PATIENT INFORMATION LEAFLET

Ebixa 5 mg /pulse, oral solution

Memantine hydrochloride

Read this leaflet carefully before you start taking the medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Ebixa is and for what it is used

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

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

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

If you have renal tubular acidosis (RTA, excess acid-producing substances in the blood due to renal dysfunction) 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 medication generally used as an anesthetic), dextromethorphan (a medication for cough treatment) and other NMDA antagonists.

Children and adolescents

Do not recommend the use of Ebixa 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.

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

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 dosage.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be 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 affect your reaction time, making driving or operating machinery unsuitable.

Ebixa contains sorbitol

This medication contains sorbitol. If your doctor has indicated that you have an intolerance to certain sugars, consult with them before taking this medication. Your doctor will advise you accordingly.

This medication also contains potassium, less than 1 mmol (39 mg) per dose, essentially potassium-free.

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

One pulsation contains 5 mg of memantine hydrochloride.

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

The initial starting dose is one pulsation once a day (1 x 5 mg) in the first week. This dose is increased in the second week to two pulsations once a day (1 x 10 mg) and in the third week to three pulsations once a day (1 x 15 mg). From the fourth week, the recommended dose is four pulsations once a day (1 x 20 mg).

Dosing for patients with reduced renal function

If you have reduced renal function, your doctor will decide on the appropriate dose for your condition. In this case, your doctor must monitor your renal function periodically.

Administration

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

For detailed instructions on the preparation and handling of the product, see the end of this leaflet.

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 harm you. 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, 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.Reporting adverse effects can help provide 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 label of the bottle after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 30°C.

Once opened, the contents of the bottle must be used within 3 months.

The bottle with the dosifier mounted must be stored and transported only in a vertical position.

Medications should not be thrown down the drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you do not need. In this way, you will help protect the environment.

Composition of Ebixa

-The active ingredient is memantine hydrochloride. Each pump of the dosifier releases 0.5 ml of solution containing 5 mg of memantine hydrochloride, equivalent to 4.16 mg of memantine.

-The other components are potassium sorbate, sorbitol E420, and purified water.

Appearance of the product and contents of the package

Ebixa, oral solution, is a transparent, colorless to slightly yellowish solution.

Ebixa, oral solution is available in 50 ml, 100 ml, or 10 x 50 ml bottles.

Only some package sizes may be commercially available.

Holder of the marketing authorization and responsible manufacturer

H. Lundbeck A/S

Ottiliavej, 9

2500 Valby

Denmark

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.

Instructions for the correct use of the dosifier

The solution must not be poured or dispensed directly into the mouth from the bottle or dosifier. Measure the dose in a spoon or in a glass of water using the dosifier.

Removing the cap from the bottle:

The cap must be turned in the opposite direction to the clock, unscrewed completely, and removed (fig.1).

Mounting the dosifier on the bottle:

Remove the dosifier from the plastic bag (fig.2) and place it on top of the bottle. Carefully insert the plastic tube into the bottle. Hold the dosifier on the bottle neck and turn it clockwise until it is securely attached (fig.3). The dosifier should only be screwed on once at the start of use and should never be unscrewed.

How the dosifier works:

The dosifier head has two positions and can be easily turned

-in the opposite direction to the clock to open

-in the direction of the clock to close

The dosifier head must not be pressed down while it is in the closed position. The solution can only be dispensed in the open position. To open, turn the dosifier head in the direction indicated by the arrow until it cannot be turned any further (about one-eighth of a turn, fig.4). The dosifier is then ready for use.

Preparing the dosifier:

When used for the first time, the dosifier does not dispense the correct amount of oral solution. It must therefore be prepared (primed) by pressing the dosifier head down completely five times in a row (fig.5).

The solution dispensed in this way must be discarded. The next time the dosifier head is pressed down completely (equivalent to one press), it will already dispense the correct dose (fig.6).

Correct use of the dosifier:

Place the bottle on a flat, horizontal surface, such as a table, and it should only be used in an upright position. Place a glass with a little water or a spoon under the nozzle. Press the dosifier head down firmly but calmly and sustainably, not too slowly (fig.7, fig.8).

The head can then be released and is ready for the next press.

The dosifier should only be used with Ebixa oral solution in the bottle provided, not for other products or containers. If the dosifier does not work correctly, consult your doctor or pharmacist. Close the dosifier after use.