Flucloxacillin 500mg Capsules
PACKAGE LEAFLET: INFORMATION FOR THE USER
Flucloxacillin 250 mg and 500 mg Capsules Flucloxacillin
Read all of this leaflet carefully before you start using 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 only. 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. See section 4.
What is in this leaflet:
1. What Flucloxacillin Capsules are and what are they used for
2. What you need to know before you take Flucloxacillin Capsules
3. How to take Flucloxacillin Capsules
4. Possible side effects
5. How to store Flucloxacillin Capsules
6. Contents of the pack and other information
1. What Flucloxacillin Capsules are and what are they used for
Flucloxacillin is an antibiotic used to treat infections by killing bacteria that can cause them. It belongs to a group of antibiotics called "penicillins".
Flucloxacillin is used to treat:
- chest infections
- throat or nose infections
- ear infections
- skin and soft tissue infections
- heart infections
- bone and joint infections
- meningitis
- digestive system infections
- blood infections
- kidney, bladder or urethra (the tube which carries urine from the bladder) infections.
Flucloxacillin may also be used to prevent infections during major surgery, particularly heart or orthopaedic surgery.
2. What you need to know before you take Flucloxacillin Capsules Do not take Flucloxacillin Capsules if:
• You are allergic to flucloxacillin or any other penicillin antibiotics (see symptoms in section 4).
• You are allergic to any of the other ingredients of this medicine (listed in section 6).
• You have suffered previously from liver problems (e.g. jaundice) after taking 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
• 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 low sodium diet
Other medicines and Flucloxacillin Capsules
Tell your doctor or pharmacist before taking this medicine if you are taking any other medicines, especially:
• Probenecid or sulfinpyrazone (used to treat gout)
• Methotrexate (a chemotherapy drug)
• The contraceptive pill as antibiotics can make these less effective (you will need to use extra precautions such as condoms while taking flucloxacillin and for a full 7 days after you finish taking it)
• 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)
Some medicines may affect the way others work. Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This means medicines you have bought yourself as well as medicines on prescription from a doctor.
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.
Driving and using machines
Flucloxacillin Capsules should not affect your ability to drive or operate machinery
Flucloxacillin Capsule contains sodium
This medicinal product contains 13 mg of sodium per dose. To be taken into consideration by patients on a controlled sodium diet.
3. How to take Flucloxacillin Capsules
Always take this medicine exactly as your doctor has told you. Their directions may differ from the information contained in this leaflet. The pharmacist's label should tell you how much to take and how often. Check with your doctor or pharmacist if you are not sure.
Take this medicine when your stomach is empty. This means an hour before food or 2 hours after food. It is important that you take your medicine at the right times. The capsules should be swallowed whole with water. The dose will depend on the patient and will be decided by your doctor. However, the usual doses for each age group are:
Adults including older patients
The usual dose for adults, older patients and children over 10 years old is one 250 mg capsule four times a day. Your doctor may increase the dosage depending on your infection.
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For bone or heart infections the dose is up to 8 g daily, in divided doses at six to eight hours apart.
For preventing infections during surgery the dose is 1 to 2g given into a vein at the same time as anaesthesia followed by 500 mg every six hours for up to 72 hours.
Use in children
For children 2 to 10 years old the dose is half the adult dose. For children under 2 years old the dose is quarter of the adult dose.
Your doctor may prescribe a syrup formulation for children younger than 10 years.
Patients with kidney problems
If you suffer from severe kidney failure your doctor will give you lower or fewer doses.
If you take more Flucloxacillin Capsules than you should
If you have taken more capsules than you should, talk to your pharmacist or doctor immediately.
If you forget to take Flucloxacillin Capsules
If you have missed a dose, do not take a double dose to make up for the missed dose. If you forget to take a dose take it as soon as you remember it and carry on as before.
If you stop taking your medicine
Keep taking your medicine until your doctor tells you to stop. Do not stop taking it just because you feel better. If you stop taking the medicine, your infection may return or get worse. If you are still unwell after taking all the medicine, go and see your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, Flucloxacillin Capsules 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.
The following side effects are important and will require immediate action if you experience them.
