Mineral oil

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT VASELINE OIL (Oleum Vaselini)

Composition:

Active substance: Vaseline oil;

1 vial contains vaseline oil - 25 ml or 50 ml.

Pharmaceutical form. Oil.

Main physicochemical properties: transparent, colorless, oily, non-fluorescent in daylight liquid.

Pharmacotherapeutic group. Laxatives. ATC code A06A A01.

Pharmacological Properties

Pharmacodynamics

Vaseline is a purified mixture of solid and liquid hydrocarbons derived from petroleum. When administered orally, it is not absorbed and acts by softening fecal masses, thereby facilitating their passage through the intestines. When applied topically, it alleviates skin dryness and is practically not absorbed into the systemic circulation.

Pharmacokinetics

Not studied.

Indications

Oral use: chronic constipation in adults.

Topical use: prior to cupping therapy, for dry skin (including around natural orifices), and before medical procedures (e.g., lubricating the tip of an enema or a gas-release tube).

Contraindications

Hypersensitivity to the product.

Oral use is contraindicated in acute inflammatory conditions of the abdominal organs (e.g., appendicitis, peritonitis, gastric and duodenal ulcers, ulcerative colitis), hemorrhoids, and during menstruation.

Do not use in cases of poisoning with phosphorus and organophosphorus compounds. Do not administer orally concomitantly with fat-soluble anthelmintic agents (e.g., natamol, vermox, medamin, avermol).

Special precautions

Shake well before use.

If necessary, after application, wipe off excess oil with a cotton or gauze swab and wash the area with warm water and soap.

After discontinuation of oral treatment, vaseline oil may continue to be excreted through the anus for some time, potentially soiling undergarments; therefore, the use of protective pads is recommended.

Interaction with other medicinal products and other forms of interaction

May enhance the adverse effects of fat-soluble drugs and anthelmintic agents.

Special precautions for use.

Use during pregnancy or breastfeeding.

Use during pregnancy is contraindicated. During breastfeeding, use should be based on the benefit-risk ratio for mother and child, as determined by a physician.

Ability to affect reaction rate while driving or operating machinery.

Data are lacking.

Dosage and Administration.

For adults, take orally 1–2 tablespoons once daily. The duration of use should be determined by a physician depending on the therapeutic effect and tolerability of the drug.

For external use in adults and children – apply thinly to the skin with light rubbing.

Children.

For children, use only externally.

Overdose.

May result in an increase of adverse effects.

Adverse reactions.

Prolonged use may cause digestive disturbances, nausea, anorexia, hypovitaminosis A, D, K, and irritation or itching in the anal area.

Allergic reactions are possible, including hyperemia and skin itching.

Shelf life.

5 years.

Storage conditions.

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

Keep out of reach of children.

Packaging.

25 ml, 50 ml in bottles.

Prescription status. Over-the-counter.

Manufacturer. JSC "FITOFARM".

Manufacturer's address and place of business.

2 Sybirtseva Street, Bakhmut, Donetsk region, 84500, Ukraine.

Marketing Authorization Holder. JSC "FITOFARM".

Address of the Marketing Authorization Holder.

7, Verkhovnoyi Rady Boulevard, Building 18, Floor 3, Kyiv, 02100, Ukraine.