200 mg film-coated tablets 
fidaxomicin

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

– Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.

– If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What DIFICLIR is and what it is used for 
2. What you need to know before you use DIFICLIR 
3. How to use DIFICLIR 
4. Possible side effects 
5. How to store DIFICLIR 
6. Contents of the packaging and other information 

1. What DIFICLIR is and what it is 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 the infection in the colonic mucosa, caused by bacteria called Clostridioides difficile. This serious illness can cause painful, severe diarrhea. DIFICLIR works by killing the bacteria that cause infection and helps reduce diarrhea associated with infection.

2. What you need to know before using DIFICLIR

Do not use DIFICLIR

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

Warnings and cautions

Talk to your doctor or pharmacist before using DIFICLIR.

If you think you may have a severe allergic reaction such as difficulty breathing ( dyspnoea ), swelling of the face or throat ( angioedema ), severe skin rash, severe itching, or severe hives ( urticaria ), stop taking DIFICLIR and contact a doctor, pharmacist immediately or the nearest emergency department (see section 4).

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

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

There are only limited data from the use of fidaxomicin in severe cases of the disease (eg pseudomembranous colitis ). Your doctor knows if your disease belongs to the difficult categories and will tell you if this medicine is suitable for you.

Children and young people

Do not give this medicine to children weighing less than 12.5 kg as these children need a lower dose. For an appropriate dosage for these patients, DIFICLIR granules for oral suspension may be used.

Other medicines and DIFICLIR

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

Blood levels of DIFICLIR may be affected by other medicines you are taking, and blood levels of other medicines may be affected by your taking DIFICLIR. Such drugs are, for example:

  • ciclosporin (a medicine used to suppress the body’s immune reactions. It is used eg after an organ or bone marrow transplant, for psoriasis or eczema, rheumatoid arthritis, or nephrotic syndrome )
  • ketoconazole (a medicine used to treat fungal infections)
  • erythromycin (a medicine used to treat infections of the ears, nose, throat, chest, and skin)
  • clarithromycin (a drug used to treat infection slower respiratory tract infection s throat and sinuses, infection s skin and tissue s and infection s with Helicobacter pylori in gastric ulcers and duodenal a)
  • verapamil (a medicine used to treat high blood pressure or to prevent angina) It can also be used after a heart attack to prevent a new heart attack)
  • dronedarone and amiodarone (medicines used to regulate heart rhythm)
  • dabigatran etexilate (a medicine used to prevent the formation of blood clots after hip or knee surgery)

You should not use DIFICLIR in combination with any of these medicines unless your doctor tells you to. If you are taking any of these medicines, ask your doctor for advice before taking this medicine.

Pregnancy and breastfeeding

You should not take DIFICLIR if you are pregnant unless your doctor tells you to.

The reason is that it is not known if fidaxomicin can harm your baby.

If you are pregnant or think you may be pregnant, ask your doctor or pharmacist for advice before taking this medicine.

It is not known if fidaxomicin passes into breast milk, but it is not expected to do so.

If you are breast-feeding, talk to your doctor or pharmacist before taking this medicine.

Driving and using machines

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

DIFICLIR contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per tablet, ie it is essentially ‘sodium-free’.

3. How to use DIFICLIR

Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

The recommended dose for patients weighing at least 12.5 kg is one tablet (200 mg), twice daily (one tablet every 12 hours) for 10 days. Swallow the tablets whole with a glass of water. You can take DIFICLIR before, during, or after a meal.

DIFICLIR granules for oral suspension should be used in patients weighing less than 12.5 kg. This form of medicine ( oral suspension ) may also be more suitable for patients over 12.5 kg, consult a doctor or pharmacist.

If you use more DIFICLIR than you should 

If you take more tablets than you should, talk to a doctor. Take the medicine pack with you so that the doctor knows what you have taken.

If you forget to use DIFICLIR

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

If you stop using DIFICLIR

Do not stop taking DIFICLIR unless your doctor has advised you to do so.

Continue to take this medicine until the end of the treatment, even if you feel better.

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

If you have any further questions on the use of this product, ask your doctor or pharmacist.

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 ( dyspnoea ), swelling of the face or throat ( angioedema ), severe rash, or severe itching ( pruritus ) (see section 2). If any of these reactions occur, stop taking DIFICLIR and contact a doctor, pharmacist, or nearest emergency department immediately.

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

  • vomiting
  • nausea
  • constipation

Other possible side effects are:

Uncommon side effects (may affect up to 1 in 100 people)

  • decreased appetite
  • dizziness, headache
  • dry mouth changed taste ( dysgeusia )
  • bloating, gas production ( flatulence )
  • skin rash, itching ( pruritus )

Unknown side effects (frequency cannot be calculated from the available data)

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

Additional side effects are in children and adolescents

  • hives

5. How to store 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 expiration date is the last day of the specified month.

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 to protect the environment.

6. Contents of the packaging and other information

Content declaration

  • The active substance is fidaxomicin. 1 film-coated tablet contains 200 mg fidaxomicin.
  • Other ingredients are Tablet core: microcrystalline cellulose, pregelatinized starch, hydroxypropyl cellulose, butylhydroxytoluene, sodium starch glycolate, and magnesium stearate. Coating: polyvinyl alcohol, titanium dioxide (E171), talc, polyethylene glycol, and lecithin (soy).

What the medicine looks like and the contents of the pack

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

DIFICLIR is available in:

100 x 1 film-coated tablets in perforated aluminum / aluminum single-dose blisters.

20 x 1 film-coated tablets in perforated alu / alu unit dose blisters.

DIFCLIR is also available as granules for oral suspension.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Astellas Pharma Europe BV

Sylviusweg 62

2333 BE Leiden

Netherlands

Contact the representative of the marketing authorization holder to find out more about this medicine:

Muhammad Nadeem

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