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CHENODEOXYCHOLIC ACID LEADIANT 250 mg HARD CAPSULES

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About the medicine

How to use CHENODEOXYCHOLIC ACID LEADIANT 250 mg HARD CAPSULES

Translated with AI

This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.

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Introduction

Package Leaflet: Information for the User

Chenodeoxycholic Acid Leadiant 250 mg Hard Capsules

Chenodeoxycholic Acid

This medicine 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 this leaflet includes information on 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 or pharmacist.
  • 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 or pharmacist, even if you think they are not serious. See section 4.

Contents of the Package Leaflet

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

1. What is Chenodeoxycholic Acid Leadiant and what is it used for

Chenodeoxycholic Acid Leadiant capsules contain a substance called chenodeoxycholic acid. This substance is normally produced in the liver from cholesterol. It is part of bile, a liquid that helps digest fats and vitamins from food. Patients with a rare disease called cerebrotendinous xanthomatosis (CTX) cannot produce chenodeoxycholic acid, which causes an accumulation of fatty acid deposits in various parts of the body. This accumulation can cause damage to the affected areas.

Chenodeoxycholic Acid Leadiant capsules treat CTX by replacing chenodeoxycholic acid, thus preventing the accumulation of fatty acid deposits.

Chenodeoxycholic Acid Leadiant capsules can be used from the first month of life and patients with CTX require treatment for the rest of their life.

Doctor consultation

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2. What you need to know before you take Chenodeoxycholic Acid Leadiant

Do not take Chenodeoxycholic Acid Leadiant

  • 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 treatment, your doctor will perform blood and urine tests to monitor your response to this medicine and to adjust the dose if necessary. Your doctor will inform you if there is any reason why you should stop treatment with Chenodeoxycholic Acid Leadiant.

Infants

The safety and efficacy of Chenodeoxycholic Acid Leadiant in infants under one month of age have not been studied.

Taking Chenodeoxycholic Acid Leadiant with other medicines

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

The following medicines may affect Chenodeoxycholic Acid Leadiant levels:

  • ciclosporin and sirolimus (medicines used to suppress the immune system)
  • phenobarbital (a medicine for epilepsy)

If your doctor considers it necessary for you to take ciclosporin, sirolimus or phenobarbital, they will closely monitor your blood and urine test results and adjust the dose of Chenodeoxycholic Acid Leadiant if necessary.

Oral contraceptives may affect the functioning of Chenodeoxycholic Acid Leadiant, making it less effective. It is not recommended to take oral contraceptives during treatment with Chenodeoxycholic Acid Leadiant. Consult your doctor about other suitable contraceptive methods.

The following medicines may reduce the effect of Chenodeoxycholic Acid Leadiant:

  • cholestyramine, colestipol (bile acid sequestrants)
  • medicines for heartburn (antacids) containing aluminium hydroxide and/or smectite (aluminium oxide)

If you need to take colestyramine, take Chenodeoxycholic Acid Leadiant one hour before colestyramine or 4 to 6 hours after.

Other medicines mentioned should be taken 2 hours before or 2 hours after taking Chenodeoxycholic Acid Leadiant.

Consult your doctor if you are taking any of these medicines.

Pregnancy and breastfeeding

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

Chenodeoxycholic Acid Leadiant is not recommended during pregnancy and breastfeeding. It is not known whether Chenodeoxycholic Acid Leadiant passes into breast milk.

Women should use an effective contraceptive method while being treated with Chenodeoxycholic Acid Leadiant. Oral contraceptives are not recommended. Consult your doctor about other suitable contraceptive methods.

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

Follow exactly the administration instructions of this medicine given by your doctor.

In case of doubt, consult your doctor again. The usual initial dose is one 250 mg capsule three times a day.

The maximum dose 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 taken whole and with water, approximately at the same time every 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 them.

Use in children and adolescents (from 1 month to 18 years)

In infants and children, the dose should be calculated based on body weight. The initial dose will be 5 mg per kg per day. The maximum dose for children is 15 mg per kg per day. Your doctor will decide on the number and frequency of doses to cover the child's total daily dose. Your doctor may decide to change the dose depending on how the child's body responds to treatment.

