Patient leaflet - Flucloxacillin 125 mg / 5 ml sugar free powder for oral solution
WHAT FLUCLOXACILLIN SUGAR FREE ORAL SOLUTION 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.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE FLUCLOXACILLIN SUGAR FREE ORAL SOLUTION
Do not take this medicine if you:
- are allergic to flucloxacillin or any other penicillin antibiotics (see symptoms in section 4).
- are allergic to any of the other ingredients of this medicine (listed in section 6).
- have had liver problems, after taking this medicine (flucloxacillin).
- have had an allergic reaction to β lactam antibiotics (e.g. penicillins, cephalosporins).
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)
- suffer from liver problems, as this medicine could cause them to worsen
- have ever had swelling of the face or skin rash while taking an antibiotic
- are 50 years of age or older
- are giving this medicine to a newborn child
- have other serious illnesses (apart from the infection this medicine is treating)
- are taking this medicine for a long time as regular tests of liver and kidney function are advised
- 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.
The use of flucloxacillin, especially in high doses, may reduce the potassium levels in the blood (hypokalaemia). Your doctor may measure your potassium levels regularly during the therapy with higher doses of flucloxacillin.
Other medicines and Flucloxacillin Sugar Free Oral Solution
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).
- other antibiotics (used to treat infections).
- paracetamol.
- warfarin (medicine to prevent blood clotting).
- voriconazole (used against fungal infections).
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 Sugar Free Oral Solution has no or negligible influence on the ability to drive and use machines.
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. Long term use may cause increased resistance of bacteria to this medicine, which will reduce its effectiveness.
Flucloxacillin Sugar Free Oral Solution contains sorbitol and sodium.
This medicine contains sorbitol.
The 125mg/5ml solution contains 697.67 mg of sorbitol in each 5 ml dose.
The 250mg/5ml solution contains 1000.34 mg of sorbitol in each 5 ml dose.
Sorbitol is a source of fructose. If your doctor has told you that you (or your child) have an intolerance to some sugars or if you have been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your doctor before you (or your child) take or receive this medicine.
This medicine contains sodium.
The 125mg/5ml solution contains less than 1mmol sodium (23mg) per 5ml dose, that is to say essentially ‘sodium-free’.
The 250mg/5ml solution contains 49.41mg sodium (main component of cooking/table salt) in each 5ml dose. This is equivalent to 2.47% of the recommended maximum daily dietary intake of sodium for an adult.
This medicine contains 5mg sodium benzoate in each dose which is equivalent to 5mg/ 5ml. Sodium benzoate may increase jaundice (yellowing of the skin and eyes) in newborn babies (up to 4 weeks old).
HOW TO TAKE FLUCLOXACILLIN SUGAR FREE ORAL SOLUTION
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.
The recommended dose is
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): 250mg four times a day
Children (2-10 years of age): 125mg four times a day
Children under 2 years of age: 62.5mg four times a day
Flucloxacillin Sugar Free Oral Solution is not recommended for premature or babies less than 4 weeks old.
Avoid contact with the skin in case of sensitivity.
Severe kidney disease - your doctor may reduce your dose, the maximum dose in adults is 1g every 8 to 12 hours.
When to take Flucloxacillin Sugar Free Oral Solution
Take Flucloxacillin Sugar Free Oral Solution at least 1 hour before or 2 hours after meals. To reduce the risk of pain in your oesophagus (the tube that connects your mouth with your stomach) take a full glass of water (250ml) after oral suspension intake and do not lie down immediately after Flucloxacillin intake.
If you take more Flucloxacillin Sugar Free Oral Solution than you should
If you (or somebody else) takes too much of your medicine, or you think a child may have swallowed any contact your nearest hospital 1.
2.
3.
casualty department or talk to your doctor or pharmacist immediately.
If you forget to take Flucloxacillin Sugar Free Oral Solution
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 Sugar Free Oral Solution
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.
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 need medical attention.
