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.
Fucidin 250 mg 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 Sodium fusidate 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 Fucidin Tablets contain sodium fusidate. It is a type of antibiotic. Fucidin Tablets work by killing germs (bacteria) that cause infections. Fucidin Tablets are used to treat infections such as:
- Infections of the skin and wounds
- Infections of the blood such as septicaemia
- Infections of the bone and heart tissue
- Infections of the lungs such as pneumonia
- Infections connected with the condition cystic fibrosis.
What you need to know before you take it
e Fucidin® Tablets Do not take Fucidin Tablets
- If you are allergic to sodium fusidate or any of the other ingredients of this medicine (listed in section 6). Warnings and precautions Talk to your doctor or pharmacist before taking Fucidin Tablets if: • • • •
You are taking statins (medicines to lower blood cholesterol) You have problems with your liver or if you have recently been jaundiced (skin and whites of the eyes appear yellow) You have a blockage or a problem with your bile duct, e.g. gallstones You are taking some medicines called HIV-Protease Inhibitors used to treat the HIV virus.
When you are taking Fucidin Tablets, your doctor may take regular blood tests if you are taking other medicines which affect the liver. If you are concerned that your treatment is not as effective as it should be, tell your doctor. As with any antibiotic treatment, long-term or repeated use may increase the risk of developing antibiotic resistance. If you have been told by your doctor that you have intolerance to some sugars, contact your doctor before taking this medicinal product. Serious skin reactions including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported with the use of Fucidin Tablets. •
SJS/TEN can appear initially as reddish target-like spots or circular patches often with central blisters on the trunk. Also, ulcers of mouth, throat, nose, genitals and eyes (red and swollen eyes) can occur. These serious skin rashes are often preceded by fever and/or flu-like symptoms. The rashes may progress to widespread peeling of the skin and life-threatening complications or be fatal.
•
DRESS appears initially as flu-like symptoms and a rash on the face, then an extended rash with a high body temperature, increased levels of liver enzymes seen in blood tests and an increase in a type of white blood cell (eosinophilia) and enlarged lymph nodes.
The highest risk for occurrence of serious skin reactions is within 8 weeks of treatment. If you develop a serious rash or another of these skin symptoms, stop taking Fucidin Tablets and contact your doctor or seek medical attention immediately. Other medicines and Fucidin Tablets Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes any medicines which you have bought without a prescription and herbal medicines. Fucidin Tablets may interact with other medicines, which could mean your dose of these medicines may need to be changed.
- Do not take statins (medicines to lower blood cholesterol) while using this medicine. You must tell your doctor or pharmacist if you are taking any of the following medicines:
- Medicines to lower blood cholesterol, such as statins. Taking Fucidin Tablets and statins at the same time may lead to muscle weakness, tenderness or pain. Also see section 4 of this leaflet.
- Oral anti-coagulants (medicines to "thin" your blood). You may be likely to bleed more easily. Your doctor may need to change your dose.
- Medicines used to treat HIV (e.g. ritonavir or saquinavir). Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
- Fucidin Tablets should not be used during pregnancy unless you are told to do so by your doctor
- If you are breast-feeding or planning to breast-feed, ask your doctor or pharmacist for advice before taking this medicine. Tell your doctor if you become pregnant while using this medicine. Driving and using machines
This medicine should not have any effect on your ability to drive or use machines. Check with your doctor if you feel any side effect that may stop you from driving or using machines. Fucidin Tablets contains
- Lactose (a type of sugar). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product. Each tablet contains 71.9 milligrams (mg) of lactose per tablet. Please ask your doctor if you are worried about any of the ingredients in this medicine.
3.
How to take it
Fucidin® Tablets
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. How many Fucidin Tablets to take Your doctor will tell you how many tablets to take. Your doctor will tell you how many times each day to take your medicine. You should take the medicine at equally spaced times in the day. For oral administration. Take the tablets with a glass of water. The recommended dose is: Adults and the Elderly
- Skin infections: 1 tablet twice each day. Take for 5 to 10 days.
