POLYFITOL-1

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT POLYPHYTOL-1 (POLYPHYTOL-1)

Composition:

Active substances: 1 ml of the preparation contains liquid extract (1:7, 14) (extraction solvent – 40% ethanol) from a mixture of: peppermint leaf (Menthae piperitae folia) 30 mg; sand everlasting flowers (Helichrysi arenarii flores) 10 mg; St. John's wort herb (Hyperici herba) 10 mg; wormwood herb (Absinthii herba) 0.1 mg; oak bark (Quercus cortex) 20 mg; tormentil rhizomes (Tormentillae rhizomata) 20 mg; sweet flag rhizomes (Calami rhizomata) 10 mg; dandelion roots (Taraxaci radices) 10 mg; corn silk (Zeae maydis styli cum stigmatis) 10 mg;

Excipient: confectionery sugar.

Pharmaceutical form. Oral tincture.

Main physicochemical properties: clear reddish-brown liquid with an aromatic odor. Formation of sediment during storage is permissible.

Pharmacotherapeutic group. Agents used in biliary tract and liver disorders. ATC code A05AX.

Pharmacological properties.

Pharmacodynamics.

Biologically active substances contained in the medicinal product exert choleretic, spasmolytic, and anti-inflammatory effects.

Clinical characteristics.

Indications.

As part of complex therapy in patients with chronic cholecystitis, cholangitis, biliary tract dyskinesia, chronic gastritis with decreased gastric secretory function.

Contraindications.

Hypersensitivity to the components of the drug. Peptic ulcer of the stomach and duodenum, cholelithiasis with stones larger than 10 mm in diameter, obstructive jaundice, acute inflammatory diseases of the liver, gallbladder and pancreas, chronic pancreatitis, chronic hepatitis in the stage of exacerbation, anorexia, liver cirrhosis, diseases of the small and large intestine accompanied by diarrhea, constipation. Increased blood coagulation, elevated prothrombin index, thrombophlebitis. Arterial hypertension. Spasmophilia, croup, bronchial asthma. History of bleeding from pelvic organs, anemia. Pregnancy and breastfeeding period, childhood.

Interaction with other medicinal products and other forms of interaction.

Due to the presence of St. John's wort, simultaneous use is not recommended in patients taking anticoagulants, antibiotics, sulfonamides, contraceptives, antihypertensive agents (calcium channel blockers), female sex hormones, hypocholesterolemic agents (statins), cardiac glycosides.

The interval between administration of this drug and other medicinal products should be at least 1 hour.

Special precautions for use.

Polyphitol-1 is a conventional herbal medicinal product intended for use according to indications supported by long-standing use.

The patient should consult a physician if symptoms of the disease do not resolve during treatment with this medicinal product or if any adverse reactions occur.

Patients with gastroesophageal reflux (heartburn) should avoid using the product, as it may exacerbate heartburn.

Since 1 ml of the product contains 20 mg of sugar, it should be used with caution in patients with diabetes mellitus. The product must not be used in patients with rare hereditary fructose intolerance, glucose-galactose malabsorption syndrome, or sucrase-isomaltase deficiency.

It is recommended to take the product with a small amount of water.

Use during pregnancy or breastfeeding.

The medicinal product is contraindicated during pregnancy and breastfeeding.

Ability to influence reaction speed when driving or operating machinery.

Since Polyphitol-1 contains ethanol, it may affect reaction speed; therefore, during treatment, patients should refrain from working with potentially hazardous machinery or driving vehicles.

Method of Administration and Dosage.

Polyphitol-1 should be taken orally, 10 ml (1 dessert spoon) 3 times daily, 15–30 minutes before meals, accompanied by a small amount of water.

The treatment course lasts 10–15 days.

Shake well before use.

Children.

There is no experience with the use of the drug in children.

Overdose.

Symptoms: overdose and prolonged use may cause a bitter taste in the mouth, discomfort in the liver area, poisoning: development of seizures, hallucinations, loss of consciousness, dizziness, impaired coordination; possible enhancement of the drug's sedative effect, chest pain.

Treatment: symptomatic.

Side effects.

Unreasonable use of the medicinal product Polifitol-1 may lead to chest pain due to the presence of peppermint extract.

Immune system side effects: hypersensitivity reactions are possible.

Gastrointestinal side effects: irritation of the mucous membrane, stomach pain, nausea, vomiting; with prolonged use, cholestasis may occur. Absinthin, contained in wormwood, may cause intestinal atony with prolonged use. If adverse reactions occur, discontinue use of the medication and consult a physician.

Skin side effects: allergic reactions are possible, including hyperemia, rash, itching, skin swelling, urticaria, contact dermatitis, and photosensitization (avoid UV radiation during treatment).

Nervous system side effects: dizziness, impaired motor coordination, increased blood pressure (with prolonged use in patients with arterial hypertension). Prolonged use of wormwood tincture may cause so-called "wormwood epilepsy" and may lead to poisoning, manifesting as seizures and hallucinations.

If adverse reactions occur, discontinue use of the medication and consult a physician.

Shelf life. 3 years.

Storage conditions.

Store at a temperature not exceeding 25 °C, in a place inaccessible to children.

Packaging.

100 mL in a bottle; 1 bottle per carton.

Prescription status.

Over-the-counter.

Manufacturer.

LLC "DKP "Pharmaceutical Factory".

Manufacturer's address and location of business activity.

4 Korolyova St., Stanishivka, Zhytomyr District, Zhytomyr Oblast, 12430, Ukraine.