Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Fidaxomicin 40 mg/ml granules for oral suspension
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Fidaxomicin may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for FIDAXOMICIN is an antibiotic which contains the active substance fidaxomicin. FIDAXOMICIN 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. FIDAXOMICIN works by killing the bacteria that cause the infection and helps to reduce the associated diarrhoea.
What you need to know before you take it
e FIDAXOMICIN Do not take FIDAXOMICIN − 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 FIDAXOMICIN. 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 FIDAXOMICIN 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.
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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 FIDAXOMICIN Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. FIDAXOMICIN blood levels can be affected by other medicines you take, and blood levels of other medicines can be affected by taking FIDAXOMICIN. 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 FIDAXOMICIN 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 FIDAXOMICIN 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 FIDAXOMICIN is not expected to affect your ability to drive, use tools or machines. FIDAXOMICIN 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). FIDAXOMICIN 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 FIDAXOMICIN 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). 2
It is possible that your doctor has prescribed an alternate dosing. The recommendation for an alternate dosing is twice daily administration for days 1-5. Do not take any 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
5 ml
5 ml
5 ml
5 ml
5 ml
5 ml
5 ml
5 ml
5 ml
5 ml
5 ml
5 ml
5 ml
5 ml
5 ml
5 ml
5 ml
5 ml
5 ml
5 ml
Morning Evening
Scheme 2 – Alternate dosing DAY 1 2
3
4
5
5 ml
5 ml
5 ml
5 ml
5 ml
5 ml
5 ml
5 ml
5 ml
5 ml
Morning Evening
DAY
6 7 8 9 10 5 ml 5 ml DAY 16 17 18 19 20 5 ml 5 ml 5 ml – Fidaxomicin 40 mg/ml granules for oral suspension No medicine
11
12
13
14
15
5 ml
–
5 ml
–
5 ml
21
22
23
24
25
5 ml
–
5 ml
–
5 ml
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)
< 4.0 kg 4.0 – < 7.0 kg 7.0 – < 9.0 kg 9.0 – < 12.5 kg ≥ 12.5 kg
40 mg 80 mg 120 mg 160 mg 200 mg
Volume of fidaxomicin oral suspension (every 12 hours) 1 ml 2 ml 3 ml 4 ml 5 ml
You can take FIDAXOMICIN before, during or after meals.
How to take it
the FIDAXOMICIN dose using an oral syringe Your pharmacist or heatlthcare professional will prepare FIDAXOMICIN 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 FIDAXOMICIN suspension. 1. 2. 3. 4.
Take the bottle from the refrigerator 15 minutes prior to administration. After 15 minutes, shake the bottle gently 10 times and let the bottle stand for 1 minute. Verify if the liquid is smooth and not lumpy (i.e. homogenous). 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. 3
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 FIDAXOMICIN 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 FIDAXOMICIN 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 FIDAXOMICIN Do not stop taking FIDAXOMICIN, 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.
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 FIDAXOMICIN 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) 4
−
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: www.mhra.gov.uk/yellowcard 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.
How to store it
FIDAXOMICIN 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. FIDAXOMICIN 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.
Contents of the pack and other information
What FIDAXOMICIN 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 FIDAXOMICIN looks like and contents of the pack FIDAXOMICIN is presented in an amber glass bottle as white to yellowish white granules for oral suspension. FIDAXOMICIN 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. FIDAXOMICIN 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: [email protected] Manufacturer Almac Pharma Services Limited Seagoe Industrial Estate, Portadown, Craigavon, 5
BT63 5UA, United Kingdom Tillotts Pharma GmbH Warmbacher Strasse 80 79618 Rheinfelden Germany This leaflet was last revised in 01/2024 ————————————————————————————————————————–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 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 commercially available oral syringe and adaptor suitable for dispensing of liquid medicines should be selected by the healthcare professional in order to allow the patient or caregiver to measure the correct dose. The adaptor should be suitable for use in combination 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 syringe capacity for accurate dispensing Prescribed dosing volume 1 ml 2 – 5 ml
Recommended oral syringe capacity 1 ml oral syringe 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.
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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 tubes 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) 4 Fr 5 Fr 6 – 7 Fr 8 Fr
- Based on tubes of 120 cm
Recommended flush volume* at least 1 mL at least 2 mL at least 3 mL at least 4 mL
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Frequently asked questions about Fidaxomicin 40 mg/ml granules for oral suspension
How do I take Fidaxomicin 40 mg/ml granules for oral suspension?
