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 200mg film-coated tablets
⚠ 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 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 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. Children and adolescents 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, FIDAXOMICIN granules for oral suspension may be used. 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 This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodiumfree'.
How to take it
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. The standard dosing for patients weighing at least 12.5 kg is one tablet (200 mg) twice daily (one tablet 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 2
dosing is twice daily administration for days 1-5. Do not take a tablet on day 6, then once daily every other day for days 7-25 (see also scheme 2 below). Scheme 1 – Standard dosing DAY 1 2
3
4
5
6
7
8
9
10
200 mg
200 mg
200 mg
200 mg
200 mg
200 mg
200 mg
200 mg
200 mg
200 mg
200 mg
200 mg
200 mg
200 mg
200 mg
200 mg
200 mg
200 mg
200 mg
200 mg
10
11
12
13
14
15
–
200 mg
–
200 mg
–
200 mg
20
21
22
23
24
25
–
200 mg
–
200 mg
–
200 mg
Morning Evening
Scheme 2 – Alternate dosing DAY 1 2
3
4
5
200 mg
200 mg
200 mg
200 mg
200 mg
200 mg
200 mg
200 mg
200 mg
200 mg
Morning Evening
DAY
6 7 8 9 200 mg 200 mg DAY 16 17 18 19 200 mg 200 mg 200 mg – Fidaxomicin 200 mg film-coated tablet No tablet
Swallow the tablets whole with a glass of water. You can take FIDAXOMICIN before, during or after meals. FIDAXOMICIN 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 FIDAXOMICIN 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 FIDAXOMICIN 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 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. 3
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 Yellow Card Scheme at: 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. 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. Each film-coated tablet contains 200 mg of fidaxomicin. − The other ingredients are: Tablet core: microcrystalline cellulose, pregelatinised starch, hydroxypropyl cellulose, butylated hydroxytoluene, sodium starch glycolate and magnesium stearate Coating: polyvinyl alcohol, titanium dioxide (E171), talc, polyethylene glycol and lecithin (soy) What FIDAXOMICIN looks like and contents of the pack FIDAXOMICIN 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. FIDAXOMICIN 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. FIDAXOMICIN is also available in the form of granules for oral suspension. Not all pack sizes may be marketed. Marketing Authorisation Holder Tillotts Pharma UK Ltd Wellingore Hall, Wellingore 4
Lincolnshire, LN5 0HX, UK Tel: + 44 (0) 1522 813500 e-mail: [email protected] Manufacturer Tillotts Pharma GmbH Warmbacher Strasse 80 79618 Rheinfelden Germany
This leaflet was last revised in 11/2022
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Frequently asked questions about Fidaxomicin 200mg film-coated tablets
How do I take Fidaxomicin 200mg film-coated tablets?
Fidaxomicin 200mg film-coated tablets comes as tablet containing 200mg. 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 200mg film-coated tablets?
The active substance in Fidaxomicin 200mg film-coated tablets is fidaxomicin.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Fidaxomicin 200mg film-coated tablets, 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 200mg film-coated tablets 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 film-coated tablets is indicated for the treatment of Clostridioides difficile infections (CDI) also known as C. difficile-associated diarrhoea (CDAD) in adult and paediatric patients with a body weight of at least 12.5 kg (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
Standard Dosing
Adults
The recommended dose is 200 mg (one tablet) administered twice daily (once every 12 hours) for 10 days (see section 5.1).
FIDAXOMICIN 40 mg/ml granules for oral suspension may be used in adult patients with difficulties in swallowing tablets.
Extended-pulsed dosing
Fidaxomicin 200 mg tablets should be administered twice daily for days 1-5 (no intake of a tablet 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 tablet should be skipped altogether.
Special populations
Elderly population
No dose adjustment is considered necessary (see section 5.2).
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
The recommended dose in paediatric patients weighing at least 12.5 kg is 200 mg administered twice daily (once every 12 hours) for 10 days using the film-coated tablets or the granules for oral suspension.
Reduced doses are recommended for patients with a body weight of less than 12.5 kg. See the SmPC of FIDAXOMICIN 40 mg/ml granules for oral suspension.
Method of administration
FIDAXOMICIN is intended for oral use.
The film-coated tablets should be administered whole with water.
They can be taken with or without food.
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.
Paediatric population
Only one paediatric patient below 6 months of age has been exposed to fidaxomicin in clinical trials. Therefore, patients below 6 months of age should be treated with caution.
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.
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 sections 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 1 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 1: 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 1, 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 200mg film-coated tablets. 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.