SKINOREN Cream (2019)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Skinoren 20% Cream.
Qualitative and quantitative composition
1 g of Skinoren Cream contains 200 mg (20% w/w) azelaic acid. For the full list of excipients, see section 6.1.
Pharmaceutical form
Cream. White, opaque cream.
Therapeutic indications
Topical treatment of acne vulgaris.
Posology and method of administration
Method of administration Cutaneous use. Dosage regimen Skinoren Cream should be applied to the affected areas of skin twice daily (mornings and evenings), and rubbed in gently. As a guide 2.5 cm (approx. ...
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. Care must be taken when using Skinoren Cream to avoid contact with the eyes, mouth and other mucous membranes, and patients should be instructed accordingly (see Section 5.3 Preclinical ...
Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
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
Skinoren Cream 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 burning, application site pruritus and application site erythema. Frequencies ...
Overdose
No known cases of azelaic acid overdosage resulting from topical administration of Skinoren Cream have been reported. Results from acute toxicity studies do not indicate that any risk of acute intoxication ...
Pharmacodynamic properties
Pharmacotherapeutic group: other anti-acne preparations for topical use. ATC Code: D10AX03 The antimicrobial action and a direct influence on follicular hyperkeratosis are assumed to be the basis for the ...
Pharmacokinetic properties
After dermal administration of the cream, azelaic acid penetrates into all layers of human skin. The penetration is more rapid into damaged skin than into intact skin. A total of 3.6% of the administered ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, contact hypersensitivity, genotoxicity and toxicity to reproduction and ...
List of excipients
Benzoic acid (E210) Cetearyl octanoate Glycerol 85% Glyceryl stearate + cetearyl alcohol + cetyl palmitate + cocoglycerides (CUTINA CBS) Propylene glycol Purified water Stearoyl macrogolglycerides
Incompatibilities
None known.
Shelf life
3 years. After first opening of the container, the in-use shelf life is 6 months.
Special precautions for storage
Do not store above 30°C.
Nature and contents of container
Tubes containing 20, 30 or 50 g. Not all pack sizes are marketed. Aluminium tube with internal epoxide coating and polyethylene screw cap.
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 00043/0236
Date of first authorization / renewal of the authorization
Date of first authorisation: 12 December 1989 Date of latest renewal: 24 November 2005
Date of revision of the text
September 2019
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