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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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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.

--------------------------------------------------------------------------------------------------------------------

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

Tomasz Grzelewski

Dermatology 21 years exp.

Dr Tomasz Grzelewski is an MD, PhD specialist in allergy, paediatrics, general practice and sports medicine, with a clinical focus on dermatology, endocrinology, allergology and sports-related health. He has more than 20 years of clinical experience and completed his medical training at the Medical University of Łódź, where he defended his PhD thesis with distinction. His doctoral research was recognised by the Polish Society of Allergology for its innovative contribution to the field. Throughout his career, he has gained extensive expertise in diagnosing and managing a wide range of allergic and paediatric conditions, including modern allergen desensitisation techniques. For five years, Dr Grzelewski served as the Head of two paediatric departments in Poland, managing complex clinical cases and leading multidisciplinary teams. He also worked in medical centres in the United Kingdom, gaining experience across both primary care and specialist environments. With over a decade of telemedicine experience, he has provided online consultations across Europe and is valued for his clear, structured and evidence-based medical guidance. Dr Grzelewski is actively involved in clinical programmes focused on modern anti-allergic therapies. As a Principal Investigator, he leads research projects on sublingual and oral allergen desensitisation, supporting evidence-based progress in allergy treatment for both children and adults. In addition to his background in allergology and paediatrics, he completed dermatology studies through the Cambridge Education Group (Royal College of Physicians of Ireland) and a Clinical Endocrinology course at Harvard Medical School. This advanced training enhances his ability to manage skin manifestations of allergies, atopic conditions, urticaria, endocrine-related symptoms and complex immunological reactions. Patients commonly seek his care for: 

  • seasonal and perennial allergies
  • allergic rhinitis and chronic nasal symptoms
  • asthma and breathing difficulties
  • food and medication allergies
  • urticaria, atopic dermatitis and skin reactions
  • recurrent infections in children
  • sports-related health questions
  • general family medicine concerns

Dr Tomasz Grzelewski is known for his clear communication style, structured medical approach and ability to explain treatment options in a concise and accessible way. His multidisciplinary background across allergy, paediatrics, dermatology and endocrinology allows him to provide safe, up-to-date and comprehensive care for patients of all ages.

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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

Daniel Cichi

Family medicine 24 years exp.

Dr Daniel Cichi is a family medicine doctor with over 20 years of clinical experience. He provides online consultations for adults, supporting patients with acute symptoms, chronic conditions, and everyday health concerns that require timely medical guidance. His background includes work in emergency care, ambulance services, and family medicine, which allows him to assess symptoms quickly, identify warning signs, and help patients choose the safest next steps – whether that means home care, treatment adjustment, or in-person evaluation. Patients commonly consult Dr Daniel Cichi for: 

  • acute symptoms: fever, infections, flu-like illness, cough, sore throat, shortness of breath;
  • chest discomfort, palpitations, dizziness, fatigue, and blood pressure concerns;
  • digestive problems: abdominal pain, nausea, diarrhoea, constipation, reflux;
  • sexually transmitted infections, erectile dysfunction;
  • muscle, joint, and back pain, minor injuries, post-traumatic symptoms;
  • chronic conditions: hypertension, diabetes, high cholesterol, thyroid disorders, weight loss, hair loss;
  • review and interpretation of lab tests, imaging reports, and medical documents;
  • medication review and treatment adjustment;
  • medical advice while travelling or living abroad;
  • second opinions and guidance on whether in-person care is needed.

Dr Cichi’s consultations are structured and practical. He focuses on clear explanations, risk assessment, and actionable recommendations, helping patients understand their symptoms and make informed decisions about their health.

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Doctor

Svetlana Kolomeeva

Cardiology 18 years exp.

Dr. Svetlana Kolomeeva is a general practitioner and internal medicine doctor providing online consultations for adults. She helps patients manage acute symptoms, chronic conditions, and preventive care. Her clinical focus includes cardiovascular health, hypertension control, and managing symptoms like fatigue, weakness, sleep issues, and overall low energy.

Patients commonly seek her help for:

  • High blood pressure, headaches, dizziness, swelling, palpitations.
  • Diagnosis and management of hypertension, arrhythmias, and tachycardia.
  • Metabolic syndrome, excess weight, high cholesterol.
  • Chronic fatigue, insomnia, poor concentration, anxiety.
  • Respiratory symptoms: colds, flu, sore throat, cough, fever.
  • Digestive issues: heartburn, bloating, constipation, IBS symptoms.
  • Chronic conditions: diabetes, thyroid disorders.
  • Interpretation of lab tests and medical reports, therapy adjustment.
  • Second opinion and decision-making support.
  • Cardiovascular disease prevention and metabolic risk reduction.
  • Long-term follow-up and dynamic health monitoring.

Dr Kolomeeva combines clinical expertise with personalised care. She clearly explains diagnoses, guides patients through symptoms and treatment options, and provides actionable plans. Her consultations are designed not only to address current complaints but also to stabilise chronic conditions and prevent future complications. She supports patients through every stage of care – from first symptoms to ongoing health management.

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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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