Uromax Side Effects

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

What is Uromax?

Uromax contains the active ingredient oxybutynin hydrochloride.

• Active ingredient — oxybutynin hydrochloride
• Registration number — 37/5.4/0106
• Registration holder — iPharma (Pty) Ltd

It is approved for:

• OXYREST is a medicine which relaxes the smooth muscle found in the stomach and intestines, uterus, ducts carrying bile and ducts carrying urine from the kidneys to the bladder
• OXYREST is used for the relief of a compelling urge to urinate, frequent urination, incontinence, painful or difficult urination and bedwetting

Common side effects of Uromax

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

• signs of a severe allergic reaction: swelling of your hands, feet, ankles, face, lips and mouth, difficulty breathing or swallowing, rash or itching, fainting
• reduced sweating leading to overheating in hot environments
• sudden blurred or loss of vision and/or eye pain
• These are all very serious side effects. You may need urgent medical attention or hospitalisation. Tell your doctor as soon as possible if notice any of the following: Side effects experienced frequently:
• confusion, dizziness, headache, sleepiness
• blurred vision, dry eyes
• flushing which may be more marked in children, dry skin
• constipation, nausea, dry mouth, diarrhoea, vomiting
• difficulty in passing water (urine) Side effects experienced less frequently:
• abdominal discomfort
• decreased appetite and weight loss
• difficulty swallowing Side effects experienced at an unknown frequency:
• urinary tract infection
• allergic reaction which can include a skin rash, difficulty breathing or swallowing, swelling of the face, mouth, eyes, lips and tongue
• reduced breast milk
• nervousness and anxiety, seeing and hearing things that are not there (hallucinations), nightmares and paranoia
• difficulty in learning, remembering and problem solving especially in the elderly; depression; dependence on OXYREST especially in patients with a history of medicine or substance abuse); difficulty sleeping
• fits, drowsiness, disorientation, weakness
• increased pressure in the eye (glaucoma), dilation of the pupils, eyes are more sensitive to light
• abnormally fast heart rate, noticeably strong or irregular heartbeat
• formation of mucous plugs in the airway
• heartburn, difficulty in swallowing and talking, thirst, chest pain
• reduced sweating and heat stroke; skin is more sensitive to light; itchy, lumpy skin rash (urticaria)
• impotence

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 known to be allergic (hypersensitive) to oxybutynin hydrochloride or any of the other ingredients of OXYREST tablets
• If you have glaucoma (increased pressure in the eye)
• If you have an obstruction in the stomach or intestinal tract
• If your intestinal tract is not functioning properly especially if you are elderly or debilitated
• If you have ulcerative colitis which is an inflammatory bowel disease that causes inflammation and sores (ulcers) in the colon
• If you have an autoimmune disease called myasthenia gravis which causes abnormal weakness of certain muscles
• If you have an obstruction in the urinary tract
• If you have lost a lot of blood
• If you have a bladder condition where the bladder muscle is unable to contract
• If you have an enlarged prostate
• If you are pregnant or breastfeeding your baby
• In children under the age of 5 years

Use with care, and tell your doctor, if

• If the environmental temperature is high; especially when giving OXYREST to children and persons with fever. OXYREST reduces sweating and your body’s ability to reduce your temperature; you may develop heat exhaustion
• If you are taking certain medicines that may enhance the effects of OXYREST
• If you are elderly or a child, you may be more sensitive to the effects of OXYREST
• If you are elderly you are at risk of developing cognitive impairment (e.g. trouble remembering, concentrating and making decisions)
• If you develop diarrhoea while taking OXYREST, tell your doctor or healthcare provider as soon as possible
• If you experience a faster than normal heart rate and suffer from hyperthyroidism (overactive thyroid), congestive heart failure, dysrhythmia (irregular heartbeat), coronary heart disease, high blood pressure or have had heart surgery, tell your doctor. OXYREST may worsen your condition
• If you experience hallucinations, agitation, confusion or sleepiness during the first few months of OXYREST treatment or when your doctor increases your dose, tell your doctor as soon as possible
• If you experience sudden blurred vision or eye pain, tell your doctor immediately
• If you develop tooth decay/cavities, inflammation of the gums or oral thrush while taking OXYREST, tell your doctor
• If you are suffering from acid reflux associated with a hernia or are taking medicines which can cause or exacerbate inflammation of the oesophagus (such as bisphosphonates used for osteoporosis), OXYREST may worsen your condition

Pregnancy and breastfeeding

• OXYREST is not recommended for use during pregnancy or breastfeeding
• If you are pregnant or breastfeeding your baby, please consult your doctor, pharmacist or other healthcare provider for advice before taking OXYREST

Interactions and medicines to check

The approved leaflet names these interactions.

• medicines for Parkinson’s disease (e.g. amantadine, biperiden, levodopa)
• antihistamines used for allergies
• medicines for certain mental illnesses (e.g. chlorpromazine, prochlorperazine, haloperidol, clozapine)
• medicines for depression (e.g. amitriptyline, imipramine, clomipramine, nefazodone)
• medicines for heart conditions (e.g. quinidine, digitalis, amiodarone, verapamil, diltiazem)
• certain antispasmodics (e.g. atropine, dipyridamole, hyoscine butylbromide)
• certain antibiotics (e.g. clarithromycin, erythromycin)
• antifungal medicines (e.g. ketoconazole, itraconazole, fluconazole)
• medicines for HIV/AIDS (e.g. ritonavir, indinavir, nelfinavir, saquinavir). Tell your doctor if you are taking any of the following medicines, OXYREST may weaken their effect:
• medicines that increase bowel movement (e.g. cisapride, domperidone, metoclopramide)
• medicines for Alzheimer’s disease (e.g. galantamine)
• medicines for myasthenia gravis a muscle disorder (e.g. pyridostigmine, neostigmine). Taking OXYREST with food and drink OXYREST can make you feel drowsy which is worsened by alcohol. You should not consume alcohol while taking OXYREST. You should not consume grapefruit juice as it may increase the effect of OXYREST

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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