MEMANTINE AUROVITAS 10 mg FILM-COATED TABLETS

2. What you need to know before you take Memantina Aurovitas

Do not take Memantina Aurovitas:

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

Warnings and precautions

Consult your doctor or pharmacist before taking Memantina Aurovitas:

• if you have a history of seizure,
• if you have recently suffered 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 Memantina Aurovitas.

If you have kidney problems, your doctor should closely monitor your kidney function and, if necessary, adjust the dose of memantine.

The use of memantine with other medicines such as amantadine (for the treatment of Parkinson's disease), ketamine (a medicine commonly used as an anesthetic), dextromethorphan (a medicine for the treatment of cough) and other NMDA antagonists should be avoided.

Children and adolescents

Memantina Aurovitas is not recommended for use in children and adolescents under 18 years of age.

Using Memantina Aurovitas with other medicines

Tell your doctor or pharmacist that you are taking, have recently taken, or might take any other medicines.

In particular, the administration of Memantina Aurovitas may produce 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 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 Memantina Aurovitas.

Using Memantina Aurovitas with food, drinks, and alcohol

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

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Memantine is not recommended during pregnancy.

Breastfeeding

Women taking Memantina Aurovitas should stop breastfeeding.

Driving and using machines

Your doctor will inform you whether your illness allows you to drive and use machines safely. Additionally, Memantina Aurovitas may alter your reaction ability, so driving or operating machinery may be inappropriate.

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

3. How to take Memantina Aurovitas

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

The recommended dose of Memantina Aurovitas 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 normal starting dose is half a 10 mg tablet once a day (5 mg) the first week. It is increased to one 10 mg tablet a day (10 mg) the second week and to one and a half 10 mg tablets 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 (20 mg).

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 periodically monitor your kidney function.

Administration

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

If you take more Memantina Aurovitas than you should

• Generally, taking an excessive amount of Memantina Aurovitas 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 Memantina Aurovitas, contact your doctor or seek medical advice, as you may need medical attention.

If you forget to take Memantina Aurovitas

• If you realize you have forgotten to take your dose of Memantina Aurovitas, 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 further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Memantina Aurovitas can cause side effects, although not everybody gets them.

Side effects are usually 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 medicine.

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 the 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 Memantina Aurovitas.

Reporting of side effects:

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Surveillance System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Memantina Aurovitas

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

Do not use this medicine after the expiry date which is stated on the label, carton, bottle after EXP. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you have any further questions on the disposal of unused medicines, ask your pharmacist. This will help protect the environment.

6. Contents of the pack and other information

Composition of Memantina Aurovitas

• The active substance is memantine hydrochloride.

Each film-coated tablet contains 10 mg of memantine hydrochloride equivalent to 8.31 mg of memantine.

• The other ingredients (excipients) are:

Core of the tablet:microcrystalline cellulose, silicified microcrystalline cellulose, anhydrous colloidal silica, sodium starch glycolate (type A), talc, and sodium stearyl fumarate.

Coating:hydroxypropyl cellulose, titanium dioxide (E171), macrogol (6000), and talc.

Appearance of the product and contents of the pack

Film-coated tablets.

Memantina Aurovitas 10 mg film-coated tablets[Size: approximately 12.7 mm x 5.7 mm]

Film-coated tablets, white or almost white, oval, biconvex, with a single score line on both sides and engraved with 'ME' and '10' on each side of the score line on one side and smooth on the other side.

The tablet can be divided into equal doses.

Memantina Aurovitas film-coated tablets are presented in transparent PVC/PE/PVdC/Aluminum blisters and HDPE bottles.

Blister:

For the 10 mg tablets: 14, 28, 42, 56, 98, 100, and 112 film-coated tablets.

For the 20 mg tablets: 28, 42, 56, and 98 film-coated tablets.

Bottle: 60 and 1,000 film-coated tablets.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Aurovitas Spain, S.A.U.

Avenida de Burgos, 16-D

28036 Madrid

Spain

Phone: 91 630 86 45

Fax: 91 630 26 64

Manufacturer:

APL Swift Services (Malta) Limited

HF26, Hal Far Industrial Estate, Hal Far

Birzebbugia, BBG 3000

Malta

This medicine is authorized in the Member States of the European Economic Area under the following names:

France: MEMANTINE ARROW LAB 10 mg, film-coated tablet, divisible

Germany: Memantin Aurobindo 10 mg film-coated tablets

Malta: Memantine Aurobindo 10 mg film-coated tablets

Portugal: Memantina Aurobindo

Romania: Memantina Aurobindo 10 mg film-coated tablets

Spain: Memantina Aurovitas 10 mg film-coated tablets EFG

Date of last revision of this leaflet:December 2021

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