Patient leaflet - FLUCLOXACILLIN CAPSULES BP 500 MG
IN THIS LEAFLET
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1. What Flucloxacillin Capsules are and what they are used for
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2. Before you take Flucloxacillin Capsules
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3. How to take Flucloxacillin Capsules
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4. Possible side effects
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5. How to store Flucloxacillin Capsules
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6. Further information
1. WHAT FLUCLOXACILLIN CAPSULES ARE AND WHAT THEY ARE USED FOR
280 mm
Flucloxacillin is a medicine known as an antibiotic. The capsules are used to treat infections caused by staphylococcal bacteria which are resistant to benzylpenicillin. It is also used to treat infections caused by a mixture of staphylococcal and streptococcal bacteria when the staphylococcal bacteria are resistant to penicillin.
- Flucloxacillin is used to treat: chestinfections
- throat or nose infections
- skin and soft tissue infections such as boils, abscesses, carbuncles (cluster of boils) cellulitis (infections of the skin and the tissue beneath it) and Infected skin conditions e.g. ulcer, eczema, and acne
- earinfections.
- bone and joints infections
- heart infections
- kidney, bladder, or urethra (the tube which carries urine
from the bladder) infections
- meningitis
- digestive system infections
- Blood infections
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2. BEFORE YOU TAKE FLUCLOXACILLIN CAPSULES
Do not take Flucloxacillin Capsules if you
- are allergic (hypersensitive) to Flucloxacillin Sodium or any of the other ingredients of this medicine listed in section 6.
- are allergic to penicillin.
- you have suffered previously from liver problems (e.g. jaundice) after taking flucloxacillin
The product may cause an allergic reaction in babies that are allergic to penicillin antibiotics including Flucloxacillin.
Warnings and precautions
Talk to your doctor or pharmacist before taking flucloxacillin capsules if:
- you suffer from kidney problems, as you may require a lower dose than normal (convulsions may occur very rarely in patients with kidney problems who take high doses)
- you suffer from liver problems, as this medicine could cause them to worsen
- you are 50 years of age or older
- you have other serious illnesses (apart from the infection this medicine is treating)
- you are taking this medicine for a long time as regular tests of liver and kidney function are advised
- you are on a sodium-restricted diet.
- you are giving this medicine to a newborn child.
- are taking or will be taking paracetamol. There is a risk of blood and fluid abnormality (high anion gap metabolic acidosis) which occurs when there is an increase in plasma acidity, when flucloxacillin is used concomitantly with paracetamol, particularly in certain groups of patients at risk, e.g. patients with severe renal impairment, sepsis or malnutrition, especially if the maximum daily doses of paracetamol are used. High anion gap metabolic acidosis is a serious disease that must have urgent treatment.
Taking other medicines
Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription.
Care is needed if you are taking any of the following medicines
- probenecid (used to treat gout, a form of arthritis)
- methotrexate (a chemotherapy drug)
- oral typhoid vaccine (antibiotics can make this less effective)
- sugammadex (used with general anaesthetics)
- piperacillin (an antibiotic taken by injection)
- warfarin (medicine to prevent blood clotting)
- paracetamol
- other antibiotics (used to treatinfections)
Pregnancy and breast-feeding
Flucloxacillin should be used with caution if you are pregnant, think you are pregnant, planning to become pregnant or breast-feeding currently. Flucloxacillin may be excreted in breast milk and may provoke an allergic reaction in infants that are allergic to penicillin.
Ask your doctor or pharmacist for advice before taking any medicine.
Tests
Regular monitoring of liver and kidney function should be performed whilst taking flucloxacillin capsules.
Tell your doctor that you are taking flucloxacillin capsules if you are having urine tests or blood tests because flucloxacillin capsules may affect the results.
Important information about some of the ingredients of Flucloxacillin Capsules
Flucloxacillin Capsules contain sodium
Each 250 mg capsules contains 22.63 mg of Sodium:
This medicine contains less than 1 mmol sodium (23 mg) per 250 mg capsule, that is to say essentially'sodium-free'.
Each 500 mg capsules contains 45.25 mg of Sodium
This medicine contains 45.25 mg sodium (main component of cooking/table salt) in each 500 mg capsule. This is equivalent to 2.3% of the recommended maximum daily dietary intake of sodium for an adult.
3. how to take flucloxacillin capsules
Flucloxacillin Capsules should be taken as directed by your doctor. Check the medicine label to see how many capsules to take and how often to take them. Your pharmacist or doctor can help if you are not sure.
- Take the capsules by mouth
- Do not open capsules.
- The capsules should be taken half to one hour before food or 2 hours after food. It is important that you take your medicine at the right times.
The dose will depend on the patient and will be decided by your doctor. However, the usual doses for each age group are:
The usual dose forAdults
Usually 250mg (1 × 250mg capsule) 4 times a day (up to 1g)
Joint infections (osteomyelitis) or heart infections (endocarditis) – up to 8g daily in divided doses, six to eight hourly.
To prevent infection due to surgery – 1 to 2g by injection into a vein, at the same time as the anesthetic, followed by 500mg six hourly either by mouth or injection into a vein or muscle for up to 72 hours.
Infection of the bone and bone marrow (osteomyelitis) or inflammation of the internal lining of the heart (endocarditis).
Up to 8g daily in divided doses (every 6–8 hours) may be given. Your doctor will decide upon a suitable dose for you.
