TERBINAFINE MYLAN Cream (2019)
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Περιεχόμενα
Name of the medicinal product
Terbinafine 1% Cream.
Qualitative and quantitative composition
One gram of cream contains 10 mg terbinafine hydrochloride equivalent to 8.89 mg of terbinafine. Excipients with known effect: Each gram of cream contains 10 mg benzyl alcohol, 40 mg cetostearyl alcohol ...
Pharmaceutical form
Cream. White or almost white cream, with a slight almond odour.
Therapeutic indications
The treatment of tinea pedis (athletes foot) and tinea cruris (dhobie itch/jock itch). Fungal infections of the skin caused by dermatophytes such as species of Trichophyton (e.g. T. rubrum, T. mentagrophytes, ...
Posology and method of administration
Posology Adults and adolescents (>12 years of age) Duration and frequency of treatment Terbinafine can be applied once or twice daily. The likely duration of each treatment is as follows: Tinea pedis: ...
Contraindications
Hypersensitivity to the active substance, terbinafine, or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Terbinafine 1% Cream cream is for external use only. Terbinafine 1% Cream cream may be irritating to the eyes. Contact with the eyes should be avoided. In case of accidental contact with the eyes, rinse ...
Interaction with other medicinal products and other forms of interaction
No drug interactions are known with the topical forms of terbinafine.
Fertility, pregnancy and lactation
Pregnancy There is no clinical experience with terbinafine in pregnant women. Foetal toxicity studies conducted in animals suggest no adverse effects (see section 5.3). Terbinafine 1% Cream should not ...
Effects on ability to drive and use machines
Terbinafine 1% Cream cream has no influence on the ability to drive and use machines.
Undesirable effects
Local symptoms such as pruritus, skin exfoliation, application site pain, application site irritation, pigmentation disorder, skin burning sensation, erythema, scab, etc. may occur at the site of application. ...
Overdose
The low systemic absorption of topical terbinafine renders over dose extremely unlikely. Symptoms Accidental ingestion of one 30 g tube of terbinafine cream, which contains 300 mg terbinafine hydrochloride, ...
Pharmacodynamic properties
Pharmacotherapeutic group: Antifungal for topical use ATC code: D01AE15 Terbinafine is an allylamine that has a broad spectrum of antimycotic activity. It has an antimycotic effect on fungal infections ...
Pharmacokinetic properties
Less than 5% of the dose is absorbed after topical application to humans: systemic exposure is thus very low.
Preclinical safety data
In long-term studies (up to 1 year) in rats and dogs no marked toxic effects were seen in either species up to oral doses of about 100 mg/kg a day. At high oral doses, the liver and possibly also the kidneys ...
List of excipients
Sodium hydroxide Benzyl alcohol Sorbitan monostearate Cetyl palmitate Cetyl alcohol Cetostearyl alcohol Polysorbate 60 Isopropyl myristate Purified water
Incompatibilities
Not applicable.
Shelf life
4 years. Shelf life after opening: 28 days.
Special precautions for storage
Store in original container after first opening. Do not freeze. Keep the tube tightly closed.
Nature and contents of container
Collapsible aluminium tube with a polyethylene screw cap in pack sizes of 7.5 g, 15 g or 30 g. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
Not applicable.
Marketing authorization holder
Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
Marketing authorization number(s)
PL 04569/0889
Date of first authorization / renewal of the authorization
10/02/2010
Date of revision of the text
04/2019
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