250 mg hard capsules
ursodeoxycholic acid
What Ursodeoxycholic acid Orion is and what it is used for
Ursodeoxycholic acid Orion contains the active substance ursodeoxycholic acid, which is a naturally occurring bile acid found in small amounts in human bile.
Ursodeoxycholic acid Orion is used to dissolving small gallstones and in liver disease (primary biliary cirrhosis ) to stimulate bile flow, among other things.
In children between 6 and 18 years of age, Ursodeoxycholic acid Orion is used to treating liver-biliary disorders associated with cystic fibrosis.
Ursodeoxycholic acid contained in Ursodeoxycholic acid Orion may also be approved to treat other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you use Ursodeoxycholic acid Orion
Do not use Ursodeoxycholic acid Orion
- if you are allergic to ursodeoxycholic acid or any of the other ingredients of this medicine (listed in section 6).
- if you have acute inflammation of the gallbladder or bile ducts.
- if you have a blockage in the common bile duct or bile ducts.
- if you often have biliary colic (cramp-like pain in the upper abdomen).
- if your doctor has told you that you have calcified gallstones
- or if you have reduced gallbladder function.
- if your child has reduced bile flow (biliary atresia). Ask your doctor about the conditions mentioned above. Also, ask your doctor 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 to see that the treatment is working and to detect side effects in the liver.
Women taking Ursodeoxycholic acid Orion for the dissolution of gallstones should only use non-hormonal contraceptives as hormonal contraceptives can increase the formation of gallstones (see also pregnancy, breast-feeding, and fertility section below).
When treating the liver disease primary biliary cirrhosis, in rare cases certain symptoms (e.g. itching ) may worsen at the beginning of treatment. The treatment can be continued with a lower daily dose. Each week your doctor will then gradually increase the daily dose by one to the recommended daily dose.
If you get diarrhea, you must tell your doctor. Your dose of Ursodeoxycholic acid Orion may need to be changed.
Other medicines and Ursodeoxycholic acid Orion
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
It is especially important if you are taking the following medicines:
- colestipol and cholestyramine (for high blood lipids)
- antacids (against a sour stomach) containing aluminum hydroxide or aluminum oxide.
If it is necessary to use a medicine containing any of the substances mentioned above, the medicine must be taken 2 hours before or after Ursodeoxycholic acid Orion.
- ciclosporin (to reduce the effect on the immune system during transplants)
- ciprofloxacin (for infection )
- nitrendipine (for high blood pressure )
- dapsone (for HIV )
- estrogenic hormones (found in some birth control pills and medicines for menopause)
- clofibrate (for high blood lipids)
- rosuvastatin (for high blood lipids)
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Before starting treatment with Ursodeoxycholic acid Orion, a check should be made to rule out that you are pregnant.
Ursodeoxycholic acid Orion should not be used during pregnancy unless necessary. Women of childbearing age should be treated only if they use contraception. Non-hormonal contraceptives or low-dose estrogen birth control pills are recommended.
However, if you are taking Ursodeoxycholic acid Orion to dissolve gallstones, non-hormonal contraceptives must be used because hormonal contraceptives can increase the formation of gallstones.
It is unknown whether Ursodeoxycholic acid Orion passes into breast milk. Therefore, ask your doctor for advice before taking Ursodeoxycholic acid Orion if you are breastfeeding.
Driving ability and use of machinery
There is no known effect on the ability to drive and use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with a doctor or pharmacist if you are unsure.
Ursodeoxycholic acid Orion contains Capsule contents: corn starch, colloidal hydrogenated silicon, and magnesium stearate. Capsule shell: titanium dioxide (E171), gelatin
How to use Ursodeoxycholic acid Orion
Always use this medicine as directed by your doctor or pharmacist. Ask your doctor or pharmacist if you are unsure.
The hard capsules should be swallowed whole with liquid.
Dissolution of gallstones: The recommended dose for adults is 10-12 mg/kg body weight daily divided into 2 dosing occasions. Generally, it takes 6-24 months to dissolve gallstones. If the size of the gallstone has not decreased after 12 months, treatment should be discontinued. 6 to 10 months after starting treatment, your doctor will perform a test to see if the treatment has been successful.
Primary biliary cirrhosis: The recommended dose for adults is 12-16 mg/kg body weight daily. During the first 3 months of treatment, Ursodeoxycholic acid Orion should be taken in divided doses throughout the day. When the liver values have improved, the daily dose can be taken once a day, preferably in the evening.
The use of Ursodeoxycholic acid Orion in the treatment of primary biliary cirrhosis can be continued indefinitely.
Use for children and adolescents
Children with cystic fibrosis aged 6 to 18 years:
The recommended dose is 20 mg/kg/day divided into 2-3 dosing occasions. Escalation to 30 mg/kg/day if necessary.
If you have used too much Ursodeoxycholic acid Orion
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
Possible symptoms are diarrhea in case of an overdose of Ursodeoxycholic acid Orion.
If you forget to use Ursodeoxycholic acid Orion
Do not take a double dose to make up for a missed dose. Continue the treatment as prescribed.
If you stop using Ursodeoxycholic acid Orion
Always talk to your doctor before you stop taking Ursodeoxycholic acid, Orion.
If you have any further questions about this medicine, ask your doctor, pharmacist, or nurse.
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 users
- Diarrhea, pale stools
Very rare: may affect up to 1 in 10,000 users
- Severe pain in the right upper part of the stomach when treating liver disease (primary biliary cirrhosis ).
- Impaired function of the liver in the treatment of liver disease (primary biliary cirrhosis ) which may return to normal upon cessation of treatment.
- Calcium deposits in gallstones
- Hives.
How to store Ursodeoxycholic acid Orion
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the packaging after EXP. The expiration date is the last day of the specified month.
Store at a maximum of 30 ° C. Store in the original packaging. Moisture sensitive.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medications that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is ursodeoxycholic acid. One hard capsule contains 250 mg of ursodeoxycholic acid.
- Other ingredients are:
Capsule content: corn starch, colloidal hydrogenated silicon, magnesium stearate.
Capsule shell: titanium dioxide (E171), gelatin
Appearance and package sizes of the medicine
White, hard gelatin capsule, approximately 21.7 mm x 7.64 mm in size, containing white or off-white powder.
PVC/Aluminium blisters: 25, 50, 75, 100 capsules.
Not all pack sizes may be marketed.
Orion Corporation
Orion Indie 1
FI-02200 Espoo
Finland
Manufacturer
Orion Corporation Orion Pharma
Orion Indie 1
FI-02200 Espoo
Finland
Orion Corporation Orion Pharma
Joensuunkatu 7
FI-24100 Salo
Finland
Joint Stock Company “Grindeks”
Krustpils Street 53
Riga
LV 1057
Latvia
For further information about this medicine, contact your local representative:
Orion Pharma AB
medinfo@orionpharma.com