Disprin Side Effects

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

What is Disprin?

Disprin contains the active ingredient Aspirin.

• Active ingredient — Aspirin
• Registration number — R/2.8/99
• Registration holder — Reckitt Benckiser Pharmaceuticals (Pty) Ltd

It is approved for:

• DISPRIN MELTS belong to a group of medicines which have analgesic (pain relieving), anti-pyretic (fever reducing) and anti-inflammatory (inflammation reducing) properties
• S0 DISPRIN MELTS is used for the relief of mild to moderate pain and/or fever

Common side effects of Disprin

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

• increased risk of bleeding
• slow blood clotting
• bone marrow failure
• reduced number of blood cells
• fever
• skin rash
• severe itching of the skin
• swelling of the skin
• DRESS reaction (rash, facial swelling accompanied by abnormal heart rates) These are all very serious side effects
• If you have them, you may have had a serious allergic reaction to DISPRIN MELTS. 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:
• increased blood level of sodium
• fluid retention
• stiff neck, sensitivity to light, headache caused by inflammation (swelling and redness) of the linings of the brain
• heart failure
• excess of watery fluid collecting in the cavities or tissues of the body
• high blood pressure
• narrowing of the small airways of the lungs that can cause wheezing and shortness of breath
• asthma
• shortness of breath
• hay fever
• bleeding in the digestive tract
• disturbances in the digestive tract
• sore (ulcer) in the lining of the stomach
• dark sticky faeces containing partly digested blood
• vomiting of blood
• sore (ulcer) in the lining of the mouth
• cell death causing the epidermis (outer layer) to separate from the dermis (inner layer)
• increase in blood uric acid

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 or your child is hypersensitive (allergic) to Aspirin or any of the other ingredients of DISPRIN MELTS (listed in section 6)
• If you or your child is hypersensitive to other non-steroidal anti-inflammatory medicines
• If you are pregnant of breastfeeding your baby
• If you or your child has Asthma – DISPRIN MELTS may cause allergic reactions in asthmatics
• A history of peptic ulcers, a blood or bleeding disorder
• If you or your child has haemophilia
• If you or your child has liver disease
• If you or your child has kidney disease
• If you or your child has heart failure
• If you or your child has dehydration
• If you or your child has anaemia
• If you or your child is receiving oral therapy to prevent blood clots such as warfarin
• If you or your child has a history of gastrointestinal disease/complications
• If your child is under 16 years of age
• If you are over 60, only use DISPRIN MELTS after consulting your doctor

Use with care, and tell your doctor, if

• stomach problems
• above 65 years of age (the elderly)
• SLE and mixed connective tissue disease
• skin conditions
• a history of hypertension or fluid retention
• asthma or allergic disease
• liver problems
• kidney problems
• gout
• if you are planning on becoming pregnant
• if you are receiving medicines which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin. If you are undergoing surgery, stop taking DISPRIN MELTS several days before. You need to discontinue DISPRIN MELTS treatment and consult your doctor if these occur during treatment:
• Drug reaction with eosinophilia and systemic symptoms (DRESS): a life-threatening reaction which may resemble a flu-like infection, other signs may include rash, facial swelling, abdominal pain and abdominal heartbeat
• Serious skin reactions including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis: these are indicated by severe skin peeling, painful blisters and starts by flu-like illness. Children and adolescents There is an association between aspirin and Reye’s syndrome when given to children. Reye’s syndrome is a very rare disease, which affects the brain and liver, and can be fatal. For this reason, aspirin should not be given to children aged under 16 years

Pregnancy and breastfeeding

• Do not take DISPRIN MELTS during pregnancy and while breastfeeding your infant
• 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 Fertility: The use of DISPRIN MELTS may cause impairment of female fertility by an effect on ovulation
• This is reversible on withdrawal of treatment

Interactions and medicines to check

The approved leaflet names these interactions.

• Always tell your healthcare provider if you are taking any other medicine before taking DISPRIN MELTS
• (This includes complementary or traditional medicines)
• DISPRIN MELTS should NOT be used together with: Corticosteroids: steroid hormones used for severe allergies and skin problems
• Anti-platelet agents: Medications are used to prevent blood clots from forming e.g aspirin or clopidogrel Antidepressants: used in the treatment of mood disorders Calcium channel blockers: are used mainly in the management of chest pains, high blood pressure and irregular heartbeat
• Cardiac glycosides: These are medicines for treating heart failure and certain irregular heartbeats e.g digoxin
• Varicella vaccine: Chicken pox vaccine Antihypertensives (ACE inhibitors and Angiotensin II Antagonists) and diuretics: Water tablets and other high blood pressure medicines
• Anti-coagulants: Medicines used for prevention of blood clots, e.g warfarin
• Other NSAIDs painkillers like ibuprofen and those used in the treatment of arthritis Zidovudine: is used in the treatment of HIV infection and AIDS
• Metoclopramide & domperidone: are used for nausea and/or vomiting disorders
• Valproate: is used in the treatment of seizures (fits)

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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