- Other infections: 2 tablets, 3 times each day. In severe infections, your doctor may increase the dose. If you take more Fucidin Tablets than you should You may experience a sudden onset of vomiting, diarrhoea, stomach pain, heartburn and nausea (feeling sick) if you take too many tablets. Tell your doctor straight away if you have taken more tablets than you should. You may need to stop taking this medicine. If you forget to take Fucidin Tablets If you forget to take the tablets at the right time, take them as soon as you remember. Then next take this medicine at the usual time. Do not take a double dose to make up for a forgotten dose. If you stop taking Fucidin Tablets It is very important to take all the medicine that your doctor has told you to take. You must finish this medicine even if you feel better. You must do this because otherwise your infection may come back. If you have any further questions about taking this medicine, please ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Important serious side effects to look out for: Tell your doctor or pharmacist immediately if any of the following happen. You may need to stop your treatment:
- You have difficulty breathing
- Your face or throat swell
- Your skin develops a severe rash.
Tell your doctor or pharmacist immediately if any of the following happen. You may be developing a condition called rhabdomyolysis:
- You develop muscle weakness
- You develop muscle pain
- You develop muscle tenderness. Problems with your liver or kidneys. Tell your doctor or pharmacist immediately if any of the following happen:
- Your skin or the whites of your eyes appear yellow
- You are not passing water. The level of some cells in your blood may change. Tell your doctor or pharmacist immediately if any of the following happen:
- You develop any unexplained bruising or bleeding
- You develop persistent or repeated mouth ulcers, sore throats or other infections. A few cases have been reported of severe skin reactions after taking Fucidin, which may develop into potentially life-threatening skin reactions if they are not treated. Tell your doctor or pharmacist immediately if you experience any of the following symptoms. The frequency of these side effects is not known (cannot be estimated from the available data): •
•
•
Serious skin rashes including Stevens-Johnson syndrome and toxic epidermal necrolysis. These can appear as reddish target-like macules or circular patches often with central blisters on the trunk, skin peeling, ulcers of mouth, throat, nose, genitals and eyes and can be preceded by fever and flu-like symptoms. Stop using Fucidin Tablets if you develop these symptoms and contact your doctor or seek medical attention immediately. See also section 2. Widespread rash, high body temperature, liver enzyme elevations, blood abnormalities (eosinophilia), enlarged lymph nodes and other body organs involvement (Drug Reaction with Eosinophilia and Systemic Symptoms which is also known as DRESS or drug hypersensitivity syndrome). Stop using Fucidin Tablets if you develop these symptoms and contact your doctor or seek medical attention immediately. See also section 2. A red, scaly widespread rash with bumps under the skin and blisters accompanied by fever at the initiation of treatment (acute generalised exanthematous pustulosis). Stop using Fucidin Tablets if you develop these symptoms and contact your doctor or seek medical attention immediately.
The following less serious side effects have also been reported. If any of them last a long time or cause problems, you should tell your doctor or pharmacist as soon as possible: Common (may affect up to 1 in 10 people):
- Vomiting
- Stomach pain or discomfort
- Heartburn
• • •
Nausea Fatigue Diarrhoea.
Uncommon (may affect up to 1 in 100 people): Drowsiness Headache Pale stools Dark urine Upper right hand side stomach pain Loss of appetite Itchy rash Rash.
• • • • • • • •
Rare (may affect up to 1 in 1,000 people):
- Itching
- Skin redness. 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
Fucidin® Tablets • • •
Keep this medicine out of the sight and reach of children. Do not use Fucidin Tablets after the expiry date which is stated on the blister and carton after EXP. The expiry date refers to the last day of that month. This medicine does not require any special storage conditions.
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 protect the environment.
Contents of the pack and other information
What Fucidin Tablets contain
- The active substance is sodium fusidate. Fucidin Tablets contain 250 mg of sodium fusidate in each tablet.
- The other ingredients are crospovidone, hypromellose, lactose monohydrate, magnesium stearate, cellulose microcrystalline, silica, talc, titanium dioxide (E171) and all-rac-α-tocopherol. You can find important information about some of the ingredients in your medicine near the end of section 2 of this leaflet. What Fucidin Tablets look like and contents of the pack Fucidin Tablets are white to off-white greyish marbled oval film-coated tablets. Fucidin Tablets come in blister packs of 2, 4, 10 and 100. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: LEO Laboratories Limited, Maidenhead, Berkshire SL6 3UD, UK.
Manufacturer: Laboratoires LEO, 28500 Vernouillet, France. This leaflet was last revised in April 2023. ® Registered Trade Mark
Frequently asked questions about Fucidin 250 mg Tablets
How do I take Fucidin 250 mg Tablets?
Fucidin 250 mg Tablets comes as tablet containing 250mg. 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 Fucidin 250 mg Tablets?
