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Orphacol (cholic acid) – Package leaflet - A05AA03

Updated on site: 09-Oct-2017

Medication nameOrphacol
ATC CodeA05AA03
Substancecholic acid
ManufacturerLaboratoires CTRS

PACKAGE LEAFLET: INFORMATION FOR THE USER

Orphacol 50 mg hard capsules Orphacol 250 mg hard capsules cholic acid

This medicine is subject to additional monitoring. This will allow quick identification of newsafety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

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 yourdoctor or pharmacist.

-This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

-If you get any side effects, talk to yourdoctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.What Orphacol is and what it is used for

2.What you need to know before you take Orphacol

3.How to take Orphacol

4.Possible side effects

5.How to store Orphacol

6.Contents of the pack and otherinformation

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, adolescents 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 knowbefore you take Orphacol

Do not take Orphacol

-if you are allergic to cholic acid or any of the other ingredients ofthis medicine (listed in section 6)..

-if you are taking phenobarbital, a medicine to treat epilepsy.

Warnings and precautions

Your doctor will prescribe laboratory tests on your blood, urine and liver for you when you start treatment and regularly thereafter. Make sure you see your doctor for these regular examinations at least once a year.

Other medicines and Orphacol

Tell your doctor or pharmacist if you are taking,have recently taken any or might takeother 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 Orphacol.If

you take these medicines, take Orphacolat 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 such medicines.

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 whichtreatment 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 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 your doctor if you are not sure.

The usual starting dose is 5 to 15mg 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 ameal 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 nda 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.

Use in children

For babies and children who cannot swallow capsules,the capsule can be opened and its contents added to baby formula ot apple/orange or apple/apricot juice adapted for small children.

If you take more Orphacol than you should

If you take 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 upfor 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 useof this medicine, ask your doctor.

4.Possible side effects

Like all medicines, Orphacol 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 isto occur (frequency cannot be estimated from the available data). If itching and/or diarrhoea last for more than three days, please tell your doctor.

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 inAppendix 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 blisterafter EXP. The expiry date refers to the last day of that month.

Store below 30°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 otherinformation

What Orphacol contains

-The active substance is cholic acid.

Orphacol 50 mg: Each hard capsule contains 50mg of cholic acid. Orphacol 250 mg: Each hard capsule contains 250mg of cholic acid.

-The other ingredients are:

Content of capsules: Lactose monohydrate, 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 hard capsules (capsules) of oblong shape. Capsules of 50mg cholic acid are blue and white and capsules of 250 mg cholic acid are green and white. They are contained in blisters of 10capsules 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 Laboratoires CTRS

63, rue de l’Est

92100 Boulogne-Billancourt France

Manufacturer Amatsi

17, Parc des Vautes 34980 Saint Gély du Fesc France

or

Laboratoires CTRS 63, rue de l'Est

92100 Boulogne-Billancourt France

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien

Lietuva

Laboratoires CTRS

Medical Need Europe AB

Tél/Tel: +32 (0)2 40 11 442

Tel/Puh: +46 (0)8 533 39 500

ctrs@ctrs.fr

info@medicalneed.com

България

Luxembourg/Luxemburg

Laboratoires CTRS

Laboratoires CTRS

Teл.: + 33 (0)1 707 60 637

Tél/Tel: +352 278 62 329

ctrs@ctrs.fr

ctrs@ctrs.fr

Česká republika

Magyarország

Laboratoires CTRS

Medis Hungary Kft

Tel.: + 33 (0)1 70 76 06 37

Tel: +36 (2) 380 1028

ctrs@ctrs.fr

info@medis.hu

Danmark

Malta

Medical Need Europe AB

Laboratoires CTRS

Tlf: +46 (0)8 533 39 500

Tel: +356 2776 1358

 

ctrs@ctrs.fr

 

Deutschland

Laboratoires CTRS

Tel: +49 (0)6 922 221 311 ctrs@ctrs.fr

Eesti

Medical Need Europe AB Tel/Puh: +46 (0)8 533 39 500 info@medicalneed.com

Ελλάδα

Laboratoires CTRS

Tel: + 33 (0)1 70 76 06 37 ctrs@ctrs.fr

España

Pharma International S.A Tel: + (34) 915635856 ctrs@ctrs.fr

France

Laboratoires CTRS

Tél: + 33 (0)1 70 76 06 37 ctrs@ctrs.fr

Hrvatska

Medis Adria d.o.o. Tel: +385 (1) 230 3446 info@medisadria.hr

Ireland

Laboratoires CTRS

Tel: +353 (0)1 695 00 63 ctrs@ctrs.fr

Ísland

Medical Need Europe AB Sími: + 46 (0)8 533 39 500 info@medicalneed.com

Italia

Laboratoires CTRS

Tel: + 33 (0)1 70 76 06 37 ctrs@ctrs.fr

Κύπρος

Laboratoires CTRS

Tel: + 33 (0)1 70 76 06 37 ctrs@ctrs.fr

Nederland

Laboratoires CTRS

Tel: +31 (0)2 070 38 155 ctrs@ctrs.fr

Norge

Medical Need Europe AB Tel/Puh: +46 (0)8 533 39 500 info@medicalneed.com

Österreich

Laboratoires CTRS

Tel: +43 (0)7 208 16 847 ctrs@ctrs.fr

Polska

Laboratoires CTRS

Tel.: + 33 (0)1 70 76 06 37 ctrs@ctrs.fr

Portugal

Laboratoires CTRS

Tel: + 33 (0)1 70 76 06 37 ctrs@ctrs.fr

România

Laboratoires CTRS

Tel: + 33 (0)1 70 76 06 37 ctrs@ctrs.fr

Slovenija

Medis d.o.o.

Tel: +386 (1) 589 6900 info@medis.si

Slovenská republika

Laboratoires CTRS

Tel: + 33 (0)1 70 76 06 37 ctrs@ctrs.fr

Suomi/Finland

Medical Need Europe AB Tel/Puh: +46 (0)8 533 39 500 info@medicalneed.com

Sverige

Medical Need Europe AB Tel: +46 (0)8 533 39 500 info@medicalneed.com

Latvija

United Kingdom

Medical Need Europe AB

Laboratoires CTRS

Tel: +46 (0)8 533 39 500

Tel: +44 (0)3 301 002 375

info@medicalneed.com

ctrs@ctrs.fr

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.

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