Urbanol Side Effects

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

Part of mental health medication side effects side effects.

What is Urbanol?

Urbanol contains the active ingredient Clobazam.

• Active ingredient — Clobazam
• Registration number — 51/2.6/0566; 51/2.6/0567
• Registration holder — PHARMACARE LIMITED

It is approved for:

• Relief of severe anxiety over a short time
• Relief of anxiety before an operation
• Relief of acute symptoms of alcohol withdrawal syndrome

Common side effects of Urbanol

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

• decreased appetite
• the persistent feeling of sadness or loss of interest in normal daily tasks
• reduced reaction to QLOCAM (especially during prolonged use)
• tiredness and sleepiness, sedation, dizziness, disturbance in attention, slowed or unclear speech
• headache
• tremor, loss of control of body movements (ataxia) or a fine tremor of the fingers may occur
• dry mouth, constipation, nausea, vomiting
• fatigue, especially at the beginning of treatment and when higher doses are used

Less frequent side effects

• abnormal behavior, confusional state
• loss of libido (particularly with high doses or in long-term treatment, and is reversible)
• numbed emotions, have a lack of emotions (emotional poverty), decreased ability to remember new information (anterograde amnesia), inappropriate behaviour, memory impairment
• eye problems such as double vision
• weight gain
• increased risk of falling. Side effects with an unknown frequency:
• bleeding or bruising more easily than normal, nosebleeds, looking pale, fever, severe chills, sore throat or mouth ulcers
• difficulty in staying awake or alert, reacting to things more slowly than usual, loss of memory, confusion
• lack of interest and energy (lethargy)
• involuntary, rapid movement of one or both eyes (nystagmus)
• sensitivity to light
• muscle spasms, muscle weakness
• slow response to stimuli
• abnormally low body temperature

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

• you are hypersensitive (allergic) to benzodiazepines, or clobazam or any of the other ingredients of QLOCAM (listed in section 6)
• you have ever had problems with drugs or alcohol dependence in the past
• you have a long-term (chronic) condition in which the muscles become weak and tire easily (myasthenia gravis)
• you have serious breathing problems (severe respiratory insufficiency)
• you stop breathing for short periods during sleep (sleep apnoea syndrome)
• you have liver problems
• you are in the first three months of pregnancy or think you might be pregnant
• you are breastfeeding
• the patient or your child is 3 years old or younger

Use with care, and tell your doctor, if

• If you are using anti-epileptic medication
• If you have a serious skin reaction. Serious skin reactions have been seen when clobazam, as contained in QLOCAM, is taken with other medicines and may require stopping its use. Do not stop taking QLOCAM without first talking to your healthcare provider. A serious skin reaction can happen at any time during your treatment with QLOCAM, but is more likely to happen within the first 8 weeks of treatment. These skin reactions may need to be treated right away. Call your healthcare provider immediately if you have skin blisters, rash, sores in mouth, hives or any other allergic reaction
• If you have a serious allergic reaction that may affect your skin or other parts of your body such as your liver, kidneys, heart, or blood cells. This allergic reaction can be life-threatening and can cause death, particularly if it is not treated as early as possible. Call your healthcare provider immediately if you have: o a skin rash o fever or swollen glands that do not go away o swelling of your face o shortness of breath o dark urine o yellowing of the skin or whites of the eyes
• If you experience memory loss
• If you drink alcohol as you should avoid drinking alcohol during treatment with QLOCAM, as this could increase the risk of the side effects of QLOCAM
• If you have problems controlling your movements (spinal or cerebellar ataxia) or suffer from pre-existing muscle weakness
• If you have depression, irrational fears and obsessions
• QLOCAM can be addictive and cause withdrawal effects if treatment is stopped abruptly. Your doctor will prescribe QLOCAM for a limited duration and decrease your dosage gradually to prevent these withdrawal effects from happening
• If you are sexually active and still of the age to conceive and are not using oral contraceptives
• If you have shallow breathing (respiratory depression)
• If you have liver or kidney problems
• If you are an elderly person as you may experience the side effects of QLOCAM more intense
• If you have delusions (believing things which are not true) or hallucinations (sensing things which are not there)
• If you have ever become dependent upon another drug or alcohol
• If you are using any other opioid type medications as this can lead to respiratory depression, coma, and death
• If you are using other barbiturates, antihistamines, narcotics or other CNS depressants. Children and adolescents QLOCAM should not be used in children three years of age and younger

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 this medicine

Interactions and medicines to check

The approved leaflet names these interactions.

• Medicines for epilepsy (such as phenytoin, carbamazepine or valproic acid)
• Medicines for depression such as MAOIs (monoamine oxidase inhibitors) or tricyclic antidepressants (such as amitriptyline)
• Medicines for severe mental illness called ‘neuroleptics’ (such as chlorpromazine, haloperidol and/or clozapine)
• Painkillers (medicines containing e.g. codeine, dihydrocodeine or morphine)
• Medicines used for sleep (such as zolpidem)
• Other tranquillisers (such as diazepam or lorazepam)
• Muscle relaxants (such as baclofen)
• Antihistamines that make you sleepy (such as chlorphenamine, promethazine or diphenhydramine)
• Lithium, used for a mental illness called ‘manic-depressive illness’ (mood changes between a state of high excitability or exaggerated emotions and depression)
• If you are going to have an anaesthetic, tell your doctor or anaesthetist you are taking QLOCAM. QLOCAM with food and alcohol You should not use alcohol during treatment with QLOCAM. QLOCAM can be taken with food 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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