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Orphacol 50mg hard capsules

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About the medicine

How to use Orphacol 50mg hard capsules

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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

Orphacol 50 mg hard capsules

Orphacol 250 mg hard capsules Cholic acid

This medicinal product 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 the leaflet includes information on how to report side effects.

  • Read all of this leaflet carefully before you start taking this medicine.
  • 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, as it may harm them, even if their symptoms 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 or were not listed in this leaflet. See section 4.

of side effects that are not listed in this leaflet.

Contents of the pack:

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

1. What Orphacol is and what it is used for

Orphacol contains cholic acid, a bile acid produced normally by the liver. Some medical disorders are caused by defects in bile acid production, and Orphacol is used to treat infants from 1 month of age to 2 years, children, adolescents, and adults with these disorders. The cholic acid in Orphacol replaces the missing bile acids due to the defect in bile acid production.

Doctor consultation

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2. What you need to know before you take Orphacol

Do not take Orphacol

  • if you are allergic to cholic acid or any of the other ingredients of this medicine (listed in section 6).
  • if you are taking phenobarbital, a medicine used to treat epilepsy.

Warnings and precautions

Your doctor will ask you to have blood and urine tests and liver tests when you start treatment and then at regular intervals. Do not forget to visit your doctor for these regular check-ups at least once a year.

Using Orphacol with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Some medicines used to reduce cholesterol levels, known as bile acid sequestrants (cholestyramine, colestipol, colesevelam), and medicines used to treat heartburn that contain aluminum, may reduce the effect of Orphacol. If you take these medicines, you should take Orphacol at least 5 hours before or at least 5 hours after these other medicines. Cyclosporine (a medicine used to suppress the immune system) may also alter the effect of Orphacol. Tell your doctor if you are taking these medicines.

Pregnancy and breastfeeding

Consult your doctor if you are planning to become pregnant. Have a pregnancy test as soon as you think you may be pregnant. It is very important that you continue to take Orphacol during pregnancy.

If you become pregnant during treatment with Orphacol, your doctor will decide on the best treatment and dose for your situation. As a precaution, your doctor will closely monitor your condition and that of the fetus throughout the pregnancy.

Orphacol can be administered during breastfeeding. Tell your doctor if you plan to start or have started breastfeeding before taking Orphacol.

Consult your doctor or pharmacist before taking any medicine.

Driving and using machines

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

Orphacol contains lactose

Orphacol contains a sugar (lactose monohydrate). If your doctor has told you that you have an intolerance to some sugars, consult them before taking this medicine.

3. How to take Orphacol

Follow the instructions for administration of Orphacol exactly as told by your doctor. If you are unsure, consult your doctor.

The usual starting dose is 5 to 15 mg per kilogram of body weight per day in infants, children, adolescents, and adults.

Before treatment, your doctor will assess the results of your tests to determine the correct dose for your case. Your doctor will then adjust the dose based on your body's response.

Orphacol capsules should be taken with food, approximately at the same time every day, in the morning and/or evening. Taking Orphacol at the same time every day with a meal will help you remember to take this medicine and may help your body absorb it better. The capsules should be swallowed whole with water, without chewing.

If your doctor has prescribed a dose that requires you to take more than one capsule per day, you and your doctor will decide how to take it throughout the day. You can, for example, take one capsule in the morning and another in the evening. This way, you will have to take fewer capsules at one time.

Use in children

In infants and children who cannot swallow capsules, the capsules can be opened and the contents added to an infant formula or a juice suitable for young children.

If you take more Orphacol than you should

If you take more Orphacol than you should, contact your doctor as soon as possible. Your doctor will assess the results of your tests and tell you if you should resume your treatment with the normal dose.

If you forget to take Orphacol

Take the next dose at the usual time. Do not take a double dose to make up for forgotten doses.

If you stop taking Orphacol

If you stop taking Orphacol, you risk suffering from irreversible liver damage. Never stop taking Orphacol unless your doctor tells you to.

If you have any other questions about the use of this product, ask your doctor.

Medicine questions

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Discuss your symptoms and treatment with a doctor online.

4. Possible side effects

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

Some patients have experienced itching and/or diarrhea, but the frequency cannot be estimated from the available data. If you experience itching or diarrhea for more than three days, tell your doctor.

Bile duct stones have been reported after long-term treatment with Orphacol.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if you think they are not serious or were not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Orphacol

Keep out of the sight and reach of children.

Do not use Orphacol after the expiry date which is stated on the carton and blister after "EXP". The expiry date refers to the last day of the month shown.

Store below 30°C.

