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Flucloxacillin (Flucloxacillin sodium)

What Flucloxacillin capsules are and what they are used for

Flucloxacillin sodium belongs to a class of antibiotics called “penicillinase-resistant penicillins” and is used to treat bacterial infections including:

Skin and soft tissue infections

  • boils, abscesses, carbuncles (multiple boils)
  • cellulitis (inflammation of tissue below the skin)
  • infected wounds, infected burns o protection for skin grafts
  • otitis (ear infection).

Respiratory tract infections

  • pneumonia (chest infection), lung abscess, empyema (a collection of pus in a body cavity, especially in the lung cavity) o sinusitis (sinus infection) o pharyngitis (throat infection) o tonsillitis (inflammation of the tonsils).

Other infections

  • osteomyelitis (affecting the bone and bone marrow)
  • enteritis (affecting the intestinal tract, especially the small intestine)
  • endocarditis (inflammation of the lining of the heart and its valves)
  • urinary tract infections
  • meningitis (a serious disease characterised by inflammation of the membranes around the brain or spinal cord)
  • septicaemia (blood poisoning).

Before you take Flucloxacillin capsules

Do not take Flucloxacillin Capsules if you:

  • are allergic (hypersensitive) to penicillins/flucloxacillin sodium or any of the other ingredients in the product (see Section 6 and end of Section 2)
  • have previous history of liver problems from taking flucloxacillin.

Take special care with Flucloxacillin Capsules

Speak to your doctor if you have:

  • impaired kidney function
  • congestive heart failure
  • liver problems.

Taking other medicines

Please inform your doctor if you are taking or have recently taken any other medicines, including those obtained without a prescription, particularly:

  • oral contraceptives
  • probenecid (used in the treatment of gout).
  • Taking Flucloxacillin Capsules with food and drink
  • The capsules should be taken 1 hour before meals, or on an empty stomach.

Pregnancy and breast-feeding

Flucloxacillin Capsules should only be used by pregnant women if considered essential by the doctor. Flucloxacillin passes into breast milk, so ask your doctor for advice before taking any medicine.

Driving and using machines

Flucloxacillin Capsules are not expected to affect your ability to drive or operate machinery.

Important information about some of the ingredients of Flucloxacillin Capsules

Propyl paraben (E216) and methyl paraben (E218) – may cause allergic reactions (possibly delayed).

How to take Flucloxacillin capsules

Always take the capsules exactly as your doctor has told you. The pharmacist’s label should tell you how much to take and how often.

For oral use only.

Take Flucloxacillin Capsules one hour BEFORE meals or on an empty stomach.

Adults:

Osteomyelitis, endocarditis: up to 8g a day in divided doses (every 6-8 hours) o Other infections: take 1 x 250mg capsule 4 times a day. If the infection is severe, you may be given a doubled dose (1 x 500mg capsule 4 times a day)

Elderly:

Same doses as for adults.

Patients with severe kidney impairment: Lower doses may be used.

Children (2-10 years):

One half of the adult dose, given in syrup form.

This medicine is not recommended for use in children under 2 years of age.

Make sure you complete your prescribed course; do not stop taking Flucloxacillin Capsules if you feel better.

If you take more Flucloxacillin Capsules than you should

Contact your doctor or nearest hospital casualty department if you or a child have swallowed too much medicine. Take this leaflet and any remaining capsules with you, if possible. Symptoms of overdose include nausea, vomiting, diarrhoea.

If you forget to take Flucloxacillin Capsules

If you miss a dose, take the capsules as soon as you remember and carry on as before. If it is almost time for your next dose, skip the forgotten dose and continue as usual.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible side effects

Like all medicines, Flucloxacillin Capsules can cause side effects, although not everybody gets them.

You may suffer an allergic reaction, symptoms of which include rash, itching, difficulty in breathing or swelling of the face, lips, throat or tongue. If this happens to you, stop taking the capsules immediately and seek medical help.

The following have also been reported:

  • convulsions with very high doses of flucloxacillin, particularly in infants, the elderly, and those patients with renal failure
  • diarrhoea, nausea, heartburn
  • pruritus ani (itching)
  • pseudomembranous colitis (type of inflammation of the colon)
  • changes in liver function tests
  • hepatitis (inflammation of the liver) and cholestatic jaundice (yellowing of the skin and whites of the eyes)
  • blood abnormalities i.e. neutropenia and thrombocytopenia.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

How to Store

Keep out of the reach and sight of children.

Tablet container and blister: Do not store above 25°C. Store in the original pack and keep tightly closed.

Do not use the capsules after the expiry date shown on the label.

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.

Further information

What Flucloxacillin Capsules contain

The active substance is flucloxacillin sodium, 250mg or 500mg per capsule.

The other ingredients are:

Capsule shell componentsmagnesium stearate (E572), colloidal anhydrous silica.

Body- red iron oxide (E172), yellow iron oxide (E172), methyl paraben (E218), propyl paraben (E216), titanium dioxide (E171), gelatin.

Capblack iron oxide (E172), titanium dioxide (E171), methyl paraben (E218), propyl paraben (E216), gelatin.

Ink componentstitanium dioxide (E171), shellac (E904), industrial methylated spirits, soya lecithin, antifoam DC 1510 {contains poly dimethyl siloxane simethicone, mono- and diglycerides of fatty acids (E471), methyl cellulose, polyethylene glycol stearate, xanthan gum, benzoic acid, polyethylene glycol, sorbic acid}.

What Flucloxacillin Capsules look like and contents of the pack

The capsules are hard gelatin, elongated with caramel body and black cap overprinted with ‘Rimaflox 250’ or ‘RFXC 250’ for the 250mg strength, or ‘Rimaflox 500’ or ‘RFXC 500’ for the 500mg strength. They are available in white plastic containers containing 14, 28,100,250, 500 and 1000 capsules, or blister strips of 14 and 28 capsules (not all pack sizes may be marketed).

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