In this leaflet:

• 1. What Ebixa is and what it is used for
• 2. Before you take Ebixa
• 3. How to take Ebixa
• 4. Possible side effects
• 5. Storing Ebixa
• 6. Further information

Ebixa 10 mg film-coated tablets
Memantine hydrochloride

The active substance is memantine hydrochloride.

The other ingredients are lactose monohydrate, microcrystalline cellulose, colloidal anhydrous silica, talc and magnesium stearate, all in the tablet core; and methacrylic acid - ethyl acrylate copolymer (1:1), sodium lauryl sulphate, polysorbate 80, talc, triacetin and simethicone emulsion, all in the tablet coating.

What Ebixa is:

Ebixa tablets are presented as white to off-white, long shaped, film-coated tablets with a single breakline on both sides. Each tablet contains 10 mg of memantine hydrochloride.

Ebixa tablets are available in blister packs of 28 tablets, 30 tablets, 49 x 1 tablets, 50 tablets, 56 tablets, 100 tablets, 100 x 1, 112 tablets or 1000 (20 x 50) tablets. The pack sizes 49 x 1 film-coated tablets and 100 x 1 film-coated tablets are presented in perforated unit dose blister.

Not all pack sizes may be marketed.

What Ebixa is used for:

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

Memory loss in Alzheimer's disease is due to a disturbance of message signals in the brain. The brain contains so-called NMDA-receptors that are involved in transmitting nerve signals important in learning and memory. Ebixa belongs to a group of medicines called NMDA-receptor antagonists. Ebixa acts on these NMDA-receptors improving the transmission of nerve signals and the memory.

Do not take Ebixa:

• if you are hypersensitive (allergic) to memantine hydrochloride or any of the other ingredients of Ebixa tablets listed above.

Take special care with Ebixa:

• if you have a history of epileptic seizures
• if you have recently experienced a myocardial infarction (heart attack), or if you are suffering from congestive heart failure or from an uncontrolled hypertension.

In these situations the treatment should be carefully supervised, and the clinical benefit of Ebixa reassessed by your doctor on a regular basis.

If you suffer from moderate renal impairment, your doctor should closely monitor your kidney function and adapt the memantine doses accordingly. For patients with severe renal impairment, the use of memantine is not recommended.

The use of medicinal products called amantadine, ketamine, dextromethorphan and other NMDA-antagonists at the same time should be avoided.

Ebixa is not recommended for children and adolescents under the age of 18 years.

Taking Ebixa with food and drink:

You should inform your doctor if you have recently changed or intend to change your diet substantially (e.g. from normal diet to strict vegetarian diet) or if you are suffering from states of renal tubulary acidosis (RTA, an excess of acid-forming substances in the blood due to renal dysfunction) or severe infections of the urinary tract, as your doctor may need to adjust the dose of your medicine.

Pregnancy:

Tell your doctor if you are pregnant or planning to become pregnant. The use of memantine in pregnant women is not recommended.

Breast-feeding:

Women taking Ebixa should not breast-feed.

Driving and using machines:

Your doctor will tell you whether your illness allows you to drive and to use machines safely.

Also, Ebixa may change your reactivity, making driving or operating machinery inappropriate.

Taking other medicines:

Please inform your doctor or pharmacist if you are taking, or have recently taken, any other medicines, even those obtained without a prescription.

In particular, the effects of the following medicines may be changed by Ebixa and their dose may need to be adjusted by your doctor:

• 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 cramps)
• anticonvulsants (substances used to prevent and relieve seizures)
• barbiturates (substances generally used to induce sleep)
• dopaminergic agonists ( substances such as L-dopa, bromocriptine)
• neuroleptics (substances used in the treatment of mental disorders).
• oral anticolagulants

If you go into hospital, let your doctor know that you are taking Ebixa.

Dosage:

The recommended dose of Ebixa for adults and elderly patients is 20 mg (2x 1 tablet) daily. In order to reduce the risk of side effects this dose is achieved gradually by the following daily treatment scheme:

• week 1
  • morning
  • ½ tablet
  • afternoon or evening
  • none

• week 2
  • morning
  • ½ tablet
  • afternoon or evening
  • ½ tablet

• week 3
  • morning
  • 1 tablet
  • afternoon or evening
  • ½ tablet

• week 4 and beyond
  • morning
  • 1 tablet
  • afternoon or evening
  • 1 tablet

The usual starting dose is half a tablet once daily (1x 5 mg) for the first week. This is increased to half a tablet twice a day (2x 5 mg) in the second week and to 1 tablet (1x 10 mg) and half a tablet (1x 5 mg) daily taken in separate doses in the third week. From the fourth week on, the usual dose is 1 tablet twice a day (2x 10 mg).

Dosage in patients with impaired kidney function:

If you have impaired kidney function, your doctor will decide upon a dose that suits your condition. In this case, monitoring of your kidney function should be performed by your doctor at specified intervals.

Administration:

Ebixa should be administered orally twice a day (except for the first week of treatment). The tablets should be swallowed with some water. The tablets can be taken with or without food.

Duration of treatment:

Continue to take Ebixa as long as it is of benefit to you and you do not experience any unacceptable side effects. Your doctor should assess your treatment on a regular basis.

If you take more Ebixa than you should:

• In general, taking too much Ebixa should not result in any harm to you. You may experience increased symptoms as described in section 4. "Possible side effects".
• If you take a large overdose of Ebixa, contact your doctor or get medical advice, as you may need medical attention.

If you forget to take Ebixa:

• If you find you have forgotten to take your dose of Ebixa, wait and take your next dose at the usual time.
• Do not take a double dose to make up for the forgotten dose.