Effigel Gel 1% - Diclofenac Epolamine - Sprains, Strains, Bruises - Flector - 60g

NAME OF THE MEDICINAL PRODUCT

FLECTOREFFIGEL 1%, gel

QUALITATIVE AND QUANTITATIVE COMPOSITION

Diclofenac epolamine............................................... 1,293 g

Corresponding amount of diclofenac sodium............ 1.000 g

For 100 g of gel Excipients: castor oil, propylene glycol, methyl benzoate For the full list of excipients see the ansm leaflet.

PHARMACEUTICAL FORM

Gel.

CLINICAL DATA

Therapeutic indications: Short-term local treatment in adults and children over 15 years of age, in case of minor trauma: sprains, contusions.

Dosage and method of administration 1 application, 3 times a day.

Duration of treatment The duration of treatment is limited to 4 days.

Method of administration Local use

For adults and children over 15 years of age only.

EXTERNAL USE Massage the gel into the painful or inflamed area for a prolonged period.

Wash hands thoroughly after each use.

Contraindications in the following cases:

- hypersensitivity (allergy) to diclofenac, to substances of similar activity such as other NSAIDs, aspirin or to any of the excipients contained in FLECTOREFFIGEL

- from the beginning of the 6th month of pregnancy (see section 4.6)

- injured skin, regardless of the lesion: oozing dermatitis, eczema, infected lesion, burn or wound.

Special warnings and precautions for use: do not apply to mucous membranes or the eyes

Apply only to the painful area

- If a rash appears after application, treatment must be stopped immediately.

- this medicine contains propylene glycol and may cause skin reactions ... see leaflet on ansm.

PHARMACOLOGICAL PROPERTIES

Pharmacodynamic properties Pharmacotherapeutic class: NON-STEROIDIC ANTI-INFLAMMATORY FOR TOPICAL USE.