Mineral oil

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT VASELINE OIL (OLEUM VASELINII)

Composition:

Active substance: Vaseline oil;

1 vial contains 25 ml or 30 ml or 40 ml or 50 ml or 100 ml of vaseline oil.

Pharmaceutical form. Oil.

Main physicochemical properties: Colorless transparent oily liquid that does not fluoresce in daylight.

Pharmacotherapeutic group.
Laxatives. ATC code A06A A01.

Pharmacological properties.

Pharmacodynamics.

Vaseline is a purified mixture of solid and liquid hydrocarbons obtained from petroleum. When administered orally, it is not absorbed, softens fecal masses, and facilitates their movement through the intestine. When applied externally, it eliminates skin dryness and is practically not absorbed into the systemic circulation.

Pharmacokinetics.

Pharmacokinetics has not been determined.

Clinical characteristics.

Indications.

Oral use – chronic constipation in adults. External use – prior to cupping therapy, for dry skin (including around natural orifices), prior to medical procedures (lubrication of enema tips, gas evacuation tubes).

Contraindications.

Hypersensitivity to the drug. Oral use is contraindicated in acute inflammatory conditions of the abdominal organs (appendicitis, peritonitis, peptic ulcer of the stomach and duodenum, ulcerative colitis), hemorrhoids, and during menstruation. Do not use in case of poisoning with phosphorus and organophosphorus compounds. Oral use should not be combined simultaneously with fat-soluble antihelminthic agents (natamol, vermox, medamin, avermole).

Special precautions.

Shake before use. If necessary, after application, wipe off the oil with a cotton or gauze swab and wash with warm water and soap. After discontinuation of oral treatment, mineral oil may continue to be excreted through the anus for some time and may stain underwear; therefore, the use of protective pads is recommended.

Interaction with other medicinal products and other forms of interaction.

Enhances adverse effects of fat-soluble and antihelminthic agents.

Special precautions.

Use during pregnancy or breastfeeding.

The drug is contraindicated during pregnancy. During breastfeeding, use should be based on the benefit to the mother/ risk to the infant ratio as determined by the physician.

Ability to affect reaction rate when driving or operating machinery.

No data available.

Dosage and Administration.

For adults, administer orally at a dose of 1–2 tablespoons per day. The duration of use should be determined individually by a physician, depending on the therapeutic effect and drug tolerance. For external use – apply thinly and rub gently into the skin in both adults and children.

Children.

For external use only in children.

Overdose.

Not reported. Overdose may enhance adverse effects.

Side effects.

Prolonged use may cause digestive disturbances, nausea, anorexia, hypovitaminosis A, D, K, irritation and itching in the anal area. Allergic reactions are possible, including hyperemia, skin itching.

Shelf life.

5 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C. Keep in a place inaccessible to children.

Packaging.

25 ml in glass bottles stoppered with plugs and caps or caps only; 30 ml, 40 ml, 50 ml, or 100 ml in glass bottles stoppered with plugs and caps or dropper plugs and caps, in a carton or without a carton; 30 ml, 40 ml, or 50 ml in polymer bottles stoppered with dropper plugs and caps, in a carton or without a carton; 40 ml, 50 ml, or 100 ml in polymer bottles closed with caps, in a carton or without a carton.

Availability category. Over-the-counter (without prescription).

Manufacturer. JSC Pharmaceutical Factory "Viola".

Manufacturer's location and address of business activity.

69063, Ukraine, Zaporizhzhia, Akademika Amosova St., 75.

Marketing Authorization Holder. JSC Pharmaceutical Factory "Viola".

Address of the Marketing Authorization Holder.

69063, Ukraine, Zaporizhzhia, Akademika Amosova St., 75.