For infants, children, and adults who cannot swallow capsules and/or need to take a dose less than 250 mg, these can be opened and mixed with a sodium bicarbonate solution (8.4%, 1 mmol/ml) to produce a suspension containing 10 mg/ml of chenodeoxycholic acid.

For infants: the capsules can be opened to add their contents to 50 ml of sodium bicarbonate solution (8.4%, 1 mmol/ml) to produce a suspension containing 5 mg/ml of chenodeoxycholic acid.

Remove the mixture until all the powder is suspended. Make sure to introduce all the powder that has remained on the edges into the mixing glass and stir the contents (for about 5 minutes) until the mixture is homogeneous without visible powder residues. The mixture will be ready when no powder residues are visible.

The resulting suspension contains 22.9 mg of sodium per ml, which should be taken into account in patients with low-sodium diets.

The suspension is easily formed and is ready when no powder residues are visible. It is recommended that this suspension be prepared in a pharmacy and that instructions be provided to parents on how to administer it.

The suspension should be stored in a glass container. Do not refrigerate or freeze. The suspension remains stable for a maximum of 7 days.

In the pharmacy, you can be provided with oral dosing syringes with the correct volume and graduation to administer the suspension. It is preferable that oral syringes have the correct volumes marked.

A label from the pharmacy should be placed on the container, including the patient's name, dosing instructions, expiration date, medicine name, and any other information required by local pharmacy regulations.

Your doctor will provide information on the dose to be administered to the child based on their weight. The dosing interval in children is 5-15 mg/kg per day.

Dose calculation (children from 1 to 12 years, adolescents from 12 to 18 years, and adults):10 mg/mlof chenodeoxycholic acid in suspension

Table with daily dose calculations and divided doses in mg/kg for a 10 kg patient using chenodeoxycholic acid and its administration volumes

Dose calculation (infants from 1 month to 1 year):5 mg/mlof chenodeoxycholic acid in suspension

Table with daily dose calculations divided into milligrams per kilogram of weight and volume to be administered in milliliters

Medicine questions

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Discuss your symptoms and treatment with a doctor online.

4. Possible side effects

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

Adverse reactions of unknown frequency (cannot be estimated from the available data)

  • Constipation
  • Abnormal liver function test values

Reporting of side effects

If you experience side effects, talk to your doctor or pharmacist, even if you think they are not serious. 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. Storage of 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 on the blisters after “EXP”. The expiry date is the last day of the month stated.

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

  • What Chenodeoxycholic Acid Leadiant contains
  • The active substance is chenodeoxycholic acid.
  • Each capsule contains 250 mg of chenodeoxycholic acid.
  • The other ingredients are:

Each capsule contains: corn starch, magnesium stearate, colloidal anhydrous silica, water. Capsule shell: gelatin, titanium dioxide (E 171), quinoline yellow (E 104), erythrosine (E 127)

Appearance of the product and pack contents

Chenodeoxycholic Acid Leadiant is presented in hard capsules. The capsules are formed by a yellow body and an orange cap containing a white compressed powder.

Chenodeoxycholic Acid Leadiant is available in blisters containing 100 hard capsules.

Marketing authorisation holder

Leadiant GmbH

Liebherrstr. 22

80538 Munich

Germany

Email: [email protected]

Manufacturer

Pharmaloop S.L.

C/Bolivia, no 15 Polígono Industrial Azque

Alcalá de Henares

Madrid 28806

Spain

Date of last revision of this leaflet: <{MM/AAAA}>.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu. There are also links to other websites on rare diseases and orphan medicines.

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Information for healthcare professionals

Patients who cannot swallow the capsules

For children, adolescents, and adults who cannot swallow the capsules, or who need to take doses less than 250 mg, these can be opened to add their contents to 25 ml of sodium bicarbonate solution (8.4%, 1 mmol/ml) to produce a suspension containing 10 mg/ml of chenodeoxycholic acid.

