MEMANTINE PENSA 10 mg FILM-COATED TABLETS
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How to use MEMANTINE PENSA 10 mg FILM-COATED TABLETS
Introduction
Package Leaflet: Information for the Patient
MemantinaPensa 10 mg film-coated tablets EFGHydrochloride of memantine
Read the entire package leaflet carefully before starting to take this medication, as it contains important information for you.
- Keep this package leaflet, as you may need to read it again.
- If you have any questions, consult your doctor or pharmacist.
- This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
- If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. See section 4.
Contents of the Package Leaflet
- What is Memantina Pensa and what is it used for
- What you need to know before taking Memantina Pensa
- How to take Memantina Pensa
- Possible side effects
- Storage of Memantina Pensa
- Package contents and additional information
1. What is Memantina Pensa and what is it used for
How Memantina Pensa works
Memantina Pensa belongs to a group of medications called anti-dementia medications. 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 participate in the transmission of important nerve signals in learning and memory. Memantina Pensa belongs to the group of medications called NMDA receptor antagonists. Memantina Pensa acts on these receptors, improving the transmission of nerve signals and memory.
What Memantina Pensa is used for:
Memantina Pensa is used in the treatment of patients with moderate to severe Alzheimer's disease.
2. What you need to know before taking Memantina Pensa
Do not takeMemantina Pensa:
- if you are allergic to the active ingredient hydrochloride of memantine or to any of the other components of this medication (listed in section 6).
Warnings and precautions
Consult your doctor or pharmacist before starting to take Memantina Pensa:
- 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 reassess the clinical benefit of Memantina Pensa.
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 medications such as amantadine (for the treatment of Parkinson's disease), ketamine (a medication generally used to produce anesthesia), dextromethorphan (a medication for the treatment of cough), and other NMDA antagonists should be avoided.
Children and adolescents
The use of Memantina Pensa is not recommended in children and adolescents under 18 years of age.
Taking Memantina Pensa with other medications
Inform your doctor or pharmacist if you are using, have recently used, or may need to take any other medication.
In particular, the administration of Memantina Pensa may produce changes in the effects of the following medications, 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 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 Memantina Pensa.
Taking Memantina Pensa with food and beverages
You should inform your doctor if you have recently changed or plan 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 medication.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication.
The use of memantine is not recommended in pregnant women.
Women taking Memantina Pensa should stop breastfeeding.
Driving and using machines
Your doctor will inform you if your illness allows you to drive and use machines safely.
Additionally, Memantina Pensa may alter your reaction ability, so driving or operating machines may be inappropriate.
3. How to take Memantina Pensa
Follow your doctor's instructions for taking this medication exactly. If you are unsure, consult your doctor or pharmacist again.
Posology
The recommended dose of Memantina Pensa in adult patients 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 subsequent weeks | two 10 mg tablets once a day |
The normal starting dose is half a 10 mg tablet (5 mg) once a day the first week. It is increased to one 10 mg tablet (10 mg) a day the second week and to one and a half tablets once a day (15 mg) in the third week. From the fourth week onwards, the normal dose is two 10 mg tablets administered once a day (20 mg).
Posology for patients with renal insufficiency
If you have kidney problems, your doctor will decide on the appropriate dose for your condition. In this case, your doctor should periodically monitor your kidney function.
Administration
Memantina Pensa 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 Pensa as long as it is beneficial for you. Your doctor should periodically evaluate the effects of your treatment.
If you take more Memantina Pensa than you should
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 medication and the amount ingested. In general, taking an excessive amount of Memantina Pensa should not cause you any harm. You may experience an increase in the symptoms described in section 4.
If you forget to take Memantina Pensa
If you realize you have forgotten to take your dose of Memantina Pensa, 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 medication, ask your doctor, pharmacist, or nurse.
4. Possible side effects
Like all medications, this medication can cause side effects, although not everyone experiences them.
In general, side effects are classified as mild to moderate.
Frequent (may affect between 1 and 10 out of 100 patients):
- Headache, drowsiness, constipation, elevated liver function tests, dizziness, balance disorders, shortness of breath, high blood pressure, and hypersensitivity to the medication.
Uncommon (may affect between 1 and 10 out of 1000 patients):
- Fatigue, fungal infections, confusion, hallucinations, vomiting, gait disturbances, heart failure, and venous thrombosis/thromboembolism.
Very rare (may affect less than 1 in 10,000 people):
- Seizures.
Frequency not known (frequency cannot be estimated from 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 memantine.
Reporting side effects
If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.
5. Storage of Memantina Pensa
Keep this medication out of the sight and reach of children.
Do not use this medication after the expiration date stated on the carton and blister. The expiration date is the last day of the month indicated.
No special storage conditions are required.
Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE collection point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.
6. Package contents and additional information
Composition of Memantina Pensa
- The active ingredient is hydrochloride of memantine. Each film-coated tablet contains 10 mg of hydrochloride of memantine, equivalent to 8.31 mg of memantine.
- The other components are croscarmellose sodium, colloidal anhydrous silica, microcrystalline cellulose, magnesium stearate, polyvinyl alcohol, titanium dioxide (E171), talc, macrogol 3350, yellow iron oxide (E172).
Appearance of the product and package contents
Memantina Pensa 10 mg is presented in the form of yellow, oval, film-coated tablets with a score line on one side. It is available in PVC-PVDC/Aluminum blisters containing 28, 56, and 112 tablets.
The tablets can be divided into equal doses.
Not all pack sizes may be marketed.
Marketing authorization holder
Towa Pharmaceutical, S.A.
C/ de Sant Martí, 75-97
08107 Martorelles (Barcelona)
Spain
Manufacturer
NOUCOR HEALTH, S.A.
Av. Camí Reial, 51-57
08184 – Palau-solità i Plegamans, Barcelona
Spain
This medication is authorized in the Member States of the European Economic Area under the following names:
PT: Memantina Pensa, 10 mg, film-coated tablets.
ES: Memantina pensa 10 mg film-coated tablets EFG
Date of the last revision of this package leaflet:January 2018
Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/
- Country of registration
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a licensed doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
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