Ebixa 5 mg + 10 mg + 15 mg + 20 mg film-coated tablets

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ebixa 5 mg film-coated tablets

Ebixa 10 mg film-coated tablets

Ebixa 15 mg film-coated tablets

Ebixa 20 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 must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents

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 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 starting to take Ebixa

Do not take Ebixa

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

Warnings and precautions
Talk to your doctor or pharmacist before starting to take Ebixa:

• 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 reassess the clinical benefit of Ebixa.

If you have renal impairment (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 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 should be avoided together with other medicines such as amantadine (used to treat Parkinson’s disease), ketamine (a drug generally used as an anesthetic), dextromethorphan (a drug used to treat cough), and other NMDA antagonists.

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 need to take any other medicines.

Specifically, taking Ebixa may cause 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 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 and operate machines safely.

Furthermore, Ebixa may affect your reaction capabilities, so driving or operating machinery may be inappropriate.

3. How to take Ebixa

The starter pack for Ebixa treatment should only be used at the beginning of Ebixa treatment.

Always follow exactly the instructions for taking this medicine as given by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is 20 mg daily, which is achieved by gradually increasing the dose of Ebixa over the first 3 weeks of treatment. The dosing schedule is also indicated on the starter pack. Take one tablet once daily.

Week 1 (day 1-7)

Take one 5 mg tablet once daily (white to off-white, spindle-shaped) for 7 days.

Week 2 (day 8-14)

Take one 10 mg tablet once daily (pale yellow to yellow, oval-shaped) for 7 days.

Week 3 (day 15-21)

Take one 15 mg tablet once daily (pale orange to greyish-orange, spindle-shaped) for 7 days.

Week 4 (day 22-28)

Take one 20 mg tablet once daily (pale red to greyish-red, spindle-shaped) for 7 days.

Maintenance dose

The recommended daily dose is 20 mg once daily.

To continue treatment, consult your physician.

Dosage for patients with renal impairment

If you have kidney problems, your doctor will decide the appropriate dose for your condition. In such cases, your doctor should periodically monitor your kidney function.

Administration

Ebixa should be administered orally once daily. To obtain the maximum benefit from your medication, you must 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 Ebixa for as long as it benefits you. Your doctor should periodically evaluate 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 can cause adverse effects, although not everybody will experience them.

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

Common (affects between 1 and 10 in 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 in every 1,000 patients):

• 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 (affects less than 1 in 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 on the blister after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

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

6. Contents of the pack and other information

Composition of Ebixa

• The active substance is memantine hydrochloride. Each tablet contains 5/10/15/20 mg of memantine hydrochloride, equivalent to 4.15/8.31/12.46/16.62 mg of memantine.

• The other components of Ebixa 5/10/15 and 20 mg film-coated tablets are microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate in the tablet core; and hypromellose, macrogol 400, titanium dioxide (E171), and additionally, yellow iron oxide (E172) for Ebixa 10 mg film-coated tablets, and for Ebixa 15 mg and Ebixa 20 mg film-coated tablets, yellow and red iron oxide (E172) in the coating layer.

Appearance of the product and contents of the pack

Ebixa 5 mg film-coated tablets are white to off-white, capsule-shaped, with the number “5” printed on one side and “MEM” on the other.

Ebixa 10 mg film-coated tablets are pale yellow to yellow, 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 15 mg film-coated tablets are pale orange to greyish orange, capsule-shaped, with the number “15” printed on one side and “MEM” on the other.

Ebixa 20 mg film-coated tablets are pale red to greyish red, capsule-shaped, with the number “20” printed on one side and “MEM” on the other.

Each starter pack contains 28 tablets in 4 blisters: 7 tablets of Ebixa 5 mg, 7 tablets of Ebixa 10 mg, 7 tablets of Ebixa 15 mg, and 7 tablets of Ebixa 20 mg.

Marketing Authorisation Holder and Manufacturer

• Lundbeck A/S

Ottiliavej 9

2500 Valby

Denmark

Further information on this medicinal product is available upon request to the local representative of the Marketing Authorisation Holder.

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

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