For infants: the capsules can be opened to add their contents to 50 ml of sodium bicarbonate solution (8.4%, 1 mmol/ml) to produce a suspension containing 5 mg/ml of chenodeoxycholic acid.

Remove the mixture until all the powder is suspended. Make sure to introduce all the powder that has remained on the edges into the mixing glass and stir the contents (for about 5 minutes) until the mixture is homogeneous without visible powder residues. The mixture will be ready when no powder residues are visible.

The resulting suspension contains 22.9 mg of sodium per ml, which should be taken into account in patients with low-sodium diets.

The suspension is easily formed and is ready when no powder residues are visible. It is recommended that this suspension be prepared in a pharmacy and that instructions be provided to parents on how to administer it.

The suspension should be stored in a glass container. Do not refrigerate or freeze. The suspension remains stable for a maximum of 7 days.

In the pharmacy, you can be provided with oral dosing syringes with the correct volume and graduation to administer the suspension. It is preferable that oral syringes have the correct volumes marked.

A label from the pharmacy should be placed on the container, including the patient's name, dosing instructions, expiration date, medicine name, and any other information required by local pharmacy regulations.

Your doctor will provide information on the dose to be administered to the child based on their weight. The dosing interval in children is 5-15 mg/kg per day.

Dose calculation (children from 1 to 12 years, adolescents from 12 to 18 years, and adults):10 mg/mlof chenodeoxycholic acid in suspension

Dose calculation (infants from 1 month to 1 year):5 mg/mlof chenodeoxycholic acid in suspension

Online doctors for CHENODEOXYCHOLIC ACID LEADIANT 250 mg HARD CAPSULES

Discuss questions about CHENODEOXYCHOLIC ACID LEADIANT 250 mg HARD CAPSULES, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

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Doctor

Hocine Lokchiri

General medicine 21 years exp.

Dr. Hocine Lokchiri is a French consultant with over 20 years of experience in General and Emergency Medicine. He works with adults and children, helping patients with urgent symptoms, infections, sudden health changes and everyday medical concerns that require timely evaluation. His background includes clinical practice in France, Switzerland and the United Arab Emirates, which allows him to navigate different healthcare systems and manage a wide range of conditions with confidence. Patients value his calm, structured approach, clear explanations and evidence-based decision-making.

Online consultations with Dr. Lokchiri are suitable for many situations when someone needs quick medical guidance, reassurance or a clear next step. Common reasons for booking include:

  • fever, chills, fatigue and viral symptoms
  • cough, sore throat, nasal congestion, breathing discomfort
  • bronchitis and mild asthma flare-ups
  • nausea, diarrhoea, abdominal pain, digestive infections
  • rashes, allergic reactions, redness, insect bites
  • muscle or joint pain, mild injuries, sprains
  • headache, dizziness, migraine symptoms
  • stress-related symptoms, sleep disturbances
  • questions about test results and treatment plans
  • management of chronic conditions in stable phases
Many patients reach out when symptoms appear suddenly and cause concern, when a child becomes unwell unexpectedly, when a rash changes or spreads, or when it’s unclear whether an in-person examination is necessary. His emergency medicine background is particularly valuable online, helping patients understand risk levels, identify warning signs and choose safe next steps.

Some situations are not suitable for online care. If a patient has loss of consciousness, severe chest pain, uncontrolled bleeding, seizures, major trauma or symptoms suggesting a stroke or heart attack, he will advise seeking immediate local emergency services. This improves safety and ensures patients receive the right level of care.

Dr. Lokchiri’s professional training includes:

  • Advanced Trauma Life Support (ATLS)
  • Basic and Advanced Cardiac Life Support (BLS/ACLS)
  • Pediatric Advanced Life Support (PALS)
  • Prehospital Trauma Life Support (PHTLS)
  • eFAST and critical care transthoracic echocardiography
  • aviation medicine
He is an active member of several professional organisations, including the French Society of Emergency Medicine (SFMU), the French Association for Emergency Physicians (AMUF) and the Swiss Society of Emergency and Rescue Medicine (SGNOR). In consultations, he works with clarity and precision, helping patients understand their symptoms, possible risks and the safest treatment options.
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Doctor

Yevgen Yakovenko

General surgery 12 years exp.

