Ursobil

Ursodeoxycholic acid.

Ursodeoxycholic acid, the active substance in Ursobil, is a naturally-occurring bile acid. Small amounts are found in human bile. White capsules.
One capsule contains 250 mg ursodeoxycholic acid.
Excipients/Inactive Ingredients: The other ingredients are magnesium stearate, maize starch, colloidal anhydrous silica, titanium dioxide (E171) and gelatin.

Ursodeoxycholic acid is used: To dissolve gallstones caused by excess cholesterol in the gall bladder (in patients for whom surgery is not an option), where the gallstones are not visible on a plain x-ray (gallstones that are visible will not dissolve) and not more than 15 mm in diameter. The gall bladder should still be working despite the gallstone(s).
To treat inflammation of the stomach lining due to the backflow of bile acids (bile reflux gastritis).
For the treatment of primary biliary cholangitis (PBC) a condition where the bile ducts in the liver become damaged leading to a build-up of bile. This may cause scarring of the liver (cirrhosis of the liver). The liver should not be so damaged that it is not functioning properly.
For liver disease associated with a condition called cystic fibrosis in children aged 6 to 18 years.

This medicine should be taken exactly as prescribed by the doctor or pharmacist. The patient should check with the doctor or pharmacist if unsure.
The capsules should be swallowed whole with sufficient liquid.
To dissolve cholesterol gallstones: Dosage: The recommended dose is about 10 mg ursodeoxycholic acid per kg body weight (BW) daily, as follows: See Table 1.

Click on icon to see table/diagram/image

Method of administration: The capsules should be swallowed whole with a drink of water or other liquid. Take the capsules in the evening at bedtime. Take the medicine regularly.
Duration of treatment: It generally takes 6-24 months to dissolve gallstones. If there is no reduction in the size of the gallstones after 12 months, therapy should be stopped.
Every 6 months, the doctor should check whether the treatment is working. At each of these follow-up examinations, it should be checked whether a build-up of calcium causing hardening of the stones has occurred since the last time. If this happens, the treatment will be stopped.
To treat bile reflux gastritis: Method of administration: One capsule a day should be taken in the evening before bedtime. The capsule should be swallowed whole (not chewed) with some liquid.
Duration of treatment: To treat bile reflux gastritis, Ursodeoxycholic acid should generally be taken for 10-14 days. The doctor will decide on the duration of treatment, depending on the progression of the disease.
For primary biliary cholangitis (chronic inflammatory disease of the biliary ducts): Dosage: During the first 3 months of treatment, Ursodeoxycholic acid should be taken in the morning, at midday and in the evening. As liver function values improve, the total daily dose can be taken once daily in the evening. (See Table 2.)

Click on icon to see table/diagram/image

Method of administration: The capsules should be swallowed whole with a drink of water or other liquid. Take the medicine regularly.
Duration of treatment: Ursodeoxycholic acid may be continued indefinitely in cases of primary biliary cholangitis.
Note: If the patient has primary biliary cholangitis, the symptoms may worsen at the start of treatment. One sign of this may be increased itching. This happens only in rare cases. In this event, treatment can be continued with a reduced daily dose of Ursodeoxycholic acid. The doctor will then increase the daily dose every week, until the required dose is once again reached.
Use in children (6 to 18 years) for treatment of liver disease associated with cystic fibrosis: The recommended dose is about 20 mg/kg/day in 2-3 divided doses. If necessary the doctor may increase the dose further to 30 mg per kg body weight daily. (See Table 3.)

Click on icon to see table/diagram/image

Be advised if the patient feels that the effect of Ursodeoxycholic acid is too strong or too weak.
If Ursodeoxycholic acid was taken more than it should: Diarrhoea may occur in the event of an overdose. The doctor must be informed immediately if the patient has persistent diarrhoea. If the patient does suffer from diarrhoea, make sure he/she drinks enough liquids to replace the fluid and electrolyte balance.
If Ursodeoxycholic acid was forgotten to be taken: Do not take a double dose to make up for a forgotten dose, but just continue the treatment with the prescribed dose.
If the patient stopped taking Ursodeoxycholic acid: The doctor should always be advised before the patient decides to interrupt treatment with Ursodeoxycholic acid or to stop the treatment early.

Ursodeoxycholic acid should not be taken if: allergic to bile acids (like ursodeoxycholic acid) or to any of the other ingredients of this medicine (listed in Description); have acute inflammation of the gall bladder and biliary tract; have a blockage of the common bile duct or cystic duct (obstruction of the biliary tract); have frequent cramp-like pains in the upper abdomen (biliary colic); have calcified gallstones; the gall bladder does not work properly; child with biliary atresia and have poor bile flow, even after surgery.
Be advised about any of the conditions mentioned previously.

