Ursodeoxycholic Acid 250 mg hard capsule - UK - PIL

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Package leaflet: Information for the patient

Ursodeoxycholic Acid 250 mg hard capsule

Ursodeoxycholic Acid

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

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Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.    What Ursodeoxycholic Acid is and what it is used for

2.    What you need to know before you use Ursodeoxycholic Acid

3.    How to use Ursodeoxycholic Acid

4.    Possible side effects

5.    How to store Ursodeoxycholic Acid

6.    Contents of the pack and other information

1. What Ursodeoxycholic Acid is and what it is used for

Ursodeoxycholic acid (UDCA), the active substance from rsodeoxycholic Acid is a bile acid produced naturally, which is ound in small amounts in human bile.

Ursodeoxycholic Acid is used for:

- for the treatment of 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. The liver should not be so damaged that it is not functioning properly. This condition is called primary biliary cirrhosis 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) for liver disease associated with a condition called cystic fibrosis in children 6 to 18 years.

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2. What you need to know before you use Ursodeoxycholic Acid

-    colestyramine, colestipol (to lower blood lipids) or antacids (drugs that bind hydrochloric acid in the gastric juice) containing aluminium hydroxide or smectite (aluminium oxide). If you must take medication that contains any of these ingredients, it must be taken at least two hours before or after Ursodeoxycholic Acid.

-    rosuvastatin (used to lower blood lipids). It may be necessary for your doctor to alter the dose of these medicines.

-    ciprofloxacin, dapsone (antibiotics), nitrendipine (used to treat high blood pressure) and other medicines which are metabolised in a similar way. It may be necessary for your doctor to alter the dose of these medicines.

Ursodeoxycholic Acid may increase the effects of the following medicines:

-    ciclosporin (to reduce the activity of the immune system). If you are

being treated with ciclosporin, your doctor should check the amount of ciclosporin in your blood. Your doctor will adjust its dose, if necessary.

If you are taking Ursodeoxycholic Acid for the dissolution of gallstones, please inform your doctor in case you are 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.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

You should not take Ursodeoxycholic Acid during pregnancy unless your doctor thinks it is absolutely necessary. The use of Ursodeoxycholic Acid during the first 3 months of pregnancy may cause foetal harm.

Check that you are not pregnant before taking this medicine

Women of child-bearing potential

Even if you are not pregnant you should talk to your doctor because women of childbearing potential must use contraception. Non-hormonal or oral contraceptives containing small amounts of estrogen are recommended. However, if you take Ursodeoxycholic Acid for dissolve gallstones, you should use non-hormonal contraception because hormonal contraceptives may increase gallstone risk.

Your doctor must exclude the possibility of a pregnancy before beginning of treatment.

Breastfeeding

You should not take Ursodeoxycholic Acid during breast-feeding. It is not known whether Ursodeoxycholic Acid passes into breast milk. If treatment with Ursodeoxycholic Acid is absolutely necessary, you should stop breastfeeding.

Driving and using machines

Ursodeoxycholic Acid has no or negligible influence on the ability to drive and use machines.

Do not use Ursodeoxycholic Acid:

-    If you are allergic to bile acids like UDCA or any of the other ingredients of this medicine (listed in section 6).

-    If you have an acute inflammation of the gall bladder or biliary tract. If you have a blockage of the common bile duct or cystic duct (obstruction of the biliary tract).

If you have frequent cramp-like upper abdomen pain (biliary colic). If your doctor has said you have calcified gallstones.

If you have an insufficiency of the contractility of the gall bladder.

If you are or have a child with biliary atresia or has poor bile flow even after surgery.

Please ask your doctor about the conditions mentioned above. You should also ask if you have previously had any of these conditions.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before taking Ursodeoxycholic Acid. Ursodeoxycholic Acid should be administered under medical supervision.

our doctor should test your liver function regularly every 4 weeks 'or the first 3 months of treatment. After this time, it should be onitored at 3 month intervals.

hen used to dissolve gallstones, your doctor should arrange for a can of your gall bladder after the first 6-10 months of treatment.

Talk to your doctor immediately if you have diarrhoea, as this may require a reduction in the dose or discontinuation of the treatment with rsodeoxycholic Acid.

f you suffer from primary biliary cirrhosis and your symptoms get orse at the beginning of the treatment a reduction in the dose may be equired and gradually increased again as described in section 3 How to take Ursodeoxycholic Acid). f you are a woman of childbearing potential you must use contraception. Non-hormonal or oral contraceptives containing small amounts of estrogen are recommended. However, if you take Ursodeoxycholic Acid for dissolve gallstones, you should use non-hormonal contraception because hormonal contraceptives may increase gallstone risk.

Other medicines and Ursodeoxycholic Acid

Tell your doctor or pharmacist if you are taking, have recently taken ir might take any other medicines, including those without medical rescription. Treatment with Ursodeoxycholic Acid may still be flowed. Your doctor will know what is right for you.

A reduction in the effects of the following medicines is possible when taking Ursodeoxycholic Acid:

3. How to take Ursodeoxycholic Acid

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Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

The daily dose is determined by therapeutic indication.

For the treatment of the of _ primary biliary cirrhosis (PBC)

The recommended daily dose will be determined by the doctor based on body weight and is between 3 to 7 hard capsules of Ursodeoxycholic Acid (12 - 16 mg of UDCA per kg of body weight per day).

During the first 3 months of treatment you should take Ursodeoxycholic Acid in the morning, to midday and evening.

The recommended treatment schedule is as follows:

With improvement of the liver values your doctor will advise to take the daily dose once daily in the evening.

The use of Ursodeoxycholic Acid in primary biliary cirrhosis may be continued indefinitely.

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Take the capsules two to three times a day as advised for your doctor or pharmacist. Take the capsules regularly.

How to use Ursodeoxycholic Acid

Swallow the capsules whole with a glass of water.

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