MEMANTINE AUROVITAS SPAIN 20 mg ORALLY DISINTEGRATING TABLETS

Introduction

Package Leaflet: Information for the User

Memantina Aurovitas Spain 20 mg Oral Disintegrating Tablets EFG

Memantine Hydrochloride

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, ask 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 Memantina Aurovitas Spain and what is it used for
2. What you need to know before taking Memantina Aurovitas Spain
3. How to take Memantina Aurovitas Spain
4. Possible side effects
5. Storage of Memantina Aurovitas Spain
6. Package Contents and Additional Information

1. What is Memantina Aurovitas Spain and what is it used for

Memantina Aurovitas Spain contains the active ingredient memantine hydrochloride.

Memantine 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.

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

2. What you need to know before taking Memantina Aurovitas Spain

Do not take Memantina Aurovitas Spain:

• if you are allergic to memantine hydrochloride or any of the other ingredients of this medication (listed in section 6).

Warnings and Precautions

Consult your doctor or pharmacist before starting to take this medication:

• If you have a history of epileptic seizures.
• If you have recently had a myocardial infarction (heart attack), if you have 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 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.

If you have renal impairment (kidney problems), your doctor should closely monitor kidney function and, if necessary, adapt the doses of memantine.

The use of memantine with other medications such as amantadine (for the treatment of Parkinson's disease), ketamine (a medication commonly 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 memantine is not recommended in children and adolescents under 18 years of age.

Other Medications and Memantina Aurovitas Spain

Tell your doctor or pharmacist if you are taking, have recently taken, or may take any other medication.

In particular, the administration of memantine 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 commonly used to treat movement disorders or intestinal spasms)
• anticonvulsants (substances used to prevent and eliminate convulsions)
• barbiturates (substances commonly 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 memantine.

Taking Memantina Aurovitas Spain with Food and Drinks

You should inform your doctor if you have recently changed or intend 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 stop breastfeeding.

Driving and Using Machines

Your illness may affect your ability to drive or use machines, and you should not perform these activities unless your doctor tells you it is safe to do so. Memantine may cause dizziness and somnolence, mainly at the start of treatment or when increasing the dose. If you experience these effects, do not drive or use machines.

Memantina Aurovitas Spain contains Aspartame, Lactose, and Sodium

Aspartame

This medication contains 5 mg of aspartame in each 10 mg oral disintegrating tablet. Aspartame contains a source of phenylalanine that may be harmful in case of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body is unable to eliminate it properly.

Lactose

This medication contains lactose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication.

Sodium

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

3. How to Take Memantina Aurovitas Spain

Follow the instructions for administration of this medication exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Dosage

The recommended dose of memantine in adult 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:

The usual starting dose is one 5 mg tablet once a day for the first week. It is increased to one 10 mg tablet per day for the second week and to 15 mg once a day for the third week. From the fourth week onwards, the usual dose is two 10 mg tablets or one 20 mg tablet administered once a day.

For doses not available for this medication, you should use another medication containing memantine for which the dose is available.

Dosage for Patients with Renal Impairment

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.

Method of 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 as long as it is beneficial for you. Your doctor should periodically evaluate the effects of your treatment.

Instructions for Use

The oral disintegrating tablets of memantine are fragile, so they should be handled with care. Do not handle the tablets with wet hands, as they may break.

1. Hold the blister pack by the ends and separate one of the cells from the rest, gently breaking it along the perforations surrounding it.
2. Gently remove the back of the cell.

Place the tablet on your tongue. It will dissolve directly in the mouth, so it can be swallowed without water.

If You Take More Memantina Aurovitas Spain Than You Should

• 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.

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 administered.

If You Forget to Take Memantina Aurovitas Spain

• 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 forgotten doses.

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

4. Possible Side Effects

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

Generally, side effects are classified as mild to moderate.

Common (may affect up to 1 in 10 people):

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

Uncommon (may affect up to 1 in 100 people):

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

Rare (may affect up to 1 in 10,000 people):

• 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, 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 help provide more information on the safety of this medication.

5. Storage of Memantina Aurovitas Spain

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 pack after EXP. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medications should not be disposed of via wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at the pharmacy. If in doubt, 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 Memantina Aurovitas Spain

• The active ingredient is memantine hydrochloride. Each oral disintegrating tablet contains 20 mg of memantine hydrochloride, equivalent to 16.62 mg of memantine.
• The other ingredients are polacrilin, sodium hydroxide (for pH adjustment), lactose monohydrate, microcrystalline cellulose, mannitol (E421), sodium croscarmellose, aspartame (E951), anhydrous colloidal silica, red iron oxide (E172), peppermint flavor, and magnesium stearate.

Appearance of the Product and Package Contents

The oral disintegrating tablets of Memantina Aurovitas Spain 20 mg are pale pink, round, flat, speckled, with beveled edges, 12 mm in diameter, and engraved with a "20" on one face.

Memantina Aurovitas Spain is presented in single-dose blister packs of 56 oral disintegrating tablets.

Marketing Authorization Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer

Genepharm, S.A.

18 km Marathon Avenue

15351 Pallini Attikis

Greece

Date of Last Revision of this Package Leaflet:

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.