EBIXA 10 mg FILM-COATED TABLETS

Introduction

PATIENT INFORMATION 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. Storing Ebixa
6. Contents of the pack and further 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 called anti-dementia medicines.

Memory loss in Alzheimer's disease is due to a disturbance of signal transmission in the brain. The brain contains so-called N-methyl-D-aspartate (NMDA) receptors that are involved in the transmission of nerve signals that are 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

Tell your doctor or pharmacist before you start taking 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 should be carefully supervised and your doctor should regularly re-evaluate the clinical benefit of Ebixa for you.

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

If you have renal tubular acidosis (a condition where the blood becomes too acidic due to kidney problems) or severe urinary tract infections (infections of the urinary system), your doctor may need to adjust the dose of the medicine.

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

Children and adolescents

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

Taking Ebixa with other medicines

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

In particular, the administration of Ebixa may affect the action 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 usually used to treat movement disorders or intestinal spasms),
• anticonvulsants (substances used to prevent and eliminate convulsions),
• barbiturates (substances usually 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, tell your doctor that you are taking Ebixa.

Taking Ebixa with food and drinks

You should tell 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 breast-feeding

If you are pregnant or breast-feeding, 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.

Breast-feeding:Women taking Ebixa should not breast-feed.

Driving and using machines

Your doctor will tell you whether your illness allows you to drive or use machines safely.

Also, Ebixa may affect your ability to react, so driving or operating machinery may be inappropriate.

3. How to take Ebixa

Take this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

The recommended dose of Ebixa for adults and elderly patients is 20 mg once a day. To reduce the risk of side effects, this dose is achieved gradually by following the following daily scheme:

The usual starting dose is half a tablet once a day (1 x 5 mg) for the first week. It is increased to one tablet a day (1 x 10 mg) for the second week and to one and a half tablets once a day for 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 impairment

If you have kidney problems, your doctor will decide on the appropriate dose for your condition. In this case, your doctor should regularly check your kidney function.

Administration

Ebixa should 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.

Duration of treatment

Continue taking Ebixa as long as it is beneficial for you. Your doctor should regularly assess the effects of your treatment.

If you take more Ebixa than you should

• Generally, taking too much 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 further questions on 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.

Common (affects 1 to 10 users in 100):

• headache, drowsiness, constipation, elevated liver function tests, dizziness, balance disorders, 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 disturbances, 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. Storing 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 that month.

No special storage conditions 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 further information

What Ebixa contains

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 and packaging

Ebixa is presented as film-coated tablets, pale yellow to yellow in color, oval in shape, with a break line and engraved "1 0" on one side and "M M" on the other side. 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 single-dose blisters.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

• Lundbeck A/S

Ottiliavej, 9

2500 Valby

Denmark

For further information about this medicine, contact the local 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.