Heliscan®

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT HЕLІSCAN® (CHELISCAN)

Composition:

Active substance: tincture (1:10) from a mixture of herbal raw materials "Cheliscan®": calendula flowers (calendulae flores) – 1.5 g; white mistletoe shoots and leaves (visci albi cormi et folia) – 1.5 g; Japanese sophora fruits (sophorae japonicae fructus) – 1 g; spotted thistle fruits (silibi mariani fructus) – 1.5 g; anomalous peony rhizomes and roots (paeoniae anomalae rhizomata cum radicibus) – 1.5 g; common oat herb (avenae sativae herba) – 1.5 g; celandine herb (chelidonii herba) – 1.5 g; (extraction agent: ethanol 40%);

Excipients: none, except the extraction agent.

Pharmaceutical form. Tincture.

Main physico-chemical properties: yellowish-brown liquid with an aromatic specific odor. Sediment formation is permissible.

Pharmacotherapeutic group.

Cytokines and immunomodulators. Immunostimulants.

ATC code L03A X.

Pharmacological Properties

Pharmacodynamics

A herbal medicinal product exhibiting a therapeutic effect due to a complex of biologically active substances contained in its composition.

Calendulae flos (marigold flowers) exert wound-healing, bactericidal, anti-inflammatory, and moderate cholagogue effects, and reduce reflex excitability.

Visci albi herba (herb of white mistletoe) exerts diuretic, hemostatic, analgesic, anti-inflammatory, antiatherosclerotic, and antihypertensive effects; stimulates cardiac activity and reduces excitability of the central nervous system.

Fructus Sophorae japonicae (fruits of Japanese sophora) possess wound-healing properties, accelerate tissue regeneration, reduce capillary fragility and permeability, and enhance the body's ability to absorb ascorbic acid.

Fructus Silybi marini (fruits of spotted milk thistle) exert hepatoprotective, choleretic, and cholagogue effects, promote improvement of liver function, and normalize digestion.

Paeoniae rhizomata et radices (rhizomes and roots of Paeonia anomala) exert a calming effect in conditions of increased excitability, phobias, hypochondriac states, and vegetative-vascular disorders of various etiologies, as well as analgesic action; increase gastric juice acidity.

Avenae herba (herb of cultivated oat) exhibits diaphoretic, diuretic, and antipyretic effects.

Chelidonii herba (herb of greater celandine) exerts anti-inflammatory, antimicrobial, antifungal, antitrichomonad, antituberculous, immunosuppressive, cytostatic, and antihistaminic effects.

Heliscan® exerts immunomodulatory, antitoxic, stress-protective (normalizes somatic, immunological, biochemical, and morphological parameters of the organism's stress response), tonic, and antioxidant effects. The drug reduces adverse effects and helps maintain normal bone marrow hematopoiesis during cytostatic and radiation therapy, and enhances nonspecific resistance of the organism.

Pharmacokinetics

Not studied.

Clinical characteristics.

Indications.

For use in adults as part of combination therapy:

• in frequent recurrent and chronic viral, fungal, and bacterial infectious-inflammatory diseases of the respiratory tract, bronchitis (including in patients with mastopathy and benign prostatic hyperplasia);
• in manifestations of secondary immunodeficiency syndrome following infectious diseases;
• during and after cytostatic and radiation therapy.

Contraindications.

Hypersensitivity to any component of the drug. Arterial hypotension, neurological syndromes, epilepsy, bronchial asthma, angina pectoris, organic liver and kidney changes, acute poisonings of various etiologies.

Interaction with other medicinal products and other types of interactions.

Ethanol may slightly increase the body's sensitivity to clonidine and neuroleptics and reduce thiamine activity.

The drug may potentiate the effects of sedatives and hypnotics, tranquilizers, neuroleptics, and antidepressants with sedative action.

When silimarin (a biologically active substance from fruits of Silybum marianum) is used concomitantly with oral contraceptives or drugs used in estrogen replacement therapy at maximum doses, a reduction in the efficacy of the latter is possible. By inhibiting the cytochrome P450 system, silimarin thereby enhances the effect of certain medicinal products, namely: antiallergic agents (fexofenadine); hypocholesterolemic agents (lovastatin); anticoagulants (clopidogrel, warfarin); antipsychotic agents (alprazolam, diazepam, lorazepam); antifungal agents (ketoconazole); and some anticancer drugs (vinblastine).

Special precautions for use.

The medication should be used diluted in water.

Prior to use, consult a physician.

The medication contains ethanol and therefore should not be used in chronic liver diseases or alcoholism.

Treatment with this medication will be more effective in liver diseases if combined with a proper diet and complete abstinence from alcohol.

Due to the possible estrogen-like effect of silymarin at maximally high doses, it should be used with caution in patients with hormonal disorders (endometriosis, uterine fibroids, breast, ovarian or uterine carcinoma, prostate carcinoma). In such cases, medical consultation is required.

