Venteze Side Effects

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

What is Venteze?

Venteze contains the active ingredient Salbutamol.

• Active ingredient — Salbutamol
• Registration number — M/10.2/14; M/10.2/15; T/10.2/84
• Registration holder — PHARMACARE LIMITED

It is approved for:

• Bronchial asthma
• Emphysema
• Chronic obstructive bronchitis

Common side effects of Venteze

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

• Headache

Less frequent side effects

• Hives
• decreased appetite
• nausea (feeling sick), vomiting (being sick)
• increased saliva in your mouth, increase sweating
• muscle cramps
• difficulty in urination, urinary retention
• weakness

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 (hypersensitive) to salbutamol or to any of the inactive ingredients
• If you are taking a medicine called a beta-blocker (used to the treatment of high blood pressure or heart disorders)
• If you have an overactive thyroid gland
• If you have a heart disorder
• If you are taking a medicine called a monoamine oxidase inhibitor (used in the treatment of mood disorders such as depression), or if you have stopped it within the last 14 days
• Threatened abortion (potential miscarriage) during the first 6 months of pregnancy. VENTEZE should not be used to prevent premature labour during the first or second trimesters of pregnancy

Use with care, and tell your doctor, if

• Your body may develop a tolerance (get used to) to VENTEZE after continued use. If your asthma gets worse, consult your doctor for additional or other treatment
• If you are about to undergo an operation where you will be put to sleep during the operation
• If you have high blood pressure
• If you have an aneurysm (abnormal widening or ballooning of a portion of an artery due to weakness in the wall of the blood vessel)
• If you have diabetes (high blood sugar)
• If you have an eye disorder called glaucoma
• If you have a heart rhythm disorder
• If you participate in certain sports where the use of VENTEZE may be prohibited
• If you feel that the relief from taking VENTEZE becomes less, this may indicate that your asthma is not under control. Please consult your doctor for additional or other treatment. Children There is no experience with VENTEZE in children younger than 2 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 taking VENTEZE

Interactions and medicines to check

The approved leaflet names these interactions.

• Beta-blockers (medicines used to treat high blood pressure or heart disorders)
• Corticosteroids (used to treat conditions with pain, swelling and inflammation)
• Diuretics (water tablets)
• Other medicines used to treat asthma (such as aminophylline or theophylline)
• Certain medicines used to treat heart disorders (such as digoxin or quinidine)
• Monoamine oxidase inhibitors or tricyclic antidepressants (used to treat mood disorders such as depression)
• High blood pressure medicines (such as reserpine and methyldopa)
• Anti-diabetic medicines. Taking VENTEZE with food and drink VENTEZE may 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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