Memantina Aurovitas Spain 10 mg orodispersible tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Memantina Aurovitas Spain 10 mg orodispersible 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 adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Memantina Aurovitas Spain is and what it is used for
2. What you need to know before taking Memantina Aurovitas Spain
3. How to take Memantina Aurovitas Spain
4. Possible adverse effects
5. How to store Memantina Aurovitas Spain
6. Contents of the pack and other information

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

Memantina Aurovitas Spain contains the active substance memantine hydrochloride.

Memantina 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 belongs to a group of medicines called NMDA receptor antagonists. Memantina works on these receptors to improve nerve signal transmission and memory.

Memantina 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 to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to 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 disease, or if you have uncontrolled hypertension (high blood pressure).

In the above situations, treatment must be carefully monitored, and your doctor should regularly reassess the clinical benefit of memantine.

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

If you have renal impairment (kidney problems), your doctor must closely monitor kidney function and, if necessary, adapt the doses 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 cough medicine), and other NMDA antagonists.

Children and adolescents

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

Other medicines and Memantina Aurovitas Spain

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

Specifically, administration of memantine 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 memantine.

Taking Memantina Aurovitas Spain with food and drinks

You should inform your doctor if you have recently changed or intend to substantially change your diet (e.g. from a normal diet to a strict vegetarian diet), as your doctor may need to adjust the dose of the medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, 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.

Breastfeeding: Women taking memantine should discontinue breastfeeding.

Driving and using machines

Your illness may affect your ability to drive or operate machinery, and you should not perform these activities unless your doctor tells you it is safe to do so. Memantine may cause dizziness and somnolence, especially at the beginning of treatment or when the dose is increased. If you experience these effects, you must not drive or operate machinery.

Memantina Aurovitas Spain contains aspartame, lactose and sodium

Aspartame

This medicine contains 2.5 mg of aspartame in each 10 mg orodispersible tablet. Aspartame is a source of phenylalanine, which may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates because the body cannot eliminate it properly.

Lactose

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

Sodium

This medicine contains less than 1 mmol of sodium (23 mg) per orodispersible tablet; i.e., essentially "sodium-free".

3. How to take Memantina Aurovitas Spain

Follow exactly the instructions for use of this medicine provided 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 daily. To reduce the risk of adverse effects, this dose should be reached gradually according to the following daily schedule:

The usual starting dose is one 5 mg tablet once daily (1 x 5 mg) during the first week. This should be increased to one 10 mg tablet daily in the second week, and to 15 mg once daily in the third week. From the fourth week onwards, the usual dose is two 10 mg tablets or one 20 mg tablet administered once daily.

For doses not available of this medicine, you should use another medicine containing memantine with the available dose.

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

Memantine must be administered orally once daily. To get the maximum benefit from your medication, you should take it every day at the same time. The tablets should be swallowed with some water. The tablets may be taken with or without food.

Duration of treatment

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

Instructions for use

Memantine orodispersible tablets are fragile and therefore must be handled carefully. Do not handle the tablets with wet hands, as they may disintegrate.

1. Hold the blister pack at the edges and separate one blister from the rest by gently breaking it along the perforations surrounding it.
2. Gently peel back the backing of the blister.

Place the tablet on your tongue. It will dissolve directly in the mouth and can therefore be swallowed without water.

If you take more Memantina Aurovitas Spain than you should

• In general, 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 require medical treatment.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount taken.

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 further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, memantine can cause adverse effects, although not everyone will experience them.

In general, adverse effects are mild to moderate in severity.

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

• Headache, somnolence, constipation, elevated liver function tests, dizziness, balance disorder, dyspnoea, hypertension, and drug hypersensitivity.

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).

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

• Seizures.

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

• Pancreatitis, liver inflammation (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 of 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 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 Spain

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

Do not use this medicine after the expiry date stated on the carton and on the blister pack after EXP. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

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 have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Memantina Aurovitas Spain

• The active substance is memantine hydrochloride. Each orodispersible tablet contains 10 mg of memantine hydrochloride, equivalent to 8.31 mg of memantine.
• The other components are polacrilin, sodium hydroxide (for pH adjustment), lactose monohydrate, microcrystalline cellulose, manitol (E421), sodium croscarmellose, aspartame (E951), colloidal anhydrous silica, iron oxide red (E172), mint flavour, and magnesium stearate.

Appearance of the product and contents of the pack

The orodispersible tablets of Memantina Aurovitas Spain 10 mg are pale pink, rounded in shape, flat, speckled, with bevelled edges, 9 mm in diameter, and marked with a "10" on one side.

Memantina Aurovitas Spain is available in unit-dose blister packs containing 112 orodispersible 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 the most recent review of this leaflet:

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