Ursosan (Ursodeoxycholic Acid 250mg)

Ursosan general information

What is Ursosan used for?

The liver is our largest organ and performs a wide range of vital functions.  These include natural detoxification by breaking down harmful chemicals such as alcohol and drugs and aiding digestion.  The liver also plays an essential in eliminating waste products, synthesising blood clotting factors, regulating the synthesis of steroid hormones, storing and releasing energy reserves, and supporting the body’s immune protection against harmful pathogens.  The liver also synthesises and releases bile.  If the regulation of bile production is disrupted, it can cause cholestatic liver disease, which is the build-up of bile in the liver.  A build-up of bile can be due to impaired formation of bile by the liver, or reduced flow of bile out of the liver.  Ursosan capsules 100mg are used to treat chronic cholestatic liver diseases to break up gallstones caused by a build-up of bile. 

What is bile?

Bile is produced by the liver and plays an essential role in the digestion of fats.  Bile also carries waste products back to the intestines to be excreted in the faeces and urine.  Bile is a mixture of lipids (cholesterol and fatty acids) and bile salts (formed from bile acids and amino acids).  Bile also contains bilirubin, which is a pigment released as a breakdown product of red blood cells. 

Bile passes from the liver through the bile duct into the gall bladder where it is stored.  Bile is secreted into the small intestine to aid the digestion of fat during a meal.  The liver makes cholesterol, which is essential for many vital functions.  These include building cell membranes, transporting fat-soluble vitamins around the body and synthesising steroid hormones, (sex hormones and cortisol).  If the liver produces more cholesterol than the body needs, the excess is dissolved by bile acids and eliminated in the bile.  

Cholestasis and the formation of gallstones

Cholestasis is reduced bile flow through the bile ducts.  Cholestasis causes bile to become concentrated, resulting in a build-up of bilirubin, cholesterol and bile salts.  Too much cholesterol and bilirubin in bile combined with a low salt content can cause cholesterol to form crystals in the gallbladder.  These crystals will eventually turn into gallstones, causing pain and inflammation, and may need surgery to remove them. 

Causes of cholestasis also include chronic cholestatic liver diseases.  These are primary biliary cirrhosis, which is an autoimmune disease (where the immune system attacks self), causing destruction of the bile ducts.  Primary sclerosing cholangitis is inflammation of the bile ducts and can result in narrowing and scarring of the bile ducts and the formation of gallstones in the liver itself before the bile is released. 

Symptoms of cholestasis include itching, jaundice, pale stools, dark urine, weight loss, weakness, and abdominal pain.

How does Ursosan work?

Ursosan capsules 100mg contain ursodeoxycholic acid (also known as ursodiol) that is used to treat chronic cholestatic liver diseases to help break up gallstones caused by a build-up of bile and to reduce the need for surgery.

Ursodeoxycholic acid in Ursosan capsules 100mg is a secondary bile acid that is produced in the liver and usually makes up a small proportion of bile acids.  Taking ursodeoxycholic acid orally changes the overall composition of bile, which has the effect of diluting out the more toxic bile acids.  Ursodeoxycholic acid works by decreasing cholesterol formation by the liver and reducing the amount of cholesterol absorbed by the intestine, which regulates the body’s cholesterol levels. 

Ursodeoxycholic acid also acts as a surfactant (detergent).  It works by dispersing cholesterol into small droplets or micelles, so that it becomes solubilised, and can be metabolised more easily.  This helps break down small gallstones that have a high cholesterol content and do not need surgery to remove them.  This process is slow and can take months or years of treatment.  Ursodeoxycholic acid is also thought to have some anti-inflammatory activity.

What does Ursosan contain?

Ursosan capsules 100mg contain the active ingredient ursodeoxycholic acid, a secondary bile acid produced in the liver that is used to treat chronic cholestatic liver diseases to dissolve gallstones caused by a build-up of bile.  They also contain maize starch, pregelatinized maize starch, magnesium stearate, colloidal anhydrous silica, gelatin, titanium dioxide, and purified water.

What are the side effects of Ursosan?

Most medications have some side effects, but they are not experienced by everyone.  Some side effects are commonly experienced when taking Ursosan capsules 100mg, but others are not so common, and you should discuss any problems or concerns with your primary care physician. 

Common side effects when taking Ursosan include loose stools or diarrhoea, nausea, and vomiting.

When should Ursosan not be used?

Have a talk with your primary healthcare physician before taking Ursosan capsules 100mg so that you have a full understanding of what this medicine is for and how to use it.  There are some reasons for not taking a medication; these are called contraindications, and for Ursosan you should consider the following before taking Ursosan:

• Have you ever had an unusual reaction or an allergy when taking Ursosan?
• Are you pregnant or breastfeeding?
• Do you have calcified cholesterol, radio-opaque or radiolucent bile pigment stones?
• Do you have a condition causing the bile duct or gall bladder to be swollen, painful or blocked such as acute cholecystitis, cholangitis, obstruction of the biliary duct (common bile duct), gallstone pancreatitis or biliary-gastrointestinal fistula?

What medications interact with Ursosan?

Some medicines interact with Ursosan capsules 100mg and may affect the way it works, or are affected by Ursosan or increase side effects; you should discuss possible interactions with your primary care physician.  These may include bile sequestering agents cholestyramine and colestipol for high cholesterol, aluminium-based antacids, oestrogens, oral contraceptives and clofibrate a lipid-lowering agent. 

If other medications may interact with Ursosan, your doctor will discuss these with you. 

How should Ursosan be taken and for how long?

You should take your Ursosan capsules 100mg swallowed whole with a glass of water and with a meal, once daily as a single dose or in divided doses.  The dose you take depends on your condition and your doctor’s recommendation.  The usual recommended dose of Ursosan is 10-15mg/kg (22-33mg/pound).  If you are taking bile acid-binding resins, you should take your Ursosan capsules either 2-3 hours before or 4 hours after the doses of resins.  You should continue to take your Ursosan capsules for as long as recommended by your doctor, which may be several months.

Missed dose of Ursosan

If you miss a dose of Ursosan capsules 100mg take it as soon as you remember, unless it is time to take the next dose, then skip the missed dose.  Do not take a double dose.

How should Ursosan be stored?

You should store your Ursosan capsules 100mg below 25°C in a cool dry place.