Package Insert: Information for the User

Memantine Hydrochloride 20 mg Film-Coated Tablets

Hidrocloruroof memantina

Read this package insert carefully before starting to take this medication because it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist
• This medication has been prescribed only for you and should not be given to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

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

The loss of memory in Alzheimer's disease is due to an alteration in brain signals. The brain contains the so-called N-methyl-D-aspartate (NMDA) receptors that participate in the transmission of important nervous signals in learning and memory.

Memantin belongs to the group of medications called NMDA receptor antagonists. Memantin acts on these receptors, improving the transmission of nervous signals and memory.

Protalón is used in the treatment of patients with moderate to severe Alzheimer's disease.

Do not take Protalón

• if you are allergic to 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 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 high blood pressure.

The treatment must be closely monitored and your doctor must regularly reevaluate the clinical benefit of memantine.

If you have renal insufficiency (kidney problems), your doctor must closely monitor your renal function and, if necessary, adjust the memantine dosage.

If you have renal tubular acidosis (RTA, excessive acid-producing substances in the blood due to renal dysfunction [kidney problems]) or severe urinary tract infections (urine pathway infections), your doctor may need to adjust the medication dosage.

Memantine should be avoided when used with other medications such as amantadine (for Parkinson's treatment), ketamine (a medication generally used as an anesthetic), dextromethorphan (a medication for cough treatment) and other NMDA antagonists.

Children and adolescents

Protalón is not recommended for use in children and adolescents under 18 years old.

Memantine Alter use with other medications

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

Specifically, the administration of Protalón may produce changes in the effects of the following medications, so your doctor may need to adjust the dosage:

• 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).
• dopamine agonists (substances like L-dopa, bromocriptine).
• neuroleptics (substances used in the treatment of mental illnesses).
• oral anticoagulants.

Inform your doctor that you are taking Protalón if you are admitted to a hospital.

Protalón use with food and beverages

Inform your doctor if you have recently changed or intend to change your diet significantly (for example, from a normal diet to a strict vegetarian diet), as your doctor may need to adjust the medication dosage.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy:Memantine is not recommended for use in pregnant women.

Breastfeeding:Women taking memantine should not breastfeed.

Driving and operating machinery

Your doctor will inform you if your condition allows you to drive and operate machinery safely. Additionally, memantine may alter your reaction time, making driving or operating machinery inappropriate.

Important information about some of the components of Protalón:

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

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

It may provoke asthma, especially in patients allergic to acetylsalicylic acid.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, 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 adverse effects, this dose should be achieved gradually following a daily treatment schedule.There are tablets with different doses available for adjusting the dose.

At the beginning of treatment, you will start taking 5 mg of memantine film-coated tablets once a day. This dose will be increased weekly by 5 mg to reach the recommended maintenance dose. The recommended maintenance dose is 20 mg once a day, which is reached at the beginning of the fourth week.

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 monitor your renal function periodically.

Administration

Memantine should be taken orally once a day. To get the most out of your medication, you should take it every day at the same time. The tablets should be swallowed with a little water. The tablets can be taken with or without food.

Treatment duration

Continue taking memantine as long as 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 adverse effects”.
• If you take a memantine overdose, contact your doctor or seek medical advice, as you may need medical attention.

If you forgot to take Protalón

• If you realize you have forgotten to take your memantine dose, wait and take the next dose at the usual time.
• Do not take a double dose to compensate for the missed dose.

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Adverse effects are generally classified as mild to moderate.

Frequent (affects between 1 and 10 of every 100 patients):

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

Poorly Frequent (affects between 1 and 10 of every 1,000 patients):

• Fatigue, fungal infections, confusion, hallucinations, vomiting, gait disorder, heart failure, and formation of blood clots in the venous system (venous thromboembolism).

Very Rare (affects fewer than 1 of every 10,000 patients):

• Seizures.

Unknown Frequency (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 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use website:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Keepthismedicationout of the reach of children.

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Do not dispose of medications through the drains or trash. Dispose of the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Protalón

The active ingredient ishydrochlorideof memantine. Each film-coated tablet contains 20 mg ofhydrochlorideof memantine,equivalent to 16.62 mg of memantine.

The other components are Microcrystalline cellulose, Povidone K-25, Sodium croscarmellose, Magnesium stearate, Hydroxypropyl cellulose, Hypromellose 6cP, Talc, Titanium dioxide (E171), Yellow iron oxide (E172), Red iron oxide (E172), Yellow-orange S (E110).

Appearance of the product and content of the container

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

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

Other presentations:

Protalón 10 mg film-coated tablets EFG

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorios Alter S.A.

Mateo Inurria, 30

28036 Madrid

Responsible for manufacturing

Laboratorio Alter, S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Last review of this leaflet:August2023

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/