Flucloxacillin 250 mg/5 ml - 100 ml Sugar Free Powder for Oral Solution

• 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.

1. What Flucloxacillin Sugar Free Powder for Oral Solution is and what it is used for
2. What you need to know before you take Flucloxacillin Sugar Free Powder for Oral Solution
3. How to take Flucloxacillin Sugar Free Powder for Oral Solution
4. Possible side effects
5. How to store Flucloxacillin Sugar Free Powder for Oral Solution
6. Contents of the pack and other information

Talk to your doctor or pharmacist before taking Flucloxacillin Sugar Free Powder for Oral Solution if you or your child:

• has liver or kidney problems
• have any serious illness, other than this infection
• are 50 years old or over
• are giving this medicine to a newborn child.
• 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.

Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.

Especially:

• Probenecid or sulfinpyrazone (to treat gout),
• Methotrexate (a chemotherapy drug),
• Oral typhoid vaccine (antibiotics can make this less effective),
• Warfarin (medicine to prevent blood clotting),
• Piperacillin (an antibiotic taken by injection),
• Sugammadex (used with general anaesthetics),
• Other antibiotics (used to treat infections)
• Voriconazole (used against fungal infections)

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.

Flucloxacillin Oral Solution may have insignificant or no influence on the ability to drive and use machines.

Regular monitoring of liver and kidney function should be performed whilst taking Flucloxacillin Sugar Free Powder for Oral Solution.

Tell your doctor that you are taking Flucloxacillin Sugar Free Powder for Oral Solution if you are having liver function tests as this medicine may affect the results.

The 250mg/5ml solution contains 20.686 mg sodium per 5ml dose. This medicine contains less than 1 mmol sodium (23mg) per 5ml dose, that is to say essentially “sodium free”.

• Adults and children over 10 years: 5ml four times a day.
• Children 2 to 10 years: 2.5ml four times a day, your pharmacist will explain how to give this to your child.
• Children under 2 years: 1.25 ml four times a day, your pharmacist will explain how to give this to your child.
• Premature or babies less than 4 weeks old – Not recommended.
• Severe kidney disease: your doctor may reduce the dose, maximum dose in adults is 1g every 8-12 hours.

If you still feel unwell after finishing the treatment, speak to your doctor.

Take powder for oral solution at least 1 hour before or 2 hours after meals. Never take more than the recommended dose each day.

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 solution intake and do not lie down immediately after its intake. It is important that you take your medicine at the right times.

If you (or someone else) swallow a lot of Oral Solution at the same time, or you think another child may have swallowed any contact your nearest hospital casualty department or tell your doctor immediately. Symptoms of an overdose include feeling or being sick and diarrhoea.

Do not take a double dose to make up for a forgotten dose. If you forget to take a dose, take it as soon as you remember it and carry on as before, try to wait about four hours before taking the next dose.

Do not stop treatment early because some bacteria may survive and cause the infection to come back.

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.

Each 5ml of sugar free powder for oral solution contains 250mg of flucloxacillin as flucloxacillin sodium.

The other ingredients are mannitol (E421), sucralose, Sodium Citrate, Citric Acid anhydrous, orange flavour and menthol flavour.

Powder: White granular powder, free from agglomerates and caking.

Reconstituted solution: Colourless solution with orange odour.

Flucloxacillin Sugar Free Powder for Oral Solution are available in the size of 100ml on reconstitution in the Translucent HDPE round bottle with White Round polypropylene CR Cap.