Dificlir – Package Leaflet: InfoCons – Consumer Protection presents, in an accessible format, the official package leaflet of the medicine Dificlir, as authorised in the European Union and published in the Union Register of medicinal products.
Before anything else
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 illne ss 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 i n 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 film-coated tablets are used in adults , adolescents and children with a body weight of at least 12.5 kg to treat infections of the lining of the colon (large int estine) 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 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
Talk to your doctor or pharmacist before taking DIFIC LIR.
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 t ell 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.
35 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 categor ies and will tell you whether this medicine is suitable for you.
Children and adol escents Do not give this medicine to children with a body weight below 12.5 kg , because these children require a reduced dose. For appropriate dosing in these patients , DIFICLIR granules for oral suspension may be used.
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 arthr itis or nephrotic syndrome) − ketoconazole (a medicine used to treat fungal infections) − erythromycin (a medicine used to treat ear, nose, throat, chest and skin infections) − clarit hromycin (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 t o 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 fidaxomic in 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 t his medicine.
Driving and using machines
DIFICLIR is not expected to affect your ability to drive, use tools or machine s.
DIFICLIR contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per tablet , 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.
The standard dosing for patients weighing at least 12.5 kg is one tablet (200 mg) twice daily (one table t every 12 hours) for 10 days (see scheme 1 below) .
It is possible that your doctor has prescribed an alternate dosing. The recommendation for an alternate 36 dosing is twice daily administration for days 1- 5. Do not take a tablet on day 6, then once daily every other day for the days 7- 25 (see also scheme 2 below).
Scheme 1 – Standard dosing DAY 1 2 3 4 5 6 7 8 9 10 Morning 200 mg 200 mg 200 mg 200 mg 200 mg 200 mg 200 mg 200 mg 200 mg 200 mg Evening 200 mg 200 mg 200 mg 200 mg 200 mg 200 mg 200 mg 200 mg 200 mg 200 mg Scheme 2 – Alternate dosing 200 mg – Dificlir 200 mg film -coated tablet
- No tablet Swallow the tablets whole with a glass of water. You can take DIFICLIR before, during or after meals.
DIFICLIR granules for oral suspension should be used for patients with a body weight of less than 12.5 kg. This form of this medicine (oral suspension) may also be more suitable for patients above 12.5 kg; ask your doctor or pharmacist .
If you take more DIFICLIR than you should
If you have taken more tablets 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 tablet 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 o r 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), se vere 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.
DAY 1 2 3 4 5 Morning 200 mg 200 mg 200 mg 200 mg 200 mg Evening 200 mg 200 mg 200 mg 200 mg 200 mg DAY 6 7 8 9 10 11 12 13 14 15
- 200 mg – 200 mg – 200 mg – 200 mg – 200 mg DAY 16 17 18 19 20 21 22 23 24 25
- 200 mg – 200 mg – 200 mg – 200 mg – 200 mg 37 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 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 si de 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 th at month.
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 information
What DIFICLIR contains
− The active substance is fidaxomicin. Each film -coated tablet contains 200 mg of fidaxomicin. − The other ingredients are:
Tablet core: microcrystalline cellulose, pregelatini sed starch, hydroxypropyl cellulose, butylated hydroxytoluene, sodium starch glycolate and magnesium stearate Coating: polyvinyl alcohol, titanium dioxide (E171) , talc, polyethylene glycol and lecithin (soy) What DIFICLIR looks like and contents of the pa ck DIFICLIR 200 mg film-coated tablets are capsule shaped tablets, white to off -white in colour, with “FDX” on one side and “200” on the other side.
DIFICLIR is available in:
100 x 1 film -coated tablet in alu/alu perforated unit dose blisters .
20 x 1 film-coated tablet in alu/alu perforated unit dose blisters .
DIFICLIR is also available in the form of granules for oral suspension.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Tillotts Pharma GmbH Warmbacher Strasse 80 38 79618 Rheinfelden Germany
This leaflet was last revised in
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu 39 Package leaflet: Information for the user DIFICLIR 40 mg/ml granules for oral suspension 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.
