Kolbam
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.
Keep this leaflet. You may need to read it again.
Medicinal product no longer authorised
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 Kolbam is and what it is used for
What you need to know before you use Kolbam
How to use Kolbam
Possible side effects
How to store Kolbam
Contents of the pack and other information
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.
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’.
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.
Cholic acid has not been studied for safety and effectiveness in babies under one month of age.
Medicinal product no longer authorised
Cholic acid has not been studied for safety and effectiveness in people over 65 years of age.
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, colestipol or colesevelam, 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.
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 breastfeed your baby whilst being treated with cholic acid, as levels in breast milk are considered too low to harm your baby.
This medicine is not expected to affect your ability to drive or use machines.
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.
Medicinal product no longer authorised
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.
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.
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.
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.
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.
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.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
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)
Increase liver enzymes (serum transaminases)
Gallstones
Slight tingling (pruritus)
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
Medicinal product no longer authorised
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.
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.
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:
Silicified microcrystalline cellulose
Magnesium stearate
Gelatin
Titanium dioxide (E171)
Kolbam 50 mg also contains Red iron oxide (E172).
Shellac (E904)
Propylene Glycol (E1520)
Strong Ammonia Solution (E527)
Potassium Hydroxide (E525)
Black Iron Oxide (E172)
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 Retrophin Europe Limited Palmerston House
Fenian Street Dublin 2, Ireland
Medicinal product no longer authorised
Manufacturer Patheon France
40 boulevard de champaret 38300 Bourgoin-Jallieu France
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.
. There are also links to other websites about rare diseases and treatments.