Product Information for the User

DIFICLIR 200 mg Film-Coated Tablets

fidaxomicina

Read this entire product information carefully before starting to take this medicine, as it contains important information for you.

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

DIFICLIR is an antibiotic that contains the active ingredient fidaxomicina.

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

Do not take DIFICLIR

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

Warnings and precautions

Consult your doctor or pharmacist before starting to take DIFICLIR.

If you think you may have a severe allergic reaction such as difficulty breathing (dyspnea), facial or throat swelling (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 medication. Your doctor will tell you if this medication is suitable for you.

If you have liver or kidney problems, consult your doctor before using this medication. Your doctor will tell you if this medication 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 condition falls into the severe categories and will indicate if this medication is suitable for you.

Children and adolescents

Do not administer this medication to children weighing less than 12.5 kg, as these children require a lower dose. To adequately dose DIFICLIR for these patients, DIFICLIR granulated for oral suspension may be used.

Other medications and DIFICLIR

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

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

• ciclosporin (a medication used to inhibit the body's immune reactions, used, for example, after an organ or bone marrow transplant, for psoriasis or eczema, or for rheumatoid arthritis or nephrotic syndrome)
• ketoconazole (a medication used to treat fungal infections)
• erythromycin (a medication used to treat ear, nose, throat, chest, and skin infections)
• clarithromycin (a medication 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 medication used to treat high blood pressure or to prevent angina attacks, or used after a heart attack to prevent another)
• dronedarone and amiodarone (medications used to control heart rhythm)
• dabigatran etexilate (a medication used to prevent blood clot formation after hip or knee replacement surgery).

You should not use DIFICLIR in combination with any of these medications unless your doctor tells you otherwise. If you are using any of these medications, please consult your doctor before taking this medication.

Pregnancy and breastfeeding

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

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

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

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 medication.

Driving and operating machinery

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

DIFICLIR contains sodium

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

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

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

Your doctor may have prescribed an alternate dosing. The recommendation for an alternate dosing 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 schedule 2 below).

Schedule 1 – Standard Dosing

Schedule 2 – Alternate Dosing

200 mg - Dificlir 200 mg film-coated tablets

• Not a tablet

Swallow the tablets whole with a glass of water. You can 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 take, consult a doctor. Bring the medication packaging with you so the doctor can know what you have taken.

If you forget to take DIFICLIR

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

If you interrupt treatment with DIFICLIR

Do not stop taking DIFICLIR unless your doctor has recommended it.

Continue taking this medication until you complete the treatment, even if you feel better.

If you stop taking this medication too soon, the infection may recur.

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

A severe allergic reaction may occur, including difficulty breathing (dyspnea), facial or throat inflammation (angioedema), severe rash or severe itching (pruritus) (see section 2). If such reactions occur, discontinue treatment with DIFICLIR and seek immediate medical attention from your doctor, pharmacist, or hospital emergency department.

The adverse effectsmost frequent(may affect up to 1 in 10 people) are:

• vomiting
• nausea
• constipation.

Other possible adverse effects are as follows:

Adverse effectsinfrequent(may affect up to 1 in 100 people)

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

Adverse effects ofunknown frequency(the frequency cannot be estimated from available data)

• facial and throat inflammation (angioedema), difficulty breathing (dyspnea)

Other adverse effects in children and adolescents

• hives

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report themdirectly through thenational notification system included in theAppendix V.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.

Composition of DIFICLIR

• The active ingredient 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 Tablet coating: polyvinyl alcohol, titanium dioxide (E171), talc, polyethylene glycol, and lecithin (from soy)

Appearance of the product and contents of the packaging

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 single-dose pre-cut blisters of 100 x 1 film-coated tablet.

Alu/alu single-dose pre-cut blisters of 20 x 1 film-coated tablet.

DIFICLIR is also available in a granulated form for oral suspension.

Only some package sizes may be marketed.

Marketing authorization holder andmanufacturer

Tillotts Pharma GmbH

Warmbacher Strasse 80

79618 Rheinfelden

Germany

Last review date of this leaflet:

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