In peptic ulcer disease and gastritis with increased acidity, the medication should be used in combination with antacids and spasmolytics. During prolonged administration of high doses, gastric acidity should be monitored, especially in patients predisposed to its increase.

If signs of jaundice appear (skin discoloration ranging from light yellow to dark yellow, yellowing of the sclera), medical advice must be sought.

Use during pregnancy or breastfeeding.

The medicinal product is contraindicated during pregnancy or breastfeeding.

Ability to affect reaction rate when operating vehicles or other machinery.

During the use of the tincture, patients should refrain from driving vehicles or performing tasks that require heightened attention and rapid psychomotor reactions.

Method of administration and dosage.

The medication should be taken orally, 30 minutes before meals.

Shake well before use.

Recommended dosage for adults: 5 ml (1 teaspoon) to 15 ml (1 tablespoon) per dose (as prescribed by a physician depending on the course of the disease), diluted in a small amount of water, 3 times daily (morning, afternoon, evening).

The duration of treatment depends on the indication, the course of the disease, and usually lasts from 14 to 21 days. Prolonged use beyond the specified period should be determined individually by a physician and requires monitoring of blood analysis dynamics. During long-term use, a 5–7 day break is required after each month of treatment.

Children.

Not recommended for use.

Overdose.

Symptoms: epigastric pain (resolves after dose adjustment according to recommendations); dyspeptic symptoms (nausea, vomiting); in case of significant overdose – bradycardia, dizziness, drowsiness, respiratory center paralysis, decreased arterial blood pressure.

Treatment: discontinue the drug, symptomatic therapy.

Adverse Reactions.

Gastrointestinal system: dyspeptic symptoms (vomiting, nausea, diarrhea, heartburn, dyspepsia).

Respiratory system: respiratory center paralysis (in severe cases), dyspnea.

Cardiovascular system: arterial hypotension.

Nervous system: drowsiness, weakness.

Skin and its derivatives: increased alopecia; hypersensitivity reactions may occur in isolated cases, including skin rashes, itching, urticaria, hyperemia, edema.

Renal and urinary system: increased diuresis.

Other: very rarely, exacerbation of pre-existing vestibular disorders may be observed.

Shelf life.

2 years.

Do not use after the expiry date stated on the packaging.

Storage conditions.

Store at a temperature not exceeding 25 °C.

Keep out of reach of children.

Sedimentation may occur during storage; this does not affect the drug's efficacy.

Shake well before use.

Packaging.

100 ml in a bottle; 1 bottle per cardboard pack.

100 ml in a jar; 1 jar per cardboard pack.

Prescription status.

Over-the-counter (without prescription).

Manufacturer.

JSC "Chemical-Pharmaceutical Plant "Chervona Zirka".

Manufacturer’s address and location of its operations.

61010, Ukraine, Kharkiv, Gordienkivska St., 1.

INSTRUCTION

for medical use of medicinal product

CHELISCAN

(CHELISCAN)

Composition:

Active substance: tincture (1:10) from a mixture of medicinal plant raw materials "Cheliskan": calendulae flores – 1.5 g; visci albi cormi et folia – 1.5 g; sophorae japonicae fructus – 1 g; silybi mariani fructus – 1.5 g; paeoniae anomalaе rhizomata cum radicibus – 1.5 g; avenae sativae herba – 1.5 g; chelidonii herba – 1.5 g; (extractant: ethanol 40%).

Excipients: none, except extractant.

Pharmaceutical form. Tincture.

Main physicochemical properties: yellowish-brown liquid with a characteristic aromatic odor. Sedimentation may occur.

Pharmacotherapeutic group.

Cytokines and immunomodulators. Immunostimulants.

ATC code L03AX.

Pharmacological properties.

Pharmacodynamics.

A plant-derived medicinal product exhibiting a therapeutic effect due to a complex of biologically active substances in its composition.

Calendulae flores exert wound-healing, bactericidal, anti-inflammatory, and mild cholagogue effects, and reduce reflex excitability.

Visci albi cormi et folia exert diuretic, hemostatic, analgesic, anti-inflammatory, anti-atherosclerotic, and hypotensive effects; stimulate cardiac activity and reduce excitability of the central nervous system.

Sophorae japonicae fructus have wound-healing properties, accelerate tissue regeneration, reduce capillary fragility and permeability, and enhance the body's ability to absorb ascorbic acid.

Silybi mariani fructus exert hepatoprotective, choleretic, and cholagogue effects, improve liver function, and normalize digestion.

Paeoniae anomalaе rhizomata cum radicibus exert sedative effects in conditions of hyperexcitability, phobias, hypochondriac states, and vegetative-vascular disorders of various etiologies; also exert analgesic effects and increase gastric juice acidity.

Avenae sativae herba exhibit diaphoretic, diuretic, and antipyretic effects.

Chelidonii herba exert anti-inflammatory, antimicrobial, antifungal, antitrichomonal, antituberculous, immunosuppressive, cytostatic, and antihistamine effects.

