Adco-Dol Side Effects

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

What is Adco-Dol?

Adco-Dol contains the active ingredient Aspirin, Paracetamol, Caffeine.

• Active ingredient — Aspirin, Paracetamol, Caffeine
• Registration number — R/2.9/238
• Registration holder — Adcock Ingram Limited

It is approved for:

• ADCO-DOL PAIN RELIEF POWDERS combine the analgesic and antipyretic action of aspirin and paracetamol together with the anti-inflammatory action of aspirin
• ADCO-DOL PAIN RELIEF POWDERS is used for the relief of mild to moderate pain and fever

Common side effects of Adco-Dol

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

• Anaemia, blood disorders, swelling, hypertension, cardiac failure
• peptic ulcers, gastrointestinal bleeding, nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, black stools, vomiting blood, worsening of colitis and Crohn’s disease, gastritis, dizziness, renal papillary necrosis, Liver disease, kidney disease, reversible skin rash, headache and insomnia
• Hypersensitivity reactions which may include skin eruptions, paroxysmal bronchospasm and dyspnoea
• Bullous reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis

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 aspirin, paracetamol, caffeine or any of the other ingredients of ADCO-DOL PAIN RELIEF POWDERS (listed in section 6.1)
• If you are suffering from renal diseases
• If you have chronic gastritis
• If you have peptic ulcers and dyspepsia
• If you have haemophilia or on an oral anticoagulant
• If you have heart failure
• If you have history of gastrointestinal perforation (small holes in the stomach), ulceration or bleeding (PUBs) related to previous NSAIDs, including ADCO-DOL PAIN RELIEF POWDERS
• If you have active or history of recurrent ulcer/haemorrhage/perforations
• If you are pregnant, do not use ADCO-DOL PAIN RELIEF POWDERS at 20 weeks or later in your pregnancy unless specifically advised to do so by your health care professional because these medicines may cause problems in your unborn baby
• If you are younger than 16 years old

Use with care, and tell your doctor, if

• Tell your doctor or health care provider if you are pregnant or plan to become pregnant. Taking NSAIDs at about 20 weeks of pregnancy or later may harm your unborn baby. If you need to take NSAIDs for more than 2 days when you are between 20 and 30 weeks of pregnancy, your healthcare provider may need to monitor the amount of fluid in your womb around your baby. You should not take NSAIDs after about 30 weeks of pregnancy
• has been implicated in Reye’s Syndrome, a rare but serious illness in children and teenagers, with chicken pox and influenza
• It should be administered with caution to patients with impaired renal function, dyspepsia, anaemia and when the patient is dehydrated
• Caution is required in patients with a history of hypertension and/or heart failure as fluid retention and oedema have been reported in association with ADCO-DOL PAIN RELIEF POWDERS therapy. In view of the ADCO-DOL PAIN RELIEF POWDERS inherent potential to cause fluid retention, heart failure may be precipitated in some compromised patients
• Caution is required in patients with significant risk factors for cardiovascular events (e.g., hypertension, hyperlipidaemia, diabetes mellitus, smoking) and should only be treated with diclofenac after careful consideration
• Elderly: The elderly have an increased frequency of adverse reactions to NSAIDs including ADCO-DOL PAIN RELIEF POWDERS, especially gastrointestinal perforation, ulceration and bleeding (PUBs) which may be fatal
• The risk of gastrointestinal perforation, ulceration or bleeding (PUBs) is higher with increasing doses of ADCO-DOL PAIN RELIEF POWDERS, in patients with a history of ulcers, and the elderly
• When gastrointestinal bleeding or ulceration occurs in patients receiving ADCO-DOL PAIN RELIEF POWDERS, treatment with ADCO-DOL PAIN RELIEF POWDERS should be stopped
• ADCO-DOL PAIN RELIEF POWDERS should be given with caution to patients with a history of gastrointestinal disease (e.g. ulcerative colitis, Crohn’s disease, hiatus hernia, gastro- oesophageal reflux disease, angiodysplasia) as the condition may worsen
• Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens- Johnson syndrome, and toxic epidermal necrolysis have been reported. ADCO-DOL PAIN RELIEF POWDERS should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity
• Dosages in excess of those recommended may cause severe liver damage
• Patients suffering from liver or kidney disease should take paracetamol under medical supervision
• Do not use continuously for more than ten days without consulting your doctor
• Consult your doctor if no relief is obtained with the recommended dosage. Use in children and adolescents Do not give ADCO-DOL PAIN RELIEF POWDERS to children under the age of 16 years

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

Interactions and medicines to check

The approved leaflet names these interactions.

• Always tell your health care provider if you are taking any other medicine (including all complementary or traditional medicines)
• Aspirin may enhance the activities of oral anti-diabetic preparations and sulphonamides
• Aspirin diminishes the effects of anti-gout preparations such as probenecid and sulphinpyrazone
• Barbiturates and other sedatives may mask the respiratory symptoms of aspirin overdosage and have been reported to enhance its toxicity NSAIDs: use of two or more NSAIDs concomitantly could result in an increase in side effects Corticosteroids: increased risk of gastrointestinal perforation, ulceration or bleeding (PUBs) Anti-coagulants: ADCO-DOL PAIN RELIEF POWDERS may enhance the effects of anti- coagulants such as warfarin Anti-platelet medicines and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding
• ADCO-DOL PAIN RELIEF POWDERS with food and drink No known interactions with food and drink

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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