Memantina Aurovitas 10 mg film-coated tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Memantina Aurovitas 10 mg film-coated tablets EFG

memantine hydrochloride

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents

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

2. What you need to know before taking Memantina Aurovitas

3. How to take Memantina Aurovitas

4. Possible side effects

5. How to store Memantina Aurovitas

6. Contents of the pack and other information

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

Memantina Aurovitas contains the active substance memantina hydrochloride. It belongs to a group of medicines known as anti-dementia drugs.

Memory loss in Alzheimer's disease is due to disturbances in brain signaling. The brain contains so-called N-methyl-D-aspartate (NMDA) receptors, which are involved in the transmission of nerve signals important for learning and memory. Memantina Aurovitas belongs to a group of medicines called NMDA receptor antagonists. Memantina Aurovitas acts on these receptors, improving the transmission of nerve signals and memory.

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

2. What you need to know before taking Memantina Aurovitas

Do not take Memantina Aurovitas:

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

Warnings and precautions

Talk to your doctor or pharmacist before starting Memantina Aurovitas:

• if you have a history of epileptic seizures,
• if you have recently had a myocardial infarction (heart attack), if you have congestive heart disease, or if you have uncontrolled high blood pressure (hypertension).

In the above situations, treatment should be carefully monitored and your doctor should regularly re-evaluate the clinical benefit of Memantina Aurovitas.

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

The use of memantine should be avoided together with other medicines such as amantadine (used to treat Parkinson's disease), ketamine (a drug generally used as an anaesthetic), dextromethorphan (a medicine used to treat cough), and other NMDA antagonists.

Children and adolescents

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

Taking Memantina Aurovitas with other medicines

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

Specifically, the administration of Memantina Aurovitas may cause changes in the effects of the following medicines, so your doctor may need to adjust the dosage:

• amantadine, ketamine, dextromethorphan,
• dantrolene, baclofen,
• cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine,
• hydrochlorothiazide (or any combination containing hydrochlorothiazide),
• anticholinergics (substances generally used to treat movement disorders or intestinal spasms),
• anticonvulsants (substances used to prevent and stop seizures),
• 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 admitted to hospital, inform your doctor that you are taking Memantina Aurovitas.

Taking Memantina Aurovitas with food, drinks and alcohol

You should inform your doctor if you have recently changed or intend to substantially change your diet (for example, from a normal diet to a strict vegetarian diet), or if you have renal tubular acidosis (RTA, excess acid-producing substances in the blood due to kidney dysfunction (kidney problem)) or severe urinary tract infections (urine passage infections), as your doctor may need to adjust the dose of the medicine.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Pregnancy

The use of memantine is not recommended in pregnant women.

Breast-feeding

Women taking Memantina Aurovitas should discontinue breast-feeding.

Driving and using machines

Your doctor will advise you whether your condition allows you to drive or operate machinery safely. In addition, Memantina Aurovitas may affect your reaction time, so driving or operating machinery may be inappropriate.

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

3. How to take Memantina Aurovitas

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The recommended dose of Memantina Aurovitas in adult and elderly patients is 20 mg taken once daily. To reduce the risk of adverse effects, this dose is reached gradually according to the following daily schedule:

The usual starting dose is half a 10 mg tablet once daily (5 mg) during the first week. This is increased to one 10 mg tablet daily (10 mg) during the second week, and to one and a half 10 mg tablets once daily during the third week. From the fourth week onwards, the usual dose is two 10 mg tablets or one 20 mg tablet administered once daily (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 daily. To obtain the maximum benefit from your medication, you should take it every day at the same time. The tablets should be swallowed with a little water. The tablets may be taken with or without food.

Duration of treatment

Continue taking Memantina Aurovitas for 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

• In general, 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 require 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 your next dose at the usual time.
• Do not take a double dose to make up for forgotten doses.

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

4. Possible adverse effects

Like all medicines, Memantina Aurovitas may cause adverse effects, although not everyone experiences them.

In general, adverse effects are classified as mild to moderate.

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

• Headache, somnolence, constipation, elevated liver function tests, dizziness, balance disorder, dyspnoea, 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 formation of blood clots in the venous system (venous thrombosis/venous thromboembolism).

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

• Seizures.

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

• Inflammation of the pancreas, inflammation of the liver (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 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 leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Memantine Aurovitas

Keep this medicine out of sight and reach of children.

Do not use this medicine after the expiry date stated on the label, carton, or bottle following "EXP". The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. 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 components (excipients) are:

Tablet core: microcrystalline cellulose, silicified microcrystalline cellulose, colloidal anhydrous 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-shaped, biconvex, with a single break line on both sides and engraved with 'ME' and '10' on each side of the break line on one face, and smooth on the other face.

The tablet can be divided into equal doses.

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

Blister:

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

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

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

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Aurovitas Spain, S.A.U.
Avda. de Burgos, 16-D
28036 Madrid
Spain
Tel.: 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 medicinal product is authorized in the European Economic Area member states under the following names:

France: MEMANTINE ARROW LAB 10 mg, comprimé pelliculé sécable
Germany: Memantin Aurobindo 10 mg Filmtabletten
Malta: Memantine Aurobindo 10 mg film-coated tablets
Portugal: Memantina Aurobindo
Romania: Memantina Aurobindo 10 mg comprimate filmate
Spain: Memantina Aurovitas 10 mg comprimidos recubiertos con película EFG

Date of the most recent review of this leaflet: December 2021

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/