Cheliskan exerts immunomodulatory, antitoxic, stress-protective (normalizes somatic, immunological, biochemical, and morphological parameters of stress response), tonic, and antioxidant effects. The drug reduces adverse effects and helps maintain normal bone marrow hematopoiesis during cytostatic and radiation therapy, and enhances nonspecific resistance of the body.

Pharmacokinetics.

Not studied.

Clinical characteristics.

Indications.

For use in adults as part of combination therapy:

• In frequent relapsing and chronic viral, fungal, and bacterial infectious-inflammatory diseases of the respiratory tract, bronchitis (including in patients with mastopathy and benign prostatic hyperplasia);
• In manifestations of secondary immunodeficiency syndrome following previous infections;
• During and after cytostatic and radiation therapy.

Contraindications.

Hypersensitivity to any component of the drug. Arterial hypotension, neurological syndromes, epilepsy, bronchial asthma, angina pectoris, organic liver and kidney diseases, acute poisonings of various etiologies.

Interaction with other medicinal products and other types of interactions.

Ethanol may slightly increase organism sensitivity to clonidine and neuroleptics, and reduce thiamine activity.

The drug may potentiate the effects of sedatives, hypnotics, tranquilizers, neuroleptics, and antidepressants with sedative action.

When silimarins (biologically active substances from Silybum marianum fruits) are used at maximum doses simultaneously with oral contraceptives or drugs used in estrogen replacement therapy, a reduction in the efficacy of the latter may occur. By inhibiting the cytochrome P450 system, silimarin enhances the effect of certain drugs, namely: antiallergic agents (fexofenadine); hypocholesterolemic agents (lovastatin); anticoagulants (clopidogrel, warfarin); antipsychotic agents (alprazolam, diazepam, lorazepam); antifungal agents (ketoconazole); and certain anticancer drugs (vinblastine).

Special precautions.

The drug should be used diluted in water.

Prior consultation with a physician is recommended.

The drug contains ethanol and therefore should not be used in chronic liver diseases or alcoholism.

Treatment with the drug in liver diseases is more effective when combined with dietary measures and abstinence from alcohol.

Due to the possible estrogen-like effect of high-dose silimarin, it should be used cautiously in patients with hormonal disorders (endometriosis, uterine fibroids, breast, ovarian, or uterine carcinoma, prostate carcinoma). In such cases, medical consultation is required.

In peptic ulcer disease and gastritis with high acidity, the drug should be used together with antacids and spasmolytics. When large doses are used long-term, gastric acidity should be monitored, especially in patients prone to increased acidity.

If signs of jaundice appear (skin coloration from light yellow to dark yellow, yellowing of the sclera), medical consultation is required.

Use during pregnancy or breastfeeding.

The medicinal product is contraindicated during pregnancy and breastfeeding.

Effect on ability to drive or operate machinery.

During use of the tincture, patients should refrain from driving or performing tasks requiring high attention and rapid psychomotor reactions.

Administration and dosage.

The drug should be taken orally, 30 minutes before meals.

Shake well before use.

Recommended doses for adults: 5 ml (1 teaspoon) to 15 ml (1 tablespoon) per dose (as recommended by a physician depending on disease course), diluted in a small amount of water, 3 times daily (morning, afternoon, evening).

Duration of treatment depends on the indication, disease course, and usually ranges from 14 to 21 days. Use beyond this period should be individually prescribed by a physician and requires monitoring of blood test parameters. With prolonged use, a 5–7 day break should be taken after each month of treatment.

Children.

Do not use.

Overdose.

Symptoms: epigastric pain (disappears after dose adjustment according to recommendations); dyspeptic symptoms (nausea, vomiting); in significant overdose – bradycardia, dizziness, drowsiness, respiratory center paralysis, decreased arterial pressure.

Treatment: discontinue the drug, symptomatic therapy.

Adverse reactions.

Gastrointestinal system: dyspeptic symptoms (vomiting, nausea, diarrhea, heartburn, dyspepsia).

Respiratory system: respiratory center paralysis (in severe cases), dyspnea.

Cardiovascular system: arterial hypotension.

Nervous system: drowsiness, weakness.

Skin and its derivatives: increased alopecia; hypersensitivity reactions may occur in rare cases, including skin rashes, itching, urticaria, hyperemia, edema.

Renal and urinary system: increased diuresis.

Other: very rarely, exacerbation of pre-existing vestibular disorders may be observed.

Shelf life.

2 years.

Do not use after the expiry date stated on the packaging.

Storage conditions.

Store at a temperature not exceeding 25 °C.

Keep out of reach of children.

Sedimentation may occur during storage; this does not affect the drug's efficacy.

Shake well before use.

Packaging.

100 ml in a bottle; 1 bottle per cardboard pack.

100 ml in a jar; 1 jar per cardboard pack.

Prescription status.

Over-the-counter (without prescription).

Manufacturer.

JSC "Chemical-Pharmaceutical Plant "Krasna Zirka".

Manufacturer’s address and location of its operations.

61010, Ukraine, Kharkiv, Gordienkivska St., 1.