PROSPECTO: 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 this prospectus carefully before starting to take the medicine, as it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. See section 4.

1. What is Ebixa and for what it is used

2. What you need to know before starting to take Ebixa

3. How to take Ebixa

4. Possible adverse 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 in 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 should regularly reevaluate the clinical benefit of Ebixa.

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

If you have renal tubular acidosis (RTA, excessive 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 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 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.

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 significantly change your diet (e.g., 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 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.

The packaging with the initial treatment of Ebixa should only be used at the beginning of treatment with Ebixa.

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

The recommended dose is 20 mg per day, which is achieved through gradual increases in the Ebixa dose during the first 3 weeks of treatment. The treatment schedule is also indicated on the packaging of the initial treatment. Take one tablet once a day.

Week 1 (days 1-7)

Take one 5 mg tablet once a day (white to off-white, fusiform) for 7 days.

Week 2 (days 8-14)

Take one 10 mg tablet once a day (pale yellow to yellow, oval shape) for 7 days.

Week 3 (days 15-21)

Take one 15 mg tablet once a day (pale orange to orange-gray and fusiform) for 7 days.

Week 4 (days 22-28)

Take one 20 mg tablet once a day (pale red to red-gray and fusiform) for 7 days.

Maintenance dose

The recommended daily dose is 20 mg once a day.

For continued treatment, consult your doctor.

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 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 and 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 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 side effects”.
• If you take a Ebixa overdose, 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.

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No take a double dose to compensate for the missed dose.

If you have any other questions about the use of thismedication, 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.

Less frequent (affects between 1 and 10 of every 1000 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 (inflammation of the liver), 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.

This medication does not require special conditions for conservation.

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. By doing so, you will help protect the environment.

Composition of Ebixa

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

• The other components of Ebixa film-coated tablets 5/10/15 and 20 mg are microcrystalline cellulose, sodium croscarmellose, anhydrous colloidal silica, magnesium stearate in the core of the tablet, hypromellose, macrogol 400, titanium dioxide (E171), and in addition, yellow iron oxide (E 172) 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 film.

Appearance of the product and contents of the pack

Ebixa 5 mg film-coated tablets have a white to off-white color and are fusiform with the number “5” printed on one face and “MEM” on the other.

Ebixa 10 mg film-coated tablets have a pale yellow to yellow color, oval shape, with a breaking line engraved “1 0” on one face and “M M” on the other face.

The tablet can be divided into equal doses.

Ebixa 15 mg film-coated tablets have a pale orange to orange-gray color and are fusiform with the number “15” printed on one face and “MEM” on the other.

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

Each starter pack contains 28 tablets with 4 blisters containing 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.

Holder of the marketing authorization and responsible for manufacturing

H. Lundbeck A/S

Ottiliavej 9

2500 Valby

Dinamarca

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

Last review date of this leaflet:MM/YYYY

For detailed information about this medicine, please visit the website of the European Medicines Agency:http://www.ema.europa.eu.