Betamox Side Effects

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

What is Betamox?

Betamox contains the active ingredient Amoxycillin trihydrate.

• Active ingredient — Amoxycillin trihydrate
• Registration number — Y/20.1.2/127
• Registration holder — Ranbaxy Pharmaceuticals (Pty) Ltd

It is approved for:

• BETAMOX® (amoxycillin) belongs to a group of antibiotic medicines called penicillins
• BETAMOX® works by interfering with the growth of the bacteria that causes the infection
• BETAMOX® is used to treat various infections caused by bacteria in different parts of the body

Common side effects of Betamox

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

• diarrhoea
• nausea

Less frequent side effects

• thrush (a yeast infection of the vagina, mouth or skin folds)
• muscle spasm, hyperactivity and inability to concentrate
• dizziness
• vomiting
• the tongue may change to yellow, brown or black and it may have a hairy appearance
• discolouration of teeth

Frequency unknown side effects

• chest pain in the context of allergic reactions, which may be a symptom of allergy triggered cardiac infarction (Kounis syndrome)
• Rash with blisters arranged in a circle with central crusting or like a string of pearls (linear IgA disease)

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

• if you are allergic to penicillin (e.g. amoxycillin), or any other antibiotic or any of the other ingredients of BETAMOX® (listed in section 6)
• if have glandular fever (symptoms include fever, sore throat, swollen glands and extreme tiredness), as you will have an increased chance of getting a rash
• if you have lymphatic leukaemia, a type of cancer of the blood and bone marrow
• if you have high levels of uric acid in the blood and are taking allopurinol (a medicine used to treat gout), as you will have an increased chance of getting a rash

Use with care, and tell your doctor, if

• if you develop a rash, treatment with BETAMOX® may need to be stopped
• if you suffer from seizures
• if you have kidney problems (dosage adjustment is required)
• if you develop a secondary infection, tell your doctor
• if you are using BETAMOX® for a prolonged period of time, your doctor may conduct kidney or liver function tests, or blood tests
• if you are not urinating regularly
• if you are having urine (glucose) tests or oestriol tests (used during pregnancy) as the results of these tests may be inaccurate
• if you have a serious allergic reaction that could lead to heart problems

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 BETAMOX®

Interactions and medicines to check

The approved leaflet names these interactions.

• Probenecid (used for gout); your doctor may decide to adjust your dose of BETAMOX®
• Allopurinol (used for gout); it may be more likely that you will have an allergic skin reaction
• Medicines to help stop blood clots (such as warfarin); you may need extra blood tests
• Other antibiotics (such as tetracycline) will result in BETAMOX® being less effective
• Methotrexate (used for the treatment of cancer, rheumatoid arthritis and severe psoriasis); BETAMOX® may cause an increase in side effects
• Oral contraceptives; BETAMOX® may decrease the efficacy of oestrogen-containing oral contraceptives. BETAMOX® with food BETAMOX® can be taken with or without food

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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