EBIXA Film-coated tablet (2022)

Βιβλιογραφική αναφορά

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Περιεχόμενα

1. Name of the medicinal product

Ebixa 10 mg film-coated tablets. Ebixa 20 mg film-coated tablets.

2. Qualitative and quantitative composition

Each film-coated tablet contains 10 mg of memantine hydrochloride equivalent to 8.31 mg memantine. Each film-coated tablet contains 20 mg of memantine hydrochloride equivalent to 16.62 mg memantine. For ...

3. Pharmaceutical form

Film-coated tablet. Ebixa 10 mg film-coated tablets: Pale yellow to yellow, oval shaped film-coated tablets with breaking line and imprint 1 0 on one side and M M on the other side. The tablet can ...

4.1. Therapeutic indications

Treatment of adult patients with moderate to severe Alzheimers disease.

4.2. Posology and method of administration

Treatment should be initiated and supervised by a physician experienced in the diagnosis and treatment of Alzheimers dementia. Posology Therapy should only be started if a caregiver is available who will ...

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4. Special warnings and precautions for use

Caution is recommended in patients with epilepsy, former history of convulsions or patients with predisposing factors for epilepsy. Concomitant use of N-methyl-D-aspartate (NMDA)-antagonists such as amantadine, ...

4.5. Interaction with other medicinal products and other forms of interaction

Due to the pharmacological effects and the mechanism of action of memantine the following interactions may occur: The mode of action suggests that the effects of L-dopa, dopaminergic agonists, and anticholinergics ...

4.6. Fertility, pregnancy and lactation

Pregnancy There are no or limited amount of data from the use of memantine in pregnant women. Animal studies indicate a potential for reducing intrauterine growth at exposure levels, which are identical ...

4.7. Effects on ability to drive and use machines

Moderate to severe Alzheimers disease usually causes impairment of driving performance and compromises the ability to use machinery. Furthermore, Ebixa has minor to moderate influence on the ability to ...

4.8. Undesirable effects

Summary of the safety profile In clinical trials in mild to severe dementia, involving 1,784 patients treated with Ebixa and 1,595 patients treated with placebo, the overall incidence rate of adverse reactions ...

4.9. Overdose

Only limited experience with overdose is available from clinical studies and post-marketing experience. Symptoms Relative large overdoses (200 mg and 105 mg/day for 3 days, respectively) have been associated ...

5.1. Pharmacodynamic properties

Pharmacotherapeutic group: Psychoanaleptics. Other Anti-dementia drugs ATC code: N06DX01 There is increasing evidence that malfunctioning of glutamatergic neurotransmission, in particular ...

5.2. Pharmacokinetic properties

Absorption Memantine has an absolute bioavailability of approximately 100%. Tmax is between 3 and 8 hours. There is no indication that food influences the absorption of memantine. Distribution ...

5.3. Preclinical safety data

In short term studies in rats, memantine like other NMDA-antagonists have induced neuronal vacuolisation and necrosis (Olney lesions) only after doses leading to very high peak serum concentrations. Ataxia ...

6.1. List of excipients

Tablet cores for 10/20 mg film-coated tablets: Microcrystalline cellulose Croscarmellose sodium Colloidal anhydrous silica Magnesium stearate Tablet coat for 10/20 mg film-coated tablets: ...

6.2. Incompatibilities

Not applicable.

6.3. Shelf life

4 years.

6.4. Special precautions for storage

This medicinal product does not require any special storage conditions.

6.5. Nature and contents of container

Blister: PVDC/PE/PVC/Al-blister or PP/Al-blister. Ebixa 10 mg film-coated tablets: Pack sizes of 14, 28, 30, 42, 50, 56, 70, 84, 98, 100,112 film-coated tablets. Multipack containing 980 (10 packs ...

6.6. Special precautions for disposal and other handling

No special requirements.

7. Marketing authorization holder

H. Lundbeck A/S, Ottiliavej 9, 2500 Valby, Denmark

8. Marketing authorization number(s)

EU/1/02/219/001-003 EU/1/02/219/007-012 EU/1/02/219/014-021 EU/1/02/219/023-035 EU/1/02/219/037-049

9. Date of first authorization / renewal of the authorization

Date of first authorisation: 15 May 2002 Date of latest renewal: 15 May 2007

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