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 Περιεχόμενα  Φάρμακα Α - Ζ  Συγχορήγηση

ARICEPT Film-coated tablet (2018)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

ARICEPT 5 mg film coated tablets. ARICEPT 10 mg film coated tablets.

Qualitative and quantitative composition

Each film-coated tablet contains 5 mg donepezil hydrochloride, equivalent to 4.56 mg of donepezil free base. Excipients with known effect: Each 5 mg tablet contains 87.17 mg of lactose. Each film-coated ...

Pharmaceutical form

Film-coated tablet. ARICEPT 5 mg film coated tablets are white, round, biconvex tablets debossed ARICEPT on one side and 5 on the other side. ARICEPT 10 mg film coated tablets are yellow, round, biconvex ...

Therapeutic indications

ARICEPT film coated tablets are indicated for the symptomatic treatment of mild to moderately severe Alzheimers dementia.

Posology and method of administration

Posology Adults/Elderly people Treatment is initiated at 5 mg/day (once-a-day dosing). The 5 mg/day dose should be maintained for at least one month in order to allow the earliest clinical responses to ...

Contraindications

Hypersensitivity to donepezil hydrochloride, piperidine derivatives, or to any of the excipients listed in section 6.1.

Special warnings and precautions for use

The use of ARICEPT in patients with severe Alzheimers dementia, other types of dementia or other types of memory impairment (e.g. age-related cognitive decline), has not been investigated. Anaesthesia ...

Interaction with other medicinal products and other forms of interaction

Donepezil hydrochloride and/or any of its metabolites do not inhibit the metabolism of theophylline, warfarin, cimetidine or digoxin in humans. The metabolism of donepezil hydrochloride is not affected ...

Pregnancy and lactation

Pregnancy There are no adequate data from the use of donepezil in pregnant women. Studies in animals have not shown teratogenic effect but have shown pre and post natal toxicity (see section 5.3 preclinical ...

Effects on ability to drive and use machines

Donepezil has minor or moderate influence on the ability to drive and use machines. Dementia may cause impairment of driving performance or compromise the ability to use machinery. Furthermore, donepezil ...

Undesirable effects

The most common adverse events are diarrhoea, muscle cramps, fatigue, nausea, vomiting and insomnia. Adverse reactions reported as more than an isolated case are listed below, by system organ class and ...

Overdose

The estimated median lethal dose of donepezil hydrochloride following administration of a single oral dose in mice and rats is 45 and 32 mg/kg, respectively, or approximately 225 and 160 times the maximum ...

Pharmacodynamic properties

Pharmacotherapeutic group: anti-dementia drugs; anticholinesterase ATC-code: N06DA02 Mechanism of action Donepezil hydrochloride is a specific and reversible inhibitor of acetylcholinesterase, the predominant ...

Pharmacokinetic properties

Absorption Maximum plasma levels are reached approximately 3 to 4 hours after oral administration. Plasma concentrations and area under the curve rise in proportion to the dose. The terminal disposition ...

Preclinical safety data

Extensive testing in experimental animals has demonstrated that this compound causes few effects other than the intended pharmacological effects consistent with its action as a cholinergic stimulator (see ...

List of excipients

Tablet core: Lactose monohydrate Maize starch Cellulose, microcrystalline Hyprolose Magnesium Stearate Film coating: Talc Macrogol Hypromellose Titanium dioxide "E171" Yellow iron oxide E172 (10mg)

Incompatibilities

Not applicable.

Shelf life

Shelf life Bottles: 3 years. Blisters: 4 years.

Special precautions for storage

Do not store above 30°C.

Nature and contents of container

Bottles (HDPE): Packs of 28, 30 and 100. Blisters (PVC/Aluminium): Packs of 7, 14, 28, 30, 50, 56, 60, 84, 98,112 and 120. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

Eisai Ltd., European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, United Kingdom

Marketing authorization number(s)

PL 10555/0006 (5mg) PL 10555/0007 (10mg)

Date of first authorization / renewal of the authorization

Date of first authorisation: 14<sup>th</sup> February 1997 Date of last renewal: 10<sup>th</sup> January 2007

Date of revision of the text

11/05/2018

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