Prolonged treatment with Flucloxacillin may result in increased growth of resistant organisms.
STOP taking flucloxacillin immediately 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). If bloody diarrhoea develops, flucloxacillin treatment should be discontinued and appropriate therapy, e.g. oral vancomycin should be initiated.
- 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
- skin rash with circular, red patches (Erythema multiforme).
- severe skin rash with flushing, fever, blisters or ulcers (Stevens-Johnson syndrome) or a 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)
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, this should be mild and wear off after a few days. If severe or lasting longer, tell your doctor.
- heartburn and indigestion
Uncommon (may affect more than 1 in 100 people):
- rash, urticaria (itchy skin eruptions), purpura (brownish-red spots on the skin), hives
Very rare (may affect up to 1 in 10,000 people):
- kidney problems including inflammation (may result in difficulty passing water or blood in the urine)
- unexplained bleeding, bruising or skin discolouration (may be caused by changes in the numbers of blood cells)
- blood and lymphatic system disorders like 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. Thrombocytopenia (low platelet count) and Eosinophilia (an increased number of eosinophils in the blood)
- joint or muscle pains or fever (may develop 2 days after starting treatment)
- abnormal breakdown of red blood cells (haemolytic anaemia)
- seizures (convulsions)
- 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)
Not known (frequency cannot be estimated from the available data):
- serious skin reactions - A red, scaly rash with bumps under the skin and blisters (exanthematous pustulosis).
- low potassium levels in the blood
(hypokalaemia), which can cause muscle weakness, twitching or abnormal heart rhythm.
- pain in oesophagus (the tube that connects mouth with stomach) and other related symptoms, such as difficulties in swallowing, heartburn, throat irritation or chest pain.
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.
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, pharmacist or nurse. 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 or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
HOW TO STORE FLUCLOXACILLIN SUGAR FREE ORAL SOLUTION
KEEP THIS MEDICINE OUT OF THE SIGHT AND REACH OF CHILDREN.
Do not store above 25°C.
Once reconstituted (mixed) by the pharmacist, store the solution at 2°C to 8°C in a refrigerator and use within 7 days. Do not use this medicine after the expiry date which is stated on the label. 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.
CONTENTS OF THE PACK AND OTHER INFORMATION
What Flucloxacillin Sugar Free Oral Solution contains
The active substance is flucloxacillin as flucloxacillin sodium.
The other ingredients are Sodium Citrate Anhydrous, Disodium Edetate, Sodium Benzoate, Citric Acid Monohydrate, Colloidal Anhydrous Silica, Xanthan Gum, Saccharin Sodium, Menthol Flavour, Lemon Flavour, Strawberry Flavour and Sorbitol.
Please see further information on sorbitol and sodium in section 2.
What Flucloxacillin Sugar Free Oral Solution looks like and contents of the pack
Unconstituted powder: a free flowing white granular powder with a slight lemon smell. Reconstituted solution: an opaque off-white coloured solution with a lemon smell and flavour. The solution may become more yellow as time progresses.
On reconstitution, each bottle contains 100ml of Flucloxacillin Sugar Free Oral Solution.
Marketing Authorisation Holder
Kent Pharmaceuticals Limited, 2nd Floor, Connect 38, 1 Dover Place, Ashford, Kent, England, TN23 1FB.
Manufacturer
Athlone Laboratories Limited, Ballymurray, Co. Roscommon, Ireland.
Kent Pharmaceuticals Limited, Repton Road, Measham, DE12 7DT, U.K.
Flucloxacillin 125mg/5ml Sugar Free Powder for Oral Solution – PL 08215/0119
Flucloxacillin 250mg/5ml Sugar Free Powder for Oral Solution – PL 08215/0121
This leaflet was last revised in October 2023
4.
5.
6.
Customer: Kent Originated by: KBN (AWG)
Product: Flucloxacillin 125mg/5ml & 250mg/5ml SF Oral Solution PIL
Dimensions: 148mm x 450mm