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NEMDATINE Film-coated tablets (2018)

Αναφορές

Βιβλιογραφική αναφορά

Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
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Περιεχόμενα

Name of the medicinal product

Nemdatine 5 mg film-coated tablets. Nemdatine 10 mg film-coated tablets. Nemdatine 15 mg film-coated tablets. Nemdatine 20 mg film-coated tablets.

Qualitative and quantitative composition

Nemdatine 5 mg: Each film-coated tablet contains 5 mg of memantine hydrochloride equivalent to 4.15 mg memantine. Nemdatine 10 mg: Each film-coated tablet contains 10 mg of memantine hydrochloride equivalent ...

Pharmaceutical form

Film-coated tablet (tablet). Nemdatine 5 mg film-coated tablets: White, oval shaped, biconvex film-coated tablet, 8 mm x 4.5 mm in size, with the marking M5 engraved on one side. Nemdatine 10 mg film-coated ...

Therapeutic indications

Treatment of adult patients with moderate to severe Alzheimers disease.

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 ...

Contraindications

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

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, ...

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 ...

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 ...

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, Nemdatine has minor or moderate influence on the ability ...

Undesirable effects

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

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 ...

Pharmacodynamic properties

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

Pharmacokinetic properties

Absorption Memantine has an absolute bioavailability of approximately 100%. T<sub>max</sub> is between 3 and 8 hours. There is no indication that food influences the absorption of memantine. Distribution ...

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 ...

List of excipients

Tablet cores for 5, 10, 15 and 20 mg film-coated tablets: Microcrystalline cellulose Crospovidone Type A Talc Magnesium stearate Tablet coat for 5, 10, 15 and 20 mg film-coated tablets: Hypromellose 6cP ...

Incompatibilities

Not applicable.

Shelf life

Shelf life Blisters: 2 years. HDPE bottles: use within 100 days after opening.

Special precautions for storage

Do not store above 25°C.

Nature and contents of container

PVC/PVDC-Aluminium blisters. Nemdatine 10 mg and 20 mg film-coated tablets: HDPE bottle. Pack sizes Nemdatine 5 mg film-coated tablets: Blister packs: 42 and 98 film-coated tablets. Nemdatine 10 mg film-coated ...

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

Actavis Group PTC ehf., Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Iceland

Marketing authorization number(s)

EU/1/13/824/001 EU/1/13/824/002 EU/1/13/824/003 EU/1/13/824/004 EU/1/13/824/005 EU/1/13/824/006 EU/1/13/824/007 EU/1/13/824/008 EU/1/13/824/009 EU/1/13/824/010 EU/1/13/824/019 EU/1/13/824/011 EU/1/13/824/012 ...

Date of first authorization / renewal of the authorization

Date of first authorisation: 22 April 2013

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