50 mg and 250 mg capsules, hard
cholic acid
What Orphacol is and what it is used for
Orphacol contains cholic acid, a bile acid that is normally formed in the liver. Some 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. The cholic acid in Orphacol replaces the bile acids that are missing due to the inability to form bile acids.
What you need to know before taking Orphacol
Do not take Orphacol
- if you are allergic to cholic acid or any of the other ingredients of this medicine (listed in section 6)
- if you are taking phenobarbital, a medicine used to treat epilepsy .
Warnings and cautions
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.
Other medicines and Orphacol
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
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. If you are taking any of these medicines, take Orphacol at least 5 hours before or after taking these medicines.
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.
Pregnancy and breastfeeding
Consult a doctor if you are planning to become pregnant.
Take a pregnancy test immediately when you suspect you may be pregnant. You must continue to take Orphacol during pregnancy.
If you become pregnant during treatment with Orphacol, your doctor will decide which treatment and dose are right for you. As a precaution, you and your unborn baby should be closely monitored during pregnancy.
Orphacol can be used during breastfeeding. Tell your doctor if you are planning to breastfeed or are breastfeeding before taking Orphacol.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Orphacol is not expected to have any effect on the ability to drive or use machines.
Orphacol contains lactose
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.
How to take Orphacol
Always take this medicine exactly as your doctor has told you. Consult a doctor if you are unsure.
The usual starting dose is 5 to 15 mg per kg body weight daily for infants, children, adolescents, and adults.
Before starting treatment, your doctor will evaluate your laboratory tests to determine the appropriate dose. Dose one may need to be adjusted again depending on how you respond to the medicine.
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. If 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. The capsules must be swallowed whole with water and should not be chewed.
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.
Use for children
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.
If you take more Orphacol than you should
If you take more Orphacol than you should, contact your doctor as soon as possible. Your doctor will evaluate the results of your laboratory tests and announce when you can resume treatment at your normal dose.
If you forget to take Orphacol
Take the next dose when you would normally take it. Do not take a double dose to make up for a forgotten dose.
If you stop taking Orphacol
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.
If you have any further questions on the use of this product, ask your doctor.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Several patients have experienced itching or diarrhea, but the probability of this occurring is not known (frequency cannot be calculated from the available data). Tell your doctor if you have had itching or diarrhea for more than three days.
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.
Gallstones have been reported after long-term treatment with Orphacol.
How to store Orphacol
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 and blister after “EXP”. The expiration date is the last day of the specified month.
Do not store above 30 ° C.
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.
Contents of the pack and other information
Content declaration
- The active substance is cholic acid.Orphacol 50 mg : Each hard capsule contains 50 mg of cholic acid.Orphacol 250 mg : Each hard capsule contains 250 mg of cholic acid.
- Other ingredients are:Capsule contents: Lactose monohydrate (see section 2 under “Orphacol contains lactose” for more information), colloidal anhydrous silica, magnesium stearateCapsule housing: Orphacol 50 mg: gelatin, titanium dioxide (E 171), indigo carmine (E 132)Orphacol 250 mg: gelatin, titanium dioxide (E 171), indigo carmine (E 132), yellow iron dioxide (E 172).
What the medicine looks like and contents of the pack
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.
Available in pack sizes of 30, 60, and 120 capsules.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
CTRS Laboratories
63, rue de l’Est
F-92100 Boulogne-Billancourt
France
Manufacturer
CTRS Laboratories
63, rue de l’Est
F-92100 Boulogne-Billancourt
France
Contact the representative of the marketing authorization holder to find out more about this medicine:
Immediate Pharma AB
Tel: +46 (0) 8 533 39 500
This medicine has been authorized according to the rules of “authorization in exceptional cases”.
This means that it has not been possible to obtain complete information about this medicine as the disease is rare.
Every year, the European Medicines Agency reviews any new information and updates this leaflet when necessary.