Anaerobyl Side Effects

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Answer the side-effect intent for anaerobyl without diagnosing; distinguish common from serious reactions and give safe next-step/reporting guidance.

What is Anaerobyl?

Anaerobyl contains the active ingredient Metronidazole.

• Active ingredient — Metronidazole
• Registration number — 28/20.2.6/0036; 28/20.2.6/0037
• Registration holder — Innovata Pharmaceuticals pty ltd

It is approved for:

• Treat infections caused by certain bacteria
• Prevent infections after surgery

Common side effects of Anaerobyl

Not everyone gets side effects. The effects below are those listed in the South African approved leaflet, grouped using the leaflet’s own frequency wording.

Frequent side effects

• Gastrointestinal disturbances, especially nausea (feeling sick) and taste disorders; nausea is sometimes accompanied by headache, and vomiting (being sick). Diarrhoea, dry mouth, a furred tongue, oral mucositis (sore/red mouth) and stomatitis (sore mouth, mouth ulcers and cold sores)

Less frequent side effects

• Agranulocytosis, neutropenia and thrombocytopenia (blood problems with unexpected infections, mouth ulcers, bleeding or bruising more easily than normal)
• Psychotic disorders including confusion, irritability and hallucinations (seeing or hearing things that are not there), changes in mood or mental state such as depression or confusion
• Weakness, dizziness, drowsiness, insomnia (sleep disorder). Reports of encephalopathy (brain disease, symptoms of which vary but you may get a fever, stiff neck, headache and see or hear things that are not there) and subacute cerebellar syndrome (where you encounter problems with coordination of movement of your arms and legs, problems speaking or feel confused)
• Vision disorders such as diplopia (double vision) and myopia (short sightedness)
• Pseudomembranous colitis (watery and severe diarrhoea, which may also be bloody)
• Increase in liver enzymes (liver problem) and inflammation of the liver sometimes with jaundice (liver disease with nausea, vomiting, loss of appetite, feeling generally unwell, fever, itching, yellowing of the skin and eyes, and dark coloured urine)
• Pustular eruptions (breakouts of blisters, containing pus, on the skin), mild erythematous eruptions (mild redness) with fleeting (brief) joint pains resembling serum sickness (allergic reaction to an injection of serum)
• Urethral (bladder) discomfort and darkening of the urine

Frequency unknown side effects

• Leucopenia (lack of white blood cells)
• Angioedema (swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing), urticaria (pinkish, itchy, lumpy rash called hives or nettle rash)
• Anorexia (loss of appetite)
• Peripheral neuropathy (a disorder of the nerves), usually presenting as numbness, tingling, or a feeling of weakness in the arms or legs and, fits (convulsions) are serious adverse effects on the nervous system that have been associated especially with high doses of NIDASALL of prolonged treatment
• Nasal congestion (blocked/stuffy nose)
• Pancreatitis (inflammation of the pancreas with severe upper stomach pain, often with nausea and vomiting) and raised liver enzyme values (liver problem)
• Skin rashes, fever, flushing (reddening of skin), and pruritus (itching)
• Myalgia (pains in the muscles) and arthralgia (pains in the joints)
• Fever
• Headache, aseptic meningitis (inflammation of the membranes around the brain and spinal cord with fever, nausea, vomiting, headache, stiff neck and extreme sensitivity to bright light)
• Eyesight problems such as blurred vision, decreased in visual acuity (sharpness of vision), changes in colour vision
• Optic neuritis (pain in your eyes and increasingly blurred vision)
• Epigastric pain (pain in the upper central region of the stomach)
• Mixed hepatitis and hepatocellular liver injury (liver diseases)
• Cases of liver failure requiring liver transplant have been reported in patients treated with NIDASALL in combination with other antibiotic medication

Serious side effects and warning signs

This leaflet does not set out a separate list of serious side effects. The general warning signs below apply to any medicine.

General warning signs that apply to any medicine

How long can side effects last?

How long a side effect lasts depends on the effect, the product, how long it has been used, and the person. Some effects ease within days as the body adjusts. Others continue for as long as the product is used. A few can persist after stopping, and some need review rather than waiting.

• Settling effects — mild effects that ease over the first days or weeks of use
• Ongoing effects — effects that continue while the product is being used and improve after stopping
• Persistent effects — effects that continue after stopping and need medical review
• Delayed effects — effects that appear after weeks or months rather than immediately

Which of these applies to a particular effect is a clinical question. If a side effect is not settling, is getting worse, or is affecting your daily life, that is worth a conversation with a pharmacist or doctor regardless of how long it has been going on.

Factors that may affect side effects

The approved leaflet identifies the following cautions and factors.