Be advised before patient takes Ursodeoxycholic acid.
Test the liver function regularly every 4 weeks for the first 3 months of treatment. After this time, it should be monitored at 3 months intervals.
When used to dissolve gallstones, arrange for a scan of the gall bladder after the first 6-10 months of treatment.
If Ursodeoxycholic acid will be used for the dissolution of gallstones, be informed in case the patient is taking any medicines that contain oestrogenic hormones, as these medicines stimulate the formation of gallstones.
When used in the treatment of PBC, in rare cases the symptoms may worsen at the beginning of treatment. If this happens, consider reducing the initial dose.
Be informed if the patient has diarrhoea, as this may require a dose reduction or discontinuation of treatment.
Do not exceed the recommended dose. In a clinical trial, the use of high dose ursodeoxycholic acid (28-30mg/kg/day) was associated with higher rates of serious adverse events.
Driving and using machines: No effects on the ability to drive and use machines have been observed.
Use in Children: There are no age restrictions on the use of Ursodeoxycholic acid. The use of Ursodeoxycholic acid depends on body weight and the disease.

If the patient is pregnant or breast-feeding, thinks she may be pregnant or planning to have a baby, advise patient before taking this medicine.
Pregnancy: There are no or limited amounts of data from the use of ursodeoxycholic acid in pregnant women. Studies in animals have shown reproductive toxicity. Ursodeoxycholic acid must not be used during pregnancy unless clearly necessary.
Women of child-bearing potential: Even if the patient is not pregnant, the doctor should still be consulted.
Women of childbearing potential should be treated only if they use reliable contraception: non-hormonal or low-oestrogen oral contraceptive measures are recommended.
However, if the patient is taking Ursodeoxycholic acid to dissolve the gallstones, she should use effective, non-hormonal contraceptive measures, as hormonal oral contraceptives may promote the formation of gallstones.
The doctor must exclude the possibility of a pregnancy before beginning of treatment.
Breast-feeding: According to few documented cases of breastfeeding women milk levels of ursodeoxycholic acid are very low and probably no adverse reactions are to be expected in breastfed infants.
Fertility: Animal studies did not show an influence of ursodeoxycholic acid on fertility. Human data on fertility effects following treatment with ursodeoxycholic acid are not available.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common side effects (may affect up to 1 in 10 people): Soft, loose stools or diarrhoea.
Very rare side effects (may affect up to 1 in 10,000 people): During the treatment of primary biliary cholangitis: severe, right-sided upper abdominal pain, severe worsening of liver scarring - this partially eases after treatment is stopped; hardening of gallstones due to build up of calcium; nettle rash (urticaria).
Reporting of side effects: Be advised if the patient gets any side effects. This includes any possible side effects not listed.
By reporting side effects, it can help provide more information on the safety of this medicine.

Be advised if the patient is also taking or using medicines with the following active substances. The effects of these medicines may be altered.
A reduction in the effects of Ursodeoxycholic acid is possible when taking it with the following medicines: Cholestyramine, colestipol (used to lower blood lipid levels) or antacids containing aluminium hydroxide or smectite (aluminium oxide) (used to bind stomach acid). If the patient must take medication that contains any of these substances, it must be taken at least two hours before or after Ursodeoxycholic acid.
A reduction in the effects of the following medicines is possible when taking Ursodeoxycholic acid: Ciprofloxacin, and dapsone (antibiotics), nitrendipine (used to treat high blood pressure) and other medicines that are metabolized in a similar way. It may be necessary to alter the dose of these medicines.
A change in the effects of the following medicines is possible when taking Ursodeoxycholic acid: Ciclosporin (to reduce the activity of the immune system). If the patient is being treated with ciclosporin, the amount of ciclosporin in the blood should be checked. If necessary, adjust its dose. Rosuvastatin (for high cholesterol and related conditions).
If Ursodeoxycholic acid will be used for the dissolution of gallstones, be informed in case the patient is taking any medicines that contain oestrogenic hormones or blood cholesterol lowering agents such as clofibrate. These medicines stimulate the formation of gallstones, which is a counter-effect to the treatment with Ursodeoxycholic acid.
Be advised if the patient is taking or using, have recently taken or used or might take or use any other medicine.

Store below 25°C.
Do not throw away any medicines via wastewater or household waste. Ask the pharmacist how to throw away medicines that are no longer used. These measures will help protect the environment.

Cholagogues, Cholelitholytics & Hepatic Protectors

A05AA02 - ursodeoxycholic acid ; Belongs to the class of bile acids. Used in bile therapy.

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