PATIENT INFORMATION LEAFLET

Ebixa 20 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. 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 components of this medication (listed in section 6).

Warnings and precautionsConsult 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.

In the above situations, treatment must be closely monitored and your doctor must regularly reevaluate the clinical benefit of Ebixa.

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

If you have tubular renal acidosis (excess of acid-producing substances in the blood due to renal dysfunction) or severe urinary tract infections, your doctor may need to adjust the medication dose.

Memantine should be avoided when used with other medications such as amantadine (for Parkinson's treatment), ketamine (usually used as an anesthetic), dextromethorphan (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 or have recently usedor may need to use any other medication.

In particular, administration of Ebixa may produce changes in the effects of the following medications, 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 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.

If you are admitted to a 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 intend 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 dose.

Pregnancy and breastfeeding

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

Pregnancy:Use of memantine is not recommended 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.

Furthermore, Ebixa may alter your reaction time, making driving or operating machinery unsuitable.

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

The recommended dose of Ebixa for adults and elderly patients is 20 mg administered once a day.

To reduce the risk of adverse effects, this dose should be achieved gradually following a daily treatment schedule. There are tablets with different doses available to adjust the dose.

At the beginning of treatment, you will start taking Ebixa 5 mg film-coated tablets once a day. This dose will be increased weekly by 5 mg until the recommended maintenance dose is reached. The recommended maintenance dose is 20 mg once a day, which is reached at the beginning of the fourth week.

Posology 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 should monitor your renal function periodically.

Administration

Ebixa should be taken 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.

Duration of treatment

Continue taking Ebixa as long as it benefits you. Your doctor should evaluate 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 compensate 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.

Poorly frequent (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 thrombosis/thromboembolism).

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

• Seizures.

Unknown frequency (frequency cannot be estimated from available data):

• Pancreatitis, hepatitis (inflammation of the liver), and psychotic reactions.

Alzheimer's disease has been linked to 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.

This medication does not require special storage conditions.

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

Composition of Ebixa

The active ingredient is memantine hydrochloride. Each tablet contains 20 mg of memantine hydrochloride, which is equivalent to 16.62 mg of memantine.

The other components are microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate in the core; hypromellose, macrogol 400, titanium dioxide (E171) and iron oxide yellow and red (E 172) in the film coating.

Appearance of the product and contents of the pack

Memantine 20 mg film-coated tablets have a pale red to reddish-grey color and are fusiform with the number “20” printed on one face and “MEM” on the other.

Memantine film-coated tablets are available in blister packs of 14, 28, 42, 49 x 1, 56, 56 x 1, 70, 84, 98, 98 x 1, 100 x 1, 112 or 840 (20 x 42) tablets. The pack sizes 49 x 1, 56 x 1, 98 x 1, and 100 x 1 are presented in single-dose packs.

Not all pack sizes may be marketed.

Marketing authorization holder and responsible person for manufacturing

H. Lundbeck A/S

Ottiliavej 9

2500 Valby

Denmark

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 visit the website of the European Medicines Agency:http://www.ema.europa.eu.