URSOSAN

Main information

  • Trade name:
  • URSOSAN ursodeoxycholic acid 250 mg capsule blister pack
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • URSOSAN ursodeoxycholic acid 250 mg capsule blister pack
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218444
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218444

URSOSAN ursodeoxycholic acid 250 mg capsule blister pack

ARTG entry for

Medicine Registered

Sponsor

Boucher & Muir Pty Ltd

Postal Address

PO Box 333,NORTH SYDNEY, NSW, 2059

Australia

ARTG Start Date

7/11/2014

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. URSOSAN ursodeoxycholic acid 250 mg capsule blister pack

Product Type

Single Medicine Product

Effective date

23/08/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Ursosan is indicated in the treatment of chronic cholestatic liver diseases.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Blister Pack

PVC/PVDC/Al

24 Months

Store below 25

degrees Celsius

Not recorded

See Product

information for shelf

life

Pack Size/Poison information

Pack Size

Poison Schedule

100 capsules

(S4) Prescription Only Medicine

Components

1. URSOSAN ursodeoxycholic acid 250 mg capsule blister pack

Dosage Form

Capsule, hard

Route of Administration

Oral

Visual Identification

Hard gelatin capsule, white body, white cap, containing white or almost

white powder

Active Ingredients

Ursodeoxycholic acid

250 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 10.11.2017 at 10:24:52 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet

Ursosan

®

09112017

Consumer Medicine Information

Ursosan

®

ursodeoxycholic acid

Capsules 250 mg

What is in this leaflet

Please read this leaflet carefully before you start taking Ursosan.

This leaflet answers some common questions about Ursosan. It does not contain all the

available information. The most up-to-date Consumer Medicine Information can be

downloaded

from

www.ebs.tga.gov.au

(Australia)

www.medsafe.govt.nz

(New

Zealand).

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

Ursosan against the benefits this medicine is expected to have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine.

You may want to read it again.

What Ursosan is used for

Ursosan 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.

Ursosan may be used to treat liver diseases such as primary biliary cirrhosis (PBC),

primary sclerosing cholangitis (PSC), and cystic fibrosis (CF)-related cholestasis.

Your doctor may have prescribed this medicine for another reason.

Ask your doctor if you have any questions about why it has been prescribed for

you.

Ursosan is only available with a doctor's prescription.

Ursosan is not addictive.

Ursosan

®

09112017

Before you take Ursosan

Ursosan is not suitable for everyone.

When you must not take it

Do not take Ursosan if:

you are allergic to any medicine containing ursodeoxycholic acid, bile acids or any of

the ingredients listed at the end of this leaflet

you have a bile duct or gall bladder that is swollen, painful or blocked

you have certain types of cholesterol stones or bile pigment stones

your doctor advises you that you will have your gall bladder removed.

Do not take it after the expiry date printed on the pack.

If you take it after the expiry date has passed, it may not work as well.

Do not take it if the packaging is torn or shows signs of tampering.

If you are not sure whether you should start taking Ursosan, talk to your doctor or

pharmacist.

Before you start to take it

Tell your doctor or pharmacist if you have allergies to any other medicines, foods,

preservatives or dyes.

Tell your doctor if you have or have had any medical conditions, especially the

following:

kidneys that do not work properly

a deficiency in a certain step of metabolism (sulfation)

calcified gallstones

frequent cramp-like pains in the upper abdomen.

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

Ursosan is not generally recommended for use during pregnancy. Your doctor can discuss

with you the risks and benefits involved.

Tell your doctor if you are breast-feeding or planning to breast-feed.

It is not known whether the active ingredient in Ursosan passes into breast milk.

If you have not told your doctor or pharmacist about any of the above, tell them

before you start taking Ursosan.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any

that you get without a prescription from your pharmacy, supermarket or health food

shop.

Ursosan

®

09112017

Tell any healthcare professional who is prescribing a new medicine for you that you

are taking Ursosan.

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

colestyramine,

colestipol

statins

(e.g.

rosuvastatin,

atorvastatin,

fluvastatin,

simvastatin acid, pitavastatin and pravastatin), medicines used to lower high levels of

cholesterol in the blood

adsorbents such as charcoal

antacids or medicines used for indigestion that contain aluminium hydroxide and/or

smectite (aluminium oxide)

ciclosporine, a medicine used to suppress the immune system

ciprofloxacin, an antibiotic used to treat certain infections

nitrendipine (used to treat high blood pressure), dapsone (an anti-infective) and other

medicines which are metabolised in a similar way (by cytochrome P450 3A4)

oestrogens (female hormones)

the oral contraceptive pill

clofibrate, a medicine used to reduce high blood fat levels.