The active substance in Fucidin 250 mg Tablets is sodium fusidate.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Fucidin 250 mg 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 Fucidin 250 mg 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: sodium fusidate
- 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
Fucidin is indicated in the treatment of all staphylococcal infections due to susceptible organisms such as: cutaneous infections, osteomyelitis, pneumonia, septicaemia, wound infections, endocarditis, superinfected cystic fibrosis.
Fucidin should be administered intravenously whenever oral therapy is inappropriate, which includes cases where absorption from the gastro-intestinal tract is unpredictable.
4.2. Posology and method of administration
Posology
For staphylococcal cutaneous infections:
Adults: Standard dose: 250 mg (1 tablet) sodium fusidate (equivalent to 240 mg fusidic acid) twice daily for 5-10 days.
For staphylococcal infections such as osteomyelitis, pneumonia, septicaemia, wound infections, endocarditis, superinfected cystic fibrosis.
Adults: Standard dose: 500 mg (2 tablets) sodium fusidate (equivalent to 480 mg fusidic acid) 3 times daily.
In severe cases of fulminating infections, the dosage may be doubled or appropriate combined therapy may be used.
Elderly: No dosage alterations are necessary in the elderly.
Since Fucidin is excreted in the bile, no dosage modifications are needed in renal impairment.
The dosage in patients undergoing haemodialysis needs no adjustment as Fucidin is not significantly dialysed.
Method of administration
For oral administration.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients.
4.4. Special warnings and precautions for use
Statins (HMG-CoA reductase inhibitors) and systemic Fucidin must not be co-administered. There have been reports of rhabdomyolysis (including fatalities) in patients receiving this combination (see section 4.5). In patients where the use of systemic Fucidin is considered essential, statin treatment should be discontinued throughout the duration of treatment with systemic Fucidin. The patient should be advised to seek medical advice immediately if they experience any symptoms of muscle weakness, pain or tenderness. Statin therapy may be re-introduced seven days after the last dose of systemic Fucidin. In exceptional circumstances, where prolonged systemic Fucidin is needed e.g. for the treatment of severe infections, the need for co-administration of HMG-CoA reductase inhibitors and systemic Fucidin should only be considered on a case by case basis and under close medical supervision.
In a few cases, serious cutaneous reactions putting life at risk such as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) syndrome, toxic epidermal necrolysis (Lyell's syndrome) and Stevens-Johnson syndrome have been reported with systemic Fucidin. Patients should be advised to monitor cutaneous reactions as well as signs and symptoms suggestive of these reactions which usually appear in the first weeks of therapy. If such reactions are suspected to be due to systemic Fucidin, treatment with systemic Fucidin should be stopped and it is recommended not to reintroduce the therapy.
Fusidic acid is metabolised in the liver and excreted in the bile. Elevated liver enzymes and jaundice have occurred during systemic Fucidin therapy but are usually reversible on discontinuation of the drug.
Systemic Fucidin should be given with caution and liver function should be monitored if used in patients with hepatic dysfunction or in patients taking potentially hepatotoxic drugs. Caution is required in patients with biliary disease and biliary tract obstruction. Caution is required in patients treated with HIV-protease inhibitors (See section 4.5). Fusidic acid competitively inhibits binding of bilirubin to albumin. Caution is necessary if systemic Fucidin is administered to patients with impaired transport and metabolism of bilirubin. Particular care is advised in neonates due to the theoretical risk of kernicterus.
Bacterial resistance has been reported to occur with the use of fusidic acid. As with all antibiotics, extended or recurrent use may increase the risk of developing antibiotic resistance.
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
4.5. Interaction with other medicinal products and other forms of interaction
The risk of myopathy including rhabdomyolysis may be increased by the concomitant administration of systemic Fucidin with statins. Co-administration of this combination may cause increased plasma concentrations of both agents. The mechanism of this interaction (whether it is pharmacodynamics or pharmacokinetic, or both) is yet unknown. There have been reports of rhabdomyolysis (including some fatalities) in patients receiving this combination. If treatment with Fucidin is necessary, statin treatment should be discontinued throughout the duration of the Fucidin treatment. Also see section 4.4.
Specific pathways of Fucidin metabolism in the liver are not known, however, an interaction between Fucidin and drugs being CYP-3A4 biotransformed can be suspected. The mechanism of this interaction is presumed to be a mutual inhibition of metabolism. There is insufficient data to characterise the effect of fusidic acid on CYPs in-vitro. The use of Fucidin systemically should be avoided in patients treated with CYP-3A4 biotransformed drugs.
