Patient leaflet - Chenodeoxycholic acid Leadiant (previously known as Chenodeoxycholic acid sigma-tau)
1. What Chenodeoxycholic acid Leadiant is and what it is used for
Chenodeoxycholic acid Leadiant capsules contain a substance called chenodeoxycholic acid.This substance is normally produced by the liver from cholesterol. It is a part of the bile, a fluid which helps in the digestion of fat and vitamins from food. Patients with a rare condition known as cerebrotendinous xanthomatosis (CTX) cannot produce chenodeoxycholic acid and this causes a build-up of fatty deposits in various areas of the body.This can cause damage to the affected areas.
Chenodeoxycholic acid Leadiant capsules treats CTX by replacing the chenodeoxycholic acid, which prevents the build-up of the fatty deposits.
Chenodeoxycholic acid Leadiant capsules can be used from the age of one month and patients with CX will require treatment for the rest of their life.
2. What you need to know before you take Chenodeoxycholic acid Leadiant
Do not take Chenodeoxycholic acid Leadiant
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– if you are allergic to chenodeoxycholic acid or any of the other ingredients of this medicine
(listed in section 6)
Warnings and precautions
Chenodeoxycholic acid Leadiant should be used under medical supervision. During your treatment, your doctor will carry out blood and urine tests to monitor your response to this medicine, and adjust your dose if necessary. More frequent tests may be needed if you are growing fast, if you are ill (if you have e.g. liver problems), or if you are pregnant. Your doctor will advise you if for any reason you have to stop treatment with Chenodeoxycholic acid Leadiant.
Babies (less than one month of age )
The safety and efficacy of Chenodeoxycholic acid Leadiant has not been studied in babies less than one month of age.
Other medicines and Chenodeoxycholic acid Leadiant
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
The following medicines may affect the levels of Chenodeoxycholic acid Leadiant:
- ciclosporin and sirolimus (medicines used to suppress the immune system)
- phenobarbital (a medicine used for epilepsy)
If your doctor considers it necessary for you to take ciclosporin, sirolimus or phenobarbital they will closely monitor the results of blood and urine tests and adjust the dose of Chenodeoxycholic acid Leadiant if necessary.
Oral contraceptives may affect the way in which Chenodeoxycholic acid Leadiant works making it less effective. It is not recommended to take oral contraceptives whilst taking Chenodeoxycholic acid Leadiant. Please discuss suitable contraceptive methods with your doctor.
The following medicines may reduce the effect of Chenodeoxycholic acid Leadiant:
- colestyramine, colestipol (so called bile acid sequestrants)
- medicines to treat heartburn (antacids) containing aluminium hydroxide and/or smectite (aluminium oxide)
If you have to take colestyramine then take Chenodeoxycholic acid Leadiant either one hour before colestyramine or 4–6 hours after.
For the colestipol or heartburn medicines , take them either 2 hours before or 2 hours after taking Chenodeoxycholic acid Leadiant.
Please talk to your doctor if you are taking any of these medicines.
Pregnancy
It is not recommended to take Chenodeoxycholic acid Leadiant during pregnancy. There might be a risk to your unborn baby. If you think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Breastfeeding
It is not known if Chenodeoxycholic acid Leadiant passes into breast milk. Tell your doctor if you are breast-feeding or plan to do so. Your doctor will then help you decide whether to stop breast-feeding, or whether to stop taking Chenodeoxycholic acid Leadiant, considering the benefit of breast-feeding the baby and the benefit of Chenodeoxycholic acid Leadiant to the mother.
Contraception in females
Women who could become pregnant should use an effective contraceptive method whilst taking Chenodeoxycholic acid Leadiant. Oral contraceptives are not recommended (see Other medicines and Chenodeoxycholic acid). Please discuss suitable contraceptive methods with your doctor.
Driving and using machines
Chenodeoxycholic acid Leadiant is not expected to affect your ability to drive or use machines.
3. How to take Chenodeoxycholic acid Leadiant
Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not sure.
The usual starting dose in adults is one 250 mg capsule three times a day. The maximum dose is one 250 mg capsule four times a day. The capsules should be swallowed whole with water at approximately the same time each day. The capsules can be taken with or without food. Your doctor may decide to increase your dose depending on how your body responds to treatment. Your doctor will tell you how many capsules you need to take, and when you should take the capsules.
Use in children and adolescents (aged one month to 18 years)
In babies, children and adolescents the dose will be calculated based on the child’s weight. The starting dose will be calculated at 5 mg per kg per day. The maximum dose for children is 15 mg per kg per day. The doctor will decide how many times and when your child should receive the dose(s) to make up the total dose for the day. Your doctor may change the dose depending on how your child responds to treatment.
For babies, children and those who cannot swallow capsules and/or need to take a dose below 250 mg, a capsule may be opened and the contents mixed with 8.4% sodium bicarbonate solution. The active substance will be dissolved in the sodium bicarbonate solution and as not all the contents of the capsule will be dissolved it appears as a mixture. This mixture might be prepared and provided to you by your pharmacy. The mixture should be provided in a glass bottle and can be kept for up to 7 days. Do not refrigerate or freeze the mixture. Your doctor or pharmacist will give you instructions on how much and how often your child needs to take the mixture. The mixture contains sodium, tell your doctor if you are on a controlled sodium diet.
