FINACEA Gel (2019)

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

Finacea 15 % Gel.

Qualitative and quantitative composition

1 g Finacea Gel contains 150 mg (15%) azelaic acid. Excipients with known effect: 1 mg Benzoic acid /g Gel 0.12 g Propylene glycol /g Gel For the full list of excipients, see section 6.1.

Pharmaceutical form

Gel. White to yellowish-white opaque gel.

Therapeutic indications

For the relief of mild to moderate papular-pustular acne of the facial area. For the topical treatment of papulopustular rosacea.

Posology and method of administration

Finacea 15 % Gel is intended for cutaneous use only. Posology Finacea Gel should be applied to the affected skin areas twice a day (in the morning and in the evening) and rubbed in gently. Approximately ...

Contraindications

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

Special warnings and precautions for use

For external use only. Finacea Gel contains benzoic acid which is mildly irritant to the skin, eyes and mucous membranes and propylene glycol which may cause skin irritation. Care should be taken to avoid ...

Interaction with other medicinal products and other forms of interaction

No interaction studies have been performed. The composition of Finacea Gel gives no indication of any undesired interactions of the single components that could adversely affect the safety of the product. ...

Fertility, pregnancy and lactation

Pregnancy There are no adequate and well-controlled studies of topically administered azelaic acid in pregnant women. Animal studies do indicate the potential for effects with respect to pregnancy, embryo-fetal ...

Effects on ability to drive and use machines

Finacea Gel has no influence on the ability to drive and use machines.

Undesirable effects

From clinical studies and post-marketing surveillance, the most frequently observed side effects included application site pruritus, application site burning and application site pain. Frequencies of side-effects ...

Overdose

Due to the very low local and systemic toxicity of azelaic acid intoxication is unlikely.

Pharmacodynamic properties

Pharmacotherapeutic group: Other anti-acne preparations for topical use ATC code: D10AX03 Acne An antimicrobial action and a direct influence on follicular hyperkeratosis are assumed to be the basis for ...

Pharmacokinetic properties

Azelaic acid penetrates into all layers of the skin after topical application of the gel. Penetration is faster into damaged skin than into intact skin. A total of 3.6 % of the dose applied was absorbed ...

Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of, repeated dose toxicity and toxicity to reproduction. Embryofetal developmental studies with oral administration of ...

List of excipients

Benzoic acid (E210) Carbomers Disodium edetate Lecithin Polysorbate 80 Propylene glycol Purified water Sodium hydroxide Triglycerides medium chain

Incompatibilities

Not applicable.

Shelf life

3 years.

Special precautions for storage

This medicinal product does not require any special storage conditions.

Nature and contents of container

Aluminium tube with internal epoxide coating and polyethylene screw cap. Tubes of 5, 30, 50, 2 50 g. Not all pack sizes may be marketed.

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

LEO Laboratories Limited, Horizon, Honey Lane, Hurley, Maidenhead, Berkshire, SL6 6RJ, UK

Marketing authorization number(s)

PL 00043/0237

Date of first authorization / renewal of the authorization

03/07/2007

Date of revision of the text

September 2019

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