Memantina Mabo 20 mg film-coated tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient user
Memantina MABO 20 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, and you should not give it to other people, even if they have the same symptoms as you, because 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.
Contents of the leaflet
- What Memantina MABO is and what it is used for.
- What you need to know before taking Memantina MABO.
- How to take Memantina MABO.
- Possible side effects.
- How to store Memantina MABO.
- 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 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 play a role in the transmission of nerve signals important for learning and memory.
Memantina MABO belongs to a 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.
2. What you need to know before taking 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
Consult your doctor or pharmacist before starting Memantina MABO:
- if you have a history of epileptic seizures (convulsions),
- 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 supervised and your doctor should regularly re-evaluate the clinical benefit of Memantina MABO.
If you have renal impairment (kidney problems), your doctor should closely monitor your kidney function and, if necessary, adjust the dosage 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.
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
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Specifically, the administration of Memantina MABO may cause changes in the effects of the following medicines, so your doctor may need to adjust the dosage:
- amantadina, ketamina, dextrometorfano,
- dantrolene, baclofen,
- cimetidine, ranitidine, procainamide, quinidine, quinine, nicotinamide,
- 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 MABO.
Taking Memantina MABO with food, drinks, and alcohol
You should inform your doctor if you have recently changed or intend to make substantial changes to your diet (for example, switching 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 plan to become pregnant, consult your doctor or pharmacist before using this medicine.
Pregnancy
The use of memantine is not recommended in pregnant women.
Breastfeeding
Women taking Memantina MABO should discontinue breastfeeding.
Driving and use of machines
Your doctor will advise you whether your condition allows you to drive or operate machinery safely. Furthermore, Memantina MABO may affect your reaction time; therefore, driving or operating machinery may be inappropriate.
Memantina MABO contains sodium
This medicine contains less than 23 mg of sodium (1 mmol) per tablet; hence, it is essentially "sodium-free".
3. How to take Memantina MABO
Follow exactly the instructions for use of this medicine as given 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 daily.
To reduce the risk of adverse effects, this dose should be reached gradually according to a daily treatment schedule. Different dosage strengths of tablets are available for dose adjustment.
At the beginning of treatment, you will start by taking half a tablet of Memantina MABO 10 mg film-coated tablets once daily. This dose will be increased weekly by 5 mg until the recommended maintenance dose is reached. The recommended maintenance dose is 20 mg once daily, which is achieved at the beginning of the fourth week.
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.
Administration
Memantina MABO 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 some water. The tablets may be taken with or without food.
Duration of treatment
Continue taking Memantina MABO for 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 Toxicology 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 your usual time.
Do not take a double dose to make up for the missed dose.
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 MABO can cause adverse effects, although not everyone will experience them.
In general, adverse effects are classified as mild to moderate.
Common (may affect between 1 and 10 in every 100 patients):
- Headache, somnolence, constipation, elevated liver function tests, dizziness, balance disorder, shortness of breath, high blood pressure, and hypersensitivity to the medicine.
Uncommon (may affect between 1 and 10 in every 1,000 patients):
- Fatigue, fungal infections, confusion, hallucinations, vomiting, gait disturbance, heart failure, and formation of blood clots in the venous system (venous thrombosis/venous thromboembolism).
Very rare (may affect less than 1 in every 10,000 patients):
- Seizures
Frequency not known (frequency cannot be estimated from available data):
- Inflammation of the pancreas, 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 adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an effect not listed in this leaflet. You may also report them directly through 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.
5. Storage of Memantine MABO
Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the blister after EXP. The expiry date refers to the last day of the month indicated.
No special storage conditions are required.
Medicines should not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your doctor or pharmacist how to dispose of containers and unused medicines. This way, you 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 20 mg of memantine hydrochloride, equivalent to 16.62 mg of memantine.
- The other components are: Core: microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous 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 contents of the pack
Memantina MABO 20 mg film-coated tablets are pale red, oval-shaped, with a break line on one side.
Memantina MABO film-coated tablets are available in PVC-PVDC/Aluminum blisters in packs of 56 tablets.
Only certain pack sizes may be marketed.
Holder of the marketing authorization
MABO-FARMA S.A.
Calle Vía de los Poblados 3,
Building 6, 28033, Madrid,
Spain.
Manufacturer responsible
NOUCOR HEALTH, S.A.
Avda. Camí Reial, 51-57
08184 Palau-solità i Plegamans
Barcelona, Spain
Date of the most recent review of this leaflet: March 2023
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/