iMedi.co.uk

Flucloxacillin Capsules Bp 500mg

Document: label-leaflet MAH GENERIC_PL 04569-0040 change

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Each capsule contains: Flucloxacillin sodium Ph Eur equivalentto 250 mg Flucloxacillin.

Also contains: sodium.

Dosage: For oral use as directed by a doctor.

Read the attached leaflet.

Keep out of the sight and reach of children.

Store in a dry place below 25°C.

PL04569/0039 IPOM 10004565 Mylan, Potters Bar, Herts, EN6 ITL, U.K.


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PACKAGE LEAFLET:INFORMATION FORTHE USER FLUCLOXACILLIN CAPSULES BP 250 mg

FLUCLOXACILLINCAPSULES BP 500 mg

(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.


•    Thismedicine hasbeenprescribed for you. Do not pass it on toothers. 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 isandwhat itis used for.

2.    What you need to know before you take Flucloxacillin.

3.    How to take Flucloxacillin.


4.    PosiiBlesideeffectsT """

5.    How to store Flucloxacillin.

6.    Contentsofthepackandother information.

1. WHAT FLUCLOXACILLIN IS AND WHATITISUSEDFOR

Flucloxacillin is an antibiotic of the penicillin group. It belongs to a group of medicines called penicillinase-resistant antibiotics.

It is used:

•    totreat infectionsindifferent partsof your body caused by bacteria

•    to prevent infections during surgery.


2. WHAT YOU NEEDTO 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 yourdoctor immediately (see section 4). Your doctor will prescribe a different type ofantibiotic.

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, haverecentlytakenormight 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)

•    oral contraceptives. If you are taking an oral contraceptive it may not work so well. Yourdoctor will be able to advise you on additional contraceptive precautions.

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 ofamothertakingthismedicine.Thismay 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 youmaybepregnantorareplanningto havea baby, ask yourdoctor or pharmacist for advice before taking any medicine.

Driving and using machines

Flucloxacillinisnot knownto affect your abilityto drive oruse 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 betaken into consideration by patients on a controlled sodium diet.

3. HOW TO TAKE FLUCLOXACILLIN

I

Alwaystakethismedicineexactly asyour doctoror pharmacist has told you.Checkwith 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: i250mgfourtimesaday. Ifyourinfectionis severe your doctor may double your dose to 500 mg fourtimes a day.

Osteomyelitis (bone infection) and endocarditis (infection of the heart lining):

Totreat thesetwoconditions your doctor may prescribe a total daily dose of up to 8 grams. This will be taken as divided doses


every sixto eight hours.

Prevention of infection after surgery: The usual dose is 500 mg fourtimes a day for three days.

fyouhaveseverekidneydisease:

Yourdoctormayprescribealowerdose than those stated above.

Use in Children under 10 years old: Children aged 2to 10years 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. Yourdoctor 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. Takethecontainerandanyremaining capsules with you.

IfyouforgettotakeFlucloxacillin

Do not take a double dose to make up for a forgotten dose. Take the next dose at the usual time.

I

If you stop taking Flucloxacillin

Do not stop or change your treatment


before talking to yourdoctor. Itisimportant that you complete the course as directed by yourdoctor. 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 yourdoctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

[Likeall medicines, this medicinecan 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 takingthecapsulesimmediatelyand contact your doctor:

•    redness and swelling of the hands, feet, ankles, face, lips, mouth or throat, (which maycausedifficultyinbreathing)

•    severe diarrhoea with or without bleeding

•    skin rashes or severe allergic reactions whichmaycausedifficultyinbreathing 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(jaundiceoccurringwhenbile cannot flowfromtheliverproperly).

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 orulcers(Stevens-Johnsonsyndrome)

•    severe rash with reddening, peeling and swelling ofthe skin that resembles burns (toxic epidermal necrolysis).


Common side effects (may affect up to 1in10people):

•    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 yourdoctor.

•    skin rash (exanthema).

Uncommon side effects (may affect up to 1in100people):

•    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.

Ifyougetanysideeffects talktoyour 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 0808100 3352 (available from 10 a.m. to 2 p.m. Mondays to Fridays) or fill in a paper form available from your local pharmacy.

6. HOW TO STORE FLUCLOXACILLIN !

Keep this medicine out of the sight and reach ofchildren.

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.


Storeyourcapsulesinadryplacebelow25°C.

Do not throwaway any medicines via wastewater or household waste. Askyour 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

Theactivesubstanceis flucloxacillin sodium. Each capsule contains 250 mg or 500 mg flucloxacillin.

The other ingredients are magnesium stearate, gelatin, titanium dioxide, black


!i ro noxid e, ye I low! rdnoxid e, TecTi Ton"oxid e’

Theprintinginkcontainsshellac, ironoxide i [black(E172), n-butyl alcohol, propylene    [

glycol, isopropyl alcohol andammonium    i

hydroxide.

What Flucloxacillin looks like and contents ofthe pack

Your medicine comes as a grey and brown [capsule, hard. The250mgcapsulesare    [

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,

I    I


r25,'28,'30,"50r5676784790, T0b7 " i 250 and 500 capsules. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mylan, PottersBar, Hertfordshire, ! EN61TL, United Kingdom.

Manufacturer

Generics [UK] Ltd., Potters Bar, Hertfordshire, EN61TL,

United Kingdom.

This leaflet was last revised in 06/2013.

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capsules BP

28 capsules

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to 250 mg Flukloxa#llin.    •    • •

Also contain^: sodium. • • •    •

Dosage: For oral use as directed by a doctor.


P^ead the attached leaflet.

reep <pt of the s^#2 r2ch h cftiflren.mg

Store in a dry place below 25°C.

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Store

PL04569/0039 POM 10004565 Mylan, Potters BjeTHeTts, EN6 ITL, U.K.


Mylan i


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