Dipana^® (Tablets) Instructions for Use

Marketing Authorization Holder

Sentiss Pharma, Pvt. Ltd. (India)

Manufactured By

Surya Herbal Limited (India)

Quality Control Release

SENTISS PHARMA, Pvt. Ltd. (India)

Contact Information

SENTISS RUS LLC (Russia)

ATC Code

A05BA (Drugs for the treatment of liver diseases)

Dosage Form

Dipana^®

Film-coated tablets: 48 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets light green in color, oblong, biconvex, with rounded ends, with a specific odor; gray at the break with black, brownish-black spots.

	1 tab.
Picrorhiza kurroa rhizomata dry aqueous extract	80 mg
Andrographis paniculata folia dry aqueous extract	40 mg
Eclipta alba radices et folia dry aqueous extract	40 mg
Phyllanthus niruri radices et folia dry aqueous extract	40 mg
Solanum nigrum folia et fructus dry aqueous extract	30 mg
Tinospora cordifolia caulis dry aqueous extract	30 mg
Bacopa monnieri folia dry aqueous extract	10 mg
Boerhavia diffusa radices dry aqueous extract	10 mg
Zingiber officinale rhizomata dry aqueous extract	10 mg
Piper longum fructus dry aqueous extract	8 mg

Excipients: dried corn starch, microcrystalline cellulose, talc, magnesium stearate, sodium starch glycolate, croscarmellose sodium, sodium lauryl sulfate, sodium methylparaben, sodium propylparaben, sodium benzoate, bronopol.

Shell composition film coating “Opadry II white” (“Opadry II white 85G68918”) (lecithin (soy), titanium dioxide, polyethylene glycol/macrogol, talc, polyvinyl alcohol); film coating “Opadry II Green” (“Opadry II Green 85G51606”) (polyethylene glycol, FD&C Blue No.1 aluminum lake, lecithin, polyvinyl alcohol, titanium dioxide, talc, quinoline yellow aluminum lake); purified water (evaporates during coating application).

12 pcs. – blisters (4) – cardboard packs.

Clinical-Pharmacological Group

Hepatoprotective agent of plant origin

Pharmacotherapeutic Group

Means for the treatment of diseases of the liver and biliary tract; agents for the treatment of liver diseases, lipotropic agents

Pharmacological Action

A complex of biologically active substances of plant origin that are part of the drug Dipana^® protects the liver from the effects of toxic substances (alcohol, drugs, etc.), stimulates the regeneration of liver cells; normalizes the protein-synthetic function of the liver; helps improve the digestion process.

The drug Dipana^® contains dry aqueous extracts of plants that have the following effects.

Extracts of Picrorhiza kurroa rhizomes and Andrographis paniculata leaves and flowers have a hepatoprotective effect, preventing liver damage from toxic substances and drugs.

Extract of Solanum nigrum leaves and fruits activates the detoxification function of the liver, exerting a stimulating effect on the enzymatic systems of hepatocyte mitochondria.

Extract of Bacopa monnieri leaves and Eclipta alba roots and leaves have antioxidant properties and improve the general well-being of patients.

Extract of Boerhavia diffusa roots improves bile outflow.

Extracts of Phyllanthus niruri roots and leaves and Tinospora cordifolia stems have immunomodulatory activity.

Extract of Zingiber officinale rhizomes reduces dyspeptic disorders, normalizes intestinal peristalsis and bile duct motility.

Extract of Piper longum fruits prevents the development of liver fibrosis and potentiates the therapeutic effect of the components included in the other extracts.

Preclinical safety data

In preclinical data obtained from standard studies of pharmacological safety, repeated dose toxicity, genotoxicity, carcinogenic potential, and reproductive and ontogenetic toxicity, no particular harm to humans was identified.

Pharmacokinetics

Data are not available.

Indications

For adults and children aged 10 to 18 years with

Acute and chronic infectious, toxic and drug-induced hepatitis as part of complex therapy;
Alcoholic liver disease;
Fatty liver dystrophy of various etiologies;
Liver cirrhosis as part of complex therapy;
Prevention in chronic intoxications (including with long-term alcohol consumption);
Hypomotor dyskinesia of the biliary tract.

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
B19	Unspecified viral hepatitis
K70	Alcoholic liver disease
K71	Toxic liver disease
K73.9	Unspecified chronic hepatitis
K74	Fibrosis and cirrhosis of liver
K76.0	Fatty (change of) liver, not elsewhere classified

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Recommended dose of the drug for adults

Indication	Number of tablets per dose	Frequency of administration per day	Duration of treatment course
For treatment of alcoholic liver disease, fatty degeneration	2-3 tablets	2 times/day	8-12 weeks
For treatment of hepatitis, for toxic and drug-induced lesions, liver cirrhosis	2 tablets	3 times/day	4-8 weeks
For hypomotor dyskinesia of the biliary tract	1 -2 tablets	3 times/day	4-8 weeks
For prevention of liver damage in chronic intoxications	1 -2 tablets	3 times/day	4-8 weeks

Children

The dosage regimen for children from 10 to 18 years does not differ from the dosage regimen for adults. Safety and efficacy in children aged 0 to 10 years have not been established to date. Data are not available.

Method of administration

Orally. Dipana^® tablets should be taken before meals or liquids, with a sufficient amount of water.

Adverse Reactions

Possible allergic reactions.

In some cases the following transient phenomena are observed: dry mouth, nausea, intestinal cramps, diarrhea, sleep disturbance, headaches, increased diuresis.

Reporting of suspected adverse reactions

It is important to report suspected adverse reactions after drug registration to ensure continuous monitoring of the benefit-risk balance of the drug. Healthcare professionals are recommended to report any suspected adverse drug reactions through the national adverse reaction reporting systems of the member states of the Eurasian Economic Union.

Contraindications

Hypersensitivity to the active components of the drug and/or to any of the excipients.

Use in Pregnancy and Lactation

Due to the lack of clinical data, the use of the drug during pregnancy and breastfeeding is contraindicated.

Pediatric Use

Contraindicated for use in children under 10 years of age (insufficient data on efficacy and safety).

Special Precautions

Patients are recommended to maintain optimal body water balance while taking the drug Dipana^®.

Patients who develop gastritis after taking the drug Dipana^® should discontinue treatment.

Excipients

The drug Dipana^® contains less than 1 mmol (23 mg) of sodium per 1 tablet, i.e., it is essentially sodium-free.

The drug Dipana^® contains sodium methylparaben and sodium propylparaben, which may cause allergic reactions (including delayed ones).

The drug Dipana^® contains lecithin (soy). If the patient is allergic to peanuts or soy, this medicinal product should not be used.

Effect on ability to drive vehicles and mechanisms

The use of the drug does not affect the ability to perform potentially hazardous activities that require increased concentration and speed of psychomotor reactions (driving vehicles, working with moving mechanisms, work of a dispatcher, operator).

Overdose

Cases of overdose have not been reported to date.

Drug Interactions

Drug interactions of the drug Dipana^® have not been described.

Storage Conditions

The drug should be stored in a dry, light-protected place, out of the reach of children, at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 3 years. Do not use after the expiration date.

Dispensing Status

The drug is available without a prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer