PIMAFUCIN

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT PIMAFUCINâ (PIMAFUCINâ)

Composition:

Active substance: nystatin;

1 g of cream contains 20 mg of nystatin;

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

Pharmaceutical form. Cream.

Main physicochemical properties: cream of white to yellowish color.

Pharmacotherapeutic group. Antifungal agents for local use. Antibiotics. ATC code D01A A02.

Pharmacological properties.

Pharmacodynamics.

Nystatin is a polyene antifungal antibiotic. Its antifungal properties are related to disruption of cell membrane integrity through interaction at the level of sterol synthesis. Most pathogenic fungi are sensitive to nystatin. Candida albicans is sensitive to nystatin.

Pharmacokinetics.

Nystatin is active when applied locally and is practically not absorbed through the skin and mucous membrane membranes.

Clinical characteristics.

Indications.

Fungal skin infections caused by Candida albicans.

Contraindications.

Hypersensitivity to any component of the medicinal product.

Interaction with other medicinal products and other forms of interaction.

Unknown.

Special precautions for use.

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

Use during pregnancy or breastfeeding.

The drug may be used during pregnancy and breastfeeding.

Ability to influence reaction rate when driving vehicles or operating machinery.

No effect.

Method of Administration and Dosage.

Apply the cream to affected areas of the skin 1–4 times daily. The duration of therapy is usually 2–3 weeks.

Children.

Nystatin in the form of cream can be used in children of all age groups.

Overdose.

No data available.

Side effects.

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

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

Reporting of suspected adverse reactions

Reporting of suspected adverse reactions after marketing authorization of the medicinal product is important. This allows the benefit-risk balance of the medicinal product to be continuously monitored.

Physicians are requested to report any suspected adverse reactions through the national reporting system.

Shelf life. 3 years.

Do not use the medicinal product after the expiry date stated on the packaging.

Storage conditions.

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

Packaging.

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

Marketing authorization category. Over-the-counter.

Manufacturer.

Temmler Italia S.r.l.

Manufacturer's address and location of operations.

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