Consumer medicine information

1. Why am I using Ursodox GH?

Ursodox GH contains the active ingredient ursodeoxycholic acid. Ursodox GH is used to treat chronic cholestatic liver diseases.
For more information, see Section 1. Why am I using Ursodox GH? in the full CMI.

2. What should I know before I use Ursodox GH?

Do not use if you have ever had an allergic reaction to ursodeoxycholic acid or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use Ursodox GH? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Ursodox GH and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use Ursodox GH?

• Take Ursodox GH, or give Ursodox GH to your child, as directed by your doctor or pharmacist. This may differ from the information contained in this leaflet.

5. What should I know while using Ursodox GH?

6. Are there any side effects?

Ursodeoxycholic acid is generally well tolerated with few side effects. The common side effect is diarrhoea. Allergic reactions have been reported in some patients. Other adverse reactions reported include increased cholestasis, nausea, vomiting and sleep disturbance. The serious side effects include severe right-sided upper abdominal pain and severe worsening (decompensation) of liver cirrhosis.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

1 Name of Medicine

Ursodeoxycholic acid.

2 Qualitative and Quantitative Composition

Each Ursodox GH 250 mg capsule contains 250 mg of ursodeoxycholic acid.
Each Ursodox GH 500 mg capsule contains 500 mg of ursodeoxycholic acid.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Ursodox GH 250 mg capsules are hard gelatin size 0 capsules with a yellow body and cap.
Ursodox GH 500 mg capsules are hard gelatin size 00 capsules with a white body and cap, imprinted with "500" on body in black ink.

4 Clinical Particulars

4.9 Overdose

Diarrhoea may occur in cases of overdosage. If diarrhoea occurs, the dose must be reduced and in cases of persistent diarrhoea, the therapy should be discontinued. No specific counter-measures are necessary and the consequence of diarrhoea should be treated symptomatically with restoration of fluid and electrolyte balance.
In general, other symptoms of overdosage are unlikely because the absorption of ursodeoxycholic acid decreases with increasing dose and therefore more is excreted with the faeces.
Serious adverse effects are also unlikely to occur in overdosage. However, liver function should be monitored. If necessary, ion-exchange resins may be used to bind bile acids in the intestines.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Ursodeoxycholic acid was not genotoxic in the following studies: gene mutation assays (in vitro Ames test, gene mutation assay at the TK locus in mouse lymphoma L5178Y cells), assays of chromosome aberrations (analysis of chromosome aberrations in Chinese hamster bone marrow and in spermatogonia of mice, and micronucleus test in hamsters) and assay of sister chromatid exchanges in cultured human lymphocytes.
Carcinogenicity. In two 24-month oral carcinogenicity studies in mice, ursodeoxycholic acid at doses up to 1000 mg/kg/day was not tumourigenic. Based on body surface area (BSA), this dose represents 4 times the recommended maximum clinical dose of 20 mg/kg/day. In two 2-year oral carcinogenicity studies in rats, ursodeoxycholic acid at doses up to 300 mg/kg/day (3 times the recommended maximum human dose based on BSA) was not tumourigenic.
In 103-week oral carcinogenicity studies of lithocholic acid, a metabolite of ursodeoxycholic acid, doses up to 250 mg/kg/day in mice and 500 mg/kg/day in rats did not produce any tumours.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Ursodeoxycholic acid (UDCA) is a white or almost white powder. It is practically insoluble in water, freely soluble in ethanol, slightly soluble in acetone and practically insoluble in methylene chloride. It melts at 200-204°C.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSURSACI.gif Chemical name: 3α, 7β-dihydroxy-5β-cholan-24-oic acid.
Molecular formula: C₂₄H₄₀O₄.
Molecular weight: 392.56 g/mol.
CAS number. 128-13-2.

7 Medicine Schedule (Poisons Standard)

(S4) Prescription Only Medicine.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/URSODOST.gif