Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - orphacol

Document Subject

Generated Narrative: MedicinalProductDefinition mpd14c5d7dea1d2e7785c6d37dbbff6788

identifier: http://ema.europa.eu/identifier/EU/1/13/870/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Orphacol 50 mg hard capsules

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-d14c5d7dea1d2e7785c6d37dbbff6788

identifier: http://ema.europa.eu/identifier/EU/1/13/870/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - orphacol

Attesters

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 other information

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.

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, your 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 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.

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 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 contents added to baby formula or 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.

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.

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 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.

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 ingredients 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:

Belgi /Belgique/Belgien THERAVIA T l/Tel: +32 (0)2 40 11 question@theravia.com

Lietuva Immedica Pharma AB Tel/Puh: +46 (0)8 533 39 info@immedica.com

THERAVIA Te .: +33 (0)1 72 69 01 question@theravia.com

Luxembourg/Luxemburg THERAVIA T l/Tel: +352 278 62 question@theravia.com

esk republika THERAVIA Tel.: +33 (0)1 72 69 01 question@theravia.com

Magyarorsz g Medis Hungary Kft Tel: +36 (2) 380 1info@medis.hu

Danmark Immedica Pharma AB
Tlf: +46 (0)8 533 39 info@immedica.com

Malta THERAVIA Tel: +356 2776 1question@theravia.com

Deutschland THERAVIA Tel: +49 (0)3022153question@theravia.com

Nederland THERAVIA Tel: +31 (0)2 070 38 question@theravia.com

Eesti Immedica Pharma AB
Tel/Puh: +46 (0)8 533 39 info@immedica.com

Norge Immedica Pharma AB Tel/Puh: +46 (0)8 533 39 info@immedica.com

THERAVIA : +33 (0)1 72 69 01 question@theravia.com
sterreich THERAVIA Tel: +43 (0) 800 909 question@theravia.com

Espa a THERAVIA Tel: + (34) 914 146 question@theravia.com

Polska THERAVIA Tel.: +33 (0)1 72 69 01 question@theravia.com

France THERAVIA T l: +33 (0)1 72 69 01 question@theravia.com

Portugal THERAVIA Tel: +33 (0)1 72 69 01 question@theravia.com

Hrvatska Medis Adria d.o.o. Tel: +385 (1) 230 3info@medisadria.hr

Rom nia THERAVIA Tel: +33 (0)1 72 69 01 question@theravia.com

Ireland THERAVIA Tel: +353 (0)1 695 00 question@theravia.com

Slovenija Medis d.o.o. Tel: +386 (1) 589 6info@medis.si

sland Immedica Pharma AB S mi: + 46 (0)8 533 39 info@immedica.com Slovensk republika THERAVIA Tel: +33 (0)1 72 69 01 question@theravia.com

Italia THERAVIA Tel: +39 (0)800 959 question@theravia.com

Suomi/Finland Immedica Pharma AB Tel/Puh: +46 (0)8 533 39 info@immedica.com

THERAVIA : +33 (0)1 72 69 01 question@theravia.com

Sverige Immedica Pharma AB
Tel: +46 (0)8 533 39 info@immedica.com Latvija Immedica Pharma AB Tel: +46 (0)8 533 39 info@immedica.com United Kingdom (Northern Ireland) THERAVIA Tel: +44 (0)3 301 002 question@theravia.com

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: