Co amoxiclav Side Effects

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

What is co amoxiclav?

Co-Amoxiclav contains the active ingredient Amoxicillin.

• Active ingredient — Amoxicillin
• Registration number — 50/20.1.2/0975; 50/20.1.2/0976; 50/20.1.2/0977
• Registration holder — Unimed Healthcare (Pty) Ltd

It is approved for:

• respiratory tract infections
• urinary tract infections
• skin and soft tissue infections

Common side effects of co amoxiclav

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.

Reported side effects

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing
• rash or itching
• dizziness or collapse
• inflammation of the large intestine, causing watery diarrhoea usually with blood and mucus, stomach pain and/or fever
• less urine than is normal to you
• yellowing of the skin and eyes, dark urine, and tiredness which may be symptoms of liver problems
• inflammation of the protective membrane surrounding the brain (aseptic meningitis)
• chest pain in the context of allergic reaction, which may be a symptom of allergy triggered cardiac infarction (Kounis syndrome) These are all very serious side effects
• If you have them, you may have had a serious reaction to CO-AMOXICLAV UNIMED. You may need urgent medical attention or hospitalisation. The side effects frequently encountered are:
• Mucocutaneous candidiasis
• Serum sickness-like syndrome, anaphylactic (hypersensitivity) reaction
• Diarrhoea, nausea, vomiting, indigestion, abdominal pain, abnormal taste, gastritis, stomatitis, black hairy tongue, enterocolitis, antibiotic-associated colitis (including pseudomembranous colitis and haemorrhagic colitis)
• Urticaria, pruritus, skin rashes
• Vaginitis, genital moniliasis
• Hot flushes Less frequent side effects are:
• Dizziness, Headache, Tiredness
• Oral candidiasis (yeast infection of the mouth)
• Bullous exfoliative dermatitis, hives, itching, erythema multiforme (a skin rash, which may blister, and looks like small targets – central dark spots surrounded by a paler area, with a dark ring around the edge)
• Vaginal candidiasis (yeast infection of the vagina) The following side effects can be expected but the frequency is unknown:
• Overgrowth of non-susceptible organisms
• Haemolytic anaemia (low number of red blood cells), reversible thrombocytopenia, thrombocytopenic purpura, eosinophilia (increase in the number of white blood cells), reversible (including neutropenia), agranulocytosis, platelet dysfunction
• Hypersensitivity vasculitis (inflammation of blood vessels which may be visible as red or purple raised spots on the skin, but can affect other parts of the body), angioedema
• Clostridium difficile colitis, glossitis
• Hepatitis (inflammation of liver), cholestatic jaundice, hepatic liver dysfunction
• Stevens-Johnson syndrome (a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals), acute generalised exanthematous pustulosis (a red, scaly rash with bumps under the skin and blisters), toxic epidermal necrolysis (extensive peeling of the skin – more 30 % of the body surface)
• Interstitial nephritis (inflammation of tubes in the kidney), crystalluria (crystals in the urine leading to acute kidney injury), dysuria or urinary retention, proteinuria
• Chest pain, oedema, chills, fatigue, malaise, epistaxis
• Acute inflammation of the pancreas (acute pancreatitis). If you have severe and on- going pain in the stomach area this could be a sign of acute pancreatitis
• Drug-induced enterocolitis syndrome (DIES) has been reported mainly in children receiving amoxicillin/clavulanate. It is a certain kind of allergic reaction with the leading symptom of repetitive vomiting (1-4 hours after medicine intake). Further symptoms could comprise abdominal pain, lethargy, diarrhoea and low blood pressure
• Rash with blisters arranged in a circle with central crusting or like 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 hypersensitive (allergic) to amoxicillin, clavulanic acid, penicillin or any of the other ingredients of CO-AMOXICLAV UNIMED. See ‘Contents of the pack and other information’ in section 6
• if you have ever had a severe allergic reaction to any other antibiotic. This can include a skin rash or swelling of the face or throat
• if you have ever had liver problems or jaundice (yellowing of the skin) when taking an antibiotic

Use with care, and tell your doctor, if

• if you have a history of hypersensitivity (allergies) towards penicillins, other antibiotics or other allergens
• if you a sore throat or glandular fever
• if you have diarrhoea, abdominal cramps, pain or tenderness, nausea or fever after beginning or during treatment with the antibiotic
• if you start to have fits
• if you experience a skin reaction after beginning treatment with the antibiotic which includes itchy skin eruptions, headache and fever
• if you have or are being treated for liver or kidney problems
• if you have syphilis as the use of the antibiotic in this condition can bring on an immune reaction which includes fever, chills, and worsening of rash
• if you have lymphatic leukaemia since this condition can bring on skin rashes when used together with the antibiotic
• if you are breastfeeding
• if you are not passing urine regularly or are passing a reduced amount of urine than is normal for you Blood and urine tests If you are having blood tests (such as red blood cell status tests or liver function tests) or urine tests (for glucose), let the doctor or nurse know that you are taking CO-AMOXICLAV UNIMED
• This is because CO-AMOXICLAV UNIMED can affect the results of these types of tests

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
• CO-AMOXICLAV UNIMED may interfere with the effectiveness of your oral contraceptive, hence you should use an alternative or additional method of contraception while taking this medicine (such as condoms)
• The safety of CO-AMOXICLAV UNIMED in pregnancy has not been established
• Both of the medicines found in CO-AMOXICLAV UNIMED are excreted into breast milk
• Although significant problems in humans have not been discovered, the use of CO-AMOXICLAV UNIMED by breastfeeding mothers may lead to the baby becoming sensitive, developing diarrhoea, thrush (Candidiasis) and skin rash, hence you should consult with your doctor before commencing or the possibility of stopping treatment

Interactions and medicines to check

The approved leaflet names these interactions.

• If you are taking probenecid (used for gout), your doctor may decide to adjust your dose of CO- AMOXICLAV UNIMED
• If you are taking oral contraceptives (the “pill”), as CO-AMOXICLAV UNIMED can interfere with the medicine’s ability to work effectively
• If you are taking allopurinol (used for gout) with CO-AMOXICLAV UNIMED, it may be more likely that you will have an allergic skin reaction
• If you are taking any other antibiotics (such as doxycycline) as these can interfere with the effectiveness of CO-AMOXICLAV UNIMED
• If medicines to help stop blood clots (such as warfarin) are taken with CO-AMOXICLAV UNIMED then extra blood tests and adjusting your dose may be needed
• CO-AMOXICLAV UNIMED can affect how methotrexate (a medicine used to treat cancer or rheumatic diseases) works
• CO-AMOXICLAV UNIMED may affect how mycophenolate mofetil (a medicine used to prevent the rejection of transplanted organs) works

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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