Orphacol – Package Leaflet: InfoCons – Consumer Protection presents, in an accessible format, the official package leaflet of the medicine Orphacol, as authorised in the European Union and published in the Union Register of medicinal products.
Before anything else
ℹ️ 1. What Orphacol is and what it is used for
Orphacol contains cholic acid, a bile acid which is normally produced by the liver. Certain medical conditions are caused by defects in bile acid production and Orphacol is used to treat infants from one month to 2 years of age, children, adol escents and adults with these medical conditions. The cholic acid contained in Orphacol replaces the bile acids that are missing due to the defect in bile acid production.
⚠️ 2. What you need to know before you take 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 or primidone , a medicine to treat epilepsy.
Warnings and precautions
During your treatment, y our doctor will carry out various blood and urine tests at different time to see how your body is handling this medicine and to help work out the dose that you need. More frequent tests will be needed if you are growing fast , if you are ill (if you have e.g. liver problems) , or if you are pregnant .
Other medicines and Orphacol
Tell your doctor or pharmacist if you are taking , have recently taken any or might take other medicines.
Some medicines used to lower cholesterol levels, so -called bile acid sequestrants (cholestyramine, colestipol, colesevelam), and medicines to treat heartburn that contain aluminium may lessen the effect of 22 Orphacol. If you take these medicines, take Orphacol at least 5 hours before or at least 5 hours after taking these other medicines.
Ciclosporin (a medicine used to suppress the immune system) may also change the effect of Orphacol.
Please tell your doctor if you are taking ciclosporin .
Ursodeoxycholic acid may lessen the effect Orphacol if both medicines are taken at the same time.
If you are prescribed ursodeoxycholic acid along with Orphacol in single doses , take one product in the morning and the other product in the evening. If you are prescribed divided doses of ursodeoxycholic acid and/or Orphacol, as these products should be administered separately by several hours, please ask for the advice of your doctor or pharmacist about proper sequence of administration .
Pregnancy and breast -feeding Please consult your doctor if you plan to become pregnant. Take a pregnancy test as soon as you suspect you may be pregnant. It is very important to continue taking Orphacol during pregnancy.
If you become pregnant during treatment with Orphacol, your doctor will decide which treatment and dose is best in your situation. As a precaution, you and your unborn child should be closely monitored during pregnancy.
Orphacol can be used during breast -feeding. Tell your doctor if you plan to breast -feed or are breast – feeding before you take Orphacol.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Orphacol is not expected to have an effect on the ability to drive and 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.
💊 3. How to take Orphacol
Always take Orphacol exactly as your doctor has told you. Check with y our doctor if you are not sure.
The usual starting dose is 5 to 15 mg per kilogram body weight every day in infants, children, adolescents and adults.
Before treatment your doctor will make an assessment from your laboratory tests to determine the correct dose for you. The dose will then be further adjusted by your doctor depending on your body’s response.
Orphacol capsules are taken by mouth with a meal at approximately the same time each day, in the morning and/or evening. Taking Orphacol at regular times with a meal will help you remember to take this medicine, and may help your body to better take it up. Capsules must be swallowed whole with water.
Do not chew.
If your doctor has prescribed a dose which requires you to take more than one capsule per day, you and your doctor can decide how this will be taken during the day. You may for example take one capsule in the morning and one in the evening. This way, you will have to take fewer capsules at once. However, this might not be possible if you have been prescribed at the same time another medicine containing ursodeoxycholic acid. In this case, you should seek advice from your doctor or pharmacist about proper sequence of administration of ursodeoxycholic acid and Orphacol over the day, as these products should be administered separately by several hours (see section 2).
Use in children For babies and children who cannot swallow capsules, the capsule can be opened and its content s added to baby formula o r apple/orange or apple/apricot juice adapted for small children.
If you take more Orphacol than you should
If you have taken more Orphacol than you should, contact your doctor as soon as possible. He will assess your laboratory test results and advise you when you should resume your treatment with your normal dose.
If you forget to take Orphacol
Take your 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 permanently damaging your 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 medicine , ask your doctor.
❗ 4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Several patients have experienced itching and/or diarrhoea, however, it is not known how likely this is to occur (frequency cannot be estimated from the available data). If itching and/or diarrhoea last for more than three days, tell your doctor.
For several patients an increase of liver enzymes (serum transaminases) have been reported during the treatment with Orphacol (frequency cannot be estimated from the available data) . Your doctor will decide what to do if this happens to you.