Dr. Yevgen Yakovenko is a licensed surgeon and general practitioner in Spain and Germany. He specialises in general, paediatric, and oncological surgery, internal medicine, and pain management. He offers online consultations for adults and children, combining surgical precision with therapeutic support. Dr Yakovenko works with patients across different countries and provides care in Ukrainian, Russian, English, and Spanish.

Areas of medical expertise:

  • Acute and chronic pain: headaches, muscle and joint pain, back pain, abdominal pain, postoperative pain. Identifying the cause, selecting treatment, and creating a care plan.
  • Internal medicine: heart, lungs, gastrointestinal tract, urinary system. Management of chronic conditions, symptom control, second opinions.
  • Pre- and postoperative care: risk assessment, decision-making support, follow-up after surgery, rehabilitation strategies.
  • General and paediatric surgery: hernias, appendicitis, congenital conditions, both planned and urgent surgeries.
  • Injuries and trauma: bruises, fractures, sprains, soft tissue damage, wound care, dressing, referral when in-person care is required.
  • Oncological surgery: diagnosis review, treatment planning, and long-term follow-up.
  • Obesity treatment and weight management: a medical approach to weight loss, including assessment of underlying causes, evaluation of comorbidities, development of a personalised plan (nutrition, physical activity, pharmacotherapy if needed), and ongoing progress monitoring.
  • Imaging interpretation: analysis of ultrasound, CT, MRI, and X-ray results, surgical planning based on imaging data.
  • Second opinions and medical navigation: clarifying diagnoses, reviewing current treatment plans, helping patients choose the best course of action.

Experience and qualifications:

  • 12+ years of clinical experience in university hospitals in Germany and Spain.
  • International education: Ukraine – Germany – Spain.
  • Member of the German Society of Surgeons (BDC).
  • Certified in radiological diagnostics and robotic surgery.
  • Active participant in international medical conferences and research.

Dr Yakovenko explains complex topics in a clear, accessible way. He works collaboratively with patients to analyse health issues and make evidence-based decisions. His approach is grounded in clinical excellence, scientific accuracy, and respect for each individual.

If you are unsure about a diagnosis, preparing for surgery, or want to discuss your test results – Dr Yakovenko will help you evaluate your options and move forward with confidence.

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Doctor

Anna Biriukova

General medicine 6 years exp.

Dr Anna Biriukova is an internal medicine doctor with clinical experience in cardiology, endocrinology, and gastroenterology. She provides online consultations for adults, offering expert medical support for heart health, hormonal balance, digestive issues, and general internal medicine.

Cardiology – Diagnosis and treatment of:

  • High blood pressure, blood pressure fluctuations, and cardiovascular risk prevention.
  • Chest pain, shortness of breath, arrhythmias (tachycardia, bradycardia, palpitations).
  • Leg swelling, chronic fatigue, reduced exercise tolerance.
  • EKG interpretation, lipid profile evaluation, cardiovascular risk assessment (heart attack, stroke).
  • Post-COVID-19 cardiac monitoring and care.
Endocrinology – Diabetes, thyroid, metabolism:
  • Diagnosis and management of type 1 and type 2 diabetes, and prediabetes.
  • Individual treatment plans including oral medications and insulin therapy.
  • GLP-1 therapy– modern pharmacological treatment for weight management and diabetes control, including drug selection, monitoring, and safety follow-up.
  • Thyroid disorders – hypothyroidism, hyperthyroidism, autoimmune thyroid diseases (Hashimoto’s, Graves’ disease).
  • Metabolic syndrome – obesity, lipid disorders, insulin resistance.
Gastroenterology – Digestive health:
  • Abdominal pain, nausea, heartburn, gastroesophageal reflux (GERD).
  • Stomach and intestinal conditions: gastritis, irritable bowel syndrome (IBS), indigestion.
  • Management of chronic digestive disorders and interpretation of tests (endoscopy, ultrasound, labs).
General internal medicine and preventive care:
  • Respiratory infections – cough, colds, bronchitis.
  • Lab test analysis, therapy adjustments, medication management.
  • Adult vaccinations – planning, contraindications assessment.
  • Cancer prevention – screening strategies and risk assessment.
  • Holistic approach – symptom relief, complication prevention, and quality of life improvement.
Dr Biriukova combines internal medicine with specialist insight, offering clear explanations, personalised treatment plans, and comprehensive care tailored to each patient.
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Doctor