The above medicines may be affected by Ursosan, or may affect how well it works. You

may need different amounts of Ursosan, or take it at different times, or you may need to

take different medicines.

Your doctor and pharmacist have more information on medicines to be careful with or

avoid while taking Ursosan.

How to take Ursosan

Read the label carefully and follow all directions given to you by your doctor and

pharmacist.

They may differ from the information contained in this leaflet.

If you do not understand the instructions on the pack, ask your doctor or pharmacist

for help.

How much to take

The dose for Ursosan is determined by your body weight. Your doctor will tell you how

much Ursosan you should take.

The standard adult dose, depending on your weight and the condition being treated, is

between two to nine capsules per day.

Ask your doctor or pharmacist if you are unsure of the correct dose for you.

They will tell you exactly how much to take. This depends on your condition and whether

or not you are taking any other medicines.

If you take the wrong dose, Ursosan may not work as well and your problem may not

improve.

Ursosan

®

09112017

Swallow Ursosan whole with a full glass of water, because the content of the

capsules is bitter.

When to take it

Take it regularly and at about the same time(s) each day.

Taking it at the same time(s) each day will have the best effect. It will also help you to

remember when to take it.

If you need to take cholesterol lowering medicines or an antacid, take it at least two hours

before or two hours after the dose of Ursosan.

How long to take it

Continue taking the capsules for as long as your doctor tells you to.

Ursosan helps to control your condition, but does not cure it. It is important to keep taking

the medicine even if you feel well.

You may need to take Ursosan for many months for it to work.

If you are unsure whether you should stop taking Ursosan, talk to your doctor or

pharmacist.

If you forget to take it

If it is almost time for your next dose, skip the dose you missed and take the next

dose when you are meant to.

Do not try to make up for missed doses by taking more than one dose at a time.

This may increase the chance of getting an unwanted side effect.

If there is still a long time to go before your next dose, take it as soon as you

remember, and then go back to taking it as you would normally.

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

If you have trouble remembering to take your medicine, ask your pharmacist for

hints.

While you are taking Ursosan

Things you must do

If you are about to be started on any new medicine, tell your doctor and pharmacist

that

you

are

taking

Ursosan.

Likewise,

tell

any

other

doctors,

dentists

and

pharmacists who are treating you that you are taking this medicine.

If you are going to have surgery, tell the surgeon and anaesthetist that you are

taking this medicine.

It may affect other medicines used during surgery.

Ursosan

®

09112017

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

If you are about to have any blood tests, tell your doctor that you are taking Ursosan.

Keep all of your doctor’s appointments so that your progress can be checked.

Your doctor may perform liver function tests. During the first three months of taking

Ursosan, your doctor should monitor your liver function every four weeks. After the first

three months of taking this medicine, your doctor should monitor your liver function every

three months.

See your doctor if you feel that your condition is not improving or is getting worse.

Things you must not do

Do not give your medicine to anyone else, even if they have the same condition as

you.

This medicine is only intended for the person it has been prescribed for.

Do not take Ursosan to treat any other complaints unless your doctor tells you to.

Do not stop taking Ursosan or change the dosage without checking with your

doctor.

In case of overdose

If you take too much

Immediately telephone your doctor, or the Poisons Information Centre (Australia -

telephone 13 11 26; New Zealand – telephone 0800 POISON or 0800 764 766), or go

to Accident and Emergency at your nearest hospital, if you think that you or anyone

else may have taken too much Ursosan.

Do this even if there are no signs of discomfort or poisoning.

You may need urgent medical attention.

Symptoms of an overdose may include diarrhoea. If you suffer from diarrhoea, make sure

you drink enough liquids to replace the fluid and electrolyte balance.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you

are taking Ursosan.

Like all medicines, Ursosan may occasionally cause side effects in some people.

Sometimes they are serious, most of the time they are not. You may need medical

attention if you get some of the side effects.

Ursosan

®

09112017

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

Tell your doctor immediately if you notice any of the following:

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 abdomen, under the ribs.

During treatment of primary biliary cirrhosis (PBC), tell your doctor immediately if

you notice any of the following:

severe right-sided upper abdominal pain.

During treatment of primary biliary cirrhosis (PBC), stop taking Ursosan if you have

the following:

severe worsening (decompensation) of liver tissue damage.

Tell your doctor immediately, or go to Accident and Emergency at your nearest

hospital if you notice any of the following:

serious allergic reaction (swelling of the face, lips, mouth or throat which may cause

difficulty in swallowing or breathing)

severe diarrhoea.

These

very

serious

side

effects;

need

urgent

medical

attention

hospitalisation.

Tell your doctor or pharmacist if you notice anything else that is making you feel

unwell.

Other side effects not listed above may also occur in some patients.

Do not be alarmed by this list of possible side effects.

