Flucloxacillin Capsules Bp 500mg
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PACKAGE LEAFLET:
INFORMATION FOR THE USER
FLUCLOXACILLIN CAPSULES BP
250mg AND 500mg
(Flucloxacillin Sodium)
Read all of this leaflet carefully before you
start taking this medicine.
• Keep this leaflet. You may need to read it again.
• If you have further questions, ask your doctor or your pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
2. BEFORE YOU TAKE FLUCLOXACILLIN CAPSULES
Do not take Flucloxacillin Capsules if you:
• are allergic (hypersensitive) to Flucloxacillin Sodium or any of the other ingredients of this medicine
• you are allergic to penicillin
Take special care and consult your doctor before taking Flucloxacillin Capsules if you:
• have a history of allergies
• have kidney problems
• congestive heart failure
• have liver problems
The product may cause an allergic reaction in babies that are allergic to penicillin antibiotics including Flucloxacillin.
IN THIS LEAFLET:
1. What Flucloxacillin Capsules are and what they are used for
2. Before you take Flucloxacillin Capsules
3. How to take Flucloxacillin Capsules
4. Possible side effects
5. How to store Flucloxacillin Capsules
6. Further Information.
1. WHAT FLUCLOXACILLIN CAPSULES ARE AND WHAT THEY ARE USED FOR
Flucloxacillin is a medicine known as an antibiotic. The capsules are used to treat infections caused by staphylococcal bacteria which are resistant to benzylpenicillin. It is also used to treat infections caused by a mixture of staphylococcal and streptococcal bacteria when the staphylococcal bacteria are resistant to penicillin.
Flucloxacillin is used to treat:
• skin and soft tissue infections such as boils, abscesses, carbuncles (cluster of boils) and cellulitis (infections of the skin and the tissue beneath it)
• infected wounds and burns
• skin conditions such as ulcers, eczema and acne
• protection for skin grafts
• inflammation of the middle or external ear.
• respiratory tract infections such as pneumonia, lung abscess, empyema (accumulation of pus in a body cavity or in certain organs), sinusitis, pharyngitis, tonsillitis and quinsy (abscess around the tonsil)
• infection of bone and bone marrow (osteomyelitis)
• inflammation of small intestine (enteritis)
• inflammation of the internal lining of the heart (endocarditis)
• urinary tract infections
• meningitis and septicaemia (bacteria in the blood)
Taking Other Medicines:
Please tell your doctor or pharmacist if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription.
Care is needed if you are taking any of the following medicines:
• probenecid (used to treat gout, a form of arthritis)
• oral contraceptives (If the product is given at the same time as oral contraceptives the contraceptive may not be as effective)
Pregnancy and breast-feeding
Flucloxacillin should be used with caution if you are pregnant, think you are pregnant, planning to become pregnant or breast-feeding currently. Flucloxacillin may be excreted in breast milk and may provoke an allergic reaction in infants that are allergic to penicillin.
Ask your doctor or pharmacist for advice before taking any medicine.
Important information about some of the ingredients of Flucloxacillin Capsules
Flucloxacillin Capsules contain inactive ingredients called methyl paraben and propyl paraben.
These may cause rashes and there may be a delayed reaction such as contact dermatitis. There is rarely an immediate reaction with rashes and bronchospasm.
3. HOW TO TAKE FLUCLOXACILLIN CAPSULES
Flucloxacillin Capsules should be taken as directed by your doctor. Check the medicine label to see how many capsules to take and how often to take them. Your pharmacist or doctor can help if you are not sure.
• Take the capsules by mouth
• The capsules should be taken half to one hour before food.
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The usual doses for Adults:
250mg (1 x 250mg capsule) 4 times a day (up to 1g).
Severe Infections
The normal dose may be doubled in severe infections (1 x 500mg capsule) 4 times a day.
Infection of the bone and bone marrow (osteomyelitis) or inflammation of the internal lining of the heart (endocarditis)
Up to 8g daily in divided doses (every 6-8 hours) may be given. Your doctor will decide upon a suitable dose for you.
Elderly patients:
Your doctor may decide to give you a reduced dose. Children:
2-10 years: Usually one half the adult dose administered in syrup form.
Under 2 years: Capsules are not suitable. A syrup form of Flucloxacillin should be given.
If you forget to take Flucloxacillin Capsules at the
right time, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take a double dose to make up for forgotten individual doses.
If you have taken more Flucloxacillin Capsules
than you should, consult your doctor or go to the nearest hospital casualty department immediately. Take this leaflet with you so your doctor will know what you have taken
If you stop taking Flucloxacillin Capsules
Do not stop taking Flucloxacillin Capsules without talking to your doctor, even if you feel better. It is important that you take the full course of Flucloxacillin Capsules prescribed by your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS:
Like all medicines, Flucloxacillin can cause side effects, although not everybody gets them.
Very serious side effects
If a patient is extremely allergic to Flucloxacillin, a severe and life threatening reaction can occur within minutes or a generalised reaction may occur within 1-3 weeks.
If the following occurs stop taking the capsules and consult your doctor immediately:
• rash or fever
• eosinophilia (a blood disorder with an increase in the white blood cells)
• joint pains
• angioedema (swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing)
• inflammation of the skin or skin reaction
• convulsions (can occur at very high doses especially if given to infants, the elderly or patients with kidney failure).
• jaundice , your skin or the whites of your eyes turning yellow ( Elderly and patients taking Flucloxacillin for more than 2 weeks are at greater risk)
Other side effects
Other reactions include diarrhoea, nausea, heartburn and pruritis ani (itching of the skin around the anus).
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE FLUCLOXACILLIN CAPSULES
Keep all medicines out of the reach of children.
Do not take these capsules after the expiry date shown on the label.
These capsules should be stored in a dry place at or below 25°C.
Keep them in the pack they came in - do not transfer them to another container.
Keep the container tightly closed.
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. FURTHER INFORMATION:
What Flucloxacillin Capsules contain:
• The active ingredient is Flucloxacillin Sodium BP equivalent to 250mg or 500mg of Flucloxacillin.
• The other ingredients are magnesium stearate (E572) and colloidal anhydrous silica. The capsule shell is composed of red iron oxide (E 172), yellow iron oxide (EI72), black iron oxide (EI72), titanium dioxide (E171), methyl paraben (E218), Propyl Paraben (E216) and Gelatin.
The ink contains Shellac, Isopropyl Alcohol, Alcohol, Titanium Dioxide, Industrial Methylated Spirits, Soya Lecithin, N-butyl Alcohol, AntifoamDC 1510 and Purified Water.
What Flucloxacillin Capsules look like and contents of the pack:
• The 250mg capsules are hard gelatin capsules with a size 1 shell caramel body and black cap overprinted with RFXC 250.
• The 500mg capsules are hard gelatin capsules with a size 0 shell caramel body and black cap overprinted with RFXC 500.
• The capsules are available in polypropylene containers of 14, 28, 100, 250, 500 and 1000 and in blister packs of 14 and 28 capsules.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Ranbaxy Ireland Ltd.
Spafield,
Cork Road,
Cashel, Co.
Tipperary,
Ireland
This leaflet was last revised: November 2008 PL 6809/0056-0057