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DIFICLIR 200 mg FILM-COATED TABLETS

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About the medicine

How to use DIFICLIR 200 mg FILM-COATED TABLETS

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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

DIFICLIR 200 mg film-coated tablets

fidaxomicin

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. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is DIFICLIR and what is it used for

DIFICLIR is an antibiotic that contains the active substance fidaxomicin.

DIFICLIR film-coated tablets are used in adults, adolescents, and children who weigh at least 12.5 kg to treat infections of the lining of the colon (large intestine) caused by bacteria called Clostridioides difficile. This serious disease can cause severe and painful diarrhea. DIFICLIR works by killing the bacteria that cause the infection and helps reduce the associated diarrhea.

Doctor consultation

Not sure if this medicine is right for you?

Discuss your symptoms and treatment with a doctor online.

2. What you need to know before you take DIFICLIR

Do not take DIFICLIR

  • If you are allergic to fidaxomicin or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before taking DIFICLIR.

If you think you may have a severe allergic reaction such as difficulty breathing (dyspnea), swelling of the face or throat (angioedema), severe rash, severe itching (pruritus), or severe hives (urticaria), stop taking DIFICLIR and seek urgent medical attention (see section 4).

If you are allergic to macrolides (a type of antibiotic), consult your doctor before using this medicine. Your doctor will tell you if this medicine is suitable for you.

If you have liver or kidney problems, consult your doctor before using this medicine. Your doctor will tell you if this medicine is suitable for you.

There is limited data on the use of fidaxomicin in severe cases of the disease (e.g., pseudomembranous colitis). Your doctor will know if your disease is in the severe categories and will indicate if this medicine is suitable for you.

Children and adolescents

Do not give this medicine to children who weigh less than 12.5 kg, as these children require a lower dose. To dose DIFICLIR appropriately in these patients, DIFICLIR granules for oral suspension can be used.

Other medicines and DIFICLIR

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

The levels of DIFICLIR in your blood may be affected by other medicines you take, and the levels of other medicines in your blood may be affected by taking DIFICLIR. Some examples of such medicines are:

  • ciclosporin (a medicine used to suppress the body's immune reactions, used, for example, after organ or bone marrow transplantation, for psoriasis or eczema, or for rheumatoid arthritis or nephrotic syndrome)
  • ketoconazole (a medicine used to treat fungal infections)
  • erythromycin (a medicine used to treat ear, nose, throat, chest, and skin infections)
  • clarithromycin (a medicine used to treat chest infections, throat and sinus infections, skin and tissue infections, and Helicobacter pyloriinfections associated with duodenal or stomach ulcers)
  • verapamil (a medicine used to treat high blood pressure or to prevent chest pain attacks, or used after a heart attack to prevent another)
  • dronedarone and amiodarone (medicines used to control heart rhythm)
  • dabigatran etexilate (a medicine used to prevent blood clots after hip or knee replacement surgery).

Do not use DIFICLIR in combination with any of these medicines, unless your doctor tells you to. If you are using any of these medicines, please consult your doctor before taking this medicine.

Pregnancy and breastfeeding

Do not take DIFICLIR if you are pregnant, unless your doctor tells you to.

This is because it is not known if fidaxomicin can harm your baby.

If you are pregnant or think you may be pregnant, consult your doctor or pharmacist before using this medicine.

It is not known if fidaxomicin passes into breast milk, although it is not expected to.

If you are breastfeeding, consult your doctor or pharmacist before using this medicine.

Driving and using machines

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

DIFICLIR contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per tablet; this is essentially “sodium-free”.

3. How to take DIFICLIR

Follow exactly the administration instructions of this medicine given by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again.

The standard dosage for patients who weigh at least 12.5 kg is one tablet (200 mg) twice a day (one tablet every 12 hours) for 10 days (see Scheme 1 below).

Your doctor may have prescribed an alternative dosage. The recommendation for an alternative dosage is administration twice a day for days 1-5. Do not take a tablet on day 6, and then once a day on alternate days for days 7 to 25 (see also Scheme 2 below).

Scheme 1 – Standard Dosage

DAY

1

2

3

4

5

6

7

8

9

10

Morning

200 mg

200 mg

200 mg

200 mg

200 mg

200 mg

200 mg

200 mg

200 mg

200 mg

Evening

200 mg

200 mg

200 mg

200 mg

200 mg

200 mg

200 mg

200 mg

200 mg

200 mg

Scheme 2 – Alternative Dosage

DAY

1

2

3

4

5

Morning

200 mg

200 mg

200 mg

200 mg

200 mg

Evening

200 mg

200 mg

200 mg

200 mg

200 mg

DAY

6

7

8

9

10

11

12

13

14

15

-

200 mg

-

200 mg

-

200 mg

-

200 mg

-

200 mg

DAY

16

17

18

19

20

21

22

23

24

25

-

200 mg

-

200 mg

-

200 mg

-

200 mg

-

200 mg

200 mg - DIFICLIR 200 mg film-coated tablets

  • No tablet

Swallow the tablets whole with a glass of water. You can take DIFICLIR before, during, or after meals.

In patients who weigh less than 12.5 kg, DIFICLIR granules for oral suspension should be used. This formulation (oral suspension) may also be more suitable for patients who weigh more than 12.5 kg; consult your doctor or pharmacist.

If you take more DIFICLIR than you should

If you have taken more tablets than you should, consult a doctor. Take the medicine package with you to show the doctor what you have taken.