Oral anticoagulants
Systemic Fucidin administered concomitantly with oral anticoagulants such as coumarin derivatives or anticoagulants with similar actions may increase the plasma concentration of these agents enhancing the anticoagulant effect. Anticoagulation should be closely monitored and a decrease of the oral anticoagulant dose may be necessary in order to maintain the desired level of anticoagulation. Similarly, discontinuation of Fucidin may require the maintenance dose of anticoagulant to be re-assessed. The mechanism of this suspected interaction remains unknown.
HIV protease inhibitors
Co-administration of systemic Fucidin and HIV protease inhibitors such as ritonavir and saquinavir may cause increased plasma concentrations of both agents which may result in hepatotoxicity.
Concomitant use is not recommended. (See section 4.4).
4.6. Fertility, pregnancy and lactation
Pregnancy
There are no or limited data (less than 300 pregnancy outcomes) from the use of fusidic acid in pregnant women. Animal studies do not indicate direct or indirect harmful effect with respect to reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of systemic Fucidin during pregnancy.
Breast-feeding
Physico-chemical data suggest excretion of fusidic acid in human milk. A risk to the suckling child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from systemic Fucidin therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Fertility
There are no clinical studies with systemic Fucidin regarding fertility. Pre-clinical studies did not show any effect of sodium fusidate on the fertility in rats.
4.7. Effects on ability to drive and use machines
Fucidin has no or negligible influence on the ability to drive or to use machines.
4.8. Undesirable effects
The estimation of the frequency of undesirable effects is based on a pooled analysis of data from clinical trials and from spontaneous reporting.
The most frequently reported undesirable effects of Fucidin administered orally are gastrointestinal disorders like abdominal discomfort and pain, diarrhoea, dyspepsia, nausea and vomiting. Anaphylactic shock has been reported.
Undesirable effects are listed by MedDRA SOC and the individual undesirable effects are listed starting with the most frequently reported. Within each frequency group, adverse reactions are presented in the order of decreasing seriousness.
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 available data)
Blood and lymphatic system disorders
Uncommon
Pancytopenia
Leukopeniaa)
Thrombocytopenia
Anaemia
Immune system disorders
Uncommon
Anaphylactic shock/anaphylactic reaction
Rare
Hypersensitivity
Nervous system disorders
Uncommon
Headache
Somnolence
Gastrointestinal disorders
Common
Vomiting
Diarrhoea
Abdominal pain
Dyspepsia
Nausea
Abdominal discomfort
Hepatobiliary disorders
Uncommon
Hepatic failure
Cholestasis
Hepatitisb)
Jaundicec)
Hyperbilirubinaemia
Liver function test abnormald)
Rare
Hepatic function abnormal
Skin and subcutaneous tissue disorders
Uncommon
Acute generalized exanthematous pustulosis
Urticaria
Rashe)
Rare
Angioedema
Pruritus
Erythema
Not known
Toxic epidermal necrolysis (Lyell´s syndrome)f)
Stevens-Johnson syndromef)
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) syndrome f)
Musculoskeletal and connective tissue disorders
Uncommon
Rhabdomyolysisg)
Renal and urinary disorders
Uncommon
Renal failure h)
General disorders and administration site conditions
Common
Lethargy/Fatigue/Asthenia
a) Haematological disorders affecting the white cell line (neutropenia, granulocytopenia and agranulocytosis) have been reported.
b) Hepatitis also includes Hepatitis cholestatic /Cytolytic hepatitis
c) Jaundice also includes Jaundice cholestatic
d) Including alanine aminotransferase increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, blood bilirubin increased and gamma-glutamyltransferase increased
e) Rash includes various types of rash reactions such as drug eruption, erythematous and maculo-papular rash
f) These adverse reactions were identified through post-marketing surveillance. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency (see section 4.4)
g) Rhabdomyolysis may be fatal
h) Renal failure also includes renal failure acute
Paediatric population
Frequency, type and severity of adverse reactions in children are expected to be the same as in adults, based on limited data.
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
Acute symptoms of overdose include gastrointestinal disturbances. Management should be directed towards alleviation of symptoms. Dialysis will not increase the clearance of fusidic acid.
An overdose of 4 g/day for a duration of ten days in an adult has been reported without any adverse events.
An overdose of 1,250 mg/day for a duration of seven days in a child (three years old) has been reported without any adverse events.
💬 Ask about this leaflet
Ask anything about Fucidin 250 mg 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.