Flustat Side Effects

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

What is Flustat?

Flustat contains the active ingredient Paracetamol, Phenylpropanolamine Hydrochloride, Dextromethorphan Hydrobromide.

• Active ingredient — Paracetamol, Phenylpropanolamine Hydrochloride, Dextromethorphan Hydrobromide
• Registration number — 04/5.8/1619; 28/5.8/0231
• Registration holder — Ranbaxy Pharmaceuticals (Pty) Ltd

It is approved for:

• FLUSTAT® SYRUP is recommended for the relief of the symptoms associated with colds and influenza such as headache, minor aches and pains and coughing

Common side effects of Flustat

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.

Frequency unknown side effects

• mental confusion
• dizziness
• headache
• tremor
• anxiety
• restlessness
• difficulty sleeping (insomnia)
• drowsiness
• muscle weakness
• nausea
• vomiting
• excitation
• diarrhoea
• enlargement of the prostate gland
• increased blood pressure

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 any of the active or inactive ingredients of FLUSTAT® SYRUP (listed in section 6). Symptoms of allergic reaction includes shortness of breath, wheezing or difficulty in breathing; swelling of the face, lips, tongue or other parts of the body, rash, itching or hives on the skin
• if you have asthma
• if you are sensitive to drugs which stimulate the bodies rapid involuntary response
• if you have any liver issues
• if you have any heart problems
• if you have high blood pressure
• if you have an overactive thyroid
• if you have the tendency to be easily and excessively excited
• if you have a tumour of the adrenal gland
• if you have raised pressure in the eye
• if the patient is under 6 years of age

Use with care, and tell your doctor, if

• if you have difficulty urinating
• if you are taking medications which have the ability to cause the loss of sensation (anaesthetics)
• if you are taking medication to treat depression
• if you are taking antihypertensive medication (e.g. guanethidine, reserpine and methyldopa)
• if you have diabetes
• if you suffer from life threatening skin reactions such as Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN)
• if you develop a red, scaly widespread rash with bumps under the skin and/or blisters mainly localized on the skin folds, trunk, and upper extremities accompanied by fever at the start of treatment (acute generalized exanthematous pustulosis)
• if you develop a skin rash, swelling of lymph nodes and increase of eosinophils (a type of white blood cells)
• This is known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
• if you develop or have a history of Fixed Drug Eruptions (FDE) (may look like round or oval patches and swelling of the skin), blistering (hives), itching. Children and adolescents FLUSTAT® SYRUP are not recommended for children under the age of 6 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 healthcare provider for advice before being taking this medicine
• FLUSTAT® SYRUP should not be used in pregnancy

Interactions and medicines to check

The approved leaflet names these interactions.

• if you are taking medication to treat depression Using FLUSTAT® SYRUP with food and drink: The use of FLUSTAT® SYRUP with food and drink has not been established. Do not take this mediation with alcohol

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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