METOSYN Cream (2019)
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Περιεχόμενα
Name of the medicinal product
Metosyn FAPG Cream.
Qualitative and quantitative composition
<u>Active ingredient:</u> Fluocinonide USP 0.050% w/w.
Pharmaceutical form
Cream for topical administration.
Therapeutic indications
Metosyn is suitable for treating a wide variety of inflammatory, pruritic and allergic disorders of the skin. It is indicated for topical application in the following conditions: Eczema and dermatitis; ...
Posology and method of administration
Adults A small quantity of Metosyn' FAPG cream should be applied three to four times daily to the affected area and massaged well in. Once improvement is apparent, usage may be reduced to twice or even ...
Contraindications
Metosyn is contraindicated in rosacea, acne and peri-oral dermatitis. As with all topical steroids, Metosyn is contraindicated in tuberculous, syphilitic, fungal and viral infections of the skin. The product ...
Special warnings and precautions for use
Long-term continuous topical steroid therapy can produce atrophic skin changes and dilation of the superficial blood vessels particularly when occlusive dressings are used or where skin folds are involved. ...
Interaction with other medicinal products and other forms of interaction
None known.
Pregnancy and lactation
Pregnancy There is inadequate evidence of safety in human pregnancy. Topical administration of steroids to pregnant animals can cause abnormalities of foetal development, including cleft palate and intrauterine ...
Effects on ability to drive and use machines
No precautions are necessary.
Undesirable effects
With Metosyn side effects are extremely rare but, as with all topical steroids, the occasional patient may show an adverse reaction such as hypersensitivity. Irritation at the site of application may occur ...
Overdose
Overdose (Symptoms, Emergency Procedures, Antidotes) A 25g tube of Metosyn FAPG cream contains 12.5mg of fluocinonide. Toxic effects are not likely to occur following accidental ingestion. Similarly, the ...
Pharmacodynamic properties
Fluocinonide is a synthetic anti-inflammatory corticosteroid. Its mechanisms of action are related to vasoconstriction and suppression of membrane permeability, mitotic activity, the immune response and ...
Pharmacokinetic properties
The extent of percutaneous absorption of fluocinonide is determined by many factors including the vehicle, the integrity of the epidermal barrier and the use of occlusive dressings. Following absorption, ...
Preclinical safety data
Fluocinonide is a drug on which extensive clinical experience has been obtained. All relevant information for the prescriber is provided elsewhere in the Summary of Product Characteristics.
List of excipients
Citric Acid Ph Eur 1,2,6 Hexanetriol HSE Polyethylene Glycol USNF Stearyl Alcohol USP Propylene Glycol Ph Eur
Incompatibilities
None known.
Shelf life
3 years.
Special precautions for storage
Store below 30°C.
Nature and contents of container
Unlacquered, latex banded, collapsible aluminium tubes, in pack sizes of 25g and 100g.
Special precautions for disposal and other handling
Use undiluted, as instructed by the prescriber.
Marketing authorization holder
Reig Jofre UK Limited, Unit 9A Caddsdown Business Support Centre, Caddsdown Industrial Park, Bideford, Devon, EX39 3DX, United Kingdom
Marketing authorization number(s)
PL 44095/0014
Date of first authorization / renewal of the authorization
03/02/1989 / 08/12/2008
Date of revision of the text
29/03/2019
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