Document: Ursochol capsule, hard ENG PL change

• Ursochol capsule, hard PL
• Ursochol capsule, hard ENG PL

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Package leaflet: Information for the user

Ursochol 250 and 500 mg capsules, hard

Ursodeoxycholic acid

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

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

• If you have any further questions, ask your doctor, pharmacist or nurse.

- 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Ursochol is and what it is used for

2. What you need to know before you take Ursochol

3. How to take Ursochol

4. Possible side effects

6. Contents of the pack and other information

Ursochol contains the active substance ursodeoxycholic acid which is a naturally occuring bile acid which is found in small amounts in human bile.

Ursochol are used to dissolve small gallstones and for the treatment of a liver disease (primary biliary cirrhosis) by e.g. stimulating bile flow.

In children aged 6 to 18 years Ursochol are used to treat liver-bile disorders associated with cystic fibrosis.

Do not take Ursochol:

• if you are allergic to ursodeoxycholic acid, other bile acids or any of the other ingredients of this medicine (listed in section 6)

• if you have acute inflammation of the gall bladder or the biliary tract

• if you have a blockage of the common bile duct or cystic duct

• if you often have biliary colic (cramp-like upper abdomen pain)

• if your doctor have told you that you have calcified gallstones

• if you have imparied function of the gall bladder

• if your child with cystic fibrosis (aged 6 years to less than 18 years) have impaired bile flow (biliary atresia).

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

During the first three months of treatment the function of your liver will be tested in order to evaluate the effect of the treatment and in order to detect possible side effects in the liver.

Women taking Ursochol in order to dissolve gallstones should only use non-hormonal contraceptives as hormanal contraceptives might induce formation of gallstones (also see section on pregnancy and breast-feeding below).

In patients with primary biliary cirrhosis, the clinical symptoms may worsen at the start of treatment, e.g. the itching may increase. This only occurs in rare cases. In this case, therapy can be continued with a lower daily dose of Ursochol. Each week, your doctor will then gradually increase the daily dose, until you reach the required dose.

Please inform your doctor if you have diarrhoea, as this may require a change in the dose.

Other medicines and Ursochol

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

This especially important for the following medicines:

• colestipol and colestyramin (used to lower blood lipids)

• antacids (used to treat heartburn) containing aluminium hydroxide or aluminium oxide

Should the use of a medicinal product containing one of these substances mentioned above be necessary, it must be taken at least 2 hours before or after Ursochol.

• ciclosporin (reduces the activity of the immune system at transplantation)

• ciprofloxacin (used to treat infections)

• nitrendipin (used to treat high blood pressure)

• dapsone (used to treat HIV)

• oestrogenic hormones (in certain oral contraceptives and medicines used for menopause)

• clofibrate (used to lower blood lipids)

• rosuvastatin (used to lower blood lipidst)

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.

Before start of treatment with Ursochol it will be checked that you are not pregnant.

Ursochol should not be used during pregnancy unless clearly necessary. Women of child-bearing potential should only be treated with Ursochol if a contraceptive is used concomitantly. Non-hormonal contraceptives or low dose oestrogen oral contraceptives is recommended.

Only use non-hormonal contraceptives if you use Ursochol to dissolve gallstones as hormonal contraceptives might induce the formation of gallstones.

It is not known if Ursochol passes into breast milk. Therefore consult your doctor before use if you are breast-feeding.

Driving and using machines

There are no known effect on the ability to drive or use machines.

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 capsules should be swallowed whole with sufficient liquid.

Dissolution of gallstones:

The recommended dose in adults are 10-12 mg/kg body weight daily, divided in 2 doses during the day.

It generally takes 6-24 months to dissolve gallstones. If there are no reduction in the size of the gallstones after 12 months, treatment should be stopped.

6 to 10 months after onset of treatment your doctor will test if the treatment is succesful.

Primary biliary cirrhosis:

The recommended dose in adults are 12-16 mg/kg body weight daily.

During the first 3 months of treatment, Ursochol should be taken in divided doses during the day. As liver function tests improve, the total daily dose may be taken once a day, preferably in the evening.

Ursochol can be continued indefinitely in cases of primary biliary cirrhosis.

Ursochol

Use in children and adolescents

Children with cystic fibrosis aged 6 years to less than 18 years:

The recommended dose is 20 mg/kg/day in 2-3 divided doses, with a further increase to 30 mg/kg/day if necessary.

If you take more Ursochol than you should

Diarrhoea may occur as a result of overdose. Contact your doctor immediately if you have persistent diarrhoea.

If you forget to take Ursochol

Do not take a double dose to make up for a forgotten dose, continue treatment as prescribed.

If you stop taking Ursochol

Always consult your doctor before you stop taking Ursochol.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common: may affect up to 1 in 10 people

Very rare: may affect up to 1 in 10,000 people

• severe right-sided upper abdominal pain during the treatment of primary biliary cirrhosis

• worsening of reduced liver function during the treatment of primary biliary cirrhosis which partially regresses after treatment is discontinued

• calcification of gallstones

• nettle rash

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (See details below). By reporting side effects, you can help provide more information on the safety of this medicine.

[To be completed nationally]

5. How to store Ursochol

This medicinal product does not require any special storage conditions.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Ursochol contains

• The active substance is ursodeoxycholic acid. One capsules contains 250 or 500 mg ursodeoxycholic acid

• The other ingredients are magnesium stearate, maize starch, colloidal anhydrous silica, titanium dioxide (E171) and gelatin

What Ursochol looks like and contents of the pack

White capsules (250 mg: approx. 8 x 22 mm, 500 mg: approx. 9 x 23 mm).

Blister (PVC/Alu) : 25, 50, 75, 100 capsules

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

[To be completed nationally]

This medicinal product is authorised in the Member States of the EEA under the following names:

Denmark, Norway, Sweden Ursochol

This leaflet was last revised in 2014-06-04