PATIENT INFORMATION LEAFLET

Ebixa 10 mg Film-Coated Tablets

Memantine Hydrochloride

Read this 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. Do not pass it on to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Ebixa is and what it is used for

2. What you need to know before you start taking Ebixa

3. How to take Ebixa

4. Possible side effects

5. Storage of Ebixa

6. Contents of the pack and additional information

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

Memory loss in Alzheimer's disease is due to an alteration in brain signals. The brain contains called N-methyl-D-aspartate (NMDA) receptors that participate in the transmission of important nerve signals in learning and memory. Ebixa belongs to the group of medicines called NMDA receptor antagonists. Ebixa acts on these receptors by improving the transmission of nerve signals and memory.

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

Do not take Ebixa

• if you are allergic to memantine or any of the other ingredients of this medication (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 had a myocardial infarction (heart attack), if you have congestive heart failure or if you have uncontrolled high blood pressure.

The treatment must be closely monitored and your doctor should regularly reevaluate the clinical benefit of Ebixa in these situations.

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

If you have renal tubular acidosis (RTA, excessive acid-producing substances in the blood due to a kidney problem) or severe urinary tract infections, your doctor may need to adjust the medication dosage.

Memantine should be avoided when used with other medications such as amantadine (for Parkinson's treatment), ketamine (a general anesthetic), dextromethorphan (a cough medication), and other NMDA antagonists.

Children and adolescents

Use of Ebixa is not recommended in children and adolescents under 18 years old.

Taking Ebixa with other medications

Inform your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

Specifically, the administration of Ebixa may alter the effects of the following medications, so your doctor may need to adjust the dosage:

- 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 seizures),

- barbiturates (substances generally used to induce sleep),

- dopamine agonists (substances like L-dopa, bromocriptine),

- neuroleptics (substances used in the treatment of mental illnesses),

- oral anticoagulants.

Inform your doctor if you are admitted to a hospital that you are taking Ebixa.

Taking Ebixa with food and drinks

Inform your doctor if you have recently changed or plan to change your diet significantly (for example, from a normal diet to a strict vegetarian diet), as your doctor may need to adjust the medication dosage.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant, consult your doctor or pharmacist before using this medication.

Pregnancy:Memantine is not recommended for use in pregnant women.

Breastfeeding:Women taking Ebixa should not breastfeed.

Driving and operating machinery

Your doctor will inform you if your condition allows you to drive and use machinery safely.

Additionally, Ebixa may impair your reaction time, making driving or operating machinery unsuitable.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

The recommended dose of Ebixa in adult patients and elderly patients is 20 mg administered once a day. To reduce the risk of adverse effects, this dose is achieved gradually following the daily schedule below:

The normal starting dose is half a tablet once a day (1 x 5 mg) in the first week. It is increased to one tablet a day (1 x 10 mg) in the second week and to one and a half tablets once a day in the third week. From the fourth week onwards, the normal 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 on the appropriate dose for your condition. In this case, your doctor must monitor your renal function periodically.

Administration

Take Ebixa orally once a day. To get the most out of your medication, you should take it every day at the same time. The tablets should be swallowed with a little water. The tablets can be taken with or without food.

Treatment duration

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

If you take more Ebixa than you should

• Generally, taking an excessive amount of Ebixa should not cause any harm. You may experience an increase in the symptoms described in section 4 “Possible adverse 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 Ebixa dose, 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 other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Generally, adverse effects are classified as mild to moderate.

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

• Headache, drowsiness, constipation, elevated liver function tests, dizziness, alteration of balance, difficult breathing, high blood pressure, and hypersensitivity to the medication.

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

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

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

• Seizures.

Unknown frequency (frequency cannot be estimated from 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 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 prospectus. You can also report them directly through the national notification system included in theAnexo V.

By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not use this medication after the expiration date that appears on the packaging and on the blister after CAD. The expiration date is the last day of the month indicated.

No special storage conditions are required.

Medicines should not be disposed of through the drains or in the trash. Ask your pharmacist how to dispose of the packaging and the medication that you no longer need. In this way, you will help protect the environment.

Composition of Ebixa

The active ingredient is memantine hydrochloride. Each film-coated tablet contains 10 mg of memantine hydrochloride, which is equivalent to 8.31 mg of memantine.

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

Appearance of the product and contents of the pack

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

Ebixa film-coated 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) 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.

Only some pack sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

H. Lundbeck A/S

Ottiliavej, 9

2500 Valby

Dinamarca

For more information about this medicinal product, please contact the local representative of the marketing authorization holder.

Last update of this leaflet:MM/YYYY

For more detailed information about this medicinal product, please consult the website of the European Medicines Agency:http://www.ema.europa.eu.