STIEPROX Shampoo (2015)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Stieprox 15 mg/g Shampoo.
Qualitative and quantitative composition
Each gram of shampoo contains 15mg/g ciclopirox olamine. Excipients with known effect: Contains dipropylene glycol. For the full list of excipients, see section 6.1.
Pharmaceutical form
Shampoo. Clear, straw to light-orange coloured, viscous shampoo.
Therapeutic indications
Stieprox is indicated in the treatment of scalp disorders such as dandruff and seborrhoeic dermatitis.
Posology and method of administration
Adults and adolescents aged over 12 years Stieprox is only for topical application to the scalp and adjacent areas. The hair should be wetted and sufficient Stieprox applied to produce an abundant lather. ...
Contraindications
Hypersensitivity to the active substance, ciclopirox olamine, or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Stieprox is for external use only. As with all shampoo products avoid contact with eyes. Ciclopirox olamine may cause eye irritation. In case of accidental contact with the eyes, rinse with water. Stieprox ...
Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
Fertility, pregnancy and lactation
Pregnancy The safety of ciclopirox olamine during human pregnancy has not been established. Studies in animals given oral or subcutaneous ciclopirox olamine did not reveal any developmental toxicity. ...
Effects on ability to drive and use machines
Stieprox has no or negligible influence on the ability to drive and use machines.
Undesirable effects
Clinical trial data The following convention has been used for the classification of adverse events: Very common 1/10 Common 1/100 to <1/10 Uncommon 1/1000 to <1/100 Rare 1/10000 to <1/1000 Very rare <1/10000 ...
Overdose
Symptoms There is currently limited experience of accidental oral ingestion with ciclopirox olamine. Management Management should be as clinically indicated or as recommended by the National Poisons Information ...
Pharmacodynamic properties
Pharmacotherapeutic group: other antifungals for topical dermatological use ATC code: D01AE14 Mechanism of action Ciclopirox olamine is a hydroxypyridone antifungal agent which is active in vitro inhibiting ...
Pharmacokinetic properties
Absorption The potential for clinically significant systemic absorption of ciclopirox olamine from a wash-off shampoo containing 1.5% ciclopirox olamine is expected to be low. Distribution Following oral ...
Preclinical safety data
Ciclopirox olamine has been in use for twenty years. It is used in leave-on topical antifungal preparations and vaginal creams. Studies have not demonstrated any prohibitive findings in reproduction toxicology, ...
List of excipients
Sodium lauryl ether sulphate 70% Cocamidopropyl betaine Disodium phosphate dodecahydrate Citric acid monohydrate (for pH-adjustment) Coconut diethanolamide Hexylene glycol Oleyl alcohol Polysorbate 80 ...
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
High density polyethylene bottles fitted with polypropylene screw caps containing 20 ml or 100 ml shampoo. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
No special requirements. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24
Marketing authorization number(s)
PA1077/130/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 5<sup>th</sup> October 2001 Date of last renewal: 5<sup>th</sup> October 2006
Date of revision of the text
October 2015
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