Do not use it at all if

• You are allergic (hypersensitive) to metronidazole or any of the other ingredients in NIDASALL (listed in section 6)
• You are taking a medicine called, busulfan (treatment for cancer of blood cells)

Use with care, and tell your doctor, if

• blood dyscrasias (disease of the blood with low/lack of certain blood cells)
• active or chronic disease of the central (nerves of the brain and spinal cord) and peripheral (nerves outside the brain and spinal cord) nervous system
• hepatic encephalopathy (worsening of brain function that occurs when the liver is no longer able to remove toxic substances in the blood)
• cancer of the blood cells for which you are receiving treatment with a medicine called Busulfan. Co-administration with busulfan may lead to severe busulfan toxicity and death. Do not take alcohol beverages and medicine containing alcohol during therapy and for at least 1 to 3 days afterwards Pseudomembranous colitis (infection of the colon) has been reported with the use of NIDASALL
• Tell your doctor immediately if you develop watery and severe diarrhoea, which may also be bloody. Your doctor will lower the dose of NIDASALL if you suffer with severe liver disease. If you are taking NIDASALL for more than 10 days your doctor will monitor you and will discontinue treatment if signs of peripheral neuropathy (disorder of the nerves which can cause weakness, tingling or numbness) or central nervous system toxicity develop. NIDASALL has anti-treponemal activity (bacteria that can cause syphilis) and may mask the immunological response (the body’s natural defence) seen in untreated early syphilis. If you have syphilis and are receiving NIDASALL your doctor will continue testing you for syphilis for an additional 4 to 8 weeks. NIDASALL may cause darkening of urine (due to the substance that NIDASALL is broken down into in the body)

Pregnancy and breastfeeding

• The safety in pregnancy and lactation has not been established
• Tell your doctor before taking NIDASALL if: • You are pregnant, might become pregnant or think you may be pregnant
• • You are breastfeeding
• NIDASALL pass into the mother’s milk and women taking NIDASALL should not breastfeed their infants
• 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 healthcare professional for advice before taking NIDASALL

Interactions and medicines to check

The approved leaflet names these interactions.

• Disulfiram for the treatment of alcoholism. Taking NIDASALL with disulfiram can result in acute confusion
• Alcohol or medicine containing alcohol
• Medicines used to thin the blood such as warfarin. NIDASALL intensifies the effect of warfarin and may result in uncontrolled bleeding
• Lithium for mental illness. Blood levels of lithium may be increased by NIDASALL
• Phenytoin or phenobarbital for epilepsy reduce the effectiveness of NIDASALL
• 5-Fluorouracil for cancer. NIDASALL may intensify the of harmful effects of 5- fluorouracil
• Busulfan for leukaemia (cancer of the blood cells)
• Ciclosporin to prevent the rejection of organs after transplant. NIDASALL may increase the blood levels of ciclosporin
• Cimetidine for stomach ulcers may intensify the effects of NIDASALL. NIDASALL with food, drink, and alcohol: Do not drink any alcohol or medicine containing alcohol while you are taking NIDASALL and for 1 to 3 days after finishing your course. Drinking alcohol whilst you are being treated with NIDASALL might cause unpleasant side effects, such as:
• feeling sick (nausea)
• being sick (vomiting)
• stomach pain
• hot flushes
• very fast or
• uneven heartbeat (palpitations) and headache

What to do if you experience side effects

If you think you are having a side effect, the response depends on how severe it is. Use the warning signs above first — if any of those apply, treat it as urgent.

If the symptom is severe or frightening

Get medical help immediately. Call 10177 for an ambulance, or 112 from a mobile phone, or go to the nearest emergency department. Take the product and its packaging with you if you can.

If the symptom is mild but bothering you

• Write down what the symptom is, when it started, and how it relates to when you take the product
• Check the leaflet that came with the product to see whether the symptom is listed
• Speak to your pharmacist — for many questions this is the fastest route to a useful answer
• Contact the prescriber if the symptom is affecting your daily life or is not settling

You can also report a suspected side effect in South Africa. Reporting does not replace getting medical advice, and you do not need to be certain the product was the cause.

When to seek urgent medical help

Some symptoms need medical attention straight away rather than an appointment in a few days. Do not wait to see whether they settle.

Get same-day medical advice if you have

• A high fever, or a rash together with feeling generally unwell
• Yellowing of the eyes or skin, or unusually dark urine
• Unusual bruising or bleeding that you cannot explain
• Severe or persistent vomiting or diarrhoea, especially if you cannot keep fluids down
• A sudden change in mood, or thoughts of harming yourself
• Any symptom that is rapidly getting worse

How to report a suspected side effect in South Africa

South Africa has an official system for reporting suspected side effects, run by the South African Health Products Regulatory Authority (SAHPRA). Reports from the public and from healthcare professionals are how safety signals get detected after a product is already in use.

Who can report

Anyone can report — you do not have to be a healthcare professional, and you do not need to prove that the product caused the problem. A suspicion is enough. Patients, caregivers and family members can all submit a report.

What to have ready

• The name of the product, its strength and form, and the batch number if you have it
• Why it was being used, and when it was started and stopped
• What the suspected reaction was, when it began, and how long it lasted
• Any other medicines, supplements or remedies being used at the same time
• Basic details about the person affected — age and sex are usually enough

How to report

SAHPRA accepts adverse reaction reports through its e-Services reporting system and through the Med Safety mobile app. Healthcare professionals can also report through the same routes. Current forms and access points are published on the SAHPRA site.

• SAHPRA Health Products Vigilance — the main vigilance and reporting hub
• SAHPRA e-Services — current adverse reaction reporting access

For a fuller walkthrough see how to report an adverse drug reaction.

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