FENBID 10% w/w Gel (2021)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
Fenbid 10% w/w Gel. Phorpain maximum strength 10% w/w Gel. Ibuprofen 10% w/w Gel.
Qualitative and quantitative composition
Ibuprofen Ph. Eur. 10% w/w Gel. <u>Excipient(s) with known effects:</u> Each 100mg of gel contains 1mg of Benzyl alcohol. For the full list of excipients, see section 6.1.
Pharmaceutical form
A clear or slightly opalescent, colorless or almost colorless gel.
Therapeutic indications
For the relief of pain and inflammation associated with backache, mild to moderate arthritic conditions, rheumatic and muscular pain, sprains, strains, sports injuries and neuralgia.
Posology and method of administration
Method of administration For topical application to the skin. Dosage Adults, the elderly and children over 12 years Squeeze 50 to 125mg (2 to 5cm) of the gel from the tube and lightly rub into the affected ...
Contraindications
Hypersensitivity to any of the constituents. Hypersensitivity to aspirin, or other non-steroidal anti-inflammatory drugs, asthma, rhinitis or urticaria. Not to be used on broken or damaged skin.
Special warnings and precautions for use
Apply with gentle massage only. Avoid contact with eyes, mucous membranes and inflamed or broken skin. Discontinue if rash develops. Hands should be washed immediately after use. Not for use with occlusive ...
Interaction with other medicinal products and other forms of interaction
Non-steroidal anti-inflammatory drugs may interact with blood pressure lowering drugs, and may possibly enhance the effects of anticoagulants, although the chance of either of these occurring with a topically ...
Pregnancy and lactation
Not to be used during pregnancy or lactation. Pregnancy Although no teratogenic effects have been demonstrated, ibuprofen should be avoided during pregnancy. The onset of labour may be delayed and the ...
Effects on ability to drive and use machines
None known.
Undesirable effects
Very rarely, susceptible patients may experience the following side effects with ibuprofen, but these are extremely uncommon when ibuprofen is administered topically. If they occur, treatment should be ...
Overdose
Overdosage with a topical presentation of Fenbid Forte Gel is unlikely. Symptoms of severe ibuprofen overdosage (eg following accidental oral ingestion) include headache, vomiting, drowsiness and hypotension. ...
Pharmacodynamic properties
Pharmacotherapeutic group: Anti-inflammatory preparations, non-steroids for topical use ATC code: M02AA13 The gel is for topical application. It contains the active ingredient, ibuprofen, a phenylpropionic ...
Pharmacokinetic properties
Specially formulated for external application, the active ingredient penetrates through the skin rapidly and extensively (approximately 22% of a finite dose within 48 hours), achieving high, therapeutically ...
Preclinical safety data
There is no new data published on the active ingredient.
List of excipients
Hydroxyethyl cellulose EP Sodium Hydroxide EP Benzyl alcohol EP Isopropyl alcohol BP Purified water
Incompatibilities
None known.
Shelf life
36 months.
Special precautions for storage
Store below 25°C.
Nature and contents of container
Collapsible aluminium tubes with internal protective lacquer with polypropylene screw caps. 100g.
Special precautions for disposal and other handling
No special instructions.
Marketing authorization holder
Mercury Pharma Group Ltd, Capital House, 85 King William Street, London EC4N 7BL, UK
Marketing authorization number(s)
PL 10972/0090
Date of first authorization / renewal of the authorization
06/10/2015
Date of revision of the text
18 February 2021
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