Flucloxacillin 500mg Capsules
Eastbourne
Artwork
Origination
PL Number(s),
MA Holder & Packer:
PL 06453/0015-16
Athlone Laboratories Limited Licence. Packed at Athlone Laboratories in Ireland.
Trackwise Parent: 380858
Trackwise Child: 383830
Reason for revision: Version 1: Extra line added to the Warnings and Precautions section. Version 2: A further addition to the Warnings and Precautions section. Version 3: Rewording in Warnings and Precautions section.
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SKU (s): |
231-10-21224, 231-10-21232 |
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EAN Code: |
N/A |
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Pharma Code: |
TBC |
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Edge Code: |
N/A |
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PIP Code: |
N/A |
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Third party code: |
TBC |
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Fonts: |
Univers. |
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Base Font Size: |
8.5 Pt |
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Dimensions and Further Information: | |
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L: |
335 mm |
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W: |
148 mm |
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Foil Width: |
N/A |
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Perforated: |
N/A |
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Shelf Ready Pack: |
No |
Colours:
(PANTONE® is a registered trademark of Pantone, Inc.)
PANTONE® GREEN C
BLACK
CUTTER
IMPORTANT: Artwork, text and content must not be reset, remade, amended or altered. The only exceptions to this are: bleeds, chokes, spreads or other print related adjustments required for reproduction by the supplier. We must receive a copy of any 3rd Party Supplier’s Proof before approval to print will be granted.
Artwork Originator; Sign & Date:
Digitally signed by Lenny
DN: cn=Lenny Sole o=Artwork Origination, ou=Artwork Originator, email=helen.sole@tevau k.com, c=GB Date: 2016.04.08
Artwork Checker;
Sign & Date:
Digitally signed by Peter Horton Date:
2016.04.08 11:57:46 +01'00'
Packing Site / Technical Approval; Sign & Date:
Approved by Regulatory for submission to the authorities / internal Approval / implementation; Sign & Date:
Internal/Final Approval and/or implementation from the MA holder confirming full approval for release of components; Sign & Date:
Package leaflet: Information for the patient
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 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 your medicine is and what it is used for
2. What you need to know before you take your medicine
3. How to take your medicine
4. Possible side effects
5. How to store your medicine
6. Contents of the pack and other information
What your medicine is and what it is used for
Flucloxacillin is an antibiotic used to treat infections by killing the bacteria that can cause them. It belongs to a group of antibiotics called "penicillins'.'
Flucloxacillin is used to treat:
- chest infections
- ear infections
- heart infections
- meningitis
- blood infections
- kidney, bladder or urethra (the tube which carries urine from the bladder) infections.
throat or nose infections skin and soft tissue infections bone and joint infections digestive system infections
Flucloxacillin can also be used to prevent infections during major surgery, particularly heart or orthopaedic surgery.
Do not take this medicine 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 this medicine 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.
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)
- 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.
Your medicine contains sodium
This medicinal product contains approximately 52.3mg sodium per g. To be taken into consideration by patients on a controlled sodium diet.
Always take this medicine exactly as your doctor or pharmacist 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 dose will depend on the patient and will be decided by your doctor. However, the usual doses for each age group are:
Adults (including the elderly)
- The usual dose is 250mg four times a day.
- Bone or heart infection: Up to 8g daily, in divided doses at six to eight hours apart.
- Surgical prophylaxis: 1 to 2g IV at induction of anaesthesia followed by 500mg every six hours for up to 72 hours.
Use in children and adolescents
Children (10-18 years of age): Children (2-10 years of age): Children under 2 years of age:
250mg four times daily 125mg four times daily 62.5mg four times daily
Patients with kidney problems
If you suffer from severe kidney failure your doctor will give you lower or fewer doses.
If you take more of your medicine than you should
If you (or somebody else) accidentally takes too much of your medicine, speak to your doctor or pharmacist immediately.
If you forget to take your medicine
If you forget to take a dose, take it as soon as you remember, then carry on as before. Do not take a double dose to make up for a forgotten dose.
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.
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 Capsules and contact your doctor immediately 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, possibly bloody, diarrhoea
- jaundice (yellow colour in the skin and whites of the eyes), hepatitis (liver inflammation) - 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, stomach upset and feeling sick - should be mild and wear off after a few days. 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)
- unusual bleeding or bruising, anaemia (may be caused by changes in the numbers of blood cells)
- 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 at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.
Do not use this medicine after the expiry date which is stated on the label after EXP! The expiry date refers to the last day of that month.
Securitainers: Store below 25°C. Store in the original package. Keep the container tightly closed in order to protect from light and moisture.
Blister packs: Store below 25°C. Do not open the foil pouch until ready to use the product. Once opened the foil pouch may be discarded. Store the product in the outer carton in order to protect from light and moisture.
Return any left-over medicine to the pharmacist. 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.
What Flucloxacillin Capsules contain
The active substance is flucloxacillin as flucloxacillin sodium.
The other ingredients are sodium starch glycolate, magnesium stearate, red iron oxide (E172), yellow iron oxide (E172), black iron oxide (E172), titanium dioxide (E171) and gelatin.
Please see further information on sodium in section 2.
What Flucloxacillin Capsules look like and contents of the pack
The 250mg capsules are opaque caramel and grey, printed with 'FXN 250' in black ink. The capsules contain a granular off-white powder.
The 500mg capsules are opaque caramel and grey, printed with 'FXN 500' in black ink. The capsules contain a granular off-white powder.
Both strengths are available in the following pack sizes:
Securitainers are available in pack sizes of 15, 18, 20, 21, 28, 30, 50, 100, 250 & 500 capsules. Blister packs are available in pack sizes of 15, 18, 20, 21, 28, 30, 50, 100, 250 & 500 capsules. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Athlone Laboratories Limited, Ballymurray, Co. Roscommon, Ireland.
Distributed by: TEVA UK Limited, Eastbourne, BN22 9AG
PL06453/0015
PL06453/0016
This leaflet was last revised in April 2016.
48504-H
