Explain possible side effects and interaction/safety considerations for proman without overstating causality or efficacy.
Source
Clinical statements on this page are taken from the SAHPRA-approved patient information leaflet (approved 22/04/2022) and professional information (approved 22/04/2022) for this product: patient information leaflet, professional information. Retrieved 2026-09-03. Where this page and the approved leaflet differ, the leaflet is correct.
What is Proman?
Which leaflet this comes from
There is no approved leaflet for Proman in SAHPRA’s public repository. The information below is from the approved leaflet for PROMETHAZINE HCl 25 mg FRESENIUS and PROMETHAZINE HCl 50 mg FRESENIUS, another South African product containing Promethazine hydrochloride. Products with the same active ingredient can still differ in strength, formulation and approved uses, so check the leaflet in your own pack.
Proman contains the active ingredient Promethazine hydrochloride.
- Active ingredient — Promethazine hydrochloride
- Registration holder — Fresenius Kabi Manufacturing SA (Pty) Ltd
It is approved for:
- To relieve or prevent the symptoms of hay fever, irritation and redness in the membrane covering the eye (known as allergic conjunctivitis), allergic skin reactions (such as itching, hives) and other types of allergy
- To treat serious, potentially life-threatening allergic reactions (known as anaphylactic or anaphylactoid reactions) in conjunction with adrenaline
- To prevent and treat motion sickness, with signs like nausea, vomiting and dizziness
- To make you less anxious before and after a surgical operation and to help treat nausea and vomiting afterwards
- To treat a symptom of Parkinson’s disease characterised by uncontrolled rolling of the eyeballs (known as oculogyric crises)
Possible side effects of Proman
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.
About these frequency terms
This leaflet groups effects as “Frequent” and “Less frequent” rather than the very common/common/uncommon scale used in some other markets.
Frequent side effects
- Drowsiness, lack of energy, tiredness, dizziness and incoordination
- Increased blood pressure or occasional low blood pressure
Less frequent side effects
- Being more sensitive to the sun than usual. Side effects with unknown frequency:
- Confusion, hallucinations (seeing and hearing things that do not exist), convulsions (uncontrollable contraction of muscles)
- Blurred or double vision
- Ringing in the ears, tingling in the arms or legs
- Headache
- Difficulty in falling asleep, nightmares
- Unrealistic feeling of well-being
- Irritability and shaking
- Dry mouth, thickening of mucous and couching
- Loss of appetite, nausea and vomiting, diarrhoea or constipation and pain on the stomach
- Temporary fever while receiving the injection, known as drug fever
- Increased sweating
- Pain, burning, redness and warm skin at the site of the injection. This may lead to serious complications such as tissue death if not treated immediately. Your doctor will stop giving you PROMETHAZINE HCl FRESENIUS and you will be given urgent medical attention
Interactions and medicines to check
The approved leaflet names these interactions.
- Sedatives or tranquillisers (also known as CNS depressants), used to treat insomnia, anxiety, panic attacks and seizures
- Medicines for high blood pressure known as MAO inhibitors
- Antidepressants such as amitriptyline or maprotiline
- Medicine used in the treatment of Parkinson’s disease such as levodopa
- Antibiotics used to treat infections such as aminoglycosides
- Medicines used for high blood pressure
- Medicines used for epilepsy. Receiving PROMETHAZINE HCl FRESENIUS with food, drink and alcohol You should not take alcohol together with PROMETHAZINE HCl FRESENIUS as it will suppress your mental alertness and make you too sleepy and sedated
Bring the actual products to the conversation
A pharmacist can check for interactions much faster from the packaging than from remembered names.
Who should use extra caution?
The approved leaflet identifies the following cautions and factors.
