Sandoz Flucloxacillin 250 mg Capsules

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”.

SANDOZ FLUCLOXACILLIN capsules are used to treat:

• Infections caused by penicillinase producing staphylococci

You should not take SANDOZ FLUCLOXACILLIN:

• If you are hypersensitive (allergic) to flucloxacillin or any of the other ingredients in SANDOZ FLUCLOXACILLIN (listed in section 6).
• If you previously had an allergic reaction to other antibiotics called cephalosporins or penicillins.
• If you have ever had liver problems (e.g. jaundice) after taking SANDOZ FLUCLOXACILLIN.

Warnings and precautions

Take special care with SANDOZ FLUCLOXACILLIN:

• Cross allergy between penicillin and cephalosporins may occur
• If you take SANDOZ FLUCLOXACILLIN by mouth, you may experience diarrhoea, feeling sick (nausea), heartburn and colic, pruritus ani, and disturbances of electrolyte balance
• If you have or develop diarrhoea.
• If you suffer from liver problems, as this medicine could cause them to worsen.
• If you are 50 years of age or older.
• If you have been taking this medicine for a long time, as regular tests of liver and kidney function are advised.
• If you suffer from kidney problems, as you may require a lower dose than normal (convulsions may occur very rarely in patients with kidney problems who take high doses).

Do not share medicines prescribed for you with any other person. Always take SANDOZ FLUCLOXACILLIN exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The usual dose is 250 mg four times a day (every six hours). Doses may be doubled in severe infections; up to 8 g daily in three or four divided doses may be given for endocarditis and osteomyelitis. Take SANDOZ FLUCLOXACILLIN when your stomach is empty. This means one hour before meals.

Your doctor may need to reduce your dose if you have severe kidney problems.

If you take more SANDOZ FLUCLOXACILLIN than you should

In the event of overdosage, consult your doctor or pharmacist. If neither are available, contact the nearest hospital or poison centre. Symptoms of an overdose include feeling or being sick, vomiting, and diarrhoea. Symptoms should be treated.

If you forget to take SANDOZ FLUCLOXACILLIN

If you forget to take a dose, take it as soon as you remember unless it is time for your next dose. Do not take a double dose to make up for a missed dose.

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

If you stop taking SANDOZ FLUCLOXACILLIN

Do not stop treatment early because some bacteria may survive and cause the infection to come back.

SANDOZ FLUCLOXACILLIN can have side effects. Not all side effects reported for SANDOZ FLUCLOXACILLIN are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking SANDOZ FLUCLOXACILLIN, please consult your health care provider for advice.

If any of the following happens, stop taking SANDOZ FLUCLOXACILLIN and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Hypersensitivity or severe allergic reaction including itchy rash, itching, sore mouth or eyes, swelling of the face, lips, throat or tongue or fever.
• Severe bloody diarrhoea (pseudomembranous colitis).
• Effects on the liver including jaundice (skin or the white of your eyes turning yellow) and hepatitis (liver inflammation) - sometimes these effects on the liver can be delayed for up to 2 months after finishing treatment.
• Erythema multiforme (a red rash caused by hypersensitivity to a medicine or disease or other allergen).
• Severe skin rash with flushing, fever, blisters or ulcers (Stevens - Johnson Syndrome).
• Severe rash with reddening, peeling and swelling of the skin that looks like a burn (Toxic Epidermal Necrolysis).
• Serious skin reaction - A red, scaly rash with bumps under the skin and blisters (Acute Generalised Exanthematous Pustulosis).
• Risk of metabolic acidosis when flucloxacillin is used with paracetamol.

These are all very serious side effects. If you have them, you may have had a serious reaction to SANDOZ FLUCLOXACILLIN. You may need urgent medical attention or hospitalisation.

Other side effects that may be experienced while taking this medicine are:

Frequent side effects:

• Feeling sick (nausea)
• Diarrhoea
• Minor gastrointestinal disturbances

Less-frequent side effects:

• Changes in numbers of different blood cells (causing unexplained bleeding, bruising or skin discolouration, and seen in blood tests)
• Rapid swelling (angioneurotic oedema)
• Allergic skin reactions that can cause swelling, itching and a rash (urticaria)
• Purpura (brownish - red spots on the skin)
• Arthralgia (pain in a joint) and myalgia (pain in the muscles)
• Interstitial nephritis (inflammation of the kidneys)
• Fever
• Very rare cases of increased acid production in the body (high anion gap metabolic acidosis), causing the blood to become more acidic (confirmed with a test), which may occur when SANDOZ FLUCLOXACILLIN is used together with paracetamol, generally in the presence of risk factors (see section 2).

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of SANDOZ FLUCLOXACILLIN.

Store all medicines out of reach of children. Store at or below 25 °C. Keep tightly closed and store in a dry place. Protect from light.