Patient leaflet - FLUCLOXACILLIN 250 MG / 5ML POWDER FOR ORAL SOLUTION SUGAR FREE
Flucloxacillin 125mg/5ml & 250mg/5ml Powder for Oral Solution, Sugar Free
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. Do not pass it onto others. It may harm them, even if their symptoms are the same as yours.
- If you get any side efforts, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet (See section 4).
-
1. What Flucloxacillin is and what it is used for
-
2. What you need to know before you take Flucloxacillin
-
3. Mow to take Flucloxacillin
-
4. Possible side effects
-
5. How to store Flucloxacillin
-
6. Contents of the pack and other information
1. what flucloxacillin is and what it is used for
Flucloxacillin 125mg/5ml & 250mg/5ml Powder for Oral Solution, Sugar Free contains the active substance flucloxacillin. 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
-
* bones and joints infection
- meningitis
-
* digestive system infections
- blood infections
-
* kidney, bladder or the 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:do not take flucloxacillin and tell your doctor if you or your child:* are allergic to flucloxacillin, penicillin, any other antibiotic or any of the other ingredients of this medicine (listed in section 6).
- have ever had liver problems after taking flucloxacillin.
Warnings and Precautions
Talk to your doctor or pharmacist before taking your medicine if you or your child:
-
■ has liver or kidney problems
-
■ have any serious illness, other than this infection
-
* are giving this medicine to a newborn child.
- are 50 years old or over
-
* 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:
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines. Especially:
- Probenecid or sulfinpyrazone (to treat gout)
-
* other antibiotics (used to treat 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.
Tests
Regular monitoring of liver and kidney function should be performed whilst taking flucloxacillin. Tell your doctor that you are taking flucloxacillin if you are having liver function tests urine tests as it may affect the results.
Flucloxacillin contains Aspartame, mannitol, and sodium
The 125mg/5ml solution contains 5 mg aspartame per 5ml dose, and the 250mg/5ml solution contains 10 mg aspartame per 5ml dose. Aspartame present in this solution, which is a source of phenylalanine. It may be harmful for people with phenylketonuria.
This medicinal product contains mannitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
The 125mg/5ml solution contains 15.28mg sodium per 5ml dose, and the 250mg/5ml solution contains 30.56mg sodium per 5ml dose, this is particularly important if you are on a reduced salt diet.
3. how to take flucloxacillin
Always take Flucloxacillin exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Take your powder for 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 oral suspension intake.
The recommended dose is
-
■ Adults and children over 10 years: 250 mg four times a day.
- Joint infections (osteomyelitis) or heart infections (endocarditis) – up to 8g daily in divided doses, six to eight hourly.
-
■ To prevent infection due to surgery –1 to 2g by injection into a vein, at the same time as the anaesthetic, followed by 500mg six hourly either by mouth or injection into a vein or muscle for up to 72 hours.
-
* Children 2 to 10 years: 125 mg four times a day.
- Children under 2 years: 62.5 mg 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.
If you take more Flucioxacillin than you should
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
If you forget to take Flucioxacillin
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.
If you stop taking Fludoxacillin
Do not stop treatment early because some bacteria may survive and cause the infection to come back.
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 Oral Solution can cause side effects, although not everybody gets them.
Please tell your doctor or pharmacist if you notice any of the following effects or any effects not listed.
Stop taking Flucioxacillin and contact your doctor at once if you experience any of the following:
-
* hypersensitivity or severe allergic reaction including itchy rash, itching, sore mouth or eyes, swelling of the face, lips, throat or tongue or breathing problems.
- severe bloody diarrhoea (pseudomembranous colitis).
-
* 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 resembles burns (toxic epidermal necrolysis).
-
* A red, scaly rash with bumps under the skin and blisters (Acute generalized exanthematous pustulosis) (frequency not known).
5. how to store fludoxacillin powder for oral sdudon
Do not store above 25°C. Once reconstituted (mixed), store the solution at 2° C to 8°C in a refrigerator and use within 7 days. Do not freeze the medicine. Keep out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label//bottle.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. contents of the pack and other informationwhat fludoxacillin powder for oral solution containsthe active substance (the ingredient that makes the oral solution work) is fludoxacillin. each 5ml of solution contains 125mg or 250mg of the active ingredient.
The other ingredients are aspartame E951, sucralose, sodium citrate, citric acid anhydrous, disodium edetate, pineapple flavour, raspberry flavour and mannitol E421.
What Fludoxacillin Powder for Oral Solution looks like and contents of the pack
It is a white granular powder which after reconstitution becomes almost colourless to pale yellow solution having a pleasant odour and a sweet taste.
On reconstitution, each bottle contains 100ml of Fludoxacillin Sugar Free Oral Solution.
Marketing Authorisation Holder:
Novelgenix Therapeutics Limited, 79 College Road
Harrow
HA11BD
England
Manufadurer:
Wave Pharma Limited 4* Floor Cavendish House 369 Burnt Oak Broadway Edgware HA85AW Middlesex, United Kingdom
If you would like this leaflet in a different format information or want to report any side effects please contact marketing authorisation holder listed above