Flucloxacillin 125mg/5ml Sugar-Free Powder For Oral Solution
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, please 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
T| What Flucloxacillin Sugar-Free Oral Solution is and what it is used for
^ What you need to know before you take Flucloxacillin Sugar-Free Oral Solution
"3 How to take Flucloxacillin Sugar-Free Oral Solution
"4| Possible side effects
T| How to store Flucloxacillin Sugar-Free Oral Solution
"6 Contents of the pack and other information
T| 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.
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. In particular tell your doctor if you are taking any of the following:
• 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).
Some medicines may affect the way others work.
Always tell your doctor about all the medicines you are taking. This means medicines you have bought yourself as well as medicines on prescription from a doctor.
Pregnancy, breastfeeding and fertility
If you are pregnant, planning to become pregnant or are breastfeeding 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.
Flucloxacillin Sugar-Free Oral Solution contains Sorbitol and Sodium
This medicinal product contains sorbitol. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
This medicinal product contains sodium. The 125mg/5ml solution contains 17.08mg sodium per 5ml dose, and the 250mg/5ml solution contains 49.41mg sodium per 5ml dose. To be taken into consideration by patients on a controlled sodium diet.
"3 How to take Flucloxacillin Sugar-Free Oral Solution
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. 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. If it does not, or you are not sure, check with your doctor or pharmacist.
^ What you need to know before you take Flucloxacillin Sugar-Free Oral Solution
Do not take Flucloxacillin Sugar-Free Oral Solution
if:
• You have ever had an allergic reaction to flucloxacillin or any other penicillin antibiotics (see symptoms section 4)
• You have ever had an allergic reaction to any of the other ingredients of this medicine - see list of ingredients in section 6, Contents of the pack and other information
• You suffer from liver problems, as this medicine could cause them to worsen.
Warnings and precautions
Talk to your doctor or pharmacist before taking
Flucloxacillin Sugar-Free Oral Solution if:
• You suffer from kidney problems, as you may require a lower dose than normal
• You suffer from liver problems, as this medicine could cause them to worsen
• You are 50 years of age or older
• You have other serious illnesses (apart from the infection this medicine is treating).
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): 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.
Severe kidney disease - your doctor may reduce your dose, the maximum dose in adults is 1g every 8 to 12 hours.
INSTRUCTIONS FOR RECONSTITUTION OF THE POWDER
1. Remove the cap and add the correct volume of potable water (87mls if you have been given the 125mg/5ml strength of product and 79mls if you have been given the 250mg/5ml strength of product).
2. Replace the cap and shake well.
3. Remove the cap once more and place the adaptor (Fig 1) into the bottle opening. The adaptor should not be removed at any stage.
4. Replace the cap, do not shake any further.
INSTRUCTIONS FOR USE OF THE SYRINGE
1. Remove the cap and if necessary push the adaptor into the neck of the bottle (Fig 1).
2. Push the plunger of the syringe to remove all the air.
3. Insert the syringe into the adaptor until it is firmly in place (Fig 2).
4. Whilst holding the bottle and syringe shake the contents well.
5. While holding the bottle, turn the entire assembly upside down.
6. Whilst supporting the syringe draw off the required amount of medicine into the syringe (Fig 3).
7. Turn the assembly back up the right way and remove the syringe from the bottle.
8. Replace the cap onto the bottle.
Administer the dose by introducing the tip of the syringe into the mouth of the infant/ child, then apply a light pressure on the plunger to slowly release the solution. Keep it out of the reach of children.
Note: For subsequent dosage follow steps 3 and 4 above, before shaking in order to prevent leakage.
Fig 1
Fig 2
Fig 3
When to take Flucloxacillin Sugar-Free Oral Solution: Take your medicine on an empty stomach, at least thirty minutes to one hour before meals/food. It is important that you take your medicine at the right times.
How long to take Flucloxacillin Sugar-Free Oral Solution for:
Keep taking your medicine until your doctor tells you to stop. Do not stop taking it just because you feel better.
If you take more Flucloxacillin Sugar-Free Oral Solution 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 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 the dose you have missed.
If you stop taking Flucloxacillin Sugar-Free Oral Solution:
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 further questions on the use of this medicine, ask your doctor or pharmacist.
Tell your doctor if you notice any of the following effects:
• Common
Diarrhoea, stomach upset and feeling sick - Should be mild and wear off after a few days. If severe or lasting longer, tell your doctor.
• Very rare
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). Joint or muscle pains or fever (may develop 2 days after starting treatment).
• 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 or pharmacist. 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
By reporting side effects you can help provide more information on the safety of this medicine.
T| How to store Fludoxacillin 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 stated on the label. 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 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
Actavis Group PTC ehf. Reykjavikurvegur 76-78 220 Hafnarfjordur Iceland
"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).
Manufacturer
Athlone Laboratories Limited
Ballymurray
Co. Roscommon
Ireland
This leaflet was last revised September 2015 Flucloxacillin 125mg/5ml Sugar Free Powder for Oral Solution - PL 30306/0448
Flucloxacillin 250mg/5ml Sugar Free Powder for Oral Solution - PL 30306/0449
^actav/s
AAAH8883
Actavis, Barnstaple, EX32 8NS, UK