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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.

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Jorge Correa Bellido

General medicine 7 years exp.

Dr. Jorge Correa Bellido is a Spanish physician who offers online consultations in Spanish and English. He graduated from the University of La Laguna and has a solid background in clinical practice and international research.

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With a patient-centered approach and a strong commitment to continuous learning, Dr. Correa Bellido provides accessible and high-quality healthcare to patients both in Spain and around the world.

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Tarek Agami

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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.

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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.

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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.

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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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Chikeluo Okeke

General medicine 4 years exp.

Dr Chikeluo Okeke is an internal medicine doctor with extensive international clinical experience. Originally from Nigeria, he has worked across multiple European healthcare systems and currently practises in Sweden. This professional path has given him a strong understanding of different medical approaches and the ability to work effectively with patients from diverse cultural and linguistic backgrounds.

Dr Okeke focuses on general internal medicine and adult primary care, combining clinical accuracy with careful attention to lifestyle, personal context, and everyday health concerns. His consultations are particularly well suited for people who seek medical advice online, live abroad, or need clear guidance without unnecessary complexity.

He provides online consultations covering symptom assessment, prevention, and long-term management of chronic conditions, helping patients understand what is happening and decide on appropriate next steps.

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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.

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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.

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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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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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