
Ask a doctor about a prescription for MEMANTINE MABO 20 mg FILM-COATED TABLETS
Package Leaflet: Information for the User
Memantina MABO 20 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.
Contents of the Package Leaflet
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.
Do Not Take Memantina MABO
Warnings and Precautions
Consult your doctor or pharmacist before taking Memantina MABO:
In these situations, treatment should be carefully supervised and your doctor should regularly reassess 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 medicine generally used to produce anesthesia), dextromethorphan (a medicine for the treatment of cough) 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 dose:
If you are hospitalized, 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 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 (urinary tract), 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 affect your reaction ability, so driving or operating machinery 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".
Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.
Posology
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 scheme. To adjust the dose, there are tablets with different doses.
At the start of treatment, you will begin taking half a tablet of Memantina MABO 10 mg film-coated tablets once a day. This dose will be increased weekly by 5 mg until the recommended maintenance dose is reached (20 mg once a day), which is achieved at the beginning of the fourth week.
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
Generally, 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, phone: 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.
Like all medicines, Memantina MABO can cause side effects, although not everybody gets them.
Generally, side effects are mild to moderate.
Frequent (may affect up to 1 in 10 people):
Uncommon (may affect up to 1 in 100 people):
Rare (may affect up to 1 in 1,000 people):
Frequency Not Known (frequency cannot be estimated from the available data):
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. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Spanish Medicines and Healthcare Products Agency (AEMPS) via their website: www.notificaram.es
By reporting side effects, you can help provide more information on the safety of this medicine.
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 refers to 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.
Composition of Memantina MABO
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 presented in PVC-PVDC/Aluminum blisters in packs of 56 tablets.
Not all pack sizes may be marketed.
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 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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