Product Information for the User

DIFICLIR 40 mg/ml Powder for Oral Suspension

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 who 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 oral suspension is used in adults, adolescents, and children from birth to less than 18 years of age, 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.

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 that is 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 stomach 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 clotting 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 if 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 if fidaxomicin passes into breast milk, although it is not expected to. 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 benzoate (E211)

This medication contains 2.5 mg of sodium benzoate (E 211) in each ml of oral suspension. Sodium benzoate (E 211) may increase the risk of jaundice (yellowing of the skin and eyes) in newborns (up to 4 weeks old).

DIFICLIR contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per 5 ml of suspension; this is essentially "sodium-free".

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

Your doctor will determine the dose based on your weight.

The standard dosing for patients weighing at least 12.5 kg is 200 mg (5 ml of oral suspension) administered twice a day (every 12 hours) for 10 days (see schedule 1 below). For adults and older children (e.g., adolescents), another formulation of this medication (tablets) may be more suitable; consult your doctor or pharmacist.

Your doctor may have prescribed an alternate dosing regimen. The recommendation for an alternate dosing regimen is administration twice a day for days 1-5. Do not take the dose on day 6, and then once a day on alternate days for days 7 to 25 (see schedule 2 below).

Schedule 1 – Standard Dosing

Schedule 2 – Alternate Dosing

5 ml – Dificlir 40 mg / ml granulated for oral suspension

• No suspension

The recommended dose for children based on their body weight is as follows:

You can take DIFICLIR before, during, or after meals.

How to take the DIFICLIR dose using an oral syringe

Your pharmacist or healthcare professional will prepare the oral suspension of DIFICLIR before giving it to you. If you have not been provided with the product in the form of a suspension, contact your pharmacist or healthcare professional.

Usage instructions:

Use the oral syringe and adapter provided by your pharmacist or healthcare professional to ensure you measure the correct amount. If you have not been provided with an oral syringe and adapter, contact your pharmacist or healthcare professional.

Your pharmacist will inform you on how to measure the medication using the oral syringe. Read the following instructions before using DIFICLIR in suspension.

1. Remove the bottle from the refrigerator 15 minutes before administration.

1. After 15 minutes, shake it 10 times gently and let it rest for 1 minute.
2. Check that the liquid has a uniform appearance and no lumps (i.e., homogeneous).

1. Remove the cap and attach the adapter to the bottle following the instructions of your pharmacist or healthcare professional.

1. Insert the tip of the oral syringe into the adapter until it is firmly in place.

1. Invert the bottle three times and let it stand upside down, with the syringe at the bottom.
2. Pull the plunger of the oral syringe to extract the prescribed volume of medication from the inverted bottle.

1. Keep the syringe attached and place the bottle upright; being careful not to move the plunger. Remove the syringe from the adapter and confirm that you have measured the correct dose.
2. Administer the oral suspension slowly directly into the patient's mouth until all the liquid is dispensed.

1. If you have a pressure adapter, leave it in place on the bottle neck or follow the instructions of your pharmacist or healthcare professional.

1. After administration, store the remaining suspension in the refrigerator.
2. To be able to reuse the oral syringe, rinse it with warm water (at least 3 times) or until clear water comes out of the syringe. Dry the external and internal surfaces as best you can. Let it dry until the next use.

If you started using this product in a hospital, your pharmacist or healthcare professional will deliver the suspension, oral syringe, and adapter at the time of discharge.

If you take more DIFICLIR than you should

If you have taken more oral suspension 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 oral suspension 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 doubts about using 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 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:

• nausea
• vomiting
• constipation.

Other possible adverse effects are as follows:

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

• loss of appetite

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

Adverse effects ofunknown frequency(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 them directly 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.

DIFICLIR will be provided in the form of a suspension that can be stored for a maximum of 27 days. Store in the refrigerator (between 2 °C and 8 °C). Do not use the suspension after the expiration date written on the label of the bottle.

Medicines should not be thrown down the drain or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. In this way, you will help protect the environment.

Composition of DIFICLIR

• The active ingredient is fidaxomicin.
• The other components are: microcrystalline cellulose, sodium starch glycolate, xanthan gum, citric acid, sodium citrate, sodium benzoate (see section 2), sucralose, and mixed berry flavor.

Appearance of the product and contents of the container

DIFICLIR is presented in an amber glass bottle as an oral suspension granule in a color between white and light yellow. Your pharmacist or healthcare professional will provide DIFICLIR in the form of a suspension in a color between white and light yellow. The container does not contain the oral syringe or adapter necessary for administering this product. Both will be provided by your pharmacist or another healthcare professional.

DIFICLIR is also available in the form of film-coated tablets.

Only some container sizes may be commercially available.

Marketing Authorization Holder

Tillotts Pharma GmbH

Warmbacher Strasse 80

79618 Rheinfelden

Germany

Responsible Person for Manufacturing

Almac Pharma Services Limited

Seagoe Industrial Estate, Portadown, Craigavon,

BT63 5UA,

United Kingdom

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

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This information is intended solely for healthcare professionals:

Reconstitution instructions:

1. Shake the glass bottle to check that the granule moves freely and is not clumped.
2. Measure 105 ml of purified water and add it to the glass bottle. Note that no stability of the fidaxomicin granule suspended in mineral water, tap water, or other liquids has been established.
3. Close the glass bottle and shake it vigorously for at least 1 minute.
4. Check that the resulting liquid does not contain any clumps or clumped granules at the bottom of the bottle. If clumps or clumped granules are observed, shake the glass bottle vigorously for at least 1 minute.
5. Leave the bottle to stand for 1 minute.
6. Check if the obtained suspension is homogeneous.
7. Write the expiration date of the reconstituted suspension on the bottle label (the shelf life of the reconstituted suspension is 27 days).
8. Store the bottle at a temperature between 2 and 8 °C before and during use.
9. Choose an oral syringe and adapter suitable for dispensing liquid medications to measure the dose correctly.

After reconstitution, the suspension (110 ml) will have a color between white and light yellow.

The healthcare professional must choose an oral syringe and adapter available on the market that are suitable for dispensing liquid medications and allow the patient or caregiver to measure the correct dose. The adapter must be suitable for use with the selected oral syringe and fit the neck of the bottle (e.g., a 27 mm pressure bottle adapter or a universal bottle adapter).

If fidaxomicin treatment is initiated in a hospital setting and the patient is discharged before completing treatment in the hospital, the suspension should be provided along with an oral syringe and adapter suitable for administration. Patients or caregivers should not prepare the oral suspension at home.

The following table shows the recommended oral syringe capacity for accurate dispensing.

Recommended oral syringe capacity for accurate dispensing

If possible, the dose corresponding to the correct dose (according to the dosing table in section 3) should be marked or highlighted on the oral syringe.

Administration through enteral feeding tube:

In the case of administration through an enteral feeding tube, the healthcare professional must choose an enteral feeding tube available on the market that is suitable. Polyvinyl chloride (PVC) and polyurethane (PUR) enteral feeding tubes have shown to be compatible with the oral suspension. The following table shows the recommended enteral feeding tube size and water flush volume.

Recommended enteral feeding tube size and water flush volume

* Based on 120 cm tubes