Instructions for use Phytolysin paste for the preparation of oral suspension, tube 100 g
Composition
active ingredient: 100 g of paste contains a concentrated extract from a mixture of medicinal plant raw materials [wheat rhizome (Agropyron repens (L.) Beauv., rhizoma) – 12.5 g, onion husk (Allium cepa L., squama) – 5 g, birch leaves (Betula pendula Roth; Betula pubescens Ehrh., folium) – 10 g, fenugreek seeds (Trigonella foenum – graecum L., semen) – 15 g, parsley roots (Petroselinum sativum Hoffm., radix) – 17.5 g, goldenrod herb (Solidago virgaurea L., herba) – 5 g, horsetail herb (Equisetum arvense L., herba) – 10 g, lovage roots (Levisticum officinale Koch, radix) – 10 g, bird’s-foot trefoil herb (Polygonum aviculare L., herba) – 15 g] (1:1.3–1.6) (extractant – ethanol 45%) – 67.2 g;
excipients: sage oil, pine oil, orange oil, peppermint oil, agar, ethyl parahydroxybenzoate (E 214), wheat starch, vanillin, glycerin, purified water.
Dosage form
Paste for preparation of suspension for oral use.
Main physicochemical properties: paste of soft consistency, green-brown color, with a specific aromatic odor.
Pharmacotherapeutic group
Drugs that affect the genitourinary system and sex hormones. Drugs that help dissolve urinary stones.
ATX code G04B C.
Pharmacological properties
The drug has a diuretic, anti-inflammatory, antimicrobial and analgesic effect. These properties are due to biologically active substances that are part of medicinal herbs. Biologically active substances enhance the excretion of sodium and chlorine ions and filtration in the renal glomeruli and reduce reverse resorption in the renal tubules. Increase diuresis without disturbing the electrolyte balance.
Flavonoids inhibit the development of gram-positive microflora in the urinary tract, increase the excretion of urea, block the oxidation of ascorbic acid and prevent its transformation into oxalic acid. Saponins have a pronounced antibacterial effect against staphylococci. Aglucones have an antispasmodic effect.
Silicates (common ergot, horsetail) help maintain the balance between colloids and crystalloids in the urine, preventing the formation of stones; improve the excretion of uric acid.
Phytolysin® helps flush out sand and small urinary stones; prevents the growth of stones or postoperative re-formation of stones.
Indication
Infectious and inflammatory diseases of the urinary system accompanying urolithiasis; prevention of recurrence of urolithiasis, including after surgical removal of stones.
Contraindication
Hypersensitivity to any component of the drug or to plants of the genus Asteraceae (Compositae) (golden daisy), Apiaceae (Umbelliferae), or anethole (lovage root), birch pollen (birch leaves). Conditions in which reduced fluid intake is recommended (e.g. renal failure, heart failure).
Conditions accompanied by increased blood clotting.
Urinary tract obstruction.
Acute nephritis, nephrosis, phosphate lithiasis.
Interaction with other medicinal products and other types of interactions
Due to the diuretic effect of the drug, the possibility of accelerated elimination of other concomitantly used medications should be taken into account.
The drug may enhance the effect of hypoglycemic drugs, nonsteroidal anti-inflammatory drugs, lithium salts, monoamine oxidase inhibitors, anticoagulants; prolong the effect of pentabarbital, paracetamol, aminopyrine.
The drug may reduce the absorption of drugs in the small intestine, in particular beta-carotene, alpha-tocopherol, and cholesterol.
Application features
There were no reports of interactions.
When using the drug, glycemic control is necessary in patients with diabetes due to the possible hypoglycemic effect of fenugreek.
If you experience pain, difficulty urinating, blood in the urine, worsening symptoms, or an increase in body temperature, you should immediately consult a doctor.
The drug should not be used in patients with edema due to renal or heart failure.
It is recommended to drink plenty of fluids while using the drug.
The drug contains ethyl alcohol in an amount of approximately 200 mg per dose, which is equivalent to 5 ml of beer or 2 ml of wine. Residual amounts of alcohol do not cause clinically significant reactions.
The drug contains ethyl parahydroxybenzoate, which may cause allergic reactions (possibly delayed).
The medicine contains a small amount of gluten (found in wheat starch) and is considered “gluten-free”. The likelihood that taking the medicine Phytolysin® will lead to an exacerbation of symptoms with celiac disease is extremely low.
5 g of pasta contains no more than 15 μg of gluten.
Patients with wheat allergy (other than celiac disease) should not use this medicine.
Use during pregnancy or breastfeeding
There are no data on the safety and efficacy of the drug during pregnancy, so the drug should not be used during this period.
Since it is not known whether the use of the drug during breastfeeding is safe, breastfeeding should be discontinued for the period of use of the drug.
There are no data on fertility.
Ability to influence reaction speed when driving vehicles or other mechanisms
There is no data on the effect of the drug on the ability to drive or use machines. If dizziness occurs during treatment with the drug, you should refrain from driving or operating machinery.
Method of administration and doses
Adults
Prescribe 1 teaspoon (approximately 5 g) of paste dissolved in ½ cup of warm boiled water per dose. Apply 3–4 times a day after meals.
The course of treatment usually lasts from 2 to 4 weeks. If necessary, the course of treatment can be repeated.
If there is no improvement in the condition, the symptoms of the disease persist or the condition worsens, you should consult a doctor.
Since the amount of urine excreted increases during treatment, sufficient fluid intake should be maintained during treatment.
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 category.
Overdose
No cases of overdose have been reported.
In case of overdose, the manifestations of adverse reactions may be increased.
Treatment is symptomatic.
Side effects
On the part of the immune system:
allergic reactions, including rash, hives, itching, allergic rhinitis, facial swelling.
From the nervous system:
dizziness.
From the gastrointestinal tract:
nausea, vomiting, diarrhea, bloating.
Skin and subcutaneous tissue disorders:
increased sensitivity to ultraviolet rays (photosensitivity).
From the urinary system:
renal colic.
Expiration date
3 years.
Do not use the drug after the expiration date!
Storage conditions
Store in the original packaging at a temperature not exceeding 25°C.
Keep out of reach of children.
Packaging
100 g of paste in an aluminum tube, in a cardboard box.
Vacation category
Without a prescription.
Producer
Herbapol Warsaw Ltd.
Address
Ul. Olowkowa 54, 05-800 Pruszkow, Poland/05-800 Pruszkow Olowkowa 54, Poland.
