Protalon 20 mg film-coated tablets EFG: detailed information

Brand name Protalon 20 mg film-coated tablets EFG

Form tablets, film-coated

Active substance / Dosage

MEMANTINE HYDROCHLORIDE · 20 MG mg

Prescription type Hospital Diagnosis

ATC code

N06D N06DX N06DX01

Registration number 77763

Manufacturer Laboratorios Alter S.A.

Table of Contents

Package leaflet: Information for the user
Introduction
1. What Protalón is and what it is used for
2. What you need to know before starting to take Protalón
3. How to take Protalón
4. Possible adverse effects
5. Storage of Protalón
6. Contents of the pack and other information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Protalón 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 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 adverse 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 adverse 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 acts on these receptors, improving 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 starting to take 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 starting to take Protalón:

if you have a history of epileptic seizures
if you have recently had a myocardial infarction (heart attack), if you suffer from 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 should be avoided together with other medicines such as amantadine (for the treatment of Parkinson's disease), ketamine (a drug generally used as an anaesthetic), dextromethorphan (a drug for the treatment of cough), and other NMDA antagonists.

Children and adolescents

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

Taking Memantine Alter with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

Specifically, administration of Protalón may cause changes in the effects of the following medicines, so your doctor may need to adjust the dose:

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 (e.g. 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 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 memantine must not breastfeed.

Driving and using machines

Your doctor will advise you whether your condition allows you to drive and use machines safely. Also, memantine may affect your reaction ability, so driving or operating machinery may be inappropriate.

Important information about some of the ingredients of Protalón:

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; i.e., for practical purposes, it is "sodium-free".

This medicine can cause allergic reactions as it contains Sunset Yellow FCF (E110).

It may cause asthma, particularly in patients allergic to acetylsalicylic acid.

3. How to take Protalón

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

The recommended dose of memantine in adult patients 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 strength tablets are available to adjust the dose.

At the beginning of treatment, you will start taking 5 mg of memantine film-coated tablets once daily. This dose will be increased weekly by 5 mg until the recommended dose (maintenance dose) is reached. The recommended maintenance dose of 20 mg once daily is reached 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 monitor your kidney function periodically.

Administration

Memantine should be administered orally once daily. To get the maximum benefit from your medication, you must take it every day and at the same time each day. The tablets should be swallowed with a little water. The tablets may be taken with or without food.

Duration of treatment

Continue taking memantine for as long as it benefits you. Your doctor should periodically evaluate your treatment.

If you take more Protalón than you should

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medicine 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, this medicine may produce adverse effects, although not everyone will experience them.

In general, adverse effects are classified as mild to moderate.

Common (affects between 1 and 10 out of 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 out of 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 out of 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 the 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 dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Protalón

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 microcrystalline cellulose, povidone K-25, sodium croscarmellose, magnesium stearate, hydroxypropylcellulose, hypromellose 6cP, talc, titanium dioxide (E171), yellow iron oxide (E172), red iron oxide (E172), and Orange Yellow S (E110).

Appearance of the product and contents of the pack

Protalón 20 mg are pink-orange, elliptical, biconvex film-coated tablets.

Blister pack made of PVC+PCTFE+PVC and aluminum. The blister packs contain 56 tablets.