Bio Metronidazole IV 500 mg/100 ml Solution

BIO METRONIDAZOLE IV contains metronidazole, which is an antibiotic. BIO METRONIDAZOLE IV is used for the treatment of certain bacterial infections and to prevent infection after an operation. Your doctor or healthcare professional has prescribed this medicine for your specific condition.

You should not be given BIO METRONIDAZOLE IV:

• If you are hypersensitive (allergic) to metronidazole, other imidazoles or any of the other ingredients of BIO METRONIDAZOLE IV (listed in section 6).
• If you are pregnant or breastfeeding.
• If you have end stage liver damage, haematopoietic disorders (blood disorders) and active disease of the central or peripheral nervous systems.

Warnings and precautions

Tell your doctor or health care provider before being given the injection:

• If you are taking any alcohol (remember that medicines such as cough syrup also contains alcohol). When given with alcohol, BIO METRONIDAZOLE IV may cause reactions such as abdominal cramps, nausea, vomiting, headache or flushing, in some patients.
• If you have any disease affecting your blood or nervous system.
• If you have a severe liver disorder.
• If you have a conditional called hepatic encephalopathy (which may cause confusion, fatigue, tremors, memory loss, bad breath due to your liver failing).
• If you have a kidney disorder.
• If you experience pseudomembranous colitis (infection of the colon) which includes abdominal cramps, bloody stools, fever, urge to have a bowel movement, watery diarrhoea during your treatment with BIO METRONIDAZOLE IV.
• If you have been diagnosed with, or you suspect you might have syphilis (a sexually transmitted disease). Your doctor may need to screen you for an additional 4 to 8 weeks.
• If you are taking a medicine called busulfan used to treat cancer of the blood cells (leukaemia). Using BIO METRONIDAZOLE IV with busulfan may lead severe busulfan toxicity and death.

Do not share medicines prescribed for you with any other person. BIO METRONIDAZOLE IV is administered as an intravenous infusion (infusion into your vein). You will not be expected to give yourself BIO METRONIDAZOLE IV. It will be given to you by a person who is qualified to do so. Depending on the type of infection and the severity of your infection your doctor will prescribe the exact dosage of BIO METRONIDAZOLE IV for your specific condition and will determine the duration of your therapy. If you have the impression that the effect of BIO METRONIDAZOLE IV is too strong or too weak, tell your doctor or pharmacist. If you receive more BIO METRONIDAZOLE IV than you should Since a healthcare provider will administer BIO METRONIDAZOLE IV, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage. If a dose of BIO METRONIDAZOLE IV is missed Since a healthcare provider will administer BIO METRONIDAZOLE, it is unlikely that the dose will be missed.

BIO METRONIDAZOLE IV can have side effects. Not all side effects reported for BIO METRONIDAZOLE IV are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking BIO METRONIDAZOLE IV, please consult your health care provider for advice. If any of the following happens, stop taking BIO METRONIDAZOLE IV and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing.
• Rash or itching.
• Fainting.

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to BIO METRONIDAZOLE IV. You may need urgent medical attention or hospitalisation. Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

Side effects occurring less frequently:

• Unexplained bruising or bleeding.
• Peripheral neuropathy (numbness and pain in your hands or feet).
• Lack of voluntary coordination of muscle, tremor.
• Hepatic encephalopathy (confusion, altered level of consciousness, and coma as a result of liver failure).
• Seizures and convulsions (fits).
• Inflammation of the meninges surrounding your brain (fever, chills, headache, body ache, sensitivity to light, vomiting).
• Yellowing of your skin and eyes due to liver problems, including jaundice.
• Severe painful skin rash, causing blistering or peeling of your skin (Stevens - Johnson syndrome, toxic epidermal necrolysis or erythema multiforme).

Side effects which may occur, but the frequency is not known:

• Changes in the way your heart beats, such as beating faster than normal or skipping a beat.
• Severe or bloody diarrhoea.
• Chest pain.

These are all serious side effects. You may need urgent medical attention. Tell your doctor if you notice any of the following:

Side effects occurring frequently:

• Gastrointestinal disturbances such as nausea and vomiting.
• Diarrhoea and constipation.
• Dryness of mouth.
• Altered taste.
• Inflammation of the mouth or tongue (stomatitis and glossitis).
• Swelling and irritation in the mouth (oral mucositis).
• Furred tongue.
• Painful muscles or joints.

Side effects occurring less frequently:

• Dizziness or light-headedness.
• Headache.
• Clumsiness or unsteadiness.
• Mood or mental changes such as depression, confusion, irritability or hallucinations.
• Weakness.
• Drowsiness or sleeplessness.
• Difficulty speaking.
• Changes in your balance or way you walk (gait).
• Pain, tenderness, redness or swelling at site of injection.
• Fever or sore throat.
• Pancreatitis.
• Painful, burning urination or discomfort upon urination, increased urination, inability to control urine flow or darkening of the urine.
• Vaginal infection (thrush).
• Visual disturbances such as double vision or blurred vision, pain when moving your eyes or temporary vision loss (optic neuropathy).
• Abnormal liver function.

Side effects which may occur, but the frequency is not known:

• Vertigo (the sensation that you or the environment around you is moving or spinning).
• Burning, tingling or numb sensation of your skin.
• Total or partial loss of sensation in a part of your body.
• Nasal congestion (blocked/stuffy nose), difficulty breathing.
• Swelling of the face.
• Flushing.
• Skin rash, hives and itching.
• Excessive sweating.
• A general feeling of discomfort.
• Swelling in the arms or legs (peripheral oedema).
• Chills.

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 or pharmacist. You can also report side effects to SAHPRA via the Med Safety APP (Medsafety X SAHPRA) and eReporting platform (who-umc.org) found on SAHPRA website. By reporting side effects, you can help provide more information on the safety of BIO METRONIDAZOLE IV.

• Store all medicines out of reach of children.
• Store at or below 30 °C. Do not refrigerate.
• For single use only. Discard any remaining contents after use.
• Protect from light.
• Do not use this medicine after the expiry date stated on the container.
• Please return all unused medicine to your pharmacist for safe disposal.