ℹ️ 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 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
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 e mergency 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 probl ems, ask your doctor for advice before using this medicine. Your doctor will tell you whether this medicine is suitable for you.
40 There are limited data available on the use of fidaxomicin in severe cases of the disease (e.g. pseudomembranous colitis). Yo ur 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 me dicines.
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 pres sure 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 breas t-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 machine s.
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 jaund ice (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 standard dosing 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 (see scheme 1 below) .
It is possible that your doctor has prescribed an alternate dosing. The recommendation for an alternate 41 dosing is twice daily a dministration for days 1- 5. Do not take a dose on day 6, then once daily every other day for the days 7- 25 (see also scheme 2 below).
Scheme 1 – Standard dosing DAY 1 2 3 4 5 6 7 8 9 10 Morning 5 ml 5 ml 5 ml 5 ml 5 ml 5 ml 5 ml 5 ml 5 ml 5 ml Evening 5 ml 5 ml 5 ml 5 ml 5 ml 5 ml 5 ml 5 ml 5 ml 5 ml Scheme 2 – Alternate dosing 5 ml – Dificlir 40 mg/ml granules for oral suspension
- No medicine 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. I f 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 professiona l.
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 . DAY 1 2 3 4 5 Morning 5 ml 5 ml 5 ml 5 ml 5 ml Evening 5 ml 5 ml 5 ml 5 ml 5 ml DAY 6 7 8 9 10 11 12 13 14 15
- 5 ml – 5 ml – 5 ml – 5 ml – 5 ml DAY 16 17 18 19 20 21 22 23 24 25
- 5 ml – 5 ml – 5 ml – 5 ml – 5 ml 42 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 admi nistration, 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 m uch as possible. Leave to dry until further use.
If you started using this product in a hospital, your pharmacist or health care 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 (p ruritus) (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, itch ing (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 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. 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 27 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 information
What 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 p ack do es 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 marke ted.
Marketing Authorisation Holder
Tillotts Pharma GmbH Warmbacher Strasse 80 79618 Rheinfelden Germany
Manufacturer
Almac Pharma Services Limited Seagoe Industrial Estate, Portadown, Craigavon, BT63 5UA, United Kingdom Tillotts Pharma GmbH Warmbacher Strasse 80 79618 Rheinfelden Germany
This leaflet was last revised in
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu —————————————————————————————————————————
🩺 Information 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 min eral 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 27 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.
After reconstitution, the suspension (110 ml) will appear as white to yellowish white .
An appropriate commerci ally available oral syringe and adaptor suitable for dispensing of liquid medicines should be selected by the health care professional in order to allow the patient or caregiver to measure the correct dose. The adaptor should be suitable for use in combinat ion with the selected oral syringe and fits the bottle neck size , for example a press -in bottles adaptor (27 mm) or universal bottle adapter.
In case the treatment with fidaxomicin started in a hospital setting and the patient is discharged before the end of the treatment at the hospital, the patient should be provided with the oral suspension and a suitable oral syringe and adaptor . Patients or caregivers should not prepare the oral suspension at home.
Recommended oral syringe capacity for measuring the dose of the oral suspension is presented in the table below.
Suggested oral s yringe capacity for accurate dispensing Prescribed dosing volume Recommended oral syringe capacity 1 ml 1 ml oral syringe 2 – 5 ml 5 ml oral syringe If possible, the graduation corresponding to the appropriate dose should be marked or highlighted (according to the dosing table in section 3) on the oral syringe.
45 Administration via an enteral feeding tube :
In case of administration using an enteral feeding tube, an appropriate commercially available tube should be selected by the healthcare professional. Enteral feeding t ubes made of polyvinylchloride (PVC) and polyurethane (PUR) have been shown compatible with the oral suspension. The recommended enteral feeding tube size and flush volume of water are provided in the table below.
Recommended enteral feeding tube size and flush volume Recommended tube size (diameter) Recommended flush volume * 4 Fr at least 1 mL 5 Fr at least 2 mL 6 – 7 Fr at least 3 mL 8 Fr at least 4 mL
- Based on tubes of 120 cm
📄 Package Leaflet – official source
This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Dificlir (PDF, ec.europa.eu).
You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/11/733).
⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.