Patient leaflet - Flucloxacillin 125 mg/5 ml powder for oral solution sugar free

1. What this medicine 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 this medicine

Do not take this medicine:

if you are allergic to the active substance, other penicillin antibiotics (see symptoms in section 4) or any of the other ingredients of this medicine (listed in section 6). • if you have had liver problems after taking this medicine.
if you 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,

Are 50 years of age or older,
Have other serious illnesses (apart from the infection this medicine is treating). • 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.

Taking other medicines

Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines. This means medicines you have bought yourself as well as medicines on prescription form a doctor. 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),
Warfarin (medicine to prevent blood clotting).

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.

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.

Driving and using machines

Flucloxacillin oral solution is not expected to affect your ability to drive or operate machinery.

Important information regarding the ingredients of this medicine

This medicinal product contains below ingredients:

125mg: Sodium: This medicinal product contains 10.61 mg sodium per dose. To be taken into consideration by patients on a controlled sodium diet.

250mg: Sodium: This medicinal product contains 21.21 mg sodium per dose. To be taken into consideration by patients on a controlled sodium diet.

Aspartame (E951): Contains a source of phenylalanine. May be harmful for people with phenylketonuria.

Mannitol (E421): May have a mild laxative effect.

3. How to take this medicine

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.

How much of your medicine to take and when to take it

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): 250 mg four times a day

Children (2-10 years of age): 125 mg four times a day

Children under 2 years of age: 62.5 mg four times a day

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Flucloxacillin Sugar Free Oral Solution is not recommended for premature or babies less than 4 weeks old.

Severe kidney disease - your doctor may reduce your dose, the maximum dose in adults is 1 g every 8 to 12 hours.

Instructions for reconstitution of the powder

a. Remove the cap and add the correct volume of potable water (92 ml if you have been given the 125 mg / 5 ml strength of product and 86 ml if you have been given the 250 mg / 5 ml strength of product).

b. Replace the cap and shake well.

c. Remove the cap once more and place the adaptor into the bottle opening. The adaptor should not be removed at any stage.

d. Replace the cap, do not shake any further.

When to take your medicine

Take your powder for oral suspension 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 oral suspension intake. It is important that you take your medicine at the right times.

If you take more of your medicine than you should

If you (or somebody else) takes too much of your medicine, talk to your doctor or pharmacist immediately.

If you forget to take your medicine

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 your medicine

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.

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 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
Jaundice (yellow colour in the skin and whites of the eyes)
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).
A red, scaly rash with bumps under the skin and blisters (exanthematous pustulosis) (frequency not known). Contact a doctor immediately if you get any of these symptoms.

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.
Very rare (may affect up to 1 in 10,000 people):
Inflammation of the kidney or liver, changes in the numbers of blood cells (might cause bleeding, easy bruising or skin discolouration), anaemia, skin rash with circular red patches (erythema multiforme), severe skin rash with flushing, fever. Joint or muscle pains or fever (may develop 2 days after starting treatment). increase in the number of white blood cells in the blood (eosinophilia).
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). • Some of these reactions to flucloxacillin can be delayed for up to 2 months after finishing the treatment.
Not known (cannot be estimated from the available data):
- 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.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the YellowCard 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.

5. How to store this medicine

Keep this medicine out of the sight and reach of children.
Powder: Do not store above 25°C.
Reconstituted solution: Store in a refrigerator (2°C – 8°C) and consume within 7 days of preparation.
Do not use this medicine after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month.
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 this medicine contains

The active substance is flucloxacillin as flucloxacillin sodium.
125mg: Each 5 ml reconstituted solution contains flucloxacillin sodium equivalent to 125 mg flucloxacillin.
250mg: Each 5 ml reconstituted solution contains flucloxacillin sodium equivalent to 250 mg flucloxacillin
The other ingredients are aspartame (E951), sucralose, sodium citrate, citric acid anhydrous, disodium edetate, pineapple powder, raspberry flavour, mannitol (E421).

What this medicine looks like and contents of the pack

Unconstituted powder: a free-flowing white granular powder.
Reconstituted solution: almost colourless to pale yellow solution with pleasant odour • This medicine is available in 150 ml high density polyethylene (HDPE) bottle incorporating an edge pull induction seal wad closed with a child resistant (CRC) cap and a polypropylene measuring cup with 2.5 ml, 5 ml, 10 ml and 15 ml markings. • On reconstitution, each bottle contains 100 ml of Flucloxacillin Sugar Free Oral Solution.

Marketing Authorisation Holder and Manufacturer

Bristol Laboratories Ltd,

Unit 3, Canalside, Northbridge Road, Berkhamsted, HP4 1EG, UK

Telephone: 0044 (0) 1442 200922

Fax: 0044 (0) 1442 873717

Email: info@bristol-labs.co.uk

This leaflet was last revised in April 2021

To request a copy of this leaflet in Braille, large print or audio format, please contact the marketing authorisation holder at the address (or telephone, fax, email) above. 10 mm