Consumer medicine information

What is in this leaflet

This leaflet answers some common questions about Ursodox GH. It does not contain all of the available information. Reading this leaflet does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking Ursodox GH against the benefits they expect it will have for you or your child.

If you have any concerns about taking Ursodox GH, ask your doctor or pharmacist.

Keep this leaflet. You or your child may want to read it again.

What Ursodox GH is used for

Ursodox GH contains ursodeoxycholic acid. Ursodeoxycholic acid is a bile acid, which may have a protective effect on the liver by reducing the absorption of other potentially toxic bile salts.

Ursodox GH may be used to treat liver diseases such as:

• primary biliary cholangitis (PBC);
• primary sclerosing cholangitis (PSC);
• cystic fibrosis (CF)-related cholestasis.

However, your doctor may prescribe this medicine for another use.

If you or your child wants more information, ask your doctor.

Ask your doctor if you or your child has any questions about why this medicine has been prescribed for you or your child.

Ursodox GH is not addictive.

Ursodox GH does not cause any negative effect on driving ability and operating machinery.

Before you take Ursodox GH

When you must not take it

Do not take Ursodox GH if:

• you or your child is allergic to ursodeoxycholic acid or any other ingredients listed at the end of this leaflet;
• you or your child has a bile duct or gall bladder that is swollen, painful or blocked;
• the packaging is torn or shows signs of tampering;
• the capsules look to be deteriorating in any way;
• the expiry date (EXP) printed on the pack has passed, as it may not work as well.

If you are not sure whether you or your child should start taking this medicine, talk to your doctor.

Before you start to take it

Tell your doctor if you or your child:

• have allergies to any other medicines, foods, preservatives or dyes;
• have kidneys that do not work properly;
• have a gall bladder that cannot be seen on X-ray;
• have calcified gallstones;
• have a gall bladder which is not able to contract properly;
• suffer from frequent cramp-like pains in the upper abdomen (biliary colic).

Tell your doctor if you are pregnant or plan to become pregnant or are breast-feeding. Your doctor can discuss with you the risks and benefits involved.

If you or your child has not told your doctor any of the above, tell him/her before you or your child starts taking Ursodox GH.

Taking other medicines

Tell your doctor or pharmacist if you or your child is taking any other medicines, including any that you or your child gets without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and Ursodox GH may interfere with each other. These include:

• cholestyramine, or colestipol, medicines used to lower high levels of cholesterol in the blood;
• an absorbent such as charcoal;
• antacids or medicines used for indigestion that contains aluminium hydroxide and/or smectite (aluminium oxide);
• ciclosporin, medicine used to suppress the immune system;
• ciprofloxacin and dapsone, an antibiotic used to prevent certain infections;
• nitrendipine (used to treat high blood pressure) and other medicines which are metabolised in a similar way;
• rosuvastatin.

These medicines may be affected by Ursodox GH or may affect how well Ursodox GH works. You or your child may need different amounts of Ursodox GH or at different times, or you or your child needs to take different medicines.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.

How to take 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.

If you or your child does not understand the instructions on the box/bottle, ask your doctor or pharmacist for help.

How much to take

The dose for Ursodox GH is determined by your body weight. Your doctor should tell you how much Ursodox GH you or your child should take.

Adults

The usual dose, depending on your weight, is as follows:

For PBC and chronic cholestatic liver diseases other than CF and PSC

Two to seven capsules per day.

For CF-related cholestasis

Three to nine capsules per day.

For PSC

One to nine capsules per day.

Children

The usual dose depends on your child’s weight and will be advised by your doctor.

Administration

Ursodox GH should be taken in divided doses, two to three times a day.

For PBC patients - during the first 3 months of treatment, you or your child should take Ursodox GH capsules in two to three divided doses. With improvement of liver function tests, the daily dose may be taken in one single dose in the evening.

If you or your child is unsure of how much of the medicine you or your child should take, ask your doctor or pharmacist.

If you or your child has any questions about the prescribed dose, you or your child should ask your doctor or pharmacist.

How to take it

Ursodox GH capsules should be swallowed whole with a full glass of water because the content is bitter.

Take Ursodox GH capsules regularly.

When to take it

Take Ursodox GH at about the same time each day. Taking it at the same time each day will have the best effect. It will also help you or your child to remember when to take it.

If you or your child needs to take a cholesterol lowering medicine or an antacid, take it at least 2 hours before or 2 hours after the dose of Ursodox GH.

How long to take it

Continue taking the medicine for as long as your doctor tells you or your child to. Ursodox GH helps to control you or your child’s condition, but does not cure it. It is important to keep taking the medicine even if you or your child feels well.

If you are unsure whether you or your child should stop taking Ursodox GH, talk to your doctor or pharmacist. You or your child may need to take Ursodox GH for many months for it to work.

If you forget to take it

Take it as soon as you or your child remembers, and then go back to taking it as you or your child would normally.

If it is almost time for your next dose, skip the dose you or your child missed and take the next dose as you or your child would normally.

Do not take a double dose to make up for the dose that you or your child missed.

