50 mg and 250 mg capsules, hard
cholic acid<\/p>\n\n\n\n
Orphacol contains cholic acid, a bile acid that is normally formed in the liver.\u00a0Some diseases are caused by a lack of ability to form bile acids and Orphacol is used to treat infants in the age group 1 month to 2 years, children, adolescents, and adults with these diseases.\u00a0The cholic acid in Orphacol replaces the bile acids that are missing due to the inability to form bile acids.<\/p>\n\n\n\n
During treatment, your doctor will perform different blood and urine tests at different times to see how your body responds to this medicine, and to find out what dose you need. More frequent tests are needed if you are growing fast or if you are ill (for example, if you have liver problems), or if you are pregnant.<\/p>\n\n\n\n
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.<\/p>\n\n\n\n
Some medicines used to lower cholesterol levels, so-called bile acid sequestrants (cholestyramine, colestipol, colesevelam), and heartburn medicines that contain aluminum may reduce the effect of Orphacol.\u00a0If you are taking any of these medicines, take Orphacol at least 5 hours before or after taking these medicines.<\/p>\n\n\n\n
Ciclosporin (a medicine used to reduce the body’s immune system) may also affect the effect of Orphacol. Tell your doctor if you are taking ciclosporin.<\/p>\n\n\n\n
Consult a doctor if you are planning to become pregnant.<\/p>\n\n\n\n
Take a pregnancy test immediately when you suspect you may be pregnant.\u00a0You must continue to take Orphacol during pregnancy.<\/p>\n\n\n\n
If you become pregnant during treatment with Orphacol, your doctor will decide which treatment and\u00a0dose\u00a0are right for you.\u00a0As a precaution, you and your unborn baby should be closely monitored during pregnancy.<\/p>\n\n\n\n
Orphacol can be used during breastfeeding.\u00a0Tell your doctor if you are planning to breastfeed or are breastfeeding before taking Orphacol.<\/p>\n\n\n\n
Ask your doctor or pharmacist for advice before taking any medicine.<\/p>\n\n\n\n
Orphacol is not expected to have any effect on the ability to drive or use machines.<\/p>\n\n\n\n
Orphacol contains a certain sugar ( lactose monohydrate ). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Orphacol.<\/p>\n\n\n\n
Always take this medicine exactly as your doctor has told you. Consult a doctor if you are unsure.<\/p>\n\n\n\n
The usual starting dose is 5 to 15 mg per kg body weight daily for infants, children, adolescents, and adults.<\/p>\n\n\n\n
Before starting treatment, your doctor will evaluate your laboratory tests to determine the appropriate\u00a0dose.\u00a0Dose\u00a0one may need to be adjusted again depending on how you respond to the medicine.<\/p>\n\n\n\n
The Orphacol capsules are taken by mouth with a meal at about the same time each day, in the morning and\/or in the evening.\u00a0If you take Orphacol at regular times with a meal, it will be easier to remember to take the medicine, and it may also help make the medicine easier to absorb in your body.\u00a0The capsules must be swallowed whole with water and should not be chewed.<\/p>\n\n\n\n
If your doctor has prescribed a dose that requires you to take more than one capsule per day, you can, in consultation with your doctor, decide at what times you should take them. For example, you can take one capsule in the morning and one in the evening. That way, you only need to take one capsule at a time.<\/p>\n\n\n\n
For infants and children who are unable to swallow the capsules, the capsules can be opened and the contents mixed with a breast milk substitute or apple\/orange juice, or apple\/apricot juice intended for infants.<\/p>\n\n\n\n
If you take more Orphacol than you should, contact your doctor as soon as possible.\u00a0Your doctor will evaluate the results of your laboratory tests and announce when you can resume treatment at your normal\u00a0dose.<\/p>\n\n\n\n
Take the next\u00a0dose\u00a0when you would normally take it.\u00a0Do not take a double\u00a0dose\u00a0to make up for a forgotten\u00a0dose.<\/p>\n\n\n\n
There is a risk of permanent damage to the liver if you stop taking Orphacol. You should never stop taking Orphacol unless your doctor advises you to do so.<\/p>\n\n\n\n
If you have any further questions on the use of this product, ask your doctor.<\/p>\n\n\n\n
Like all medicines, this medicine can cause\u00a0side effects, although not everybody gets them.<\/p>\n\n\n\n
Several patients have experienced\u00a0itching\u00a0or diarrhea, but the probability of this occurring is not known (frequency cannot be calculated from the available data).\u00a0Tell your doctor if you have\u00a0had itching\u00a0or diarrhea for more than three days.<\/p>\n\n\n\n
Elevated liver enzymes (serum transaminases) have been reported in several patients treated with Orphacol (frequency cannot be calculated from the available data). The doctor decides what to do if this happens to you.<\/p>\n\n\n\n
Gallstones have been reported after long-term treatment with Orphacol.<\/p>\n\n\n\n
Keep this medicine out of the sight and reach of children.<\/p>\n\n\n\n
Do not use this medicine after the expiry date which is stated on the carton and blister after \u201cEXP\u201d. The expiration date is the last day of the specified month.<\/p>\n\n\n\n
Do not store above 30 \u00b0 C.<\/p>\n\n\n\n
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.<\/p>\n\n\n\n
Orphacol is available as oblong hard capsules. Capsules with 50 mg of cholic acid are blue and white and capsules with 250 mg of cholic acid are green and white. They are packaged in blisters with 10 capsules in each pack.<\/p>\n\n\n\n
Available in pack sizes of 30, 60, and 120 capsules.<\/p>\n\n\n\n
Not all pack sizes may be marketed.<\/p>\n\n\n\n
Marketing Authorisation Holder<\/em><\/p>\n\n\n\n CTRS Laboratories<\/p>\n\n\n\n 63, rue de l’Est<\/p>\n\n\n\n F-92100 Boulogne-Billancourt<\/p>\n\n\n\n France<\/p>\n\n\n\n Manufacturer<\/em><\/p>\n\n\n\n CTRS Laboratories<\/p>\n\n\n\n 63, rue de l’Est<\/p>\n\n\n\n F-92100 Boulogne-Billancourt<\/p>\n\n\n\n France<\/p>\n\n\n\n Contact the representative of the marketing authorization holder to find out more about this medicine:<\/p>\n\n\n\n Immediate Pharma AB<\/p>\n\n\n\n Tel: +46 (0) 8 533 39 500<\/p>\n\n\n\n