Memantina Qualigen 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Memantina Qualigen 10 mg film-coated tablets EFG

Memantine hydrochloride

Read the entire 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 other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

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

How Memantina Qualigen works

Memantina Qualigen belongs to a group of medicines known as anti-dementia drugs.

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

What Memantina Qualigen is used for

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

2. What you need to know before taking Memantina Qualigen

Do not take Memantina Qualigen

• if you are allergic to the active substance memantine hydrochloride or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before starting to take Memantina Qualigen.

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

In the above situations, treatment should be carefully monitored, and your doctor should regularly reassess the clinical benefit of memantine.

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

The use of memantine should be avoided together with other medicines such as amantadine (for the treatment of Parkinson's disease), ketamine (a drug generally used to induce anesthesia), dextromethorphan (a cough medicine), and other NMDA antagonists.

The use of Memantina Qualigen is not recommended in children and adolescents under 18 years of age.

Taking Memantina Qualigen with other medicines

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

Specifically, administration of Memantina Qualigen may produce changes in the effects of the following medicines, so your doctor may need to adjust the dosage:

amantadine, ketamine, dextromethorphan,

dantrolene, baclofen,

cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine,

hydrochlorothiazide (or any combination containing hydrochlorothiazide),

anticholinergics (substances generally used to treat movement disorders or intestinal spasms),

anticonvulsants (substances used to prevent and stop 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 admitted to hospital, inform your doctor that you are taking Memantina Qualigen.

Taking Memantina Qualigen with food, drinks, and alcohol

You should inform your doctor if you have recently changed or intend to substantially change your diet (for example, from a normal diet to a strict vegetarian diet), or if you have renal tubular acidosis (RTA, 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 dose of the medicine.

Pregnancy, breastfeeding, and fertility

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

The use of memantine is not recommended in pregnant women.

Women taking Memantina Qualigen should discontinue breastfeeding.

Driving and using machines

Your doctor will advise you whether your condition allows you to drive and use machines safely.

Also, Memantina Qualigen may affect your reaction time; therefore, driving or operating machinery may be inappropriate.

Memantina Qualigen contains lactose

If your doctor has diagnosed you with an intolerance to certain sugars, consult with him before taking this medicine.

3. How to take Memantina Qualigen

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Dosage:

The recommended dose of Memantina Qualigen in adult and elderly patients is 20 mg administered once daily. To reduce the risk of adverse effects, this dose should be reached gradually according to the following daily schedule:

The usual starting dose is half a tablet once daily (5 mg) in the first week. This is increased to one tablet daily (10 mg) in the second week, and to one and a half tablets once daily in the third week. From the fourth week onwards, the usual dose is two tablets taken once daily (20 mg).

Dosage 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 Memantina Qualigen:

Memantina Qualigen should be administered orally once daily. To get the maximum benefit from your medication, you must take it every day at the same time. The tablets should be swallowed with a little water. The tablets may be taken with or without food.

Duration of treatment:

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

If you take more Memantina Qualigen than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: (91) 5620420, indicating the medication and the amount ingested.

• In general, 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 require medical attention.

If you forget to take Memantina Qualigen

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

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

4. Possible adverse effects

Like all medicines, Memantina Qualigen may cause adverse effects, although not everyone experiences them.

In general, adverse effects are mild to moderate in severity.

Common (may affect between 1 and 10 out of 100 patients):

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

Uncommon (may affect between 1 and 10 out of 1,000 patients):

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

Very rare (may affect less than 1 out of 10,000 patients):

• Seizures.

Frequency not known (frequency cannot be estimated from the available data):

• Inflammation of the pancreas, inflammation of the liver (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 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 leaflet. They can also be reported directly via the Spanish Pharmacovigilance System for Human Medicines website: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

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

5. Storage of Memantina Qualigen

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

Do not use this medicine after the expiry date stated on the container after “EXP”. The expiry date is the last day of the month indicated.

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE Point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the pack and other information

Composition of Memantina Qualigen

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

Tablet core: lactose monohydrate, 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 pack

Memantina Qualigen 10 mg is presented as white, oblong, biconvex, film-coated tablets with a score line.

Memantina Qualigen 10 mg film-coated tablets are available in unit-dose blisters made of PVDC/Al containing 112 film-coated tablets.

Other presentations:

Memantina Qualigen 20 mg film-coated tablets.

Marketing Authorization Holder and Manufacturer

Marketing Authorization 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 the most recent review of this leaflet: July 2021

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.