Reacti fargan cream 2% minsan 002516060

REACTIFARGAN * CREAM 20G 2%

Therapeutic indications

Local symptomatic treatment for insect bites and other localized skin irritations such as redness, burning, itching and sunburn.

Dosage and method of use

Dosage: Apply 3-4 times a day. Do not exceed the recommended number of applications per day. Avoid applying to very large areas of the body. Method of administration: Topical use.

Contraindications

Hypersensitivity to the active substance or to any of the excipients. Eczema. Secreting lesions. Children under 2 years of age.

Side effects

The undesirable effects listed below arise from post-marketing and are of unknown frequency (frequency cannot be estimated from the available data).

Organ and system classification	Frequency not known
Skin and subcutaneous tissue disorders	Dermatitis, edema, erythema, bullous lesions, photosensitivity

Reporting of suspected adverse reactions. Reporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Special warnings

Prolonged and incongruous use of the product can give rise to allergic sensitization phenomena with consequent worsening of symptoms. Should this occur, treatment must be suspended and the situation re-evaluated. If applied to very large areas of the skin REACTIFARGAN can cause drowsiness (see section 4.7). Since the application of REACTIFARGAN can delay the healing process, it should not be used more than 3-4 consecutive days on lesions in which this phenomenon is taking place. In the case of sunburn, apply the product and avoid further exposure to the sun of the irritated skin. If skin rashes, irritation and burning phenomena occur, the treatment must be suspended. Important information about some of the ingredients REACTIFARGAN contains methyl p-hydroxybenzoate and propyl p-hydroxybenzoate which may cause allergic reactions (possibly delayed).

Pregnancy and breastfeeding

No clinical data are available for the risk in pregnancy and breastfeeding. Administration of REACTIFARGAN during pregnancy and breastfeeding should only be considered if the expected benefit to the mother outweighs the risk to the fetus or child.

Expiration and retention

Store below 25 ° C.

Interactions with other drugs

Not known.

Overdose

No cases of overdose have been reported.

Active principles

100 g of cream contain: Active ingredient: promethazine 2.00 g. Excipients with known effects: methyl-para-hydroxybenzoate and propyl-para-hydroxybenzoate. For the full list of excipients, see section 6.1.

Excipients

Polyacrylamide isoparaffin laureth-7, octyl methoxycinnamate, methyl-para-hydroxybenzoate, propyl-para-hydroxybenzoate, lavender compound oil, purified water.