SUMMARY CMI

APO-Ursodeoxycholic Acid Capsules

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using APO-Ursodeoxycholic Acid Capsules?

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

2. What should I know before I use APO-Ursodeoxycholic Acid Capsules?

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 APO-Ursodeoxycholic Acid Capsules? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with APO-Ursodeoxycholic Acid Capsules 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 APO-Ursodeoxycholic Acid Capsules?

Take APO-Ursodeoxycholic Acid Capsules, or give to your child, as directed by your doctor or pharmacist. This may differ from the information contained in this leaflet.

More instructions can be found in Section 4. How do I use APO-Ursodeoxycholic Acid Capsules? in the full CMI.

5. What should I know while using APO-Ursodeoxycholic Acid Capsules?

For more information, see Section 5. What should I know while using APO-Ursodeoxycholic Acid Capsules? in the full CMI.

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.

FULL CMI

APO-Ursodeoxycholic Acid Capsules

Active ingredient(s): ursodeoxycholic acid

Consumer Medicine Information (CMI)

This leaflet provides important information about using APO-Ursodeoxycholic Acid Capsules. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using APO-Ursodeoxycholic Acid Capsules.

Where to find information in this leaflet:

1. Why am I using APO-Ursodeoxycholic Acid Capsules?
2. What should I know before I use APO Ursodeoxycholic Acid Capsules?
3. What if I am taking other medicines?
4. How do I use APO-Ursodeoxycholic Acid Capsules?
5. What should I know while using APO-Ursodeoxycholic Acid Capsules?
6. Are there any side effects?
7. Product details

1. Why am I using APO-Ursodeoxycholic Acid Capsules?

APO-Ursodeoxycholic Acid Capsules contains the active ingredient ursodeoxycholic acid. APO-Ursodeoxycholic Acid Capsules is a bile acid, which may have a protective effect on the liver by reducing the absorption of other potentially toxic bile salts.
APO-Ursodeoxycholic Acid Capsules is used to treat liver diseases such as primary biliary cholangitis (PBC), primary sclerosing cholangitis (PSC), and 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 have any questions about why this medicine has been prescribed for you or your child.
APO-Ursodeoxycholic Acid Capsules is not addictive.

2. What should I know before I use APO-Ursodeoxycholic Acid Capsules?

Warnings

Do not use APO-Ursodeoxycholic Acid Capsules if:

• you or your child are allergic to ursodeoxycholic acid, or any of the ingredients listed at the end of this leaflet.

Symptoms of an allergic reaction may include: cough, shortness of breath, wheezing, difficulty breathing or tightness in chest; swelling of the face, lips, tongue, throat or other parts of the body; rash, itching or hives on the skin; fainting; or hay fever-like symptoms.

If you think you are having an allergic reaction, do not take any more of the medicine and contact your doctor immediately or go to the Accident and Emergency department at the nearest hospital.

Always check the ingredients to make sure you can use this medicine.

• 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.

Check with your doctor if you or your child:

• take any medicines for any other condition;
• 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);
• plan to have surgery or an anaesthetic;
• take or plan to take any other medicines. This includes vitamins and supplements that are available from your pharmacy, supermarket or health food shop.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Tell your doctor if you are pregnant or intend to become pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

Your doctor can discuss with you the risks and benefits involved.

Use in children

This medicine should not be used in children.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

APO-Ursodeoxycholic Acid Capsules may increase the effect of some medicines, including:

• medicines used to lower high levels of cholesterol in the blood, such as rosuvastatin, atorvastatin, fluvastatin, simvastatin, pitavastatin or pravastatin.

APO-Ursodeoxycholic Acid Capsules may decrease the effects / absorption of some medicines, including:

• nitrendipine (used to treat high blood pressure) and other medicines which are metabolised in the same way.
• medicines used to suppress the immune system, such as ciclosporin.
• antibiotics used to prevent certain infections, such as ciprofloxacin or dapsone.

