Dificlir 200 mg film-coated tablets

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

DIFICLIR 200 mg film-coated tablets

fidaxomicin

Read the entire leaflet carefully before you start taking this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

1. What DIFICLIR is and what it is used for
2. What you need to know before taking DIFICLIR
3. How to take DIFICLIR
4. Possible side effects
5. How to store DIFICLIR
6. Contents of the pack 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 weighing at least 12.5 kg to treat infections of the lining of the colon (large intestine) caused by bacteria called Clostridioides difficile. This serious condition can cause severe and painful diarrhea. DIFICLIR works by killing the bacteria causing the infection and helps reduce the associated diarrhea.

2. What you need to know before taking DIFICLIR

Do not take DIFICLIR

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

Warnings and precautions

Talk to your doctor or pharmacist before taking DIFICLIR.

If you think you may be experiencing 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 immediate medical attention from your doctor, pharmacist, or hospital emergency department (see section 4).

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

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

Limited data are available on the use of fidaxomicin in severe cases of the disease (e.g., pseudomembranous colitis). Your doctor will know whether your condition falls into a severe category and will advise you whether this medicine is appropriate for you.

Children and adolescents

Do not administer this medicine to children weighing less than 12.5 kg, as these children require a lower dose. To ensure appropriate dosing of DIFICLIR in these patients, DIFICLIR granules for oral suspension may be used.

Other medicines and DIFICLIR

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to 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 taking DIFICLIR. Some examples of such medicines are:

• cyclosporine (a medicine used to suppress immune responses in the body, 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 pylori infections associated with duodenal or gastric ulcers)
• verapamil (a medicine used to treat high blood pressure or to prevent angina 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).

You should not take DIFICLIR together with any of these medicines unless your doctor tells you otherwise. If you are taking any of these medicines, please consult your doctor before taking this medicine.

Pregnancy and breastfeeding

Do not take DIFICLIR during pregnancy unless your doctor tells you to do so.

This is because it is unknown whether fidaxomicin could harm your baby.

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

It is unknown whether fidaxomicin passes into breast milk, although it is not expected to do so.

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

Driving and use of machines

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

DIFICLIR contains sodium

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

3. How to take DIFICLIR

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The standard dosage for patients weighing at least 12.5 kg is one tablet (200 mg) twice daily (one tablet every 12 hours) for 10 days (see schedule 1 below).

Your doctor may have prescribed an alternative dosing regimen. The recommendation for an alternative dosing regimen is administration twice daily on days 1–5. Do not take a tablet on day 6, then once daily on alternate days from days 7 to 25 (see also schedule 2 below).

Schedule 1 – Standard dosing

Schedule 2 – Alternate dosing

200 mg - Dificlir 200 mg film-coated tablets

• Do not crush the tablet.

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

In patients weighing less than 12.5 kg, DIFICLIR granules for oral suspension should be used. This formulation (oral suspension) may also be more suitable for patients weighing 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 so that the doctor can see what you have taken.

If you forget to take DIFICLIR

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

If you stop taking DIFICLIR

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

Continue taking this medicine until the end of the treatment period, even if you feel better.

If you stop taking this medicine too early, the infection may return.

If you have any further 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 everyone will experience them.

A serious 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 treatment with DIFICLIR immediately and seek urgent medical advice from your doctor, pharmacist, or hospital emergency department.

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

• vomiting
• nausea
• constipation

Other possible side effects are listed below:

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

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

Side effects of unknown frequency (frequency cannot be estimated from 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 type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You may also report them directly through the national reporting system detailed in Appendix V. By reporting side effects, you help provide more information on the safety of this medicine.

5. Storage of DIFICLIR

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the packaging after “EXP”. The expiry date is the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This 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 components are:

Tablet core: microcrystalline cellulose, pregelatinized starch, hydroxypropyl cellulose, butyl hydroxytoluene, sodium starch glycolate, and magnesium stearate.
Coating: polyvinyl alcohol, titanium dioxide (E171), talc, polyethylene glycol, and lecithin (from soybean)

Appearance of the product and contents of the pack

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

DIFICLIR is available in:

Alu/alu unit dose cut blister packs containing 100 x 1 film-coated tablet.
Alu/alu unit dose cut blister packs containing 20 x 1 film-coated tablet.

DIFICLIR is also available as granules for oral suspension.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Tillotts Pharma GmbH
Warmbacher Strasse 80
79618 Rheinfelden
Germany

Date of the most recent review of this leaflet:

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