Ebixa 10 mg film-coated tablets

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ebixa 10 mg film-coated tablets

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 others, even if they have the same symptoms as you, because it may 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.

Contents of the leaflet

1. What Ebixa is and what it is used for
2. What you need to know before taking Ebixa
3. How to take Ebixa
4. Possible side effects
5. How to store 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 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. Ebixa belongs to a group of medicines called NMDA receptor antagonists. Ebixa works on these receptors, improving nerve signal transmission and memory.

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

2. What you need to know before taking Ebixa

Do not take Ebixa

• if you are allergic to memantine 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 Ebixa:

• 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 high blood pressure (hypertension).

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

If you have renal impairment (kidney problems), your doctor must closely monitor your kidney function and, if necessary, adjust the dose of memantine.

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), your doctor may need to adjust the dose of the medicine.

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

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 taking, have recently taken, or might need to take any other medicines.

Specifically, the administration of Ebixa 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 Ebixa.

Taking Ebixa with food and drinks

You should inform your doctor if you have recently changed or plan to substantially change your diet (for example, 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 Ebixa must not breastfeed.

Driving and using machines

Your doctor will advise you whether your condition allows you to drive or operate machinery safely.

Furthermore, Ebixa may affect your reaction ability, so driving or operating machinery may not be appropriate.

3. How to take Ebixa

Follow exactly the instructions for using this medicine as given by your doctor. If you are unsure, consult your doctor or pharmacist again.

The recommended dose of Ebixa 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 regimen:

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

Ebixa should be administered orally once daily. To get the maximum benefit from your medication, you must 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 Ebixa for as long as it is beneficial for you. Your doctor should periodically evaluate the effects of your treatment.

If you take more Ebixa than you should

• In general, 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 require 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 missed dose.

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone experiences them.

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

Frequent (affects between 1 and 10 out of every 100 patients):

• Headache, drowsiness, constipation, elevated liver function tests, dizziness, loss of balance, difficulty breathing, high blood pressure, and hypersensitivity to the medicine.

Uncommon (affects between 1 and 10 out of every 1,000 patients):

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

Very rare (affects less than 1 out of every 10,000 patients):

• 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 Ebixa.

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 through the national reporting system detailed in Annex V.

By reporting adverse 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 stated on the packaging and blister after EXP. The expiry date refers to the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of any unused medicine and empty packaging. 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 components are microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous 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 contents of the pack

Ebixa is presented as film-coated tablets, pale yellow to yellow in colour, oval-shaped, 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 available in packs containing 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) tablets. The packs containing 49 x 1, 56 x 1, 98 x 1 and 100 x 1 film-coated tablets are supplied in single-dose blisters.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

• Lundbeck A/S

Ottiliavej, 9

2500 Valby

Denmark

Further information on this medicinal product can be obtained by contacting the local representative of the Marketing Authorization Holder.

Date of the most recent review of this leaflet: MM/YYYY

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