Flucloxacillin Capsules Bp 500mg
PACKAGE LEAFLET: INFORMATION FOR THE USER
Flucloxacillin Capsules BP 250mg Flucloxacillin Capsules BP 500mg
(flucloxacillin)
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. 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.
What is in this leaflet:
1. What Flucloxacillin is and what it is used for.
2. What you need to know before you take Flucloxacillin.
3. How to take Flucloxacillin.
4. Possible side effects.
5. How to store Flucloxacillin.
6. Contents of the pack and other information.
1. WHAT FLUCLOXACILLIN IS AND WHAT IT IS USED FOR
Flucloxacillin is an antibiotic of the penicillin group. It belongs to a group of medicines called penicillinase-resistant antibiotics.
It is used:
- to treat infections in different parts of your body caused by bacteria
- to prevent infections during surgery
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FLUCLOXACILLIN Do not take Flucloxacillin if you:
- are allergic to flucloxacillin (or other penicillin antibiotics), or any of the other ingredients of this medicine (listed in section 6 )
- have a history of liver problems from taking Flucloxacillin.
Warnings and precautions
Talk to your doctor or pharmacist before taking Flucloxacillin if you:
- have previously taken a penicillin antibiotic and developed an allergic reaction
- have a history of allergy
- have kidney disease.
If you develop a rash during treatment you should stop taking this medicine and tell your doctor immediately (see section 4). Your doctor will prescribe a different type of antibiotic.
Tests
Your doctor may wish to monitor your liver and kidney function during prolonged treatment.
Other medicines and Flucloxacillin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription or the following:
- methotrexate (used to treat cancer)
- probenecid (used to treat gout)
- other antibiotics (used to treat infection)
- anticoagulants e.g. warfarin (used to thin blood).
Pregnancy and breast-feeding
Tell your doctor if you are pregnant or breast-feeding. Very small amounts of penicillin can be found in the breast milk of a mother taking this medicine. This may alter the normal bacteria in the gut of the breast-fed child, sometimes causing a stomach upset or allergic reaction.
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 any medicine.
Driving and using machines
Flucloxacillin is not known to affect your ability to drive or use machines.
Flucloxacillin capsules contain Sodium
The 250 mg capsules contain approximately 13 mg of sodium per capsule. The 500 mg capsules contain approximately 26 mg of sodium per capsule. To be taken into consideration by patients on a controlled sodium diet.
3. HOW TO TAKE FLUCLOXACILLIN
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Swallow the capsules whole with a full glass of water. The capsules should be taken between 30 minutes to one hour before food. Do not chew or crush the capsules.
The recommended dose is:
Adults (including the Elderly) and Children over 10 years old:
250 mg four times a day. If your infection is severe your doctor may double your dose to 500 mg four times a day.
Osteomyelitis (bone infection) and endocarditis (infection of the heart lining):
To treat these two conditions your doctor may prescribe a total daily dose of up to 8 grams. This will be taken as divided doses every six to eight hours.
Prevention of infection after surgery:
The usual dose is 500 mg four times a day for three days.
If you have severe kidney disease:
Your doctor may prescribe a lower dose than those stated above.
Use in Children under 10 years old:
Children aged 2 to 10 years old will usually be given half of the adult dose. Children under 2 years old will usually be given a quarter of the adult dose. Your doctor will tell you how much to take and how often.
If you take more Flucloxacillin than you should
Contact your doctor or nearest hospital emergency department immediately. Take the container and any remaining capsules with you.
If you forget to take Flucloxacillin
Do not take a double dose to make up for a forgotten dose. Take the next dose at the usual time.
If you stop taking Flucloxacillin
Do not stop or change your treatment before talking to your doctor. It is important that you complete the course as directed by your doctor. Do not stop taking your capsules even though you may feel better. If you stop taking your medicine your infection may return or get worse.
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. If they occur, they are likely to be temporary and mild. However, some may be serious and need medical attention.
If the following side effects occur, stop taking the capsules immediately and contact your doctor:
• redness and swelling of the hands, feet, ankles, face, lips, mouth or throat, (which may cause difficulty in breathing)
• severe diarrhoea with or without bleeding
• skin rashes or severe allergic reactions which may cause difficulty in breathing or dizziness
• severe reduction in the number of white blood cells which may cause fever, severe chills, sore throat or mouth ulcers
• hepatitis (inflamed liver) and cholestatic jaundice (jaundice occurring when bile cannot flow from the liver properly). This causes symptoms such as yellowing of the eyes and skin. This may occur up to two months after stopping treatment. Very rarely this is fatal.severe skin rash with flushing, fever, blisters or ulcers (Stevens-Johnson syndrome)
• severe rash with reddening, peeling and swelling of the skin that resembles burns (toxic epidermal necrolysis).
Common side effects (may affect up to 1 in 10 people):
• headache.
• diarrhoea and feeling sick. These should be mild and wear off after a few days. If these are severe or last longer than a few days you should see your doctor.
• skin rash (exanthema).
Uncommon side effects (may affect up to 1 in 100 people):
• fever
• muscle or joint pain
• increase in some white blood cells (eosinophilia)
• a nettle like rash, hives.
Rare side effects (may affect up to 1 in 1,000 people):
• reduction in blood platelets which increase the risk of bleeding or bruising
• inflammation of the kidney which may affect the way your kidneys work.
If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
Also you can help to make sure that medicines remain as safe as possible by reporting any unwanted side effects via the internet at www.mhra.gov.uk/yellowcard. Alternatively you can call Freephone 0808 100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays) or fill in a paper form available from your local pharmacy.
5. HOW TO STORE FLUCLOXACILLIN
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 bottle or carton after EXP. The expiry date refers to the last day of that month.
Store your capsules in a dry place below 25°C.
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.
6. CONTENTS OF THE PACK AND OTHER INFORMATION What Flucloxacillin contains
The active substance is flucloxacillin sodium. Each capsule contains 250 mg or 500 mg flucloxacillin.
The other ingredients are magnesium stearate, gelatin, titanium dioxide, black iron oxide, yellow iron oxide, red iron oxide. The printing ink contains shellac, iron oxide black (E172), n-butyl alcohol, propylene glycol, isopropyl alcohol and ammonium hydroxide.
What Flucloxacillin looks like and contents of the pack
Your medicine comes as a grey and brown capsule, hard. The 250 mg capsules are marked ‘G’ and ‘FN 250’. The 500 mg capsules are marked ‘G’ and ‘FN 500’.
Flucloxacillin is available in containers, glass bottles or blisters of 5, 7, 10, 14, 15, 20, 21, 25, 28, 30, 50, 56, 60, 84, 90, 100, 250 and 500 capsules. Not all pack sizes may be marketed.
Marketing Authorisation Holder
Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom Manufacturer
Generics [UK] Limited, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom This leaflet was last revised in 02/2016.
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