REACTIFARGAN CREMA 20G 2%

REACTIFARGAN

active ingredients

100 g cream contain: Active ingredient: promethazine 2,00 g. Excipients with known effects: methyl-para-hydroxybenzoate and propile-para-hydroxybenzoate. For the full list of excipients, see paragraph 6.1.

Excellent

Polyacrilamide isoparaffin laureth-7,octil methyl-para-hydroxybenzoate, propile-para-hydroxybenzoate, lavender oil, purified water.

Therapeutic indications

Local symptomatic treatment for insect bites and other localized skin irritative phenomena such as redness, burning, itching and solar erythema.

Contraindications

Hypersensitivity to the active ingredient or any of the excipients. Eczemi. Senient injuries. Children under 2 years of age.

Population

Posology: Apply 3-4 times a day. Do not exceed the recommended number of daily applications. Avoid application on very extended areas of the body. Method of administration: Topical use.

Conservation

Store at a temperature below 25°C.

Warnings

Prolonged and incongruous use of the product can give rise to allergic sensitization phenomena resulting in worsening of symptomatology. If this occurs, the treatment must be suspended and the situation should be reevaluated. If applied on very extended areas of the skin REACTIFARGAN can cause drowsiness (see paragraph 4.7). Since the application of REACTIFARGAN can delay the healing process, it should not be used more than 3-4 consecutive days on injuries in which this phenomenon is taking place. In the case of solar erythema, apply the product and avoid further exposure to the sun of the irritated skin. If skin rashes, irritation and burning, the treatment should be suspended. Important information about some REACTIFARGAN excipients contains p-hydroxybenzoate methyl and p-hydroxybenzoate propel that can cause allergic reactions (also delayed).

Interactions

Not known.

Effects

The side effects below result from post-marketing and have unknown frequency (frequency cannot be established on the basis of available data).

Classification for organs and systems	Frequency not known
Pathologies of skin and subcutaneous tissue	Dermatitis, edema, erythema, boiled lesions, photosensitivity

Reporting of suspicious adverse reactions. The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at the address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

No overdose cases have been reported.

Clinical data for pregnant and breast-feeding are not available. The administration of REACTIFARGAN during pregnancy and nursing with breast milk should be taken into account only if the expected benefit for the mother exceeds the risk for the fetus or the child.

Source: Farmadati