Fidaxomicin 40 mg/ml granules for oral suspension comes as oral solution containing 40mg/ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Fidaxomicin 40 mg/ml granules for oral suspension?
The active substance in Fidaxomicin 40 mg/ml granules for oral suspension is fidaxomicin.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Fidaxomicin 40 mg/ml granules for oral suspension, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Fidaxomicin 40 mg/ml granules for oral suspension without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: fidaxomicin
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
FIDAXOMICIN granules for oral suspension is indicated for the treatment of Clostridioides difficile infections (CDI) also known as C. difficile-associated diarrhoea (CDAD) in adults and paediatric patients from birth to < 18 years of age (see section 4.2 and 5.1).
Consideration should be given to official guidelines on the appropriate use of antibacterial agents.
4.2. Posology and method of administration
Posology
Adults
Standard dosing
The recommended dose is 200 mg (5 ml) administered twice daily (once every 12 hours) for 10 days (see section 5.1).
Extended-pulsed dosing
FIDAXOMICIN 40 mg/ml granules for oral suspension (5 ml) administered twice daily for days 1-5 (no intake of suspension on day 6) then once daily on alternate days for days 7-25 (see section 5.1).
If a dose has been forgotten, the missed dose should be taken as soon as possible or, if it's nearly time for the next dose, the dose should be skipped altogether.
Special populations
Renal impairment
No dose adjustment is considered necessary. Due to the limited clinical data in this population, fidaxomicin should be used with caution in patients with severe renal impairment (see sections 4.4 and 5.2).
Hepatic impairment
No dose adjustment is considered necessary. Due to the limited clinical data in this population, fidaxomicin should be used with caution in patients with moderate to severe hepatic impairment (see sections 4.4 and 5.2).
Paediatric population
For appropriate dosing in the paediatric population, granules for oral suspension or film-coated tablets may be used.
The recommended dose in paediatric patients weighing at least 12.5 kg is 200 mg (5 ml oral suspension) administered twice daily (once every 12 hours) for 10 days.
The recommended dose of the oral suspension in paediatric patients, by body weight, to be administered twice daily (once every 12 hours) for 10 days, is presented in the table below.
Table 1: Dosing instruction for the oral suspension
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
Method of administration
FIDAXOMICIN is intended for oral use (by ingestion or via an enteral feeding tube using a syringe, if necessary).
The granules for oral suspension can be taken with or without food.
For instructions on reconstitution of the medicinal product before administration and administration via an enteral feeding tube, see section 6.6.
Instructions for use for the oral suspension:
The bottle should be taken from the refrigerator 15 minutes prior to administration and approximately 10 times gently shaken. Once reconstituted, the oral suspension should only be administered using the oral syringe and adaptor provided by the healthcare professional. The bottle should be stored in a refrigerator after each use.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4. Special warnings and precautions for use
Hypersensitivity reactions
Hypersensitivity reactions including severe angioedema have been reported (see section 4.8). If a severe allergic reaction occurs during treatment with fidaxomicin, the medicinal product should be discontinued and appropriate measures taken.
Some patients with hypersensitivity reactions reported a history of allergy to macrolides. Fidaxomicin should be used with caution in patients with a known macrolides allergy.
Renal and hepatic impairment
Due to limited clinical data, fidaxomicin should be used with caution in patients with severe renal impairment or moderate to severe hepatic impairment (see section 5.2).
Pseudomembranous colitis, fulminant or life threatening CDI
Due to limited clinical data, fidaxomicin should be used with caution in patients with pseudomembranous colitis, fulminant or life threatening CDI.
Co-administration of potent P-glycoprotein inhibitors
Co-administration of potent P-glycoprotein inhibitors such as cyclosporine, ketoconazole, erythromycin, clarithromycin, verapamil, dronedarone and amiodarone is not recommended (see sections 4.5 and 5.2). In case fidaxomicin is administered concomitantly with potent P-glycoprotein inhibitors, caution is advised.
FIDAXOMICIN contains sodium
FIDAXOMICIN contains less than 1 mmol sodium (23 mg) per 5 ml suspension, that is to say essentially 'sodium-free'.
Paediatric population
Only one paediatric patient below 6 months of age and no patients with a body weight below 4 kg have been exposed to fidaxomicin in clinical trials. Therefore, fidaxomicin should be used with caution in these patients.
