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STIEPROX Shampoo (2015)

Αναφορές

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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