You may not experience any of them.

After taking Ursosan

Storage

Keep your capsules in the pack until it is time to take them.

If you take the capsules out of the pack they may not keep well.

Keep Ursosan in a cool dry place where the temperature stays below 25°C.

Do not store it or any other medicine in the bathroom, near a sink, or on a window

sill. Do not leave it in the car.

Heat and damp can destroy some medicines.

Keep it and any other medicine where children cannot reach it.

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

store medicines.

Ursosan

®

09112017

Do not keep Ursosan past its expiry date.

Disposal

Return any unused medicine and any medicine past its expiry date (as shown on

the labelling) to your pharmacy.

Product description

What it looks like

Ursosan is available in blister packs of 100 capsules. The capsules are white in colour.

Ingredients

Active ingredient:

ursodeoxycholic acid.

Inactive ingredients:

maize starch

pregelatinised maize starch

colloidal anhydrous silica

magnesium stearate

gelatin

titanium dioxide

purified water.

Ursosan does not contain lactose, sucrose, tartrazine or any other azo dyes.

Sponsor details

Distributed in Australia by:

Boucher & Muir Pty Ltd

Level 9, 76 Berry Street

North Sydney NSW 2060

AUST R 218444

Distributed in New Zealand by:

ABM Pharma Ltd

39 Anzac Road

Browns Bay

Auckland 0753

Ph: 0800 437 849

Ursosan

®

09112017

Date of preparation

This leaflet was prepared on 09 November 2017.

Ursosan

®

is a registered trademark of PRO.MED.CS Praha a.s., Czech Republic

Under licence from PRO.MED.CS Praha a.s., Czech Republic

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EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Active substance: Glycine, L-alanine, L-arginine, L-aspartic acid, L-cysteine, L-cystine, L-glutamic acid, L-histidine, L-lysine monohydrate, L-methionine, L-phenylalanine, L-proline, L-serine, L-threonine, L-tryptophan, L-tyrosine, taurine) - Orphan designation - Commission Decision (2018)7277 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/100/18

Europe -DG Health and Food Safety

29-10-2018

Clopidogrel/Acetylsalicylic acid Zentiva (Sanofi-Aventis groupe)

Clopidogrel/Acetylsalicylic acid Zentiva (Sanofi-Aventis groupe)

Clopidogrel/Acetylsalicylic acid Zentiva (Active substance: clopidogrel / acetylsalicylic acid) - Centralised - 2-Monthly update - Commission Decision (2018)7249 of Mon, 29 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1144/WS1433/0051

Europe -DG Health and Food Safety

29-10-2018

DuoPlavin (Sanofi Clir SNC)

DuoPlavin (Sanofi Clir SNC)

DuoPlavin (Active substance: clopidogrel / acetylsalicylic acid) - Centralised - 2-Monthly update - Commission Decision (2018)7255 of Mon, 29 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1143/WS/1433/0050

Europe -DG Health and Food Safety

2-10-2018

Zoledronic acid Actavis (Actavis Group PTC ehf.)

Zoledronic acid Actavis (Actavis Group PTC ehf.)

Zoledronic acid Actavis (Active substance: zoledronic acid) - Centralised - Yearly update - Commission Decision (2018)6488 of Tue, 02 Oct 2018

Europe -DG Health and Food Safety

2-10-2018

EU/3/16/1786 (Voisin Consulting S.A.R.L.)

EU/3/16/1786 (Voisin Consulting S.A.R.L.)

EU/3/16/1786 (Active substance: Recombinant adeno-associated viral vector serotype 2 carrying the gene for the human aromatic L-amino acid decarboxylase protein) - Transfer of orphan designation - Commission Decision (2018)6427 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/183/16/T/02

Europe -DG Health and Food Safety

2-10-2018

Zoledronic acid Mylan (Mylan S.A.S.)

Zoledronic acid Mylan (Mylan S.A.S.)

Zoledronic acid Mylan (Active substance: zoledronic acid) - Centralised - Yearly update - Commission Decision (2018)6486 of Tue, 02 Oct 2018

Europe -DG Health and Food Safety

2-10-2018

Zoledronic acid Teva (Teva B.V.)

Zoledronic acid Teva (Teva B.V.)