Medicines that may reduce the effect of APO-Ursodeoxycholic Acid Capsules include:

• medicines used to lower high levels of cholesterol in the blood, such as colestyramine or colestipol;
• an absorbent, such as charcoal;
• medicines such as antacids containing aluminium hydroxide and/or smectite, which are used for indigestion.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect APO-Ursodeoxycholic Acid Capsules.

4. How do I use APO-Ursodeoxycholic Acid Capsules?

How much to take

Your doctor will tell you how much of this medicine you should take. This will depend on your condition and whether you are taking any other medicines.

Do not stop taking your medicine or change your dosage without first checking with your doctor.

The dose for ursodeoxycholic acid is determined by your body weight. Your doctor should tell you how much ursodeoxycholic acid 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.

Ursodeoxycholic acid 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 ursodeoxycholic acid 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.

Follow the instructions provided and use APO-Ursodeoxycholic Acid Capsules until your doctor tells you to stop.

When to take APO-Ursodeoxycholic Acid Capsules

• Take this medicine at the same time each day. Taking it at the same time each day will have the best effect and will also help you 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 ursodeoxycholic acid.
• It does not matter if you take it before, with or after food.
• Ursodeoxycholic acid 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 ursodeoxycholic acid 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.

How to take APO-Ursodeoxycholic Acid Capsules

Follow carefully all directions given to you by your doctor. Their instructions may be different to the information in this leaflet.

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

Take ursodeoxycholic acid capsules regularly.

How long to take APO-Ursodeoxycholic Acid Capsules

Continue taking your medicine for as long as your doctor tells you.

Ursodeoxycholic acid 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 ursodeoxycholic acid, talk to your doctor or pharmacist.

You or your child may need to take ursodeoxycholic acid for many months for it to work.

Make sure you have enough to last over weekends and holidays.

If you forget to use APO-Ursodeoxycholic Acid Capsules

APO-Ursodeoxycholic Acid Capsules should be used regularly at the same time each day. If you miss your dose at the usual time, if it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise, take it as soon as you remember and then go back to taking your medicine as you would normally.

Do not take a double dose to make up for the dose you missed.

This may increase the chance of you experiencing side effects.

If you have trouble remembering to take your medicine, ask your pharmacist for some hints to help you remember.

If you use too much APO-Ursodeoxycholic Acid Capsules

If you think that you have used too much APO-Ursodeoxycholic Acid Capsules, you may need urgent medical attention.

You should immediately:

• phone the Poisons Information Centre
  (by calling 13 11 26), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

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

5. What should I know while using APO-Ursodeoxycholic Acid Capsules?

Things you should do

Call your doctor straight away if you or your child:

• are about to be started on any new medicine
• you are pregnant or are planning to become pregnant
• you are breastfeeding or are planning to breastfeed
• are about to have any blood tests
• are going to have surgery or an anaesthetic or are going into hospital.

Your doctor may occasionally do tests to make sure the medicine is working and to prevent side effects.

Go to your doctor regularly for a check-up.

Your doctor may do tests to assess you or your child's liver function.

During the first three months of taking ursodeoxycholic acid, 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.

Remind any doctor, dentist or pharmacist you visit that you or your child are using APO-Ursodeoxycholic Acid Capsules.

Things you should not do

• Do not give this medicine to anyone else, even if their symptoms seem similar to yours.
• Do not take your medicine to treat any other condition unless your doctor tells you to.
• Do not stop taking your medicine, or change the dosage, without first checking with your doctor.

Driving or using machines

Be careful when driving or operating machinery until you know how this medicine affects you.

Drinking alcohol

Tell your doctor if you drink alcohol.

Looking after your medicine

Keep your medicine in a cool dry place where the temperature will stay below 25°C.

Keep your medicine in its original packaging until it is time to take it. If you take your medicine out of its original packaging it may not keep well.

