Fitulvent phyto-balm
Ukraine
INSTRUCTIONS |
PHITULVENT PHYTOBALZAM |
Composition:Active ingredients: liquid extract (1:29.4) from a mixture of herbal raw materials: oak bark (Quercus cortex) – 1 g, valerian roots (Valerianae radix) – 0.1 g, chamomile flowers (Chamomillae flores) – 0.1 g, St. John's wort herb (Hyperici herba) – 0.5 g, yarrow herb (Achilleae millefolii herba) – 0.1 g, wild thyme herb (Thymi serpylli herba) – 0.1 g, hawthorn fruits (Crataegi fructus) – 1.5 g (extraction agent – ethanol 40%); Excipients: sugar syrup. |
| Pharmaceutical form. Balm. Main physicochemical properties: clear light-brown liquid with a characteristic aromatic odor. Sedimentation may occur during storage. |
| Pharmacotherapeutic group. Agents for treatment of acid-related disorders. ATC code A02X. |
Pharmacological properties.Pharmacodynamics. The pharmacological activity of the drug is due to the combined action of components extracted from medicinal herbs (glycosides, essential oils, terpenoids, flavonoids, resins and tannins, carotene, ascorbic acid, vitamin K, organic acids). The drug has a calming effect in insomnia caused by fatigue and anxiety, in nervous excitement, and in gastrointestinal disorders of nervous origin. It has no cumulative, teratogenic, mutagenic, or gonadotropic effects and does not suppress the immune system. It exhibits sedative, desensitizing, antiseptic, choleretic, reparative, and anti-fermentation effects, produces a spasmolytic effect on smooth muscles of the intestine, urinary and biliary tracts, normalizes gastric gland secretion, and relieves flatulence. Pharmacokinetics. Not studied. |
Clinical characteristics.Indications. As part of complex therapy for neuroses of various origins, chronic gastritis, and hypokinetic-type biliary bladder and biliary tract dyskinesia. |
| Contraindications. Hypersensitivity to any component of the medicinal product, to other plants of the Asteraceae (Compositae) family; alcoholism; severe arterial hypotension or hypertension; bradycardia; increased blood coagulation; predisposition to thrombosis; severe liver or kidney diseases; depression and other disorders associated with central nervous system depression. |
| Interaction with other medicinal products and other forms of interactions. Valerian root may potentiate the effects of cardiac, sedative, hypnotic, analgesic, and spasmolytic agents. Hawthorn fruits potentiate the action of antiarrhythmic agents, enhance the effects of cardiac glycosides, hypnotics, sedatives, and antihypertensive agents; concomitant use with alkaloid salts is not recommended due to the possibility of forming negative complexes; do not use together with cisapride. St. John's wort herb: its use is not recommended in patients taking anticoagulants, antibiotics, sulfonamides, contraceptives, antihypertensives (calcium channel blockers), hypolipidemic agents (statins), female sex hormones, or cardiac glycosides. The preparation enhances the effect of barbiturates, tranquilizers, and other medicinal products affecting the central nervous system. It may interact with products containing metal salts when taken simultaneously. The medicinal product can be prescribed separately or as part of combination therapy with other medicinal products (histamine receptor antagonists, antacids). Consultation with a physician is required before using any other medicinal products concomitantly. |
Special precautions.The medicinal product contains ethanol; therefore, it should not be taken before activities requiring high attention. Due to its sugar content, the product should be prescribed cautiously to patients with diabetes mellitus. Use during pregnancy or breastfeeding. Use of the product during pregnancy or breastfeeding is contraindicated. |
| Ability to affect reaction rate when driving or operating machinery. Due to ethanol content, patients should refrain from driving vehicles or operating potentially hazardous machinery during treatment. |
Method of administration and dosage.Adults should take the product orally, 2 tablespoons 2–3 times daily, 30 minutes before meals, diluted in 0.5 glass of water. The balm should be shaken before use. The duration of treatment depends on the course of the disease and ranges from 7 to 18 days. Repeated courses of treatment are possible if necessary (after consultation with a physician). Children. The product is not intended for use in children. |
| Overdose. Symptoms: bradycardia, decreased arterial pressure, palpitations, nausea, abdominal pain, discomfort, headache, dizziness, drowsiness or mental excitation, general weakness, decreased hearing and visual acuity. Prolonged use may cause a bitter taste in the mouth and unpleasant sensations in the liver area. Signs of alcohol intoxication may occur in case of overdose. Treatment is symptomatic. |
Adverse reactions.Cardiovascular system: increased arterial pressure, significant decrease in cardiac output. Skin: photosensitization (avoid UV radiation during treatment). Nervous system: suppression of emotional responses, drowsiness, reduced work capacity, mental depression. Immune system: allergic reactions (including hyperemia, rash, swelling, and itching of the skin). If any adverse events occur, discontinue use of the medicinal product immediately and consult a physician! |
| Shelf life. 2 years. The product must not be used after the expiry date stated on the packaging. |
| Storage conditions. Store in the original packaging at a temperature not exceeding 25 °C. Keep out of reach of children. Sediment may form during storage. |
| Packaging. 100 ml in a jar; 200 ml, 250 ml, or 500 ml in a bottle. |
| Prescription status. Over-the-counter – 100 ml, 200 ml. By prescription only – 250 ml, 500 ml. |
| Manufacturer. JSC "Biolic". |
| Manufacturer's address and place of business. 131, Nezalezhnosti St., Ladizhin, Vinnytsia region, 24321, Ukraine. |
| Marketing Authorization Holder. LLC "Ukrainian Pharmaceutical Company". |
| Address of the Marketing Authorization Holder. 1U, Starosilska St., Kyiv, 02660, Ukraine. |