Severe kidney disease
| Description | FLUCLOXACILLIN CAPSULES 250mg & 500mg | |||
| Client | Wave Pharma Limited | Market | UK | |
| Component | Leaflet | Version | 01 | |
| Actual Size | 148.5 × 280 mm | Font Size | 9pt | |
| Colors | BLACK | Font Style | Arial Narrow | |
| Track Date | 18/03/2021 | |||
Artwork Same Size Size : 148.5 × 280 mm
Your doctor may reduce your dose.
Elderly patients
Your doctor may decide to give you a reduced dose.
Children
Children aged 10–18 years – 250mg four times daily 2–10 years: 125mg four times daily.
Under 2 years: 62.5mg four times daily.
Premature or babies less than 4 weeks old: Not recommended.
Dosage for children under 10 years can only be achieved with a different formulation of this medicine.
If you forget to take Flucloxacillin Capsules at the right time, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take a double dose to make up for forgotten individual doses.
If you have taken more Flucloxacillin Capsules than you should, consult your doctor or go to the nearest hospital casualty department immediately. Take this leaflet with you so your doctor will know what you have taken
If you stop taking Flucloxacillin Capsules
Do not stop taking Flucloxacillin Capsules without talking to your doctor, even if you feel better. It is important that you take the full course of Flucloxacillin Capsules prescribed by your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. If they occur, they are likely to be temporary, and not serious. However, some may be serious and need medical attention.
STOP taking flucloxacillin and contact your doctor if you experience:
- Allergy or hypersensitivity including itchy rash, itching, sore mouth or eyes, swelling of the face, lips, throat or tongue or breathing problems
- Severe skin rash with flushing, fever, blisters or ulcers (Stevens-Johnson syndrome) or a severe rash with reddening, peeling and swelling of the skin that looks like a burn (toxic epidermal necrolysis).
- Severe, bloody diarrhoea
- Jaundice, your skin or the whites of your eyes turning yellow
- A red, scaly rash with bumps under the skin and blisters (exanthematous pustulosis) (frequency not known). Contact a doctor immediately if you get any of these symptoms
Tell your doctor if you notice any of the following side effects or notice any other effects not listed:
Common (may affect up to 1 in 10 people):
Diarrhoea, stomach upset and feeling sick, this should be mild and wear off after a few days. If severe or lasting longer, tell your doctor
Uncommon: (may affect up to 1 in 100 people)
- Urticaria (itchy skin eruption)
- Purpura (brownish-red spots on the skin)
Very rare (may affect up to 1 in 10,000 people)
- Change in number of blood cells i.e. neutropenia and thrombocytopenia (might cause bleeding, easy bruising or skin discoloration)
- hemolytic anemia
- increase in the number of white blood cells in the blood (eosinophilia).
- Anaphylactic Shock (severe allergic reaction)
- Angioneurotic Oedema (rapid swelling)
- Pseudomembranous colitis (inflammation of the colon with abdominal cramps, diarrhoea, bloody stools)
- Inflammation of the kidney orliver (hepatitis)
- Changesin liver function tests
- Erythema multiforme (a red rash caused by hypersensitivity to a drug or disease or other allergen),
- Arthralgia (painin a joint) and myalgia (pain in the muscles) or fever (may develop 2 days after starting treatment)
- Interstitial nephritis (Nephritis in which the interstitial connective tissue is chiefly affected)
- Very rare cases of blood and fluid abnormality (high anion gap metabolic acidosis) which occurs when there is an increasein plasma acidity, when flucloxacillin is used concomitantly with paracetamol, generally in the presence of risk factors (see section 2).
- Some of these reactions can be delayed for up to two months after finishing the treatment.
Other side effects: (frequency not known)
- Serious skin reactions
- A red, scaly rash with bumps under the skin and blisters (exanthematous pustulosis).
Contact a doctor immediately if you get any of these symptoms.
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 at: or search for MHRA Yellow Card in the Google Play or AppleApp Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5. how to store flucloxacillin capsules
Keep out of the sight and reach of children.
Do not take these capsules after the expiry date shown on the label. These capsules should be storedin a dry place at or below 25°C.
Keep themin the pack they came in – do not transfer them to another container. Keep the container tightly closed.
Medicines should not be disposed of via wastewater or household waste.Ask your pharmacist how to dispose of medicines nolonger required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Flucloxacillin Capsules contain:
- The active ingredientis Flucloxacillin Sodium equivalent to 250mg or 500mg of Flucloxacillin.
- The other ingredients are magnesium stearate. The
capsule shell is composed of Indigo Carmine (E132) Titanium Dioxide (E171), Gelatin, and Water.
- Theink contains Shellac, DehydratedAlcohol, Isopropyl Alcohol, Butyl Alcohol, Propylene Glycol, Titanium Dioxide and Polysorbate 80.
What Flucloxacillin Capsules look like and contents of the pack:
- The 250mg capsules are hard gelatin capsules with a size 2 Blue/Blue capsule with printing “fluc/250” on cap and bodyin whiteink containing white to off white granular powder.
- The 500mg capsules are hard gelatin capsules with a size 0 Blue/Blue capsule with printing “fluc/500” on cap and body in whiteink containing white to off white granular powder.
- The capsules are available in HDPE containers of 14, 28, 100, 250, 500 and 1000 and in blister packs of 7, 14 and 28 capsules. Not all pack sizes may be marketed.