GINEKOPHYT

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT HINEKOFIT

Composition:

Active ingredients: 1 ml of the preparation contains a combined tincture made from a mixture of medicinal plant raw materials (herb of common shepherd's purse (Bursae pastoris herba) 24 mg, yarrow herb (Millefolii herba) 24 mg, marigold flowers (Calendulae flos) 24 mg, chamomile flowers (Matricariae flos) 24 mg, sweet flag rhizomes (Calami radix) 22 mg, oregano herb (Origani vulgaris herba) 22 mg, periwinkle herb (Vincae minoris herba) 20 mg, St. John's wort herb (Hyperici herba) 20 mg, celandine herb (Chelidonii herba) 20 mg) (1:5) (extraction solvent – ethanol 70%).

Pharmaceutical form. Combined tincture.

Main physico-chemical properties: clear greenish-brown liquid with a characteristic odor. Presence of sediment is permissible.

Pharmacotherapeutic group. Agents used in gynecology.

ATC code G02CX.

Pharmacological properties.

Pharmacodynamics.

GINEKOPHYT has anti-inflammatory (suppresses exudative processes and development of fibrous-granulation tissue, reduces the severity of inflammatory response), wound-healing (accelerates regeneration of damaged tissue), and hemostatic activity. The medicinal product exhibits moderate antibacterial action.

Clinical characteristics.

Indications. As part of complex therapy for colpitis, vulvovaginitis, vulvitis, cervical erosions and endocervicitis, cervicitis, salpingo-oophoritis, as well as for hyperpolymenorrhea. The drug can also be used for prevention of recurrent inflammatory diseases of the female genital system.

Contraindications. For oral and intravaginal administration: hypersensitivity to the components of the drug.

For oral administration: hyperacid gastritis, peptic ulcer of the stomach and duodenum, acute and chronic renal failure, liver cirrhosis, organic liver changes, bronchial asthma, tendency to thrombosis, thromboembolism (in medical history), thrombophlebitis, arterial hypertension, neurological syndromes, epilepsy, angina pectoris; history of alcoholism; concomitant use of drugs containing ethyl alcohol, neuroleptics, tranquilizers; alcohol consumption.

Special precautions. During treatment, avoid intense UV radiation.

Interaction with other medicinal products and other types of interactions. Since the drug contains 70% ethanol, potentiation of the effect of hypnotics and tranquilizers is possible.

Concomitant use with indirect anticoagulants, antibiotics, sulfonamides, contraceptives, antihypertensive drugs – calcium channel blockers, female sex hormones, hypocholesterolemic agents (statins), and cardiac glycosides is not recommended.

Special precautions for use.

Due to the presence of Chelidonium herb in the formulation, internal use of the drug is permitted only under medical prescription and supervision.

Use during pregnancy or breastfeeding. Oral administration: the medicinal product is contraindicated during pregnancy; if use of the drug is necessary, breastfeeding should be discontinued.

Vaginal administration: the medicinal product is contraindicated during pregnancy; there are no contraindications during breastfeeding.

Ability to influence reaction rate when driving or operating machinery. During treatment with the drug (oral administration), patients should refrain from potentially hazardous activities requiring increased attention and rapid psychomotor reactions (such as driving vehicles or operating complex machinery).

Method of Administration and Dosage

Shake before use. For adults and children aged 12 years and older, GYNEKOPHIT should be used as vaginal douching or irrigation once daily for 2–3 weeks, depending on the course of the disease. To prepare, dilute 1 tablespoon of the tincture in 250 ml of warm water (35–38 °C).

In acute forms of disease, to enhance the therapeutic effect, it is advisable to administer GYNEKOPHIT orally to adult women concurrently with local application. The oral dose is 5–10 ml (1–2 teaspoons) mixed in 80–120 ml (⅓–½ cup) of water, taken after meals 2–3 times daily. For cervical erosions, vaginal tampons soaked in the diluted solution (1:10 or 1:20 dilution) should be used—1 tablespoon of tincture diluted in 150 ml or 300 ml of warm boiled water (35–38 °C).

For prevention of recurrences, GYNEKOPHIT should be used as vaginal douching or irrigation once daily, diluted 1:20 (1 tablespoon of tincture diluted in 300 ml of warm boiled water [35–38 °C]).

Duration of treatment is determined by the physician depending on the severity of the condition and the therapeutic response achieved. Typically, the treatment course lasts from 10 to 28 days.

Children. The drug is contraindicated for oral use in children. For children aged 12 years and older, intravaginal use may be considered only under medical supervision.

Overdose. Overdose leads to acute alcohol intoxication with symptoms similar to those of ethanol poisoning. When blood alcohol concentration reaches 3–4 g/L (300–400 mg%), severe intoxication develops.

Treatment: gastric lavage, symptomatic therapy. The patient must be kept warm during emergency management.

Additionally, dyspeptic symptoms and increased incidence of adverse reactions may occur.

Side effects.

The medicinal product is generally well tolerated by patients and has not so far caused any adverse reactions. However, it is known that the use of some of its components may cause allergic reactions such as skin hyperemia, rashes, itching, contact dermatitis, urticaria, asthma, anaphylactic shock, Quincke's edema; increased blood pressure, photosensitivity reactions, nausea, vomiting, discomfort or pain in the epigastric area, bitter taste in the mouth, dizziness, hypercoagulation. In case of any adverse reactions, consult a physician.

Shelf life. 2 years. Do not use after the expiry date stated on the packaging.

Storage conditions. In the original packaging at a temperature not exceeding 25 °C, in a place inaccessible to children.

Packaging. 100 ml in jars No. 1; 100 ml in bottles No. 1.

Availability. Over-the-counter.

Manufacturer. LLC "Scientific and Production Pharmaceutical Company "EYM".

Manufacturer's address. Ukraine, 61091, Kharkiv region, Kharkiv, St. Kharkivs'kykh Dyviziy, 20 lit. "A-5".