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 further information

Composition of Orphacol

  • The active substance is cholic acid.

Orphacol 50 mg: Each hard capsule contains 50 mg of cholic acid.

Orphacol 250 mg: Each hard capsule contains 250 mg of cholic acid.

  • The other ingredients are:

Contents of the capsules: Lactose monohydrate, colloidal anhydrous silica, magnesium stearate

Capsule shell:

Orphacol 50 mg: gelatin, titanium dioxide (E171), carmine (E132);

Orphacol 250 mg: gelatin, titanium dioxide (E171), carmine (E132), yellow iron oxide (E172);

Appearance and packaging of the product

Orphacol is presented in hard, oblong capsules. The 50 mg capsules are blue and white, and the 250 mg capsules are green and white. They are presented in blisters of 10 capsules.

The medicinal product is marketed in pack sizes of 30, 60, and 120 capsules. Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder

THERAVIA

16 Rue Montrosier

92200 Neuilly-sur-Seine

France

Manufacturer

THERAVIA

16 Rue Montrosier

92200 Neuilly-sur-Seine

France

You can obtain further information on this medicinal product by contacting the local representative of the marketing authorisation holder:

België/Belgique/Belgien

THERAVIA

Tel: +32 (0)2 40 11 442

[email protected]

Lietuva

Immedica Pharma AB

Tel: +46 (0)8 533 39 500

[email protected]

Text with the name THERAVIA and contact information including phone number and email address

Luxembourg/Luxemburg

THERAVIA

Tel: +352 278 62 329

[email protected]

Ceská republika

THERAVIA

Tel: + 33 (0)1 70 76 06 37

[email protected]

Magyarország

Medis Hungary Kft

Tel: +36 (2) 380 1028

[email protected]

Danmark

Medical Need Europe AB

Tlf: +46 (0)8 533 39 500

[email protected]

Malta

THERAVIA

Tel: +356 2776 1358

[email protected]

Deutschland

THERAVIA

Tel: +49 (0)6 922 221 311

[email protected]

Nederland

THERAVIA

Tel: +31 (0)2 070 38 155

[email protected]

Eesti

Immedica Pharma AB

Tel: +46 (0)8 533 39 500

[email protected]

Norge

Immedica Pharma AB

Tel: +46 (0)8 533 39 500

[email protected]

Ελλάδα

THERAVIA

Tel: + 33 (0)1 70 76 06 37

[email protected]

Österreich

THERAVIA

Tel: +43 (0) 800 909 699

[email protected]

España

THERAVIA

Tel: + (34) 915635856

[email protected]

Polska

THERAVIA

Tel: + 33 (0)1 70 76 06 37

[email protected]

France

THERAVIA

Tel: + 33 (0)1 70 76 06 37

[email protected]

Portugal

THERAVIA

Tel: + 33 (0)1 70 76 06 37

[email protected]

Hrvatska

Medis Adria d.o.o.

Tel: +385 (1) 230 3446

[email protected]

România

THERAVIA

Tel: + 33 (0)1 70 76 06 37

[email protected]

Ireland

THERAVIA

Tel: +353 (0)1 695 00 63

[email protected]

Slovenija

Medis d.o.o.

Tel: +386 (1) 589 6900

[email protected]

Ísland

Immedica Pharma AB

Sími: + 46 (0)8 533 39 500

[email protected]

Slovenská republika

THERAVIA

Tel: + 33 (0)1 70 76 06 37

[email protected]

Italia

THERAVIA

Tel: + 33 (0)1 70 76 06 37

[email protected]

Suomi/Finland

Immedica Pharma AB

Tel: +46 (0)8 533 39 500

[email protected]

Κύπρος

THERAVIA

Tel: + 33 (0)1 70 76 06 37

[email protected]

Sverige

Immedica Pharma AB

Tel: +46 (0)8 533 39 500

[email protected]

Latvija

Immedica Pharma AB

Tel: +46 (0)8 533 39 500

[email protected]

United Kingdom (Northern Ireland)

THERAVIA

Tel: +44 (0)3 301 002 375

[email protected]

Date of last revision of this leaflet:

This medicinal product has been authorised under an exceptional circumstances.

This means that due to the rarity of the disease and for ethical reasons, it has not been possible to obtain complete information on this medicinal product.

The European Medicines Agency will review any new information that may become available every year and this leaflet will be updated as necessary.

Other sources of information

Detailed information on this medicinal product is available on the European Medicines Agency web site http://www.ema.europa.eu. It also provides links to other web sites on rare diseases and orphan medicines.