Lina Travkina

Family medicine 13 years exp.

Dr. Lina Travkina is a licensed family and preventive medicine doctor based in Italy. She provides online consultations for adults and children, supporting patients across all stages of care – from acute symptom management to long-term health monitoring and prevention.

Areas of medical care include:

  • Respiratory conditions: colds, flu, acute and chronic bronchitis, mild to moderate pneumonia, bronchial asthma.
  • ENT and eye conditions: sinusitis, tonsillitis, pharyngitis, otitis, infectious and allergic conjunctivitis.
  • Digestive issues: gastritis, acid reflux (GERD), IBS, dyspepsia, bloating, constipation, diarrhoea, functional bowel symptoms, intestinal infections.
  • Urological and infectious diseases: acute and recurrent cystitis, bladder and kidney infections, prevention of recurrent UTIs, asymptomatic bacteriuria.
  • Chronic conditions: hypertension, diabetes, hypercholesterolemia, metabolic syndrome, thyroid disorders, excess weight.
  • Neurological and general symptoms: headache, migraine, dizziness, fatigue, sleep disturbances, reduced concentration, anxiety, asthenia.
  • Chronic pain support: back, neck, joint, and muscle pain, tension syndromes, pain associated with osteochondrosis and chronic conditions.

Additional care areas:

  • Preventive consultations and check-up planning.
  • Medical advice and follow-up consultations.
  • Test interpretation and diagnostic guidance.
  • Structured support for undiagnosed complaints.
  • Second opinion on diagnoses and treatment plans.
  • Nutritional and lifestyle support for vitamin deficiencies, anaemia, metabolic issues.
  • Post-operative recovery support and pain management.
  • Preconception counselling and postpartum support.
  • Immunity support and strategies to reduce frequency of infections.

Dr. Travkina combines evidence-based medicine with an attentive, personalised approach. Her consultations focus not only on treatment, but also on prevention, recovery, and long-term wellbeing.

If during the consultation it becomes clear that your case requires in-person assessment or specialised care outside of her scope, the session will be terminated and the payment fully refunded.

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Frequently Asked Questions

Is a prescription required for CHENODEOXYCHOLIC ACID LEADIANT 250 mg HARD CAPSULES?
CHENODEOXYCHOLIC ACID LEADIANT 250 mg HARD CAPSULES requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
What is the active substance in CHENODEOXYCHOLIC ACID LEADIANT 250 mg HARD CAPSULES?
The active ingredient in CHENODEOXYCHOLIC ACID LEADIANT 250 mg HARD CAPSULES is chenodeoxycholic acid. This information helps identify medicines with the same composition but different brand names.
Who manufactures CHENODEOXYCHOLIC ACID LEADIANT 250 mg HARD CAPSULES?
CHENODEOXYCHOLIC ACID LEADIANT 250 mg HARD CAPSULES is manufactured by Leadiant Gmbh. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of CHENODEOXYCHOLIC ACID LEADIANT 250 mg HARD CAPSULES online?
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether CHENODEOXYCHOLIC ACID LEADIANT 250 mg HARD CAPSULES is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
What are the alternatives to CHENODEOXYCHOLIC ACID LEADIANT 250 mg HARD CAPSULES?
Other medicines with the same active substance (chenodeoxycholic acid) include URSODESOXYCHOLIC ACID GRINDEKS 250 mg HARD CAPSULES, ADISOCOL 150 mg TABLETS, ADISOCOL 250 mg HARD CAPSULES. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
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