If you forget to take DIFICLIR

Take the tablet as soon as you remember, unless it is time for your next dose. In this case, skip the missed dose. Do not take a double dose to make up for forgotten doses.

If you stop taking DIFICLIR

Do not stop taking DIFICLIR unless your doctor has told you to.

Keep taking this medicine until you finish the treatment, even if you feel better.

If you stop taking this medicine too soon, the infection may come back.

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

Medicine questions

Started taking the medicine and have questions?

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.

A severe allergic reaction may occur, including difficulty breathing (dyspnea), swelling of the face or throat (angioedema), severe rash, or severe itching (pruritus) (see section 2). If such reactions occur, stop taking DIFICLIR and seek urgent medical attention.

The most commonside effects (may affect up to 1 in 10 people) are:

  • vomiting
  • nausea
  • constipation

Other possible side effects are:

Uncommonside effects (may affect up to 1 in 100 people)

  • decreased appetite
  • dizziness, headache
  • dry mouth, altered taste (dysgeusia)
  • feeling full, gas (flatulence)
  • rash, itching (pruritus)

Frequency not knownside effects (frequency cannot be estimated from the available data)

  • swelling of the face and throat (angioedema), difficulty breathing (dyspnea)

Other side effects in children and adolescents

  • hives

Reporting of side effects

If you experience 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 Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing DIFICLIR

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 after “EXP”. The expiry date refers to the last day of the month shown.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of DIFICLIR

  • The active substance is fidaxomicin. Each film-coated tablet contains 200 mg of fidaxomicin.
  • The other ingredients are:

Core of the tablet: microcrystalline cellulose, pregelatinized starch, hydroxypropyl cellulose, butylhydroxytoluene, sodium starch glycolate, and magnesium stearate

Coating: polyvinyl alcohol, titanium dioxide (E171), talc, polyethylene glycol, and lecithin (from soy)

Appearance and packaging

DIFICLIR 200 mg film-coated tablets are capsule-shaped, white to off-white, with “FDX” engraved on one side and “200” on the other side.

DIFICLIR is available in:

Alu/alu unit-dose blisters of 100 x 1 film-coated tablet.

Alu/alu unit-dose blisters of 20 x 1 film-coated tablet.

DIFICLIR is also available as granules for oral suspension.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Tillotts Pharma GmbH

Warmbacher Strasse 80

79618 Rheinfelden

Germany

Date of last revision of this leaflet:

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu

Online doctors for DIFICLIR 200 mg FILM-COATED TABLETS

Discuss questions about DIFICLIR 200 mg FILM-COATED TABLETS, including use, safety considerations and prescription review, subject to medical assessment and local regulations.

5.0 (3)
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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5.0 (29)
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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€60
5.0 (29)
Doctor

Dmytro Horobets

Family medicine 7 years exp.

Dr. Dmytro Horobets is a licensed family medicine physician in Poland, specialising in endocrinology, diabetology, obesity management, gastroenterology, pediatrics, general surgery, and pain medicine. He offers online consultations for adults and children, providing personalised medical support for a wide range of acute and chronic health concerns.

Areas of expertise:

  • Endocrinology: diabetes type 1 and type 2, prediabetes, thyroid disorders, metabolic syndrome, hormonal imbalance.
  • Obesity medicine: structured weight management plans, nutritional counselling, obesity-related health risks.
  • Gastroenterology: acid reflux (GERD), gastritis, irritable bowel syndrome (IBS), liver and biliary conditions.
  • Pediatric care: infections, respiratory symptoms, digestive issues, growth and development monitoring.
  • General surgery support: pre- and post-surgical consultations, wound care, rehabilitation.
  • Pain management: chronic and acute pain, back pain, joint pain, post-traumatic pain syndromes.
  • Cardiovascular health: hypertension, cholesterol control, risk assessment for heart disease.
  • Preventive medicine: regular check-ups, health screenings, long-term management of chronic conditions.

Dr. Horobets combines evidence-based medicine with a patient-centred approach. He carefully evaluates each patient’s medical history and symptoms, offering clear explanations and structured treatment plans adapted to individual needs.

Whether you need help managing diabetes, tackling weight-related health issues, interpreting lab results, or receiving general family medicine support, Dr. Horobets provides professional online care tailored to your specific health goals.

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€60

Frequently Asked Questions

Is a prescription required for DIFICLIR 200 mg FILM-COATED TABLETS?
DIFICLIR 200 mg FILM-COATED TABLETS 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 DIFICLIR 200 mg FILM-COATED TABLETS?
The active ingredient in DIFICLIR 200 mg FILM-COATED TABLETS is fidaxomicin. This information helps identify medicines with the same composition but different brand names.
Who manufactures DIFICLIR 200 mg FILM-COATED TABLETS?
DIFICLIR 200 mg FILM-COATED TABLETS is manufactured by Tillotts Pharma Gmbh. Pharmacy brands and packaging may differ depending on the distributor.
Which doctors can assess the use of DIFICLIR 200 mg FILM-COATED TABLETS 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 DIFICLIR 200 mg FILM-COATED TABLETS 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 DIFICLIR 200 mg FILM-COATED TABLETS?
Other medicines with the same active substance (fidaxomicin) include DIFICLIR 40 mg/ml ORAL SUSPENSION GRANULES, HUMATIN 250 mg HARD CAPSULES, MYCOSTATIN 100,000 IU/ml ORAL SUSPENSION. 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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