ZEFROXE belongs to a group of medicines known as antibiotics which help the body fight infections by killing certain bacteria that cause infection.
ZEFROXE is used for the treatment of various bacterial infections.
1. What ZEFROXE is and what it is used for
2. What you need to know before you take or give ZEFROXE
Do not take or give ZEFROXE if:
- You or your child are hypersensitive (allergic) to cefuroxime axetil, other cephalosporin antibiotics or any of the other ingredients of ZEFROXE (listed in section 6).
- You or your child previously have had an allergic reaction to penicillin antibiotics (such as piperacillin, ticarcillin, ampicillin, amoxicillin, oxacillin, cloxacillin, flucloxacillin, nafcillin etc.); you may also be allergic to ZEFROXE. You should be strictly monitored while taking ZEFROXE.
Pregnancy and breastfeeding (see Pregnancy and breastfeeding).
Warnings and precautions
Take special care with ZEFROXE if:
- You or your child have a history of gastro-intestinal (stomach-intestinal) conditions, especially ulcerative colitis (ulceration of the colon), pseudomembranous (‘false membrane’) colitis or enteritis (inflammation of the intestine).
- Renal impairment – a smaller dose may be needed.
- Porphyria – safety has not yet been evaluated.
Please inform your doctor before taking or giving ZEFROXE, even if these statements were applicable to you at any time in the past.
If you or your child have any symptoms, such as allergic reactions, fungal infections in the mouth (thrush) or vagina (vaginitis) caused by an overgrowth of yeast (Candida), stomach cramps, abdominal tenderness, severe and watery diarrhoea (pseudomembranous colitis) while you are taking or giving ZEFROXE. Stop taking or giving ZEFROXE and contact your doctor or pharmacist immediately if these symptoms occur.
Laboratory Tests
ZEFROXE may interfere with the results of some laboratory tests done on blood (used in the diagnosis of autoimmune diseases and pregnancy etc.) and urine (to check urine sugar levels) called the Coombs test. If you or your child have a blood or urine test done whilst you are taking or giving ZEFROXE, make sure that your doctor or nurse knows about your medicine, ZEFROXE.
Other medicines and ZEFROXE
Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines).
Tell your doctor if you or your child are also taking:
- probenecid - this may increase the levels of ZEFROXE in the blood.
- furosemide - this may cause kidney damage.
- aminoglycoside antibiotics (such as amikacin, gentamicin, kanamycin, neomycin, tobramycin) - this may also cause kidney damage.
- contraceptive pill - ZEFROXE may reduce the effectiveness of the contraceptive pill.
ZEFROXE with food or drink
ZEFROXE should be taken or given half an hour after food for the best possible absorption.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other health care provider for advice before taking this medicine.
Pregnancy:
Safety and effectiveness of ZEFROXE has not been evaluated in pregnant women.
Breastfeeding:
Safety and effectiveness of ZEFROXE has not been evaluated in nursing mothers.
Driving and using machines
ZEFROXE may make you dizzy and have other side effects that make you less alert. Do not drive or use machines if you do not feel well.
ZEFROXE Tablets contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
ZEFROXE SUSPENSION AND ZEFROXE SUSPENSION FORTE contains Sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Mannitol may have a mild laxative effect.
Aspartame: This medicine contains 8 mg/5 ml. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.
3. How to take or give ZEFROXE
Do not share medicines prescribed for you with any other person.
Always take or give ZEFROXE exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are unsure.
The doctor will determine the dose and duration of treatment depending on the type and severity of the infection.
If you have the impression that the effect of ZEFROXE is too strong or too weak, talk to your doctor or pharmacist.
ZEFROXE has not been studied in children less than 3 months of age.
ZEFROXE should be taken in two daily doses.
Because of the bitter taste of cefuroxime axetil, the tablets should not be crushed.
ZEFROXE should be taken or given half an hour after food for the best absorption.
Duration of treatment
The usual course of treatment is 7 days, ranging from 5 to 10 days.
If you take or give more ZEFROXE than you should
In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre. If you have taken or given more ZEFROXE than you should have, then you or your child may experience fits.
If you forget to take or give ZEFROXE
If you forget to take or give a dose, take or give it as soon as you remember, unless it is almost time for your next dose. Do not take or give a double dose to make up for forgotten individual doses. If you miss several doses, contact your doctor.
If you stop taking ZEFROXE
It is important to take or give the full course of ZEFROXE. Never stop taking or giving ZEFROXE unless on your doctor’s advice.
4. Possible side effects
ZEFROXE can have side effects. Not all side effects reported for ZEFROXE are included in this leaflet. Should your general health worsen, or if you experience any untoward effects while taking ZEFROXE, please consult your health care provider for advice.
The following side effects have been reported:
If any of the following happens, stop taking ZEFROXE and tell your doctor immediately or go to the casualty department at your nearest hospital:
- Hypersensitivity reactions (An excessive response by the body to a foreign substance) such as; skin rashes, hives, itching and bronchospasm (tight chest). Swelling of the mouth, lips or throat. Severe skin reactions such as blisters, sores or ulceration.
- Pseudomembranous colitis (stomach cramps or pain, severe watery diarrhoea which may also be bloody and fever).
- Jarisch-Herxheimer reaction. Some patients may get a high temperature (fever), chills, headache, muscle pain and skin rash while being treated with.
These are all very serious side effects. If you or your child have them you may have had a serious reaction or other type of reaction to ZEFROXE. You or your child may need medical attention or hospitalisation immediately.
Tell your doctor if you notice any of the following:
Frequent side effects:
- Nausea (Uncomfortable sensation in the stomach along with an urge to vomit), stomach cramps and diarrhoea (loose or watery stools), and headache.
- Fungal infections in the mouth or vagina (Candidiasis).
- Headache.
- Dizziness.
Less frequent side effects:
- Vomiting.
- Skin rashes.
- Severe diarrhoea.
- Skin reactions (including severe).
- Fever.
- Yellowing of the whites of the eyes or skin.
- Inflammation of the liver (hepatitis).
Side effects that may show up in blood tests:
- An increase in a type of white blood cell (eosinophilia).
- An increase in liver enzymes.
- A decrease in the number of blood platelets (cells that help the blood clot).
- A decrease in the number of white blood cells.
- Red blood cells destroyed too quickly (haemolytic anaemia).
- A positive Coomb’s test.
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 ZEFROXE.
5. How to store ZEFROXE
Store all medicines out of reach of children.
ZEFROXE 250/500 Tablets: store at or below 25 °C.
The unconstituted suspension is stored at or below 25 °C, protected from moisture. Keep the container tightly closed.
The constituted ZEFROXE / ZEFROXE Forte Suspension is stored in a refrigerator at 2 °C – 8 °C.
Do not take ZEFROXE after the expiry date stated on the pack. The expiry date refers to the last day of that month. In order to protect from moisture, do not store in the bathroom.
Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems e.g. toilets.