You should stop taking Flucloxacillin Capsules and see your doctor immediately if the following symptoms occur:
• a sudden allergic reaction with shortness of breath, itchy rash, itching, sore mouth or eyes, swelling of the face, lips, throat or tongue
• watery, severe diarrhoea that may also be bloody
• jaundice (yellowing of the skin and eyes), hepatitis (inflammation of the liver) - sometimes these effects on the liver can be delayed for up to 2 months after finishing treatment
• severe skin rash with flushing, fever, blisters or ulcers (Stevens-Johnson syndrome)
• severe rash with reddening, peeling and swelling of the skin that looks like a burn (toxic epidermal necrolysis).
Tell your doctor if you notice any of the following effects:
Common: may affect up to 1 in 10 people
• diarrhoea, minor stomach disturbances e.g. stomach upset and feeling sick - should be mild and wear off after a few days
Uncommon: may affect up to 1 in 100 people
• Rash, hives and pin-point bleeding areas in the skin
Very rare: may affect up to 1 in 10,000 people
• difficulty passing water or blood in the urine (may be a sign of inflammation of the kidney).
• a fall in the number of cells in the blood leading to anaemia (shortness of breath or looking pale), prone to infections and easy bruising or bleeding.
• joint or muscle pains or fever (may develop 2 days after starting treatment).
Check with your doctor if you have any problems while taking this medicine, even if you think the problems are not connected with the medicine, or are not listed in this leaflet.
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 Website: http://www.mhra.gov.uk /yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Flucloxacillin Capsules
Keep this medicine out of the sight and reach of children.
Do not store above 25°C. Store in the original pack.
Do not use Flucloxacillin Capsules after the expiry date which is stated on the carton or label after EXP. The expiry date refers to the last day of that month.
Medicines should not be disposed of 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.
6. Contents of the pack and other information
What Flucloxacillin Capsules contain:
• The active substance in Flucloxacillin 250 mg & 500 mg Capsules is flucloxacillin sodium.
• The other ingredients are Colloidal anhydrous silica, Magnesium stearate, gelatin, Black Iron oxide (E172), Titanium dioxide (E171), Iron Oxide Red (E172), Iron Oxide Yellow (E172). The white ink contains titanium dioxide (E171), Shellac, Tween 80.
What Flucloxacillin Capsules look like and contents of the pack
Flucloxacillin 250 mg Capsules are caramel and black and are printed with the words 'FLU250MIL' Flucloxacillin 500 mg Capsules are caramel and black and printed with the words 'FLU500MIL'
Flucloxacillin 250 mg Capsules are available in blister packs containing 28 Capsules.
Flucloxacillin 500 mg Capsules are available in blister packs containing 20 or 28 Capsules
This leaflet was last revised in June 2016.
Marketing Authorization Holder:
121XXXX-V1
NOUMED LIFE SCIENCES
5 Cattle Market, Hexham, Northumberland NE46 1NJ, United Kingdom
Manufacturer:
MEDREICH PLC
Warwick House, Plane Tree Crescent, Feltham TW13 7HF, UK E-mail : info@medreich.co.uk
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NOU/FLU/PIL/07 WIN\\192.168.1.33\pdc\Artworks\Noumed Life Sciences\Flucloxacillin\Capsules\2x14's\PIL\Noumed Flucloxacillin Capsules SL Eng PlL.ai 11(DA)/22.09.15(MA)/
Format No.: CO-QA005-F03-02 Internal Approval issued on CD issued on °3.°6(MA)/12(MA)/23(MA)/
24.08(MA)/06.09.16(MA)
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NOUMED LIFE SCIENCES LIMITED | |||
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Product |
Flucloxacillin Capsules - S/L - Eng - PIL | ||
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Customer |
NOUMED LIFE SCIENCES LIMITED, UK | ||
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Reason for Issue |
BROMI Application (for Noumed) Ref. Code: 1213847 | ||
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Related FG Codes |
130XXXX Pharmacode No |
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Item Code |
121XXXX-V1 (WOA) Layout No.: NA | ||
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Approved By | ||
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PDC: |
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Title: Art Work Approval Form | |||
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Specification: |
Printed on 56 - 60 GSM Maplitho paper | ||
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Single - Black | ||
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150 x 300 mm (Open size) | ||
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80% | |
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