Ebixa 5 mg/puff oral solution

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ebixa 5 mg/oral spray, oral solution

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 may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are 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 play a role in the transmission of nerve signals important for learning and memory. Ebixa belongs to a group of medicines called NMDA receptor antagonists. Ebixa acts on these receptors, improving nerve signal transmission and memory.

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

2. What you need to know before taking Ebixa

Do not take Ebixa

if you are allergic to memantine or to any of the other ingredients of this medicine (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 suffer from congestive heart failure, or if you have uncontrolled high blood pressure (hypertension).

In the above situations, treatment must 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, 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 anaesthetic), dextromethorphan (a drug used to treat cough), and other NMDA antagonists.

Children and adolescents

The use of Ebixa is not recommended in children and adolescents under 18 years of age.

Taking Ebixa with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Specifically, the administration of Ebixa may cause changes in the effects of the following medicines, so your doctor may need to adjust the dosage:

• 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 drink

You should inform your doctor if you have recently changed or intend 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 or operate machinery safely.

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

Ebixa contains sorbitol

This medicine contains sorbitol. If your doctor has informed you that you have an intolerance to certain sugars, consult him before taking this medicine. Your doctor will advise you on the most appropriate course of action.

In addition, this medicine contains potassium, less than 1 mmol (39 mg) per dose, i.e., essentially potassium-free.

3. How to take Ebixa

Follow exactly the instructions for use of this medicine given by your doctor. If you are in any doubt, consult your doctor or pharmacist again.

One push delivers 5 mg of memantine hydrochloride.

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

The usual starting dose is one click once daily (1 x 5 mg) during the first week. This dose is increased in the second week to two clicks once daily (1 x 10 mg), and in the third week to three clicks once daily (1 x 15 mg). From the fourth week onwards, the recommended dose is four clicks once daily (1 x 20 mg).

Dosage for patients with reduced renal function

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

Administration

Ebixa should be taken orally once daily. To get the maximum benefit from your medication, you should take it every day at the same time. The solution should be taken with some water. The solution may be taken with or without food.

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

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 everyone experiences them.

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

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

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

Very rare (affects less than 1 out of 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 can also report them directly through the national reporting system listed 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 label of the bottle after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 30°C.

After first opening, the contents of the bottle should be used within 3 months.

The bottle with the dispenser attached must be stored and transported in an upright position only.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that 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 pump actuation delivers 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 pack

Ebixa oral solution is a clear, colourless to slightly yellowish solution.

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

Some pack sizes may not be marketed.

Marketing Authorization Holder and Manufacturer

• Lundbeck A/S

Ottiliavej, 9

2500 Valby

Denmark

Further information on this medicinal product is available by contacting the local representative of the Marketing Authorization Holder.

Date of the most recent revision of this leaflet: (MM/YYYY).

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

Instructions for the correct use of the dispenser

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

Removing the screw cap from the bottle:

The cap must be turned counterclockwise, completely unscrewed, and removed (fig.1).

Attaching the dispenser to the bottle:

Remove the dispenser from the plastic bag (fig.2) and place it on top of the bottle. Carefully insert the plastic tube downward into the bottle. Hold the dispenser in place at the neck of the bottle and turn clockwise until securely attached (fig.3). The dispenser should only be screwed on once, when first used, and must never be unscrewed.

How the dispenser works:

The dispenser head has two positions and turns easily:

- counterclockwise direction to open
- clockwise direction to close

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

Preparing the dispenser:

When used for the first time, the dispenser does not deliver the correct amount of oral solution. Therefore, it must be prepared (primed) by fully pressing down the dispenser head five consecutive times (fig.5).

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

Correct use of the dispenser:

Place the bottle on a flat, horizontal surface, for example on a table, and use only in an upright position. Place a glass containing a small amount of water or a spoon under the nozzle. Press the dispenser head down firmly, calmly, and steadily—neither too slowly nor too quickly (fig.7, fig.8).

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

The dispenser must only be used with the Ebixa solution bottle provided, and not with other products or containers. If the dispenser does not function properly, consult your doctor or pharmacist. Close the dispenser after using Ebixa.