EBIXA 10 mg FILM-COATED TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ebixa 10 mg film-coated tablets

Memantine hydrochloride

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Ebixa is and what it is used for
2. What you need to know before you take Ebixa
3. How to take Ebixa
4. Possible side effects
5. Storage of Ebixa
6. Contents of the pack and other information

1. What Ebixa is and what it is used for

Ebixa contains the active substance memantine hydrochloride. It belongs to a group of medicines known as anti-dementia medicines.

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

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

2. What you need to know before you take Ebixa

Do not take Ebixa

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take Ebixa:

• if you have a history of epileptic seizures.
• if you have recently experienced 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 must be carefully supervised and your doctor must regularly re-evaluate the clinical benefit of Ebixa for you.

If you have renal insufficiency (kidney problems), your doctor should closely monitor your kidney function and, if necessary, adjust the dose 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 (urinary tract), your doctor may need to adjust the dose of the medicine.

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

Children and adolescents

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

Taking Ebixa with other medicines

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

In particular, the administration of Ebixa 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 generally used to treat movement disorders or intestinal spasms),
• anticonvulsants (substances used to prevent and eliminate convulsions),
• 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 hospitalized, inform your doctor that you are taking Ebixa.

Taking Ebixa 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 medicine.

Pregnancy and lactation

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:The use of memantine is not recommended in pregnant women.

Breastfeeding:Women taking Ebixa should not breastfeed.

Driving and using machines

Your doctor will inform you whether your illness allows you to drive and use machines safely.

Also, Ebixa may alter your reaction ability, so driving or operating machinery may be inappropriate.

3. How to take Ebixa

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

The recommended dose of Ebixa 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 following daily scheme:

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

Dosage for patients with renal insufficiency

If you have kidney problems, your doctor will decide the appropriate dose for your condition. In this case, your doctor must periodically monitor your kidney function.

Administration

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

If you take more Ebixa than you should

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

If you forget to take Ebixa

• If you realize you have forgotten to take your dose of Ebixa, wait and take the next dose at the usual time.
• Do not take a double dose to make up for the forgotten dose.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Generally, side effects are mild to moderate.

Frequent (affects 1 to 10 users in 100):

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

Uncommon (affects 1 to 10 users in 1,000):

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

Rare (affects 1 to 10 users in 10,000):

• 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 Ebixa.

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 national reporting system listed in Annex V.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Ebixa

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 carton and blister after EXP. The expiry date refers to the last day of the month shown.

No special storage precautions are required.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ebixa

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 are microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, and magnesium stearate, in the tablet core, and hypromellose, titanium dioxide (E 171), macrogol 400, and yellow iron oxide (E 172), in the tablet coating.

Appearance of the product and pack contents

Ebixa is presented in the form of film-coated tablets, pale yellow to yellow in color, oval in shape, with a break line and engraved "1 0" on one face and "M M" on the other face. The tablet can be divided into equal doses.

Ebixa tablets are presented in packs of 14, 28, 30, 42, 49 x 1, 50, 56, 56 x 1, 70, 84, 98, 98 x 1, 100, 100 x 1, 112, 980 (10 x 98), or 1000 (20 x 50) film-coated tablets. The packs of 49 x 1, 56 x 1, 98 x 1, and 100 x 1 film-coated tablets are presented in monodose blisters.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

• Lundbeck A/S

Ottiliavej, 9

2500 Valby

Denmark

You can obtain further information on this medicine from the representative of the marketing authorisation holder.

Date of last revision of this leaflet:MM/YYYY

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.