FLUCLOXACILLIN 125MG/5ML SUGAR-FREE POWDER FOR ORAL SOLUTION
FLUCLOXACILLIN 250MG/5ML SUGAR-FREE POWDER FOR ORAL SOLUTION
Read all of this leaflet carefully before you start taking your medicine. Keep this leaflet. You may need to read it again. If you have further questions, please ask your doctor or pharmacist (chemist). This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.
What Is In This Leaflet?
This leaflet answers some common questions about your medicine. It contains the following information:
1 What your medicine is and what it is used for
2 Before you take your medicine
3 How to take your medicine
4 Possible side effects of your medicine
5 How to store your medicine
6 Further information
What your 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
- ear infections
- heart infections
- meningitis
- blood infections
- kidney, bladder or urethra (the tube which carries urine from the bladder) infections.
- throat or nose infections
- skin and soft tissue infections
- bones and joint infections
- digestive system infections
Flucloxacillin can also be used to prevent infections during major surgery, particularly heart or orthopedic surgery.
Before you take your medicine
Do not take this medicine 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, Further Information.
- You suffer from liver problems, as this medicine could cause them to worsen
Check with your doctor or pharmacist before taking this medicine 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)
Check with your doctor or pharmacist before taking this medicine if you are taking any other medicines, especially:
- Probenecid or sulfinpyrazone (used to treat gout).
- Methotrexate (a chemotherapy drug)
- The contraceptive pill as antibiotics can make these less effective (you will need to use extra precautions such as condoms while taking flucloxacillin and for a full 7 days after you finish taking it).
- Oral typhoid vaccine (antibiotics can make this less effective)
- Sugammadex (used with general aesthetics)
- Pipercillin (an antibiotic taken by injection)
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 and breastfeeding
If you are pregnant, planning to become pregnant or are breast feeding 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.
Important information about some of the ingredients in your medicine:
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.
The 125mg/5ml solution contains 23mg sodium per dose, and the 250mg/5ml solution contains 49.41mg of sodium per dose. To be taken into consideration by patients on a controlled sodium diet.
How to take your medicine
Follow all directions given to you by your doctor or pharmacist. 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.
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): 5ml four times a day (5ml is equivalent to one teaspoonful)
Children (2-10 years of age): 2.5ml four times a day
Children under 2 years of age: 1.25ml four times a day
When to take your medicine:
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 your medicine for:
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 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 the dose you have missed.
Possible side effects of your medicine
Like all medicines, Flucloxacillin Sugar Free Oral Solution may cause unwanted side-effects. 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).
Tell your doctor if you notice any of the following effects:
Common (occurs in more than 1 in 100 and less than 1 in 10 users):
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 (occurs in less than 1 in 10,000 users): 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.
How to store your medicine
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.
Keep this medicine in a safe place where children cannot see or reach it.
Do not use this medicine after the expiry date shown on the label.
Return any left-over medicine to the pharmacist.
Further Information
What Flucloxacillin Sugar-Free Oral Solution contains
Active ingredient: flucloxacillin as flucloxacillin sodium
Other ingredients: Sodium Citrate Anhydrous, Disodium Edetate, Sodium Benzoate, Citric Acid Monohydrate, Silica Collodial Anhydrous, 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
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
Manufacturer
This leaflet was last revised March 2010.
P537
ATHPL014
No comments:
Post a Comment