SULFUR OINTMENT SIMPLE

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT SULPHUR OINTMENT PROSTA

Composition:

1 g of ointment contains sulfur 333 mg;

Excipients: yellow soft paraffin, emulsifier T-2, purified water.

Pharmaceutical form. Ointment.

Main physicochemical properties: ointment of yellowish color and homogeneous consistency.

Pharmacotherapeutic group.

Preparations for the treatment of acne. Sulfur-containing preparations.

ATC code D10A B02.

Pharmacological Properties.

Pharmacodynamics.

Simple sulfur ointment has antimicrobial and antiparasitic effects. When sulfur interacts with organic substances, sulfides and pentathionic acid are formed, which exert an antiseptic effect.

Pharmacokinetics.

When simple sulfur ointment is applied topically, sulfur and petroleum jelly contained in its composition are practically not absorbed into the systemic circulation.

Clinical characteristics.

Indications.

Skin disorders: seborrhea, sycosis, mycoses, psoriasis. Treatment of scabies (as part of combination therapy).

Contraindications.

Hypersensitivity to the drug.

Safety precautions.

Avoid contact of the ointment with mucous membranes and eyes. Hands should be thoroughly washed after application.

If hypersensitivity to the ointment or its components occurs, use of this medicinal product should be discontinued.

Interaction with other medicinal products and other types of interactions.

When used simultaneously with topical medicinal products, new compounds with unpredictable effects may form. Interaction of the ointment with oxidizing agents (hydrogen peroxide, potassium permanganate) may lead to chemical burns.

Special precautions for use.

Use during pregnancy or breastfeeding.

The safety and clinical efficacy of the medicinal product during pregnancy or breastfeeding have not been studied. Therefore, the ointment should be used during these periods only if the expected benefit to the mother outweighs the potential risk to the fetus or infant.

Ability to influence reaction rate when driving or operating machinery.
The use of the ointment does not affect the ability to drive or operate machinery.

Administration and Dosage

The medication is intended for external use. Apply the ointment to affected areas of the skin 2–3 times daily. When treating scabies, the treatment regimen and requirements for maintaining personal hygiene are determined individually by a physician.

The duration of treatment depends on the therapeutic response and the drug's tolerability.

Patients should consult a physician if symptoms of the disease do not resolve during treatment or if adverse reactions not listed in the drug's instructions occur.

Children

The medication is contraindicated in children under 3 years of age.

For children aged 3 years and older, the medication may be used only when the expected benefit outweighs the potential risk.

Overdose

Not observed.

Side effects.

In individual cases, local hypersensitivity reactions are possible.

Shelf life.

2 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

40 g in tubes.

Category of release.

Over-the-counter.

Manufacturer.

JSC "FITOPHARM".

Location of manufacturer and its address of business activity.

84500, 2 Sybirtseva St., Bakhmut, Donetsk Oblast, Ukraine.

Marketing authorization holder.

JSC "FITOPHARM".

Address of marketing authorization holder.

7, Verkhovnoi Rady Ave., premises 18, 3rd floor, Kyiv, 02100, Ukraine.