PROTALON 20 mg FILM-COATED TABLETS

Introduction

Package Leaflet: Information for the User

Protalón 20 mg film-coated tablets EFG

Memantine hydrochloride

Read the entire package leaflet carefully before starting to take this medication because 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 or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the package leaflet:

1. What is Protalón and what is it used for
2. What you need to know before taking Protalón
3. How to take Protalón
4. Possible side effects
5. Storage of Protalón
6. Package contents and additional information

1. What is Protalón and what is it used for

Protalón contains the active ingredient memantine hydrochloride. It belongs to a group of medications known as 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.

Memantine belongs to the group of medications called NMDA receptor antagonists. Memantine acts on these receptors, improving the transmission of nerve signals 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 any of the other components of this medication (listed in section 6).

Warnings and precautions

Consult 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 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 memantine.

If you have 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 of acid-producing substances in the blood due to kidney dysfunction) or severe urinary tract infections, your doctor may need to adjust the dose of the medication.

The use of memantine with other medications such as amantadine (for the treatment of Parkinson's disease), ketamine (a medication generally used as an anesthetic), dextromethorphan (a medication for the treatment of cough), 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 Memantina Alter with other medications

Inform your doctor or pharmacist if you are using or have recently used or may need to use any other medication.

In particular, the administration of Protalón may produce changes in the effects of the following medications, so your doctor may need to adjust the dose:

• 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 convulsions).
• 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 Protalón.

Taking Protalón 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), 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.

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 inform you if your illness allows you to drive and use machines safely. Additionally, memantine may alter your reaction ability, so driving or operating machines may be inappropriate.

Important information about some of the components of Protalón:

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

This medication may cause allergic reactions because it contains Orange Yellow S (E110).

It can cause asthma, especially in patients allergic to acetylsalicylic acid.

3. How to take Protalón

Follow the administration instructions of this medication exactly as indicated by your doctor. If you have any doubts, consult your doctor or pharmacist again.

The recommended dose of memantine in adult patients and elderly patients is 20 mg administered once a day.

To reduce the risk of side 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 5 mg of memantine 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.

Dosage 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

Memantine 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 memantine while it benefits you. Your doctor should evaluate your treatment periodically.

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, phone: 91 562 04 20, indicating the medication and the amount ingested.

• Generally, 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 need 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 forgotten dose.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Generally, side effects are classified as mild to moderate.

Frequent (affecting 1 to 10 out of 100 patients):

• Headache, drowsiness, constipation, elevated liver function tests, dizziness, balance disorder, difficult breathing, high blood pressure, and hypersensitivity to the medication.

Uncommon (affecting 1 to 10 out of 1,000 patients):

• Fatigue, fungal infections, confusion, hallucinations, vomiting, gait disturbance, heart failure, and venous thrombosis/thromboembolism.

Rare (affecting less than 1 out of 10,000 patients):

• Seizures.

Frequency not known (frequency cannot be estimated from available data):

• Pancreatitis, 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 side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use website: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

If you consider any of the side effects you are experiencing to be serious or if you notice any side effect not mentioned in this package leaflet, inform your doctor or pharmacist.

5. Storage of Protalón

Keep this medication out of the sight and reach of children.

This medication does not require special storage conditions.

Do not use this medication after the expiration date stated on the packaging after "EXP". The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at the pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of Protalón

The active ingredient 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), Orange Yellow S (E110).

Appearance of the product and package contents

Protalón 20 mg are film-coated tablets of orange-yellow color, elliptical shape, and biconvex.

Blister pack formed by PVC+PCTFE+PVC and Aluminum. The blister packs contain 56 tablets.

Other presentations:

Protalón 10 mg film-coated tablets EFG

Marketing authorization holder and manufacturer

Marketing authorization holder

Laboratorios Alter S.A.

Mateo Inurria, 30

28036 Madrid

Manufacturer

Laboratorio Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Last revision of this package leaflet:August2023

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/