Orphacol 250mg hard capsules

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Orphacol 50 mg hard capsules

Orphacol 250 mg hard capsules Cholic acid

This medicinal product is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. The last section of section 4 will tell you how to report side effects.

• Read all of this leaflet carefully before you start taking this medicine.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, as it may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist, even if you think they are not serious. See section 4.

of side effects that are not listed in this leaflet.

Contents of the pack:

1. What is Orphacol and what is it used for
2. What you need to know before you take Orphacol
3. How to take Orphacol
4. Possible side effects
5. Storage of Orphacol
6. Contents of the pack and other information

1. What is Orphacol and what is it used for

Orphacol contains cholic acid, a bile acid produced normally by the liver. Some medical disorders are caused by defects in the production of bile acids, and Orphacol is used to treat infants from 1 month of age to 2 years, children, adolescents, and adults with these disorders. The cholic acid in Orphacol replaces the missing bile acids 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, a medicine used to treat epilepsy.

Warnings and precautions

Your doctor will ask you to have blood and urine tests and liver tests when you start treatment and then at regular intervals. Do not forget to visit your doctor for these regular check-ups at least once a year.

Using Orphacol with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Some medicines used to reduce cholesterol levels, called bile acid sequestrants (cholestyramine, colestipol, colesevelam), and medicines used to treat heartburn that contain aluminum, may reduce the effect of Orphacol. If you take these medicines, you should take Orphacol at least 5 hours before or at least 5 hours after these other medicines. Cyclosporine (a medicine used to suppress the immune system) may also alter the effect of Orphacol. Tell your doctor if you are taking these medicines.

Pregnancy and breastfeeding

Consult your doctor if you are planning to become pregnant. Have a pregnancy test as soon as you think you may be pregnant. It is very important that you continue to take Orphacol during pregnancy.

If you become pregnant during treatment with Orphacol, your doctor will decide on the best treatment and dose for your situation. As a precaution, your doctor will closely monitor your condition and that of the fetus throughout the pregnancy.

Orphacol can be administered during breastfeeding. Tell your doctor if you plan to start or have started breastfeeding before taking Orphacol.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

Orphacol is not expected to affect your ability to drive and use machines.

Orphacol contains lactose

Orphacol contains a sugar (lactose monohydrate). If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Orphacol

Follow exactly the administration instructions of Orphacol given by your doctor. In case of doubt, consult your doctor.

The usual starting dose is 5 to 15 mg per kilogram of body weight per day in infants, children, adolescents, and adults.

Before treatment, your doctor will assess the results of your tests to determine the correct dose for your case. Your doctor will adjust the dose again later depending on your body's response.

Orphacol capsules should be taken with food, approximately at the same time every day, in the morning and/or evening. Taking Orphacol at the same time every day with a meal will help you remember to take this medicine, and it may help your body absorb it better. The capsules should be swallowed whole with water, without chewing.

If your doctor has prescribed a dose that requires you to take more than one capsule per day, you and your doctor will decide how to take it throughout the day. You can, for example, take one capsule in the morning and another in the evening. This way, you will have to take fewer capsules at one time.

Use in children

In infants and children who cannot swallow capsules, the capsules can be opened and their contents added to an infant formula or a juice suitable for young children.

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 assess the results of your tests and tell you if you should resume your treatment with the normal dose.

If you forget to take Orphacol

Take the next dose at the usual time. Do not take a double dose to make up for forgotten doses.

If you stop taking Orphacol

If you stop taking Orphacol, you risk suffering from irreversible liver damage. Never stop taking Orphacol unless your doctor tells you to.

If you have any other questions about the use of this product, ask your doctor.

4. Possible side effects

Like all medicines, Orphacol can cause side effects, although not everybody gets them.

Some patients have experienced itching and/or diarrhea, but the frequency with which this happens is not known (the frequency cannot be estimated from the available data). If you experience itching or diarrhea for more than three days, tell your doctor.

Bile duct stones have been reported after long-term treatment with Orphacol.

Reporting of side effects

If you experience any side effects, talk to your doctor, even if you think they are not serious. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Orphacol

Keep out of the sight and reach of children.

Do not use Orphacol after the expiry date which is stated on the carton and blister after "EXP". The expiry date is the last day of the month shown.

Store below 30°C.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Orphacol

• 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:

Capsule contents: Lactose monohydrate, colloidal anhydrous silica, magnesium stearate

Capsule shell:

Orphacol 50 mg: gelatin, titanium dioxide (E171), carmine (E132);

Orphacol 250 mg: gelatin, titanium dioxide (E171), carmine (E132), yellow iron oxide (E172);

Appearance and packaging

Orphacol is presented in hard, oblong capsules. The 50 mg cholic acid capsules are blue and white, and the 250 mg capsules are green and white. They are presented in blisters of 10 capsules.

The medicinal product is marketed in pack sizes of 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

You can request more information about this medicinal product from the local representative of the marketing authorisation holder:

Date of last revision of this leaflet:

This medicinal product has been authorised under an exceptional circumstances.

This means that due to the rarity of the disease and for ethical reasons, it has not been possible to obtain complete information on this medicinal product.

The European Medicines Agency will review any new information that may become available every year and this leaflet will be updated as necessary.

Other sources of information

Detailed information on this medicinal product is available on the European Medicines Agency web site http://www.ema.europa.eu. It also provides links to other web sites on rare diseases and orphan medicines.