If you take more Chenodeoxycholic acid Leadiant than you should
Chenodeoxycholic acid Leadiant is unlikely to cause serious side effects. You should contact your doctor for advice if you or your child has taken more than the amount prescribed.
If you forget to take Chenodeoxycholic acid Leadiant
Skip the missed dose and 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 Chenodeoxycholic acid Leadiant
This medicine is for long-term use. Do not stop taking Chenodeoxycholic acid Leadiant without first speaking with your doctor. If you stop taking this medicine your symptoms may worsen.
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.
Side effects of unknown frequency (cannot be estimated from the available data)
- constipation
- liver problems
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 this leaflet. You can also report side effects directly via the national reporting system listed in By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Chenodeoxycholic acid Leadiant
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister pack after “EXP”. The expiry date refers to the last day of that month.
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 protect the environment.
6. Contents of the pack and other information
What Chenodeoxycholic acid Leadiant contains
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– The active substance is chenodeoxycholic acid. Each capsule contains 250 mg of chenodeoxycholic acid.
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– The other ingredients are:
What Chenodeoxycholic acid Leadiant looks like and contents of the pack
Chenodeoxycholic acid Leadiant is provided as size 0 hard capsules which are 21.7 mm in length. The capsules consist of a yellow body and an orange cap containing a white compressed powder.
Chenodeoxycholic acid Leadiant is available in blister packs containing 100 hard capsules.
Marketing Authorisation Holder
Leadiant GmbH
Liebherrstr. 22
80538 Munich
Germany
e-mail:
Manufacturer
Pharmaloop S.L.
C/Bolivia, no 15 Polígono Industrial Azque
Alcalá de Henares
Madrid 28806
Spain
This leaflet was last revised in
Other sources of information
Detailed information on this medicine is available on the European Medicines Agency web site: There are also links to other websites about rare diseases and treatments.
Information for healthcare professionals only
Preparation of chenodeoxycholic acid suspension
For children and adolescents (1 year to 18 years) as well as adults who cannot swallow capsules and/or need to take a dose below 250 mg, a capsule may be opened and the contents added to 25 mL of sodium bicarbonate solution 8.4% (1 mmol/mL) to produce a suspension containing chenodeoxycholic acid 10 mg/mL.
For infants (1 month to 11 months) a capsule may be opened and the contents added to 50 mL of sodium bicarbonate solution 8.4% (1 mmol/mL) to produce a suspension containing chenodeoxycholic acid 5 mg/mL.
Stir the mixture until all the powder is in suspension. Take care to scrape any powder from the side of the bowl into the mixture and stir (for about 5 minutes) to make sure that there are no lumps. The mixture is ready when there are no visible lumps or powder.
The suspension produced contains 22.9 mg of sodium per mL, which needs to be taken into consideration by patients on a controlled sodium diet.
It is recommended that this suspension is prepared by the pharmacy and instructions given to the parent on how to administer the suspension.
The suspension should be stored in a glass bottle. Do not refrigerate or freeze. The suspension is then stable for up to 7 days.
The pharmacy should provide oral dose syringes of appropriate volume and grading for administering the suspension. The correct volumes should preferably be marked on the oral syringe.
A pharmacy label should be placed on the bottle and include the patient’s name, dosing instructions, use by date, name of medicinal product and any other required information to be in compliance with local pharmacy regulations.
The doctor should provide information on the dose to be received according to the weight of the child. The dose range for paediatric patients (1 month to 18 years) is 5–15 mg/kg per day.
Dose calculation (children 1–11 years, adolescents 12–18 years and adults) chenodeoxycholic acid
10 mg/mL suspension __________________________________________________________
| Daily dose: | (Weight in kg) x (Dose in mg/kg) = Daily dose in mg |
| Divided dose* | (Daily dose in mg) = Divided dose in mg (Dose frequency) |
| Volume to administer: | (Divided dose in mg x 1 ml ) = Amount of suspension to give 10 mg |
| Example: | 10 kg patient on a dose of 15 mg/kg of chenodeoxycholic acid. The total daily dose = 10 kg x 15 mg/kg = 150 mg The divided dose when given three times a day = 150 mg = 50 mg 3 The corresponding amount of suspension to give = (50 mg x 1 ml) = 5 ml 10 mg |
| number of divided doses dependant on advice from doctor. | |
Dose calculation (infants 1 month-11 months) chenodeoxycholic acid 5 mg/mL suspension
| Daily dose: | (Weight in kg) x (Dose in mg/kg) = Daily dose in mg |
| Divided dose | (Daily dose in mg) = Divided dose in mg (Dose frequency) |
| Volume to administer: | (Divided dose in mg) x 1 ml = Amount of suspension to give 5 mg |
| Example: | 3 kg patient on a dose of 5 mg/kg of chenodeoxycholic acid. The total daily dose = 3 kg x 5 mg/kg = 15 mg The divided dose when given three times a day = 15 mg = 5 mg 3 The corresponding amount of suspension to give = (5 mg x 1 ml) = 1 ml 5 mg |
| *number of divided doses dependant on advice from doctor. | |
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