Zoledronic acid Teva (Active substance: zoledronic acid) - Centralised - Yearly update - Commission Decision (2018)6466 of Tue, 02 Oct 2018

Europe -DG Health and Food Safety

1-10-2018

EU/3/16/1762 (Pharma Gateway AB)

EU/3/16/1762 (Pharma Gateway AB)

EU/3/16/1762 (Active substance: Synthetic 15-amino-acid macrocyclic peptide acylated with a polyethyleneglycol palmitoylated linker) - Transfer of orphan designation - Commission Decision (2018)6399 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/107/16/T/01

Europe -DG Health and Food Safety

24-9-2018

Zoledronic acid Hospira (Pfizer Europe MA EEIG)

Zoledronic acid Hospira (Pfizer Europe MA EEIG)

Zoledronic acid Hospira (Active substance: zoledronic acid) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6243 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2365/T/33

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2056 (Nogra Pharma Limited)

EU/3/18/2056 (Nogra Pharma Limited)

EU/3/18/2056 (Active substance: (S)-(-)-3-(4-aminophenyl)-2-methoxypropanoic acid) - Orphan designation - Commission Decision (2018)5728 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/075/18

Europe -DG Health and Food Safety

6-8-2018

Zoledronic acid Accord (Accord Healthcare Limited)

Zoledronic acid Accord (Accord Healthcare Limited)

Zoledronic acid Accord (Active substance: zoledronic acid) - Centralised - Yearly update - Commission Decision (2018)5386 of Mon, 06 Aug 2018

Europe -DG Health and Food Safety

1-8-2018

Ucedane (Lucane Pharma)

Ucedane (Lucane Pharma)

Ucedane (Active substance: carglumic acid) - Centralised - Yearly update - Commission Decision (2018)5230 of Wed, 01 Aug 2018

Europe -DG Health and Food Safety

27-7-2018

EU/3/17/1932 (Millendo Therapeutics SAS)

EU/3/17/1932 (Millendo Therapeutics SAS)

EU/3/17/1932 (Active substance: Synthetic cyclic 8 amino acid analogue of human unacylated ghrelin) - Transfer of orphan designation - Commission Decision (2018)5049 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/066/17/T/01

Europe -DG Health and Food Safety

11-7-2018

Vantavo (Merck Sharp and Dohme B.V.)

Vantavo (Merck Sharp and Dohme B.V.)

Vantavo (Active substance: alendronic acid / colecalciferol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4511 of Wed, 11 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1180/T/30

Europe -DG Health and Food Safety

3-7-2018

Granupas (Eurocept International B.V.)

Granupas (Eurocept International B.V.)

Granupas (Active substance: Para-aminosalicylic acid) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4256 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2709/T/25

Europe -DG Health and Food Safety

27-6-2018

EU/3/11/849 (Merck Sharp and Dohme B.V.)

EU/3/11/849 (Merck Sharp and Dohme B.V.)

EU/3/11/849 (Active substance: (S)-{8-fluoro-2-2[4-(3-methoxyphenyl)-1-piperazinyl]-3-[2-methoxy-5-(trifluoromethyl)-phenyl]-3,4-dihydro-4-quinazolinyl} acetic acid) - Transfer of orphan designation - Commission Decision (2018)4102 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/090/10/T/02

Europe -DG Health and Food Safety

19-6-2018

Dany's BienenWohl (Dany Bienenwohl GmbH)

Dany's BienenWohl (Dany Bienenwohl GmbH)

Dany's BienenWohl (Active substance: oxalic acid dihydrate) - Centralised - Authorisation - Commission Decision (2018)3892 of Tue, 19 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/4667

Europe -DG Health and Food Safety

4-6-2018

Chenodeoxycholic acid Leadiant (Leadiant GmbH)

Chenodeoxycholic acid Leadiant (Leadiant GmbH)

Chenodeoxycholic acid Leadiant (Active substance: chenodeoxycholic acid) - Centralised - Yearly update - Commission Decision (2018)3627 of Mon, 04 Jun 2018

Europe -DG Health and Food Safety

1-6-2018

Valproate

Valproate

Valproate (Active substance: medicinal products containing substances related to valproate (sodium valproate, valproic acid, valproate semisodium, valpromide, valproate magnesium)) - Community Referrals - Art 31 - Commission Decision (2018)3623 of Fri, 01 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/A-31/1454

Europe -DG Health and Food Safety

29-5-2018

EU/3/14/1400 (Orphan Europe S.A.R.L.)

EU/3/14/1400 (Orphan Europe S.A.R.L.)

EU/3/14/1400 (Active substance: (1S,4R,5R,7S)-3,4-dibenzyl-2-oxo-6,8-dioxa-3-azabyciclo[3.2.1]octane-7-carboxylic acid-L-lysine) - Transfer of orphan designation - Commission Decision (2018)3402 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/185/14/T/01

Europe -DG Health and Food Safety

29-5-2018

EU/3/10/826 (Eurocept International B.V.)

EU/3/10/826 (Eurocept International B.V.)

EU/3/10/826 (Active substance: Para-aminosalicylic acid) - Transfer of orphan designation - Commission Decision (2018)3396 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/072/10/T/02

Europe -DG Health and Food Safety