FLOGOPROFEN Gel / Cutaneous spray solution Ref.[51140] Active ingredients: Etofenamate

Source: Medicines Authority (MT)  Revision Year: 2012  Publisher: Chiesi España, S.A.U., Plaça dEuropa, 41-43, Planta 10, 08908 LHospitalet de Llobregat, Barcelona (Spain)

Product name and form

Flogoprofen 50 mg/g Gel.

Flogoprofen 50 mg/ml Cutaneous spray solution.

Pharmaceutical Form

Flogoprofen 50 mg/g gel: transparent and colourless gel.

Flogoprofen 50 mg/ml Cutaneous spray solution: clear slightly yellowish solution with an aroma of turpentine oil.

Qualitative and quantitative composition

Each gram of gel contains 50 mg of etofenamate.

Excipients with known effect: Each gram of gel contains 100 mg of dimethyl sulfoxide. For the full list of excipients, see section 6.1.

Each ml of Cutaneous spray solution contains 50 mg of etofenamate.

Excipients with known effect: Each ml of solution contains 100mg of dimethyl sulfoxide and 100 mg of propylene glycol. For the full list of excipients, see section 6.1.

Active Ingredient Description
Etofenamate

Etofenamate is a flufenamic acid derivative, which is readily transported through the skin and concentrated in inflamed tissue, where it exerts anti-inflammatory and analgesic effects by inhibiting the release of histamine, lysosomal enzymes and prostaglandin.

List of Excipients

Flogoprofen 50mg/g Gel:

Dimethyl sulfoxide
Levomenthol
Carbomers
Ethanol 96%
Turpentine oil
Triethanolamine
Purified water

Flogorpofen 50mg/ml Cutaneous spray solution:

Dimethyl sulfoxide
Turpentine oil
Levomenthol
Propylene glycol
Ethanol 96%

Pack sizes and marketing

Flogoprofen 50 mg/g Gel: Squeezable sealed aluminium tube with twist-off cap containing 30 g or 60 g of gel.

Flogoprofen 50mg/ml Cutaneous spray solution: Polyethylene spray bottle containing 100 ml of solution.

Marketing authorization holder

Chiesi España, S.A.U., Plaça d’Europa, 41-43, Planta 10, 08908 L’Hospitalet de Llobregat, Barcelona (Spain)

Marketing authorization dates and numbers

Flogoprofen 50 mg/g Gel: 55.380 (Spain)
Flogoprofen 50 mg/ml Solución para pulverización cutánea: 55.701 (Spain)

Flogoprofen 50 mg/g Gel: Date of first authorisation: 25 June 1982.
Flogoprofen 50 mg/ml Cutaneous spray solution: Date of first authorisation: 30 July 1982.

Drugs

Drug Countries
FLOGOPROFEN Spain, Hong Kong, Malta

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