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Kolbam (cholic acid) – Package leaflet - A05AA03

Updated on site: 08-Oct-2017

Medication nameKolbam
ATC CodeA05AA03
Substancecholic acid
ManufacturerRetrophin Europe Ltd

Package leaflet: Information for the user

Kolbam 50 mg hard capsules Kolbam 250 mg hard capsules cholic acid

This medicine is subject to additional monitoring. This will allow quick identification of new safety 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 your doctor, pharmacist or nurse.

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

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

What is in this leaflet

1.What Kolbam is and what it is used for

2.What you need to know before you use Kolbam

3.How to use Kolbam

4.Possible side effects

5.How to store Kolbam

6.Contents of the pack and other information

1.WHAT KOLBAM IS AND WHAT IT IS USED FOR

Kolbam contains a substance called cholic acid.

In the body cholic acid is naturally produced in the liver and is part of the bile, a fluid that helps digestion and absorbs fat and vitamins from the food. Cholic acid also promotes normal growth of children. Patients with certain types of conditions known as inborn errors of bile synthesis cannot produce cholic acid and bile normally, which leads to the production and build-up of abnormal substances that are potentially damaging to the liver.

Kolbam is used to treat these ‘inborn errors of bile acid synthesis’. By replacing the missing cholic acid it stimulates the production of normal bile and helps prevent the build-up of the abnormal substances in the liver. In growing infants, treatment with cholic acid helps with the normal development of the liver and bile circulation system.

Kolbam can be used from the age of one month and patients affected by these conditions will need treatment for the rest of their life.

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2.WHAT YOU NEED TO KNOW BEFORE YOU TAKE KOLBAM

Do not take Kolbam

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

-If you are taking phenobarbital (a medicine used for epilepsy). See under ‘Other medicines and Kolbam’.

Warnings and precautions

During your treatment, your doctor will carry out various blood and urine tests at different times 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 or if you are pregnant.

If you have a condition called familial hypertriglyceridaemia, your doctor may have to increase your dose of cholic acid.

Your doctor will advise you if for any reason you have to stop treatment with cholic acid.

Children

Cholic acid has not been studied for safety and effectiveness in babies under one month of age.

Elderly

Cholic acid has not been studied for safety and effectiveness in people over 65 years of age.

Other medicines and Kolbam

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Phenobarbital may stop cholic acid from working. Do not take any phenobarbital while you are on cholic acid. See above under ‘Do not take Kolbam’.

Ciclosporin may affect the levels of cholic acid. If your doctor considers it necessary that you keep taking ciclosporin, he will closely monitor the levels of bile acids in your blood and urine and adjust the dose of cholic acid accordingly.

Medicines for lowering cholesterol levels in the blood, such as cholestyramine or colestipol and certain antacids which contain aluminium (e.g. indigestion relief products) may affect the absorption of cholic acid. Your doctor will advise you to take cholic acid at least 5 hours before or after taking the other medicine.

These are some of the medicines that may affect the way in which Kolbam works:

oestrogen,

oral contraceptives,

lipid-lowering medicines such as clofibrate

These increase cholesterol production in the liver and as a result prevent cholic acid from working properly.

Pregnancy and breast-feeding

If you are pregnant , think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

The use of cholic acid may be considered during pregnancy if your doctor considers that the benefits to you outweigh any possible risk. Ask your doctor for advice.

You can continue to breast-feed your baby whilst being treated with cholic acid, as levels in breast milk are considered too low to harm your baby.

Driving and using machines

This medicine is not expected to affect your ability to drive or use machines.

3.HOW TO TAKE KOLBAM

Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are unsure.

The recommended dose is based on your body weight (10-15 mg per kg) taken either as a single dose, once a day, or divided into two doses, one in the morning and one in the evening. Your doctor will tell you how many capsules you need to take, and when you should take the capsules.

It is recommended that the capsules are taken with food, as this may help to make the cholic acid more effective, and also reduces the likelyhood of diarrhoea.