Gallstones have been reported after long -term therapy with Orphacol.
Reporting of side effects
If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V . By reporting side effects you can help provide more information on the safety of this medicine.
🌡️ 5. How to store Orphacol
Keep out of the reach and sight of children.
Do not use Orphacol after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
Store below 25°C.
Medicines should not be disposed of via wasterwater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
📦 6. Contents of the pack and other information
What Orphacol contains
- 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.
- The other ingredient s are:
Content of capsules : Lactose monohydrate (see section 2 under ‘Orphacol contains lactose’ for more information) , colloidal anhydrous silica, magnesium stearate Capsule shell :
Orphacol 50 mg: gelatin, titanium dioxide (E171), carmine blue (E132); Orphacol 250 mg: gelatin, titanium dioxide (E171), carmine blue (E132), yellow iron oxide (E172).
What Orphacol looks like and contents of the pack
Orphacol is available as hard capsules (capsules) of oblong shape. Capsules of 50 mg cholic acid are blue and white and capsules of 250 mg cholic acid are green and white. They are contained in blisters of 10 capsules each.
Pack sizes are available in 30, 60 and 120 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
THERAVIA 16 Rue Montrosier 92200 Neuilly -sur-Seine France
Manufacturer
THERAVIA 16 Rue Montrosier 92200 Neuilly -sur-Seine France For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien THERAVIA Tél/Tel: +32 (0)2 808 2973 [email protected] Lietuva Immedica Pharma AB Tel/Puh: +46 (0)8 533 39 500 [email protected] България THERAVIA Teл.: +33 (0)1 72 69 01 86 [email protected] Luxembourg/Luxemburg THERAVIA Tél/Tel: +352 278 62 329 [email protected] 25 Česká republika THERAVIA Tel.: +33 (0)1 72 69 01 86 [email protected] Magyarország Medis Hungary Kft Tel: +36 (2) 380 1028 [email protected] Danmark Immedica Pharma AB Tlf: +46 (0)8 533 39 500 [email protected] Deutschland THERAVIA Tel:
Tel: 08001090001 [email protected] Nederland THERAVIA Tel:
Tel : +31 (0)20 208 2161 [email protected] Eesti Immedica Pharma AB Tel/Puh: +46 (0)8 533 39 500 [email protected] Norge Immedica Pharma AB Tel/Puh: +46 (0)8 533 39 500 [email protected] Ελλάδα THERAVIA Τηλ: +33 (0)1 72 69 01 86 [email protected] España THERAVIA Tel: + (34) 914 146 613 [email protected] Polska THERAVIA Tel.: +33 (0)1 72 69 01 86 [email protected] France THERAVIA Tél: +33 (0)1 72 69 01 86 [email protected] Portugal THERAVIA Tel: 800210571 [email protected] Hrvatska Medis Adria d.o.o.
Tel: +385 (1) 230 3446 [email protected] România THERAVIA Tel: +33 (0)1 72 69 01 86 [email protected] Ireland THERAVIA Tel:
Tel : +353 -(0)1-903 8043 [email protected] Slovenija Medis d.o.o.
Tel: +386 (1) 589 6900 [email protected] Ísland Immedica Pharma AB Sími: + 46 (0)8 533 39 500 [email protected] Slovenská republika THERAVIA Tel: +33 (0)1 72 69 01 86 [email protected] 26 Italia THERAVIA Tel:
Tel : 800 959 161 [email protected] Suomi/Finland Immedica Pharma AB Tel/Puh: +46 (0)8 533 39 500 [email protected] Κύπρος THERAVIA Τηλ: +33 (0)1 72 69 01 86 [email protected] Sverige Immedica Pharma AB Tel: +46 (0)8 533 39 500 [email protected] Latvija Immedica Pharma AB Tel: +46 (0) 8 533 39 500 [email protected]
This leaflet was last revised in
This medicine has been authorised under “Exceptional Circumstances”.
This means that because of the rarity of this disease and for ethical reasons it has been impossible to get complete information on this medicine.
The European Medicines Agency will review any new information on the medicine every year and this leaflet will be updated as necessary.
Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu /. There are also links to other websites about rare diseases and treatments.
📄 Package Leaflet – official source
This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Orphacol (PDF, ec.europa.eu).
You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/13/870).
⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.