: HEPAR-P : ABOUT HEPAR-P : Safety Profile :

HEPAR-P is well tolerated. Long-term oral administration of HEPAR-P produces no severe side effects.

Minor gastric irritation, nausea, and vomiting may occur. To overcome these symptoms, patients are advised to take this medicine after foods. And if these symptoms persist, patients are advised to stop taking this medicine.

In our in-house toxicology studies, HEPAR-P was found to have good safety profile. There were no toxic effects observed.

In our chronic toxicology study, rabbits were given daily doses of up to 480 mg /kg of HEPAR-P for 270 days. There was no toxic effect observed. (Note: 480 mg /kg of HEPAR-P for rabbits is approximately equivalent to daily human dose of 115 capsules of HEPAR-P per adult.).

Most of the animal studies are carried out in our animal house.

In another chronic toxicology study, rats were also given daily doses of up to 480 mg /kg of HEPAR-P for 270 days. There was no toxic effect observed.

In acute and sub-acute toxicology studies, rats were given daily doses of up to 480 mg /kg of HEPAR-P for 270 days. There was no toxic effect observed.

SUMMARY OF OUR TOXICOLOGY STUDIES

Type of study	Animals	Daily Doses	Treatment Period	Equivalent to daily human dose of 115 capsules of HEPAR-P per adult.	Results
Chronic toxicology study	Rabbits	480 mg/kg	270 days		No toxic effect
Chronic toxicology study	Rats	480 mg/kg	270 days		No toxic effect
Acute toxicology study	Rats	480 mg/kg	270 days		No toxic effect
Sub-acute toxicology study	Rats	480 mg/kg	270 days		No toxic effect