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MEMANTINE MABO 10 mg FILM-COATED TABLETS

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About the medicine

How to use MEMANTINE MABO 10 mg FILM-COATED TABLETS

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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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Introduction

Package Leaflet: Information for the User

Memantina MABO10 mg film-coated tabletsEFG

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

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

How Memantina MABO works

Memantina MABO 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.

Memantina MABO belongs to the group of medicines called NMDA receptor antagonists. Memantina MABO acts on these receptors, 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.

Doctor consultation

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2. What you need to know before you take Memantina MABO

Do not take Memantina MABO

  • 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 taking Memantina MABO:

  • if you have a history of epileptic seizures (convulsions)
  • 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 Memantina MABO.

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.

Children and adolescents

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

Taking Memantina MABO 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 Memantina MABO may produce changes in the effects of the following medicines, so your doctor may need to adjust the doses:

  • amantadine, ketamine, dextromethorphan,
  • dantrolene, baclofen,
  • cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine,
  • hydrochlorothiazide (or any combination with hydrochlorothiazide),
  • anticholinergics (substances used to treat movement disorders or intestinal spasms),
  • anticonvulsants (substances used to prevent and eliminate convulsions),
  • barbiturates (substances 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 Memantina MABO.

Taking Memantina MABO with food, drinks, and alcohol,and

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, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

The use of memantine is not recommended in pregnant women.

Breastfeeding

Women taking Memantina MABO should stop breastfeeding.

Driving and using machines

Your doctor will inform you if your illness allows you to drive and use machines safely. Also, Memantina MABO may alter your reaction ability, so driving or operating machines may be inappropriate.

Memantina MABO contains sodium

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

3. How to take Memantina MABO

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

Posology

The recommended dose of Memantina MABO in adult and elderly patients is 20 mg administered once a day.

To reduce the risk of side effects, this dose is gradually achieved by following the daily scheme:

week 1

half a 10 mg tablet

week 2

one 10 mg tablet

week 3

one and a half 10 mg tablets

week 4 and onwards

two 10 mg tablets once a day

The normal starting dose is half a tablet once a day (1 x 5 mg) the first week. It is increased to one tablet a day (1 x 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 two tablets administered once a day (1 x 20 mg).

The tablet can be divided into equal doses.

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.

Administration

Memantina MABO 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 Memantina MABO as long as it is beneficial for you. Your doctor should periodically evaluate the effects of your treatment.

If you take more Memantina MABO than you should

In general, taking an excessive amount of Memantina MABO should not cause you any harm. You may experience an increase in the symptoms described in section 4 "Possible side 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 medicine and the amount ingested.

If you forget 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 make up for the forgotten dose.

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

Medicine questions

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Discuss your symptoms and treatment with a doctor online.

4. Possible side effects

Like all medicines, Memantina MABO can cause side effects, although not everybody gets them.

In general, side effects are classified from mild to moderate.

Frequent (may affect 1 to 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 medicine.

Uncommon (may affect 1 to 10 in every 1,000 patients):

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

Very rare (may affect less than 1 in every 10,000 patients):

  • Seizures.

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

  • Pancreatitis, hepatitis (inflammation of the liver), 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 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 them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.notificaram.es

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Memantina MABO

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 and blister after EXP. The expiry date is the last day of the month stated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Return the containers and any unused medicine to a pharmacy for proper disposal. This will help protect the environment.

6. Contents of the pack and other information

Composition of Memantina MABO

  • 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 ingredients are: Core:microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, and magnesium stearate; Coating:polyvinyl alcohol, titanium dioxide (E-171), talc, macrogol 3350, and yellow iron oxide (E-172).

Appearance of the product and pack contents

Memantina MABO is presented as yellow, oval-shaped film-coated tablets with a score line on one face.

Memantina MABO film-coated tablets are presented in PVC-PVDC/Aluminum blisters in packs of 112 tablets.

Marketing authorization holder

MABO-FARMA S.A.

Calle Vía de los Poblados 3,

Edificio 6, 28033, Madrid,

Spain.

Manufacturer

NOUCOR HEALTH, S.A.

Avda. Camí Reial, 51-57

08184 Palau-solità i Plegamans

Barcelona, Spain

Date of the last revision of this leaflet: March 2023

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

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Frequently Asked Questions

Is a prescription required for MEMANTINE MABO 10 mg FILM-COATED TABLETS?
MEMANTINE MABO 10 mg FILM-COATED TABLETS requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in MEMANTINE MABO 10 mg FILM-COATED TABLETS?
The active ingredient in MEMANTINE MABO 10 mg FILM-COATED TABLETS is memantine. This information helps identify medicines with the same composition but different brand names.
Who manufactures MEMANTINE MABO 10 mg FILM-COATED TABLETS?
MEMANTINE MABO 10 mg FILM-COATED TABLETS is manufactured by Mabo Farma S.A.. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of MEMANTINE MABO 10 mg FILM-COATED TABLETS online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether MEMANTINE MABO 10 mg FILM-COATED TABLETS is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to MEMANTINE MABO 10 mg FILM-COATED TABLETS?
Other medicines with the same active substance (memantine) include AXURA 10 mg FILM-COATED TABLETS, AXURA 10 mg FILM-COATED TABLETS, AXURA 20 mg FILM-COATED TABLETS. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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