If you or your child is not sure what to do, ask your doctor or pharmacist.

If you or your child has trouble remembering to take, or give, the medicine, ask your pharmacist for some hints.

If you take too much (overdose)

Immediately telephone your doctor, or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much Ursodox GH. Do this even if there are no signs of discomfort or poisoning. You or your child may need urgent medical attention.

Keep telephone numbers for these places handy.

Symptoms of an overdose may include diarrhoea. If you or your child suffers from diarrhoea, make sure you or your child drinks enough liquids to replace the fluid and electrolyte balance.

While you are taking Ursodox GH

Things you must do

If you or your child is about to be started on any new medicine, remind your doctor and pharmacist that you or your child is taking Ursodox GH.

Tell any other doctors, dentists, and pharmacists who treat you or your child that you or your child is taking this medicine.

If you or your child is going to have surgery, tell the surgeon or anaesthetist that you or your child is taking this medicine.

If you become pregnant while taking this medicine, tell your doctor immediately.

If you or your child is about to have any blood tests, tell your doctor that you or your child is taking this medicine.

Keep all of your doctor’s appointments so that you or your child’s progress can be checked. Your doctor may do tests to assess you or your child’s liver function.

During the first three months of taking Ursodox GH, your doctor should monitor you or your child’s liver function every 4 weeks. After the first three months of taking this medicine, your doctor should monitor you or your child’s liver function every 3 months.

See your doctor if you or your child feels that you or your child’s condition is not improving or is getting worse.

Things you must not do

Do not take Ursodox GH to treat any other complaints unless your doctor tells you or your child to.

Do not give your or your child’s medicine to anyone else, even if they have the same condition as you or your child.

Do not stop taking Ursodox GH or change the dosage without checking with your doctor.

Side effects

Tell your doctor or pharmacist as soon as possible if you or your child does not feel well while taking Ursodox GH.

Like all medicines, Ursodox GH may occasionally cause side effects in some people. Sometimes they are serious, most of the time they are not.

You or your child may need medical attention if you or your child gets some of the side effects.

Do not be alarmed by the following list of side effects. You or your child may not experience any of them.

Ask your doctor or pharmacist to answer any questions you or your child may have.

Side effects are normally mild, but if you or your child experiences the following effects, stop taking Ursodox GH and tell your doctor immediately:

• diarrhoea;
• itching/pruritus;
• urticaria (nettle rash);
• allergic reactions;
• nausea/vomiting;
• sleep disturbance;
• pain in the stomach area or in the upper right part of the belly, under the ribs.

During the treatment of primary biliary cholangitis, tell your doctor immediately if you or your child notices any of the following:

• severe right-sided upper abdominal pain.

During treatment of primary biliary cholangitis, stop taking Ursodox GH if you have the following:

• severe worsening (decompensation) of liver cirrhosis.

Tell your doctor or pharmacist if you or your child experiences any other undesirable effects, particularly if they are severe or persistent.

After taking Ursodox GH

Storage

Keep the Ursodox GH capsules in the blister pack until it is time to take them. If you or your child takes Ursodox GH capsules out of the pack they will not keep well.

Keep Ursodox GH capsules in a cool, dark and dry place where the temperature stays below 25°C.

Do not store Ursodox GH or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines.

Keep Ursodox GH and all other medicines where children cannot reach them. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you or your child to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

Product description

What it looks like

Ursodox GH capsules are hard gelatin size 0 capsules with white body and cap.

Ursodox GH capsules are packed in blisters of transparent PVC thermo-sealed with aluminium sheet packed in cardboard cartons.

Each carton contains 60 or 100 capsules.

Not all pack sizes are currently marketed in Australia.

Ingredients

Active ingredient

Each Ursodox GH capsule contains 250 mg of ursodeoxycholic acid.

Other Ingredients

• Colloidal anhydrous silica
• Empty hard gelatin capsules size 0 44.000 White opaque
• Magnesium stearate
• Maize starch

Australian Registration Numbers

Ursodox GH 250 mg: AUST R 232480

Sponsor

Generic Health Pty Ltd
Suite 2, Level 2
19-23 Prospect Street
Box Hill, VIC, 3128
Australia

E-mail: [email protected]
Telephone: +61 3 9809 7900
Website: www.generichealth.com.au

This leaflet was prepared in March 2021.

Published by MIMS June 2021

1 Name of Medicine

Ursodeoxycholic acid.

2 Qualitative and Quantitative Composition

Each capsule contains 250 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 gelatine capsules size 0 with white body and cap.

4 Clinical Particulars

4.1 Therapeutic Indications

Ursodox GH capsules are indicated in the treatment of chronic cholestatic liver diseases.

4.2 Dose and Method of Administration

Dosage for adults and the elderly.

Dosage for children.

Administration.

4.3 Contraindications

Ursodox GH capsules must not be used if there is hypersensitivity to the active ingredient or any of the excipients.

