DIFICLIR 200 mg FILM-COATED TABLETS

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.

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

Scheme 2 – Alternative Dosage

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.

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