Follow the instructions in the carton on how to take care of your medicine properly.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

• in the bathroom or near a sink, or
• in the car or on window sills.

Keep it where young children cannot reach it.

A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Serious side effects

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What APO-Ursodeoxycholic Acid Capsules contains

Do not take this medicine if you are allergic to any of these ingredients.

This medicine is gluten-free, lactose-free, sucrose-free, tartrazine-free and free of other azo dyes.

What APO-Ursodeoxycholic Acid Capsules looks like

APO-Ursodeoxycholic Acid Capsules 250 mg is a white hard gelatine capsule. The content - white or almost white powder. (Aust R 276339).

APO-Ursodeoxycholic Acid Capsules are available in blister pack of 100 capsules.

Who distributes APO-Ursodeoxycholic Acid Capsules

Arrotex Pharmaceuticals Pty Ltd
15 – 17 Chapel Street
Cremorne VIC 3121
www.arrotex.com.au

This leaflet was prepared in March 2025.

Published by MIMS May 2025

1 Name of Medicine

Ursodeoxycholic acid.

2 Qualitative and Quantitative Composition

Each capsule contains 250 mg of ursodeoxycholic acid, as the active ingredient.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

White hard gelatine capsules. The content - white or almost white powder.

4 Clinical Particulars

4.1 Therapeutic Indications

Ursodeoxycholic acid is indicated in the treatment of chronic cholestatic liver diseases.

4.2 Dose and Method of Administration

APO-Ursodeoxycholic Acid capsules are intended for oral administration. For PBC patients: In the first 3 months of treatment, APO-Ursodeoxycholic Acid capsules should be taken in 2 to 3 doses over the day. With improvement of the liver function parameters, the daily dose may be taken as a single dose in the evening.
For patients under 34 kg or patients who are unable to swallow APO-Ursodeoxycholic Acid capsules, UDCA oral suspension should be used (available from other brands).
For other cholestatic liver diseases, APO-Ursodeoxycholic Acid capsules should be taken in 2 to 3 doses over the day.
The capsules should be swallowed whole with some liquid.
Care should be taken to ensure that UDCA is taken regularly.
In patients with PBC, there may, in rare cases, be an initial deterioration in symptoms, e.g. itching. If this is the case, therapy can be continued with 1 capsule of UDCA daily, and the daily dose gradually increased weekly until the recommended daily dose has been reached.
For PSC patients, dominant stenoses of the bile ducts should be dilated before and during treatment with UDCA.

Dosage.

Dosage for adults and the elderly.

Dosage for children.

4.3 Contraindications

APO-Ursodeoxycholic Acid 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 cirrhosis, this monitoring would also enable early detection of potential hepatic deterioration, particularly in patients with advance stage primary biliary cirrhosis.
The effect of UDCA in patients with renal impairment has not been studied.
UDCA is 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 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 UDCA 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 UDCA.
UDCA may affect the absorption of cyclosporin in transplantation and nontransplant patients. Therefore, monitoring cyclosporin plasma concentrations are recommended and cyclosporin dose adjusted if necessary.
UDCA 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 UDCA (500 mg/day) and rosuvastatin (20 mg/day) resulted in a significant increase in the plasma levels of rosuvastatin. UDCA 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 UDCA 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. UDCA 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 UDCA. 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 UDCA and other statins which are known substrates of OAT1B1, such as atorvastatin, fluvastatin, simvastatin acid, pitavastatin and pravastatin.
UDCA 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)

UDCA 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

Symptoms.

Treatment.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

Primary biliary cirrhosis.

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

Each capsule contains the following inactive ingredients: maize starch, silicon dioxide, magnesium stearate. The capsule shell is composed of: titanium dioxide and gelatin.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

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.

6.5 Nature and Contents of Container

APO-Ursodeoxycholic Acid capsules 250 mg (AUST R 276339).

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, readily soluble in alcohol, sparingly soluble in acetone, in chloroform and in ether. It melts at 200 - 204°C.

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes