Flucloxacillin 250 mg Capsules

Main information

  • Trade name:
  • Flucloxacillin 250 mg Capsules
  • Dosage:
  • 250 milligram(s)
  • Pharmaceutical form:
  • Capsule, hard
  • Prescription type:
  • Product subject to prescription which may not be renewed (A)
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Flucloxacillin 250 mg Capsules
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic area:
  • Beta-lactamase resistant penicillins; flucloxacillin

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization status:
  • Marketed
  • Authorization number:
  • PA0298/016/001
  • Authorization date:
  • 14-10-2011
  • Last update:
  • 21-05-2019

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

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Package leaflet: Information for the patient

FLUCLOXACILLIN 250MG CAPSULES

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 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

What Flucloxacillin Capsules are and what they are used for

What you need to know before you take Flucloxacillin Capsules

How to take Flucloxacillin Capsules

Possible side effects

How to store Flucloxacillin Capsules6.

Contents of the pack and other information

1.

What Flucloxacillin Capsules are and what they are 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

throat or nose infections

ear infections

skin and soft tissue infections

digestive system infections

kidney, bladder or urethra (the tube which carries urine from the bladder) infections.

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 or cephalosporin antibiotics (such as amoxicillin

or cefaclor - see section 4, Possible side effects).

are allergic to any of the other ingredients of this medicine (listed in section 6, Contents of the pack

and other information).

have ever suffered from jaundice or liver problems 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

Suffer from liver problems, as this medicine could cause them to worsen

Are 50 years of age or older

Have other serious illnesses (apart from the infection being treated by this medicine)

Are giving this medicine to a newborn child

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Are on a sodium restricted diet.

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.

Tests

Regular monitoring of liver and kidney function should be performed whilst taking flucloxacillin for a

long period of time. Tell your doctor that you are taking flucloxacillin if you are having urine tests or

blood tests because it may affect the results.

Other medicines and Flucloxacillin Capsules

Tell your doctor or pharmacist if you are taking, have recently taken or might take 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).

other types of antibacterial treatments such as bacteriostatic agents (e.g. chloramphenicol and

tetracyclines).

Some medicines may affect the way others work. 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 has no or negligible influence on the ability to drive and use machines.

Flucloxacillin Capsules contains sodium

This medicinal product contains 13.2 mg sodium per capsule. 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 or pharmacist has told you. Check with your doctor or

pharmacist if you are not sure. 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. If it does not, or you are not sure,

check with your doctor or pharmacist.

When to take Flucloxacillin Capsules

Take Fluclxoacillin Capsules on an empty stomach, at least thirty minutes to one hour before meals/food.

It is important that you take Flucloxacillin Capsules at the right times.

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Doses:

The dose will depend on the patient and will be decided by your doctor. However, the usual dose

for adults, including the elderly, and children and adolescents over 10 years of age is 1 to 3 g a day in 3 to

4 equally divided doses.

For children under 10 years of age, the usual dose is 25-50 mg per kg body weight in 24 hours. This will

be given in 3 or 4 divided doses. Your pharmacist will explain how to give this medicine to your child.

If you suffer from severe kidney failure your doctor may give you lower or fewer doses.

If you take more Flucloxacillin Capsules than you should

If you (or someone else) accidentally take too much of Flucloxacillin Capsules, speak to your doctor or

pharmacist immediately. Symptoms of an overdose include feeling or being sick and diarrhoea.

If you forget to take Flucloxacillin Capsules

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 Flucloxacillin Capsules

Keep taking Flucloxacillin Capsules 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, 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 may 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, bloody diarrhoea (pseudomembranous colitis)

Blistering or peeling of the skin

Jaundice (yellow colour in the skin and whites of the eyes), hepatitis (liver inflammation) – can

develop some weeks after taking this medicine. If this happens tell your doctor immediately.

Skin rash with circular, red patches (Erythema multiforme)

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).

These are all very rare side effects (may affect up to 1 in 10,000 people).

Tell your doctor if you notice any of the following effects:

Common

(may affect up to 1 in 10 people):

Diarrhoea, stomach ache and feeling sick. This should be mild and wear off after a few days. If

severe or longer lasting, tell your doctor.

Uncommon

(may affect up to 1 in 100 people):

Rash, itching, red/purple discolourations on the skin.

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Very rare

(may affect up to 1 in 10,000 people):

Kidney problems (may result in difficulty passing urine or blood in urine)

Unexplained bleeding, bruising or skin discolouration (may be caused by changes in the numbers of

blood cells)

Abnormal breakdown of red blood cells (haemolytic anaemia)

Joint or muscle pain or fever (may develop 2 days after starting treatment)

Seizures (convulsions)

Blood and lymphatic system disorders neutropenia (reduction in white blood cells) including

agranulocytosis (serious low level of white blood cells). People with this condition are at very high

risk of serious infections due to their suppressed immune system. Patients are advised to report any

signs and symptoms of infection to their doctor

Inflammation of the liver, jaundice (yellowing of the skin or whites of the eyes). These effects may

be delayed for up to two months after treatment has stopped.

Changes in liver function test results (reversible when treatment is discontinued).

Cases 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,

generally in the presence of risk factors (see section 2).

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.

Some of these reactions to flucloxacillin can be delayed for up to 2 months after finishing the

treatment.

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 (see details below). By reporting side

effects you can help provide more information on the safety of this medicine.

HPRA Pharmacovigilance

Earlsfort Terrace

IRL-Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.hpra.ie

e-mail: medsafety@hpra.ie

5.

How to store Flucloxacillin Capsules

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date shown on the label or carton after EXP. The expiry date

refers to the last day of that month.

Securitainers: Do not store above 25

C. Keep the container tightly closed. Store in the original container

to protect from light and moisture.

Blister packs in aluminium pouch: Do not store above 25

C. Keep the blister in the outer carton in order to

protect from light and moisture. Do not open the foil pouch until ready to use the product. Once opened

the foil pouch may be discarded. Use within 3 months of opening the foil pouch.

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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 Capsules contain

The active substance is flucloxacillin sodium. The 250mg capsules contain 250mg of flucloxacillin as

flucloxacillin sodium.

The other ingredients are sodium starch glycolate (Type A), magnesium stearate, red iron oxide (E172),

yellow iron oxide (E172), black iron oxide (E172), titanium dioxide (E171) and gelatin; printing ink

contains shellac, ethyl alcohol anhydrous, isopropyl alcohol, n-butyl alcohol, ammonium hydroxide,

potassium hydroxide, water – purified, propylene glycol and black iron oxide (E172).

Please see further information on sodium in section 2, what you need to know before you take

Flucloxacillin Capsules.

What Flucloxacillin Capsules look like and contents of the pack

The 250mg capsules are size 2 hard gelatin capsules with an opaque caramel body and opaque grey cap,

printed with ‘FXN 250' in black ink. The capsules contain a granular off white powder.

They are available in the following pack sizes:

Securitainers are available in pack sizes of 40, 100 & 500 capsules.

Blister packs in aluminium pouches are available in pack sizes of 10, 16, 20, 24 or 28 capsules.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and manufacturer

Athlone Laboratories Limited, Ballymurray, Co. Roscommon, Ireland.

Distributor

Clonmel Healthcare Ltd, Waterford Road, Clonmel, Co. Tipperary

PA 298/16/1

This leaflet was revised in December 2017.