Storage of Memantine Qualigen
6. Contents of the pack and other information

1. What is Memantine Qualigen and what is it used for

How Memantine Qualigen works

Memantine Qualigen belongs to a group of medicines called anti-dementia medicines.

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

What Memantine Qualigen is used for

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

2. What you need to know before you take Memantine Qualigen

Do not take Memantine Qualigen

• if you are allergic to the active substance hydrochloride memantine or to 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 Qualigen.

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

In these situations, treatment should be carefully supervised and your doctor should regularly re-evaluate the clinical benefit of memantine.

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

The use of memantine with other medicines such as amantadine (for the treatment of Parkinson's disease), ketamine (a general anesthetic), dextromethorphan (a cough medicine), and other NMDA antagonists should be avoided.

Memantine Qualigen is not recommended for use in children and adolescents under 18 years of age.

Taking Memantine Qualigen with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

In particular, the administration of Memantine Qualigen may produce changes in the effects of the following medicines, 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),

dopaminergic agonists (substances such as L-dopa, bromocriptine),

neuroleptics (substances used in the treatment of mental illnesses), oral anticoagulants.

If you are hospitalized, inform your doctor that you are taking Memantine Qualigen.

Taking Memantine Qualigen with food, drinks, and alcohol

You should inform your doctor if you have recently changed or intend to change your diet substantially (e.g., from a normal diet to a strict vegetarian diet) or if you have renal tubular acidosis (RTA, excess of acid-producing substances in the blood due to kidney dysfunction) or severe urinary tract infections (urine conduit), as your doctor may need to adjust the dose of the medicine.

Pregnancy, breast-feeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Memantine is not recommended during pregnancy.

Women taking Memantine Qualigen should stop breast-feeding.

Driving and using machines

Your doctor will inform you if your illness allows you to drive and use machines safely.

Also, Memantine Qualigen may alter your reaction ability, so driving or operating machinery may be inappropriate.

Memantine Qualigen contains lactose

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

3. How to take Memantine Qualigen

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

Posology:

The recommended dose of Memantine Qualigen in adult and elderly patients is 20 mg administered once a day. To reduce the risk of side effects, this dose is gradually achieved following the daily scheme below.

The normal starting dose is half a tablet once a day (5 mg) the first week. It is increased to one tablet a day (10 mg) 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 one 20 mg tablet administered once a day.

Posology for patients with renal impairment

If you have kidney problems, your doctor will decide the appropriate dose for your condition. In this case, your doctor should periodically monitor your kidney function.

How to administer Memantine Qualigen

Memantine Qualigen 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.

Duration of treatment

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

If you take more Memantine Qualigen than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: (91) 5620420, indicating the medicine 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 side effects".
• If you take an overdose of memantine, contact your doctor or seek medical advice, as you may need medical attention.

If you forget to take Memantine Qualigen

• If you realize you have forgotten to take your dose of Memantine Qualigen, wait and take the next dose at the usual time.
• Do not take a double dose to make up for forgotten doses.

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

4. Possible side effects

Like all medicines, Memantine Qualigen can cause side effects, although not everybody gets them.

Generally, side effects are classified from mild to moderate.

Frequent (may affect up to 1 in 10 people):

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

Uncommon (may affect up to 1 in 100 people):

• Fatigue, fungal infections, confusion, hallucinations, vomiting, gait disturbance, heart failure, and venous thrombosis/thromboembolism.

Very rare (may affect up to 1 in 10,000 people):

• Seizures.

Frequency not known (frequency cannot be estimated from the 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 of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report side effects directly to the Spanish Medicines Agency (AEMPS) website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

If you consider any of the side effects to be serious or if you notice any side effects not mentioned in this leaflet, inform your doctor or pharmacist.

5. Storage of Memantine Qualigen

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

Do not use this medicine after the expiry date which is stated on the carton after "EXP". The expiry date is the last day of the month shown.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Memantine Qualigen

• The active substance is hydrochloride memantine. Each film-coated tablet contains 20 mg of hydrochloride memantine, equivalent to 16.62 mg of memantine.
• The other ingredients are:

Core of the tablet: lactose monohydrate, microcrystalline cellulose (E-460i), colloidal anhydrous silica, talc, and magnesium stearate (E-572).

Coating: hypromellose (E-464), titanium dioxide (E-171), macrogol 400 (E-1521), and red iron oxide (E-172).

Appearance of the product and contents of the pack

Memantine Qualigen 20 mg is presented in the form of pink, oblong, and biconvex film-coated tablets.

Memantine Qualigen 20 mg film-coated tablets are presented in blister packs of PVDC/Al of 56 film-coated tablets.

Other presentations

Memantine Qualigen 10 mg film-coated tablets.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Neuraxpharm Spain, S.L.U.

Avda. Barcelona, 69

08970 Sant Joan Despí

Barcelona – Spain

Manufacturer: Neuraxpharm Pharmaceuticals, S.L.

Avda. Barcelona, 69

08970 Sant Joan Despí (Barcelona)

Spain

Date of last revision of this leaflet:July 2021

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.