Phytolysin plus

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT FİTOLİZİN PLUS (FITOLIZIN PLUS)

Composition:

Active ingredients: 100 g of paste contains 12 g of dry herbal extract (dry residue content 65%): onion peel (Allium cepa), birch leaves (Betula alba), couch grass rhizome (Agropyron repens), parsley root (Petroselinum sativum), fenugreek seeds (Trigonella foenum-graecum), common goldenrod herb (Solidago virgaurea), field horsetail stems (Equisetum arvense), common knotweed herb (Polygonum aviculare), lovage root (Levisticum officinale), ethylparahydroxybenzoate (E 214), purified water;

Excipients: sage oil (Salvia oil), peppermint oil (Mentha oil), mountain pine oil (Oil pinus mugo), ethylparahydroxybenzoate (E 214), agar-agar, wheat starch, glycerin, orange oil (Oil citri sinensis), vanillin, purified water.

Pharmaceutical form. Paste.

Main physicochemical characteristics: soft mass of yellowish-brown to greenish-brown color, with a characteristic aromatic odor. Dark specks may be present.

Pharmacotherapeutic group. Agents affecting the genitourinary system and sex hormones. Agents promoting dissolution of urinary calculi.

ATC code G04BC.

Pharmacological Properties.

Pharmacodynamics.

Phytolysin Plus is a combined herbal medicinal product. The agent exerts diuretic, anti-inflammatory, antimicrobial, and analgesic effects. These properties are due to biologically active substances present in the medicinal herbs. The biologically active substances enhance excretion of sodium and chloride ions and glomerular filtration in the kidneys, and reduce tubular reabsorption. They increase diuresis without disturbing the electrolyte balance.

Flavonoids inhibit the growth of gram-positive microflora in the urinary tract, promote urea excretion, block oxidation of ascorbic acid, and prevent its conversion into oxalic acid. Saponins exhibit pronounced antibacterial activity against staphylococci. Aglycones exert a spasmolytic effect.

Silicates (Equisetum arvense, Polygonum aviculare) help maintain the balance between colloids and crystalloids in urine, thus preventing the formation of urinary calculi; they also improve excretion of uric acid.

The product promotes flushing out of sand and small urinary concrements, prevents enlargement of concrements, and postoperative recurrence of stone formation.

Pharmacokinetics.

Not studied.

Clinical characteristics.

Indications.

Infectious and inflammatory diseases of the urinary tract associated with urolithiasis; prevention of urolithiasis relapses, including after surgical removal of stones.

Contraindications.

Hypersensitivity to any component of the drug or to plants of the Asteraceae (Compositae) family (common goldenrod), Apiaceae (Umbelliferae), or anethole (lovage root), birch pollen (birch leaves). Conditions requiring reduced fluid intake (e.g., renal insufficiency, cardiac insufficiency). Conditions associated with increased blood coagulation. Obstruction of urinary tract. Acute nephritis, nephroses, phosphate lithiasis.

Interaction with other medicinal products and other forms of interaction.

Due to the diuretic effect of the drug, one should consider the possibility of accelerated excretion of other concurrently administered medicinal products.

The drug may enhance the effects of hypoglycemic agents, nonsteroidal anti-inflammatory drugs, monoamine oxidase inhibitors, and anticoagulants; it may prolong the action of pentobarbital, paracetamol, and amidopyrine.

The drug may reduce the absorption of medicinal products in the small intestine, particularly beta-carotene, alpha-tocopherol, as well as cholesterol.

Special precautions for use.

Glucose monitoring is necessary in diabetic patients during treatment with this medicinal product due to the possible hypoglycaemic effect of fenugreek.

The product contains wheat starch, which may contain gluten, but only in insignificant amounts; therefore, it is considered safe for patients with celiac disease. Patients with wheat allergy (other than celiac disease) should not take this medicinal product.

If pain, complications during urination, presence of blood in urine, worsening of symptoms, or elevated body temperature occur, immediate medical advice must be sought.
It is recommended to drink plenty of fluids during treatment with this medicinal product.
The product contains ethylparahydroxybenzoate (E 214), which may cause allergic reactions (possibly delayed).

Use during pregnancy or breastfeeding.

There are no data available on the safety and efficacy of this medicinal product during pregnancy; therefore, it should not be used during this period.

As it is unknown whether use of the medicinal product is safe during breastfeeding, breastfeeding must be discontinued for the duration of treatment with this product.

Ability to influence the speed of reactions while driving or operating machinery.

If dizziness occurs during treatment with this medicinal product, driving vehicles or operating machinery should be avoided.

Dosage and Administration.

Administer 1 teaspoon (approximately 5 g) of paste dissolved in 1/2 cup of warm water per dose. Use 3–4 times daily after meals.

The duration of treatment is determined by the physician depending on the nature of the disease and treatment efficacy, usually ranging from 2 to 6 weeks. If necessary, the course of treatment may be repeated.

Children.

There is no experience with the use of the drug in children and adolescents under 18 years of age; therefore, it should not be prescribed to patients in this age group.

Overdose.

In case of overdose, adverse reactions may be intensified.

Treatment is symptomatic.

Side effects.

Possible gastrointestinal disturbances, vomiting, diarrhea, bloating, renal colic, dizziness; allergic reactions including rash, urticaria, itching, allergic rhinitis. Photosensitization may occur in individuals with increased sensitivity to ultraviolet radiation.

Shelf life.

3 years.

Do not use the medicinal product 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.

Packaging. 100 g in a tube. One tube per carton.

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

Manufacturer.

JSC "Farmak".

Manufacturer's address and place of business.

74, Kyrylivska Street, Kyiv, 04080, Ukraine.