Do not use it at all if
- If you are hypersensitive (allergic) to promethazine hydrochloride or any of the other ingredients of PROMETHAZINE HCl FRESENIUS (listed in section 6)
- You have any allergies to sodium sulphites
- If the person is younger than two years of age, the injection should not be administered, as it has been linked to sudden infant death syndrome (SIDS)
- You are experiencing an asthma attack, or you are in a coma (a state of unconsciousness)
- You are already too calm and drowsy due to other medicines or alcohol
- You have been told by a doctor that your bone marrow does not function adequately (your blood has been tested and your doctor diagnosed you with blood disorders)
- You have a liver disease, or a doctor told you that your liver does not work satisfactorily
- You have been told by a doctor that you have pheochromocytoma (a tumour of the adrenal glands)
- You have been diagnosed with Reye’s syndrome (it is a very serious disorder associated with viral infection and aspirin use)
- You are taking medicines known as monoamine oxidase inhibitors (MAOIs), as these medicines will strengthen the sedative effect of PROMETHAZINE HCl FRESENIUS. Ask your doctor or pharmacist if the medicines you are taking for depression or high blood pressure are MAOIs
Use with care, and tell your doctor, if
- You have a heart or coronary artery (narrowing of arteries) disease
- You have an enlarged prostate
- You suffer from increased pressure inside the eyeballs, known as narrow angle glaucoma
- You have a destructive lung condition with loss of elasticity (known as emphysema) or chronic inflammation of the air passages of the lungs (known as bronchitis)
- You have a hereditary disease of body metabolism known as porphyria
- You suffer from recurrent fits (epilepsy)
- You have yellowing of the skin or whites of the eyes (jaundice) caused by liver or blood problems
- You have a nervous disorder characterised by tremor, stiffness and shuffling (known as parkinsonism)
- You have diabetes mellitus, a disease that causes high blood sugar
- Your pituitary glands produce insufficient amounts of thyroid hormones (known as hypothyroidism)
- You have a muscle disorder causing weakness (known as myasthenia gravis)
- You are currently suffering from an asthma attack
- Your liver or kidneys does not function normally due to a liver or kidney disease
- You have an obstruction of the bladder neck or not being able to urinate
- You have an internal obstruction that prevents gastric outflow
- Your child is younger than two years old
- Your child is dehydrated (lost a lot of water, perhaps due to vomiting or diarrhoea)
- You are older than 65 years, as you may more easily get side effects. You should also know that:
- Skin tests for allergy should be postponed as PROMETHAZINE HCl FRESENIUS may suppress the reaction on the test allergens
- PROMETHAZINE HCl FRESENIUS may cause false negative or false positive results on pregnancy tests
- PROMETHAZINE HCl FRESENIUS may cause that blood sugar tests do not yield accurate results
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 receiving PROMETHAZINE HCl FRESENIUS
- PROMETHAZINE HCl FRESENIUS should not be used during pregnancy, especially in the 2 weeks prior to delivery, as it may cause irritability and excitement in your new-born baby
- PROMETHAZINE HCl FRESENIUS should not be used while breastfeeding as it may cause jaundice (affecting the liver with yellow skin and eyes) and nervous damage (extreme restlessness, involuntary movements) in your baby
Dose, timing and other factors that can 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 promethazine hydrochloride or any of the other ingredients of PROMETHAZINE HCl FRESENIUS (listed in section 6)
- You have any allergies to sodium sulphites
- If the person is younger than two years of age, the injection should not be administered, as it has been linked to sudden infant death syndrome (SIDS)
- You are experiencing an asthma attack, or you are in a coma (a state of unconsciousness)
- You are already too calm and drowsy due to other medicines or alcohol
- You have been told by a doctor that your bone marrow does not function adequately (your blood has been tested and your doctor diagnosed you with blood disorders)
- You have a liver disease, or a doctor told you that your liver does not work satisfactorily
- You have been told by a doctor that you have pheochromocytoma (a tumour of the adrenal glands)
- You have been diagnosed with Reye’s syndrome (it is a very serious disorder associated with viral infection and aspirin use)
- You are taking medicines known as monoamine oxidase inhibitors (MAOIs), as these medicines will strengthen the sedative effect of PROMETHAZINE HCl FRESENIUS. Ask your doctor or pharmacist if the medicines you are taking for depression or high blood pressure are MAOIs
