DIFICLIR 40 MG / ML GRANULES FOR ORAL SUSPENSION - patient leaflet, side effects, dosage

DIFICLIR

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.

What is in this leaflet

• 1. What DIFICLIR is and what it is used for

• 2. What you need to know before you take 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 which contains the active substance fidaxomicin.

DIFICLIR oral suspension is used in adults, adolescents and children from birth to less than 18 years to treat infections of the lining of the colon (large intestine) with certain bacteria called Clostridioides difficile. This serious illness can result in painful, severe diarrhoea. DIFICLIR works by killing the bacteria that cause the infection and helps to reduce the associated diarrhoea.

2. what you need to know before you take dificlirdo 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

Talk to your doctor or pharmacist before taking DIFICLIR.

If you feel that you might have a severe allergic reaction such as trouble breathing (dyspnea), swelling of the face or throat (angioedema), severe rash, severe itching (pruritus) or severe hives (urticaria), stop taking DIFICLIR and seek medical advice urgently from your doctor, pharmacist or at your local hospital emergency department (see section 4).

If you are allergic to macrolides (a class of antibiotics), ask your doctor for advice before using this medicine. Your doctor will tell you whether 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 whether this medicine is suitable for you.

There are limited data available on the use of fidaxomicin in severe cases of the disease (e.g. pseudomembranous colitis). Your doctor will know whether your disease falls in the severe categories and will tell you whether this medicine is suitable for you.

Other medicines and DIFICLIR

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

DIFICLIR blood levels can be affected by other medicines you take, and blood levels of other medicines can be affected by taking DIFICLIR.

Examples of such medicines are:

• – cyclosporin (a medicine used to dampen down the body’s immune reactions, used e.g. after an organ or bone marrow transplant, 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 stomach ulcer)

• – verapamil (a medicine used to treat high blood pressure or to prevent chest pain attacks, or used following a heart attack to prevent another one)

• – dronedarone and amiodarone (medicines used to control the heartbeat)

• – dabigatran etexilat (a medicine used to prevent the formation of blood clots after hip or knee replacement surgery)

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

Pregnancy and breast-feeding

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

This is because it is not known whether 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 whether fidaxomicin passes into breast milk, but it is not expected to do so.

If you are breastfeeding ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

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

DIFICLIR contains sodium benzoate (E211)

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

DIFICLIR contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per 5 ml suspension, that is to say essentially ‘sodium-free’.

3. how to take dificlir

Always take this medicine exactly as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are not sure.

Your doctor will determine your dose depending on your weight.

The recommended dose for patients weighing at least 12.5 kg is 200 mg (5 ml oral suspension) administered twice daily (once every 12 hours) for 10 days. Another form of this medicine (tablets) may be more suitable for adults and older children (e.g. adolescents); ask your doctor or pharmacist.

The recommended dose for children by body weight is as follows:

Weight band of patient	Mg per dose (every 12 hours)	Volume of fidaxomicin oral suspension (every 12 hours)
< 4.0 kg	40 mg	1 ml
4.0-<7.0 kg	80 mg	2 ml
7.0-<9.0 kg	120 mg	3 ml
9.0-< 12.5 kg	160 mg	4 ml
> 12.5 kg	200 mg	5 ml

You can take DIFICLIR before, during or after meals.

How to take the DIFICLIR dose using an oral syringe

Your pharmacist or heatlthcare professional will prepare DIFICLIR oral suspension before giving it to you. If the product is not provided to you as a suspension, please contact your pharmacist or healthcare professional.

Instructions for use:

Use the oral syringe and adaptor provided by the pharmacist or healthcare professional to make sure you measure the right amount. If an oral syringe and adaptor has not been provided to you, please contact your pharmacist or healthcare professional.

Your pharmacist will advise you how to measure the medicine using the oral syringe. Please see instructions below before using DIFICLIR suspension.

• 1. Take the bottle from the refrigerator 15 minutes prior to administration.

• 2. After 15 minutes, shake the bottle gently 10 times and let the bottle stand for 1 minute.

• 3. Verify if the liquid is smooth and not lumpy (i.e. homogenous).

• 4. Remove the cap and attach the adaptor to the bottle according to the instructions by your pharmacist or healthcare professional.

• 5. Insert the tip of the oral syringe into the adaptor until it is firmly in place.

• 6. Invert the bottle 3 times and turn the bottle upside down, so the syringe is on the bottom.

