Package Insert: Information for the User

Memantine Aurovitas Spain 10 mg Buccal Tablets EFG

Memantine Hydrochloride

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

- Keep this package insert, as you may need to refer to it again.

- If you have any questions, consult your doctor or pharmacist.

- This medication has been prescribed only for you, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

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

2. What you need to know before starting to take Memantine Aurovitas Spain

3. How to take Memantine Aurovitas Spain

4. Possible adverse effects

5. Storage of Memantine Aurovitas Spain

6. Contents of the package and additional information

Memantina Aurovitas Spain contains the active ingredient memantine hydrochloride.

Memantine belongs to a group of medicines known as dementia medicines.

The loss of memory in Alzheimer's disease is due to an alteration in brain signals. The brain contains called N-methyl-D-aspartate (NMDA) receptors that participate in the transmission of important nervous signals in learning and memory. Memantine belongs to the group of medicines called NMDA receptor antagonists. Memantine acts on these receptors by improving the transmission of nervous signals and memory.

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

Do not take Memantina Aurovitas Spain:

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

Warnings and precautions

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

• 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 the above situations, treatment should be closely monitored and your doctor should reevaluate the clinical benefit of memantine regularly.

If you have renal tubular acidosis (RTA, excess of acid-producing substances in the blood due to renal dysfunction (kidney problem)) or severe urinary tract infections (urinary tract infection), your doctor may need to adjust the dose of the medication.or.

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

The use of memantine should be avoided 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.

Children and adolescents

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

Other medicines and Memantina Aurovitas Spain

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medicine.

Specifically, 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 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 such as L-dopa, bromocriptine)

• neuroleptics (substances used in the treatment of mental illnesses)

• oral anticoagulants.

If you are admitted to a hospital, 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 significantly (for example 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, or think you may be pregnant or intend 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 stop breastfeeding.

Driving and operating machinery

Your condition may affect your ability to drive or operate machinery and you should not engage in these activities unless your doctor tells you it is safe to do so. Memantine may cause dizziness and drowsiness, mainly at the start of treatment or when increasing the dose. If you experience these effects, do not drive or operate machinery.

Memantina Aurovitas Spain contains aspartame, lactose, and sodium

Aspartame

This medicine contains 2.5mg of aspartame in each 10 mg buccal dispersible tablet. Aspartame contains a source of phenylalanine that may be harmful in the case of phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates due to the body's inability to eliminate it correctly.

Lactose

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

Sodium

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

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

Dosage

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 is achieved gradually following the daily schedule below:

The normal starting dose is one 5 mg tablet once a day (1 x 5 mg) in the first week. It is increased to one 10 mg tablet per day in the second week and to 15 mg once a day in the third week. From the fourth week onwards, the normal dose is two 10 mg tablets or one 20 mg tablet administered once a day.

For doses not available of this medication, you should use another medication containing memantine whose dose is available.

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 must monitor your renal function periodically.

Administration

Memantine must be taken 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.

Treatment duration

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

Instructions for use

The memantine buccodispersible tablets break apart, so they should be handled with care. Do not handle the tablets with wet hands because they may disintegrate.

1. Hold the blister pack by the ends and separate one of the cells from the rest, breaking it gently around the perforations that surround it.

2. Remove the back part of the cell gently.

Deposit the tablet on your tongue. It will dissolve directly in your mouth, so you can swallow it without water.

If you take more Memantina Aurovitas Spain than you should

• In general, taking an excessive amount of memantine should not harm you. You may experience an increase in the symptoms described in the section 4 “Possible adverse effects”.

• If you take a memantine overdose,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 forgot to take Memantina Aurovitas Spain

• 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 doses.

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

Like all medications, memantine may produce adverse effects, although not everyone will experience them.

Generally, adverse effects are classified as mild to moderate.

Frequent (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.

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

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

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

• Seizures.

Unknown Frequency (frequency cannot be estimated from available data):

• Pancreatitis, hepatitis (inflammation of the liver), 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, pharmacist, or nurse, 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 Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not use this medication after the expiration date that appears on the box and on the blister pack after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE point of your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Memantina Aurovitas Spain

- The active ingredient is memantine hydrochloride. Each buccal dispersible tablet contains 10 mg of memantine hydrochloride, which is equivalent to 8.31 mg of memantine.

- The other components are carboxymethylcellulose, sodium hydroxide (for pH adjustment), lactose monohydrate, microcrystalline cellulose, mannitol (E421), sodium croscarmellose, aspartame (E951), anhydrous colloidal silica, iron oxide red (E172), peppermint flavor, and magnesium stearate.

Appearance of the product and contents of the packaging

The buccal dispersible tablets of MemantinaAurovitas Spain10 mg are pale pink in color, round, flat, speckled, with beveled edges, with a diameter of 9 mm, and engraved with a “10” on one of the faces.

Memantina Aurovitas Spain is presented in blister packs of 112 buccal dispersible tablets.

Holder of the marketing authorization

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Responsible for manufacturing

Genepharm, S.A.

18 km Marathon Avenue

15351 Pallini Attikis

Greece

Date of the last review of this leaflet:

The 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.