Pimafucin cream 20 mg/g tube 30 g

Instructions Pimafucin cream 20 mg/g tube 30 g

Composition

active ingredient: natamycin;

1 g of cream contains 20 mg of natamycin;

excipients: decyl oleate, cetyl wax ether, cetostearyl alcohol, sodium lauryl sulfate, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), propylene glycol, purified water.

Dosage form

Cream.

Main physicochemical properties: cream from white to yellowish color.

Pharmacotherapeutic group

Antifungal drugs for topical use. Antibiotics. ATX code D01A A02.

Pharmacological properties

Pharmacodynamics

Natamycin is a polyene antifungal antibiotic. Its antifungal properties are associated with disruption of the integrity of cell membranes when interacting at the level of sterol synthesis. Most pathogenic fungi are sensitive to natamycin. Candida albicans is sensitive to natamycin.

Pharmacokinetics

Natamycin is active when applied topically and is practically not absorbed through the skin and mucous membranes.

Indication

Fungal skin lesions caused by Candida albicans.

Contraindication

Hypersensitivity to any component of the drug.

Interaction with other medicinal products and other types of interactions

Unknown.

Application features

The presence of methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216) in the composition of the drug may cause allergic reactions (possibly delayed). Cetostearyl alcohol may cause local skin reactions (e.g. contact dermatitis). Propylene glycol may cause skin irritation.

Ability to influence reaction speed when driving vehicles or other mechanisms

Does not affect.

Use during pregnancy or breastfeeding

The drug can be used during pregnancy and breastfeeding.

Method of administration and doses

The cream should be applied to the affected areas of the skin 1–4 times a day daily. The duration of therapy is usually 2–3 weeks.

Children

Natamycin in the dosage form of cream can be used in children of all ages.

Overdose

No data.

Adverse reactions

Hypersensitivity reactions: at the site of application, a burning sensation and irritation may occur.

If they persist, this may be due to hypersensitivity to preservatives (parahydroxybenzoates).

Reporting of adverse reactions

Reporting suspected adverse reactions after a medicinal product has been authorised is important. This allows the benefit/risk balance of the medicinal product to be continuously assessed.

Doctors are asked to report all suspected adverse reactions through the national reporting system.

Expiration date

3 years.

Do not use the drug after the expiration date indicated on the package.

Storage conditions

Store at a temperature not exceeding 25 ° C. Do not store in the refrigerator or freezer. Keep out of the reach of children.

Packaging

30 g in a tube, 1 tube in a cardboard box.

Vacation category

Without a prescription.

Producer

Temmler Italia S.r.l.

Location of the manufacturer and its business address

Via delle Industri, 2, 20061, Carugate (MI), Italy.