Online doctors for Orphacol 50mg hard capsules

Discuss questions about Orphacol 50mg hard capsules, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

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Tarek Agami

General medicine 11 years exp.

Dr. Tarek Agami is a general practitioner registered in both Portugal and Israel, with broad experience in family and preventive medicine. He offers online consultations for adults and children, providing personalised support for primary care needs, chronic disease management, and everyday health concerns.

Dr. Agami received clinical training and worked in leading medical institutions in Israel (Kaplan Medical Center, Barzilai Medical Center, Wolfson Medical Center) and Portugal (European Healthcare City, Viscura Internacional, Hospital Dr. José Maria Grande, Hospital Vila Franca de Xira). His approach combines international medical standards with individualised attention to each patient.

Main areas of consultation:

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  • Treatment adjustments and lifestyle recommendations based on your personal history
Dr. Agami provides medical support for patients using GLP-1 medications (such as Ozempic or Mounjaro) as part of a weight loss strategy. He offers individualised treatment planning, regular follow-up, dose adjustment, and advice on combining medication with sustainable lifestyle changes. Consultations follow the medical standards accepted in Portugal and Israel.

Dr. Agami is committed to evidence-based, patient-centred care, ensuring that each person receives trusted medical support tailored to their health goals.

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Nuno Tavares Lopes

Family medicine 18 years exp.

Dr. Nuno Tavares Lopes is a licensed physician in Portugal with 17 years of experience in emergency medicine, family and general practice, and public health. He is the Director of Medical and Public Health Services at an international healthcare network and serves as an external consultant for the WHO and ECDC.

  • Emergency care: infections, fever, chest/abdominal pain, minor injuries, paediatric emergencies
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  • Sick leave (Baixa médica) connected to Segurança Social in Portugal
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Dr. Nuno Tavares Lopes provides medical support for patients using GLP-1 medications (Mounjaro, Wegovy, Ozempic, Rybelsus) as part of a weight loss strategy. He offers individualised treatment planning, regular follow-up, dose adjustment, and advice on combining medication with sustainable lifestyle changes. Consultations follow the medical standards accepted in Europe.

Dr. Lopes also provides interpretation of medical tests, follow-up care for complex patients, and multilingual support. Whether for urgent concerns or long-term care, he helps patients act with clarity and confidence.

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Anastasiia Shalko

Family medicine 13 years exp.

Dr. Anastasiia Shalko is a general practitioner with a background in both paediatrics and general medicine. She graduated from Bogomolets National Medical University in Kyiv and completed her paediatric internship at the P.L. Shupyk National Medical Academy of Postgraduate Education. After working as a paediatrician in Kyiv, she relocated to Spain, where she has been practising general medicine since 2015, providing care for both adults and children.

Her work focuses on urgent, short-term medical concerns – situations where patients need quick guidance, symptom assessment and clear next steps. She helps people understand whether their symptoms require in-person evaluation, home management or a change in treatment. Common reasons for booking an online consultation include:

  • acute respiratory symptoms (cough, sore throat, runny nose, fever)
  • viral illnesses such as colds and seasonal infections
  • gastrointestinal complaints (nausea, diarrhoea, abdominal pain, gastroenteritis)
  • sudden changes in how a child or adult feels
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Dr. Shalko works specifically with urgent and short-term problems, providing practical recommendations and helping patients determine the safest next step. She explains symptoms clearly, guides patients through decision-making and offers straightforward medical advice for everyday acute issues.

She does not provide long-term management of chronic conditions, ongoing follow-up or comprehensive care plans for complex long-term illnesses. Her consultations are designed for acute symptoms, sudden concerns and situations where timely medical input is important.

With clinical experience in both paediatrics and general medicine, Dr. Shalko confidently supports adults and children. Her communication style is clear, simple and reassuring, helping patients feel informed and supported throughout the consultation.

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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:

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  • 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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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:

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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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€55

Frequently Asked Questions

Is a prescription required for Orphacol 50mg hard capsules?
Orphacol 50mg 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 Orphacol 50mg hard capsules?
The active ingredient in Orphacol 50mg hard capsules is cholic acid. This information helps identify medicines with the same composition but different brand names.
Who manufactures Orphacol 50mg hard capsules?
Orphacol 50mg hard capsules is manufactured by Theravia. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of Orphacol 50mg 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 Orphacol 50mg 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 Orphacol 50mg hard capsules?
Other medicines with the same active substance (cholic acid) include Orphacol 250mg hard capsules, CHENODEOXYCHOLIC ACID LEADIANT 250 mg HARD CAPSULES, URSODESOXYCHOLIC ACID GRINDEKS 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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