Use in children

For babies and children who cannot swallow capsules, open the capsule by gently twisting it and add the contents to infant formula, expressed breast milk or fruit puree in a suitable clean container. The mixture should be given immediately after preparation.

This mixing of the capsule contents with food should mask any unpleasant taste of the medicine. The capsule contents will remain as fine granules in the milk or food.

It is important to give the full content of the capsule to the baby or young child where whole capsules cannot be given. Try to ensure that if any of the dose is spat out or refused, it is given again.

Use in adults

Swallow each capsule whole with water, either just before or just after food. Do not chew the capsule. Do not take more capsules than your doctor has advised you.

If you take more Kolbam than you should

Cholic acid is unlikely to cause serious side effects but you should contact your doctor for advice if you or your child have taken more than the amount prescribed.

If you forget to take Kolbam

Take the next dose as soon as you remember, as long as it is more than 12 hours until the next dose. Never take a double dose to make up for a forgotten dose.

If you stop taking Kolbam

This medicine is intended for long-term use. If you stop taking it the abnormal substances in your bile may build up again to the levels before treatment was started, potentially causing damage to your liver.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.POSSIBLE SIDE EFFECTS

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

Common side effects (may affect up to 1 in 10 people)

heartburn (gastric reflux )

diarrhoea

feeling out of sorts (malaise)

yellowing of the skin (jaundice)

skin lesions

sickness (mild nausea)

feeling of pins and needles (mild peripheral neuropathy)

Side effects of unknown frequency (cannot be estimated from the available data):

Increase liver enzymes (serum transaminases)

Gallstones

Slight tingling (Pruritis)

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in the 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 KOLBAM

Keep this medicine out of the sight and reach of children.

Do not use after the expiry date which is stated on the carton and bottle label after “EXP’’ The expiry date refers to the last day of that month.

Do not store above 30°C.

Store in the original package in order to protect from light. Use within 3 months of opening

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6.CONTENTS OF THE PACK AND OTHER INFORMATION

What Kolbam contains

-The active substance is cholic acid.

Kolbam 50 mg: Each capsule contains 50 mg of cholic acid. Kolbam 250 mg: Each capsule contains 250 mg of cholic acid.

-The other ingredients are:

Capsule content:

- Silicified microcrystalline cellulose

-Magnesium stearate

Capsule shell:

-Gelatin

-Titanium dioxide (E171)

Kolbam 50 mg also contains Red iron oxide (E172)

Printing ink

-Shellac (E904)

-Propylene Glycol (E1520)

-Strong Ammonia Solution (E527)

-Potassium Hydroxide (E525)

-Black Iron Oxide (E172)

What Kolbam looks like and contents of the pack

Kolbam is provided as hard capsules. Each capsule contains a white powder. The 50 mg capsules are orange (black imprint “ASK001” and “50mg”). The 250 mg capsules are white (black imprint “ASK002” and “250mg”).

Packs containing 90 capsules.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Retrophin Europe Limited

Palmerston House

Fenian Street

Dublin 2, Ireland

Tel: +353 86 803 8014

info@retrophin.com

Manufacturer

Patheon France

40 boulevard de champaret

38300 Bourgoin-Jallieu

France

This leaflet was last revised in DDmonthYYYY.

This medicine has been authorised under ‘exceptional circumstances’. This means that because of the rarity of this disease it has been impossible to get complete information on this medicine.

The European Medicines Agency will review any new information on this 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.

ANNEX IV

CONCLUSIONS ON THE GRANTING OF THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES PRESENTED BY THE EUROPEAN MEDICINES AGENCY

Conclusions presented by the European Medicines Agency on:

Marketing authorisation under exceptional circumstances

The CHMP having considered the application is of the opinion that the risk-benefit balance is favourable to recommend the granting of the marketing authorisation under exceptional circumstances as further explained in the European Public Assessment Report.

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