Protalon 10 mg film-coated tablets EFG
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Protalón 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 and must not be given 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 effects not listed in this leaflet. See section 4.
Leaflet contents:
- What Protalón is and what it is used for
- What you need to know before taking Protalón
- How to take Protalón
- Possible side effects
- How to store Protalón
- Contents of the pack and other information
1. What Protalón is and what it is used for
Protalón contains the active substance memantine hydrochloride. It 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.
Memantine belongs to a group of medicines called NMDA receptor antagonists. Memantine works on these receptors to improve nerve signal transmission and memory.
Protalón is used in the treatment of patients with moderate to severe Alzheimer's disease.
2. What you need to know before taking Protalón
Do not take Protalón
- if you are allergic to memantine 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 Protalón:
- if you have a history of epileptic seizures (convulsions)
- if you have recently had a myocardial infarction (heart attack), if you have congestive heart disease, or if you have uncontrolled high blood pressure (hypertension).
In the above situations, treatment must be carefully monitored and your doctor should regularly reassess the clinical benefit of memantine.
If you have renal impairment (kidney problems), your doctor should closely monitor your kidney function and, if necessary, adjust the dose of memantine.
If you have renal tubular acidosis (RTA, excess acid-producing substances in the blood due to kidney dysfunction [kidney problems]) or severe urinary tract infections, your doctor may need to adjust the dose of the medicine.
The use of memantine together with other medicines such as amantadine (used to treat Parkinson's disease), ketamine (a drug generally used as an anaesthetic), dextromethorphan (a cough medicine), and other NMDA antagonists should be avoided.
Children and adolescents
The use of Protalón is not recommended in children and adolescents under 18 years of age.
Taking Protalón with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Specifically, taking Protalón may cause changes in the effects of the following medicines, so your doctor may need to adjust their doses:
- 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 Protalón.
Taking Protalón with food and drinks
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), as your doctor may need to adjust the dose of the medicine.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning 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 memantine should not breastfeed.
Driving and using machines
Your doctor will advise you whether your condition allows you to drive and use machines safely. In addition, memantine may affect your reaction times, so driving or operating machinery may be inappropriate.
Protalón contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per tablet; therefore, for practical purposes, it is considered "sodium-free".
3. How to take Protalón
Follow exactly the administration instructions for this medicine as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.
The recommended dose of memantine 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 regimen:
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 |
The usual starting dose is half a tablet once daily (1 x 5 mg) in the first week. This is increased to one tablet once daily (1 x 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 once daily (1 x 20 mg).
Dosage for patients with renal impairment
If you have kidney problems, your doctor will determine the appropriate dose for your condition. In this case, your doctor should periodically monitor your kidney function.
Administration
Memantine must 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 memantine for as long as it is beneficial to you. Your doctor should periodically evaluate the effects of your treatment.
If you take more Protalón than you should
In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, 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 Protalón
- If you realize you have forgotten to take your dose of memantine, wait and take the next dose at the 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, Protalón may cause adverse effects, although not everyone experiences them.
In general, adverse effects are classified as mild to moderate.
Common (affects between 1 and 10 in every 100 patients):
- Headache, drowsiness, constipation, elevated liver function tests, dizziness, loss of balance, difficulty breathing, high blood pressure, and hypersensitivity to the medicine.
Uncommon (affects between 1 and 10 in every 1,000 patients):
- Fatigue, fungal infections, confusion, hallucinations, vomiting, impaired gait, heart failure, and formation of blood clots in the venous system (venous thrombosis/venous thromboembolism).
Very rare (affects less than 1 in every 10,000 patients):
- Seizures.
Frequency not known (frequency cannot be estimated from 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. You may also report them 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 Protalón
Keep this medicine out of sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date is the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.
6. Contents of the pack and other information
Composition of Memantina Alter
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 microcrystalline cellulose, povidone K-25, sodium croscarmellose, magnesium stearate, hydroxypropylcellulose and talc.
Appearance of the product and contents of the pack
Memantina Alter 10 mg are white, oblong, biconvex film-coated tablets with a score line.
The tablet can be divided into equal halves.
Blister pack made of PVC+PCTFE+PVC and aluminium. Blister packs contain 56 and 112 tablets.
Other pack sizes:
Memantina Alter 20 mg film-coated tablets EFG
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Laboratorios Alter S.A.
Mateo Inurria, 30
28036 Madrid
Manufacturer
Laboratorio Alter, S.A.
C/ Mateo Inurria 30
28036 Madrid
Spain
The most recent revision of this leaflet: August 2023
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/