Use with care, and tell your doctor, if
- You have a heart or coronary artery (narrowing of arteries) disease
- You have an enlarged prostate
- You suffer from increased pressure inside the eyeballs, known as narrow angle glaucoma
- You have a destructive lung condition with loss of elasticity (known as emphysema) or chronic inflammation of the air passages of the lungs (known as bronchitis)
- You have a hereditary disease of body metabolism known as porphyria
- You suffer from recurrent fits (epilepsy)
- You have yellowing of the skin or whites of the eyes (jaundice) caused by liver or blood problems
- You have a nervous disorder characterised by tremor, stiffness and shuffling (known as parkinsonism)
- You have diabetes mellitus, a disease that causes high blood sugar
- Your pituitary glands produce insufficient amounts of thyroid hormones (known as hypothyroidism)
- You have a muscle disorder causing weakness (known as myasthenia gravis)
- You are currently suffering from an asthma attack
- Your liver or kidneys does not function normally due to a liver or kidney disease
- You have an obstruction of the bladder neck or not being able to urinate
- You have an internal obstruction that prevents gastric outflow
- Your child is younger than two years old
- Your child is dehydrated (lost a lot of water, perhaps due to vomiting or diarrhoea)
- You are older than 65 years, as you may more easily get side effects. You should also know that:
- Skin tests for allergy should be postponed as PROMETHAZINE HCl FRESENIUS may suppress the reaction on the test allergens
- PROMETHAZINE HCl FRESENIUS may cause false negative or false positive results on pregnancy tests
- PROMETHAZINE HCl FRESENIUS may cause that blood sugar tests do not yield accurate results
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 receiving PROMETHAZINE HCl FRESENIUS
- PROMETHAZINE HCl FRESENIUS should not be used during pregnancy, especially in the 2 weeks prior to delivery, as it may cause irritability and excitement in your new-born baby
- PROMETHAZINE HCl FRESENIUS should not be used while breastfeeding as it may cause jaundice (affecting the liver with yellow skin and eyes) and nervous damage (extreme restlessness, involuntary movements) in your baby
Serious symptoms 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
Call for emergency help now if any of these happen
- Difficulty breathing, wheezing, or tightness in the throat or chest
- Swelling of the face, lips, tongue or throat
- A widespread rash with blistering or peeling skin, or sores in the mouth, eyes or genitals
- Fainting, collapse, or a sudden severe drop in alertness
- Chest pain, or sudden weakness or numbness on one side of the body
- A fit (seizure), or confusion that comes on suddenly
In South Africa call 10177 for an ambulance, or 112 from a mobile phone. Go to your nearest emergency department if it is faster. Do not wait to see whether the symptom settles.
What to do if side effects occur
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
Do not stop a prescribed treatment on your own
Stopping some treatments suddenly causes its own problems, and the condition being treated may get worse. If you want to stop, ask a pharmacist or doctor how to do it safely — they can usually offer an alternative.
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.
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
Reporting is not a substitute for medical care
If someone is unwell now, get medical help first and report afterwards. Urgent symptoms always take precedence over paperwork.
For a fuller walkthrough see how to report an adverse drug reaction.
Related pages
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Report a side effect
If you think you have had a side effect, you can report a suspected side effect in South Africa. Report a suspected side effect through the appropriate SAHPRA pathway where relevant.
Information only
This page gives general medicine-safety information for people in South Africa. It is not a diagnosis and not personalised medical advice. It cannot tell you whether a symptom you are having is caused by a particular product. Speak to a pharmacist or doctor about your own situation, and do not stop or change a prescribed treatment on the basis of a web page.
Editorial status: draft — not for publication
Brief SE-00141 · build rank 141 · Phase 1 · Tier 1. Every evidence slot on this page must be completed from the SAHPRA-approved source and the page signed off by a qualified clinical or pharmacy reviewer before it is published. Target length 1,500–2,200 words.