4.4 Special Warnings and Precautions for Use

During the first three months of therapy, it is advisable to monitor the liver parameters of AST (SGOT), ALT (SGPT), and GGT every 4 weeks, subsequently every 3 months.
Apart from allowing for identification of responders and non-responders in patients being treated for primary biliary cholangitis, this monitoring would also enable early detection of potential hepatic deterioration, particularly in patients with advance stage primary biliary cholangitis.
Ursodox GH capsules are not recommended in patients with dominant stenoses of the bile ducts unless the obstructed bile ducts are dilated (see Section 4.2 Dose and Method of Administration).
If diarrhoea occurs, the dose must be reduced and in cases of persistent diarrhoea, the therapy should be discontinued.

Treatment of patients with primary sclerosing cholangitis.

Use in renal impairment.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Some drugs, such as cholestyramine, charcoal, colestipol and certain antacids (containing aluminium hydroxide and/or smectite [aluminium oxide]) bind to ursodeoxycholic acid in the intestine and thereby inhibit its absorption and efficacy. Should the use of a preparation containing one of these substances be necessary, it must be taken at least 2 hours before or after Ursodox GH capsules.
Ursodeoxycholic acid may affect the absorption of ciclosporin in transplantation and non-transplant patients. Therefore, monitoring ciclosporin plasma concentrations are recommended and ciclosporin dose adjusted if necessary.
Ursodeoxycholic acid has been reported to decrease the absorption of ciprofloxacin in a few cases.
In a clinical study in 12 healthy volunteers with the OATP1B1*1b/*1b genotype, predicting high OATP1B1 activity, it was demonstrated that concomitant use of ursodeoxycholic acid (500 mg/day) and rosuvastatin (20 mg/day) resulted in a significant increase in the plasma levels of rosuvastatin. Ursodeoxycholic acid increased the AUC of rosuvastatin by approximately 60%, from 145.5 nanogram/mL per hour to 231.9 nanogram/mL per hour (p=0.004).
Administration of ursodeoxycholic acid for 14 days also significantly increased total bilirubin by 139 ± 39% (p=0.003), conjugated bilirubin by 127 ± 29% (p=0.005) and unconjugated bilirubin by 151 ± 52% (p=0.004). The proposed biological mechanism for this interaction is that bilirubin and rosuvastatin are both metabolites of organic anion transporting polypeptide 1B1 (OATP1B1). OATP1B1 expression is regulated by transcription factor hepatic nuclear factor (HNF) 1α. Ursodeoxycholic acid acts as an inhibitor of HNF 1α and consequently may decreased expression of OAT1B1. A dose reduction in rosuvastatin should be considered in any individuals exposed to both rosuvastatin and ursodeoxycholic acid. The clinical relevance of this interaction with regard to other statins is unknown. However, it is biologically possible that this interaction may also occur between ursodeoxycholic acid and other statins which are known substrates of OAT1B1, such as atorvastatin, fluvastatin, simvastatin acid, pitavastatin and pravastatin.
Ursodeoxycholic acid reduces the peak plasma concentrations (C_max) and the area under the curve (AUC) of the calcium channel blocker, nitrendipine. On the basis of this, together with a single case report of an interaction with the substance dapsone (reduction of the therapeutic effect) and in vitro findings, it may be assumed that UDCA induces the medicinal product-metabolising enzyme cytochrome P450 3A4. Caution should therefore be exercised in cases of co-administration of medicinal products metabolised by this enzyme, and a dose adjustment may be necessary. Induction has, however, not been observed in a well-designed interaction study with budesonide which is a known cytochrome P450 3A substrate.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

Ursodeoxycholic acid is generally well tolerated with few side effects. Diarrhoea is the main reported side effect. The incidence of diarrhoea in controlled studies was up to 3%.
Some patients may experience increased pruritus in the early weeks of treatment. In such cases a dose reduction, and thereafter a slow (weekly) increase of dose to the recommended dose, may help.
Severe right upper abdominal pain has occurred during the treatment of PBC (≤ 1 in 10,000 patients). During advanced stages of PBC, in very rare cases (≤ 1 in 10,000 patients), decompensation of hepatic cirrhosis has been observed, which partially regressed after the treatment was discontinued.
Calcification of gallstones can occur in ≤ 1 in 10,000 patients.
Allergic reactions have been reported in some patients. Urticaria can occur in ≤ 1 in 10,000 patients.
Other adverse reactions reported include increased cholestasis, nausea, vomiting and sleep disturbance.

Reporting suspected adverse effects.

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

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

Primary biliary cholangitis.

Primary sclerosing cholangitis.

Cystic fibrosis-related cholestasis.

5.2 Pharmacokinetic Properties

Absorption.

Distribution.

Metabolism.

Excretion.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Ursodox GH capsules contain the following excipients: maize starch, colloidal anhydrous silica, magnesium stearate and Empty hard gelatin capsules size 044.000 White opaque.

6.2 Incompatibilities

See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C. Store in original container.

6.5 Nature and Contents of Container

Ursodox GH capsules are supplied in PVC/Al blister packs of 60 or 100 capsules.
Not all pack sizes are currently marketed in Australia.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

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.

CAS number.

7 Medicine Schedule (Poisons Standard)

(S4) Prescription Only Medicine.

Summary Table of Changes