• 7. Pull back the plunger of the oral syringe to withdraw the amount prescribed by your doctor from the inverted bottle.

• 8. Leave the syringe in place and turn the bottle upright, ensuring the plunger does not move. Gently remove the syringe from the adaptor and confirm the appropriate dose has been measured.

• 9. Slowly dispense the oral suspension directly into the patient’s mouth until all of the liquid medicine is given.

• 10. If you have been given a press-in adaptor, leave the bottle adaptor in the neck of the bottle or follow the instructions by your pharmacist or healthcare professional.

• 11. After administration, store the remaining suspension in a refigerator.

• 12. To allow reuse of the oral syringe, flush the syringe with warm drinking water (3 times minimally) or until clear water comes out of the syringe. Dry external surfaces and internal surfaces as much as possible. Leave to dry until further use.

If you started using this product in a hospital, your pharmacist or healthcare professional will provide you with the suspension, oral syringe and adaptor at your discharge.

If you take more DIFICLIR than you should

If you have taken more of the oral suspension than you should have, talk to a doctor. Take the medicine pack with you so the doctor knows 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 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. Keep taking this medicine until the course is finished, even if you feel better. If you stop taking this medicine too soon, the infection may come back.

If you have any further questions on 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 trouble breathing (dyspnea), swelling of the face or throat (angioedema), severe rash or severe itching (pruritus) (see section 2). If such reaction occurs, stop taking DIFICLIR and seek medical advice urgently from your doctor, pharmacist or at your local 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 the following:

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

• – decreased appetite

• – dizziness, headache

• – dry mouth, altered taste (dysgeusia)

• – bloated feeling, wind (flatulence)

• – rash, itching (pruritus)

Not known side effects (frequency cannot be estimated from the available data)

• – swelling of the face and throat (angioedema), trouble breathing (dyspnea)

Additional side effects in children and adolescents

• – hives

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

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 expiry date refers to the last day of that month.

DIFICLIR will be supplied to you as a suspension, which can be stored for up to 12 days. Store in a refrigerator (2°C – 8°C). Do not use the suspension after the expiry date which is written on the bottle label.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. contents of the pack and other informationwhat dificlir contains- the active substance is fidaxomicin.

• – The other ingredients are: microcrystalline cellulose, sodium starch glycolate, xanthan gum, citric acid, sodium citrate, sodium benzoate (see section 2), sucralose and mixed berry flavour

What DIFICLIR looks like and contents of the pack

DIFICLIR is presented in an amber glass bottle as white to yellowish white granules for oral suspension. DIFICLIR will be supplied to you as a suspension by your pharmacist or healthcare professional, which will appear as white to yellowish white suspension.

The pack does not contain the oral syringe and adaptor for use with this product. These will be provided to you by your pharmacist or other healthcare professional.

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

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Tillotts Pharma UK Ltd

Wellingore Hall, Wellingore

Lincolnshire, LN5 0HX, UK

Tel: + 44 (0) 1522 813500

e-mail:

Manufacturer

Almac Pharma Services Limited

Seagoe Industrial Estate, Portadown, Craigavon, BT63 5UA,

United Kingdom

Tillotts Pharma GmbH

Warmbacher Str. 80

79618 Rheinfelden

Germany

This leaflet was last revised in 09/2021

The following information is intended for healthcare professionals only:

Instructions for reconstitution:

• 1. Shake the glass bottle to ensure the granules move around freely and no caking of the granules has occurred.

• 2. Measure 105 ml of purified water and add to the glass bottle. Note that the stability of fidaxomicin granules suspended in mineral water, tap water, or other liquids has not been established.

• 3. Close the glass bottle and shake vigorously for at least 1 minute.

• 4. Verify that the resulting liquid has no remaining caked granules left at the bottom of the bottle or any lumps. If caked granules or any lumps are observed, shake the glass bottle vigorously again for at least 1 minute.

• 5. Let the bottle stand for 1 minute.

• 6. Verify if a homogenous suspension is obtained.

• 7. Write the date of expiration of the reconstituted suspension on the bottle label (the shelf-life of the reconstituted suspension is 12 days).

• 8. Store the bottle at refrigerated temperature (2–8°C) before and during use.

• 9. Select an appropriate oral syringe and bottle adaptor suitable for dispensing liquid medicinal product to measure the correct dose.