NOVAPHERGAN 2% CR 30G

NOVAPHERGAN 2% CREMA

active ingredients

100 g cream contain: Active ingredient: prometazine hydrochloride 2,25 g equal to 2.0 g of promethazine base. For the full list of excipients, see paragraph 6.1.

Excellent

Liquid paraffin, stearic acid, glycerol, xalifin 15, p-hydroxybenzoate methyl, p-hydroxybenzoate propile, white wax, purified water, tiourea.

Therapeutic indications

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

Contraindications

NOVAPHERGAN is contraindicated in case of: - Hypersensitivity to the active ingredient or any of the excipients or other substances related to a chemical point of view; - eczema; - secretive injuries. NOVAPHERGAN is contraindicated in children under 2 years of age.

Population

Apply the cream 2-3 times a day on the affected area. Avoid application on very extended areas, more than 10% of the body surface. Do not exceed the recommended doses.

Conservation

Store in suitable container, sheltered from light and heat.

Warnings

Prolonged and incongruous use of the medicine can give rise to allergic sensitization phenomena resulting in worsening of symptomatology. If this occurs, the treatment must be suspended and consulted by the doctor in order to establish suitable therapy. Since the application of NOVAPHERGAN can delay the healing process, the medicinal product 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 medicine 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 excipients: the drug contains p-hydroxybenzoate methyl and p-hydroxybenzoate propile, which could cause allergic reactions, even delayed.

Interactions

There are no known interactions with other medicines for topical use.

Effects

NOVAPHERGAN can cause allergic reactions. The use of promethazine has been associated with photosensitivity reactions. The abundant application of medicine on very extensive areas of the skin can cause drowsiness. 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 www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

No overdose cases have been reported.

In pregnant women, the medicine should only be used in case of actual need and under medical control.

Source: Farmadati