Testing for C. difficile colonization or toxin is not recommended in children younger than 1 year due to high rate of asymptomatic colonisation unless severe diarrhoea is present in infants with risk factors for stasis such as Hirschsprung disease, operated anal atresia or other severe motility disorders. Alternative aetiologies should always be sought and C. difficile enterocolitis be proven.
Sodium benzoate content
This medicine contains 2.5 mg sodium benzoate (E 211) in each ml oral suspension. Sodium benzoate (E 211) may increase jaundice in newborn babies (up to 4 weeks old).
4.5. Interaction with other medicinal products and other forms of interaction
Effect of P-gp inhibitors on fidaxomicin
Fidaxomicin is a substrate of P-gp. Co-administration of single doses of the P-gp inhibitor cyclosporine A and fidaxomicin in healthy volunteers, resulted in a 4- and 2-fold increase in fidaxomicin Cmax and AUC, respectively and in a 9.5 and 4-fold increase in Cmax and AUC, respectively, of the main active metabolite OP-1118. As the clinical relevance of this increase in exposure is unclear, co-administration of potent inhibitors of P-gp, such as cyclosporine, ketoconazole, erythromycin, clarithromycin, verapamil, dronedarone and amiodarone is not recommended (see section 4.4 and 5.2).
Effect of fidaxomicin on P-gp substrates
Fidaxomicin may be a mild to moderate inhibitor of intestinal P-gp.
Fidaxomicin (200 mg twice daily) had a small but not clinically relevant effect on digoxin exposure. However, a larger effect on P-gp substrates with lower bioavailability more sensitive to intestinal P-gp inhibition such as dabigatran etexilat cannot be excluded.
Effect of fidaxomicin on other transporters
Fidaxomicin does not have a clinically significant effect on the exposure of rosuvastatin, a substrate for the transporters OATP2B1 and BCRP. Co-administration of 200 mg fidaxomicin twice daily with a single dose of 10 mg rosuvastatin to healthy subjects did not have a clinically significant effect on the AUCinf of rosuvastatin.
Paediatric population
Interaction studies have only been performed in adults.
4.6. Fertility, pregnancy and lactation
Pregnancy
There are no data available from the use of fidaxomicin in pregnant women. Animal studies did not indicate direct or indirect harmful effects with respect to reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of fidaxomicin during pregnancy.
Breast-feeding
It is unknown whether fidaxomicin and its metabolites are excreted in human milk. Although no effects on the breastfed newborns/infants are anticipated since the systemic exposure to fidaxomicin is low, a risk to the newborns/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from fidaxomicin therapy, taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Fertility
Fidaxomicin had no effects on fertility when evaluated in rats (see section 5.3).
4.7. Effects on ability to drive and use machines
FIDAXOMICIN has no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
Summary of the safety profile
The most common adverse reactions are vomiting (1.2%), nausea (2.7%) and constipation (1.2%).
Tabulated list of adverse reactions
Table 2 displays adverse reactions associated with twice daily administration of fidaxomicin in the treatment of C. difficile infection, reported in at least two patients, presented by system organ class.
The frequency of adverse reactions is defined as follows: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Table 2: Adverse reactions
MedDRA system organ class
Common
Uncommon
Frequency not known
Immune system disorders
rash, pruritus
hypersensitivity reactions (angioedema, dyspnea)
Metabolism and nutrition disorders
decreased appetite
Nervous system disorders
dizziness, headache, dysgeusia
Gastrointestinal disorders
vomiting, nausea, constipation
abdominal distention, flatulence, dry mouth
Description of selected adverse reactions
Acute hypersensitivity reactions, such as angioedema and dyspnea, have been reported during post-marketing (see section 4.3 and 4.4).
Paediatric population
The safety and efficacy of fidaxomicin has been evaluated in 136 patients from birth to less than 18 years of age. Frequency, type and severity of adverse reactions in children are expected to be the same as in adults. In addition to the ADRs shown in table 2, two cases of urticaria were reported.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9. Overdose
No adverse reactions for acute overdose have been reported during clinical studies or from post-marketing data. However, the potential for adverse reactions cannot be ruled out and general supportive measures are recommended.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
- DIFICLIR 200 mg prescriptionFIDAXOMICINUM · taken by mouth
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
- DificlirFidaxomicinum · taken by mouth
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about Fidaxomicin 40 mg/ml granules for oral suspension. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.