Flucloxacillin 125mg/5ml Oral Solution BP

Main information

  • Trade name:
  • Flucloxacillin 125mg/5ml Oral Solution BP
  • Dosage:
  • 125 mg/5ml
  • Pharmaceutical form:
  • Powder for oral solution
  • Prescription type:
  • Product subject to prescription which may not be renewed (A)
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Flucloxacillin 125mg/5ml Oral Solution BP
    Ireland
  • Language:
  • English

Therapeutic information

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

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization status:
  • Not marketed
  • Authorization number:
  • PA0298/016/003
  • Authorization date:
  • 14-10-2011
  • Last update:
  • 12-12-2018

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

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Package leaflet: Information for the patient

FLUCLOXACILLIN 125MG/5ML ORAL SOLUTION BP

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 Oral Solution BP is and what it is used for

What you need to know before you take Flucloxacillin Oral solution BP

How to take Flucloxacillin Oral solution BP

Possible side effects

How to store Flucloxacillin Oral solution BP

Contents of the pack and other information

1.

What Flucloxacillin Oral solution BP 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

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 can also be used to prevent infections during major surgery, particularly heart or

orthopaedic surgery.

2.

What you need to know before you take Flucloxacillin Oral solution BP

Do not take Flucloxacillin Oral Solution if you:

Are allergic to flucloxacillin or any other penicillin or cephalosporin antibiotics (such as

amoxicillin or cefaclor - see symptoms listed in section 4)

Are allergic to any of the other ingredients of this medicine (listed in section 6)

Have suffered before 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 Oral Solution BP

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.

Driving and using machine

Flucloxacillin Oral solution

has no or negligible influence on the ability to drive and use machines.

Flucloxacillin Oral solution BP contains sodium and sucrose.

This medicinal product contains 18mg of

sodium

in each 5ml spoonful of solution. To be taken into

consideration by patients on a controlled sodium diet.

This medicinal product contains 3.094g of

sucrose (sugar)

per 5ml. This should be taken into account

in patients with diabetes mellitus. If you have been told by your doctor that you have an intolerance to

some sugars, contact your doctor before taking this medicinal product.

Flucloxacillin Oral Solution BP contains Sodium Benzoate

This medicinal product also contains sodium benzoate which is a mild irritant to the skin, eyes and

mucous membrane.

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3.

How to take Flucloxacillin Oral solution BP

Always take Flucloxacillin Oral solution BP exactly as your doctor or pharmacist has told you to.

Check with your doctor or pharmacist if you are not sure.

When to take Flucloxacillin Oral solution BP

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

Doses

Adults and children over 10 years:

two 5ml spoonfuls four times a day

Children (2-10 years of age):

one 5ml spoonful four times a day

Children under 2 years of age:

half a 5ml spoonful (2.5ml) four times a day

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

If you take more of Flucloxacillin Oral solution BP than you should

If you (or somebody else) accidentally take too much Flucloxacillin Oral solution BP e, speak to your

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

diarrhoea.

If you forget to take Flucloxacillin Oral solution BP

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 Oral solution BP

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 Flucloxacillin Oral solution BP, ask your doctor or

pharmacist.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Please tell

your doctor or pharmacist if you notice any of the following side effects or any side effects not listed.

STOP taking Flucloxacillin Oral solution BP 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. If any hypersensitivity reaction occurs, the

treatment should be discontinued.

Severe, bloody diarrhoea (pseudomembranous colitis)

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

be delayed for up to 2 months after finishing treatment

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 looks like a burn (toxic

epidermal necrolysis).

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

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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 lasting longer, tell your doctor.

Uncommon (may affect up to 1 in 100 people)

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

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)

Convulsions (especially with high doses or in patients with severe kidney problems).

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 Oral solution BP

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 label and the carton. The expiry

date refers to the last day of that month.

Dry powder: Store below 25

C. Store in the original container in order to protect from light and

moisture.

Do not open the foil pouch until ready to reconstitute the product.

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Once opened the foil pouch may be discarded.

Store the solution at 2

C to 8

C in a refrigerator. Do not freeze. Once reconstituted (mixed) by the

pharmacist, this medicine must be used within 7 days. Store the product in the outer carton.

Do not throw away medicines 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 125mg/5ml Oral Solution BP contains

The active substance is flucloxacillin sodium. Each 5ml spoonful contains 125mg of flucloxacillin as

flucloxacillin sodium.

The other ingredients are saccharin sodium, sodium benzoate, disodium edetate, ammonium

glycyrrhizinate, sodium citrate anhydrous, pineapple flavour, menthol flavour, erythrosine (E127) and

sucrose.

Please see further information in section 2.

What Flucloxacillin 125mg/5ml Oral Solution BP looks like and contents of the pack

Unreconstituted powder: a pink granular powder with a characteristic odour of pineapple.

Reconstituted solution: a pink coloured solution with a characteristic flavour and odour of pineapple.

Flucloxacillin 125mg/5ml Oral Solution BP is available in a size of 100ml upon reconstitution.

Marketing Authorisation Holder and Manufacturer

Athlone Laboratories Limited, Ballymurray, Co. Roscommon, Ireland

PA 298/16/3

This leaflet was revised in December 2017.