Clobazam Side Effects

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Answer the side-effect intent for clobazam 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 clobazam?

Clobazam contains the active ingredient Clobazam.

• Active ingredient — Clobazam
• Registration number — 55/2.6/0546; 55/2.6/0547
• Registration holder — Adcock Ingram Limited

It is approved for:

• CLOBAZAM ADCO contains the active substance clobazam
• CLOBAZAM ADCO is used to treat anxiety in neurotic patients and for pre-operative medication
• CLOBAZAM ADCO can also be effective in relieving acute symptoms of alcohol withdrawal syndrome

Common side effects of clobazam

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
• irritability
• aggression
• restlessness
• Depression (pre-existing depression may be unmasked)
• medicine tolerance (when your body adapts to the continued presence of the medicine and doesn’t respond to the medicine as well anymore)
• agitation (a state of anxiety or nervous excitement)
• somnolence (a strong desire to sleep and a feeling of drowsiness)
• sedation
• dizziness
• disturbance in attention
• slow speech/dysarthria (slurred speech)/speech disorder
• headache
• tremor
• ataxia (impaired balance or coordination)
• dry mouth
• nausea
• constipation
• fatigue, especially at the beginning of treatment

Less frequent side effects

• abnormal behaviour
• confessional state (confused thinking and reduced awareness of surroundings)
• anxiety (intense and persistent worry and fear about everyday)
• delusion (believing things that isn’t true)
• nightmare
• loss of libido (sexual drive)
• emotional poverty
• amnesia (memory loss that may be associated with abnormal behaviour)
• memory impairment (changes in your memory)
• anterograde amnesia (loss of the ability to recall the recent past but long-term memories are still intact)
• depression of mood and affect
• lethargy
• increased motor activity
• decreased motor activity
• paradoxical reactions (inconsistent or contradictory) such as an excess
• excitability with rage
• diplopia (double vision)
• rash
• weight increase
• increased possibility of tripping or falling, especially in elderly patients
• fall Unknown frequency
• dependence (becoming dependent of CLOBAZAM ADCO)
• initial insomnia (problem falling asleep and staying asleep)
• anger
• hallucination (seeing things that isn’t real)
• psychotic disorder (a mental disorder characterised by a disconnection from reality)
• poor sleep quality
• suicidal ideation (to think or plan suicide)
• cognitive disorder (disorders that affect cognitive abilities including learning, memory, perception and problem solving)
• altered state of consciousness (particularly in elderly patients, may be combined with respiratory disorders)
• nystagmus (involuntary movement of the eye causing the eye to rapidly move from side to side)
• gait disturbance (change in the way you walk)
• muscle spasms
• muscle weakness
• slow response to stimuli (slow reaction time)

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 hypersensitive (allergic) to clobazam or any of the other ingredients of CLOBAZAM ADCO (listed in section 6)
• if you have a history of drug or alcohol dependence
• if you suffer from an illness that causes muscle weakness (called ‘myasthenia gravis’)
• if you have breathing problems
• if you stop breathing for short periods during sleep (called ‘sleep apnoea syndrome’)
• if you have severe liver problems
• if you are in your first trimester of pregnancy or breastfeeding your baby
• if the patient is under 3 years. S5

Use with care, and tell your doctor, if

• if you experience any memory loss, please inform your doctor
• if you have existing muscle weakness or experience any muscle weakness while being treated
• if you have existing depression or aggression problems
• if you have ever become dependent upon another drug or alcohol. Alcohol should not be taken during treatment with CLOBAZAM ADCO as there is an increased risk of experiencing side effects
• if you experience any skin reaction during treatment with CLOBAZAM ADCO
• if you have chronic or acute breathing problems
• if you have kidney or liver problems
• if you are over 65 or debilitated
• This is due to the increased sensitivity to adverse reactions in the elderly such as drowsiness, dizziness and muscle weakness. There is also an increased risk of fall that may result in serious injury
• if you are a poor CYP2C19 metaboliser
• if you are drinking alcohol during treatment
• if you are using any opioids (pain medication) or any other benzodiazepines
• if you are using any barbiturates (to treat anxiety or sleep disorders), antihistamines (to treat allergies), narcotics (to induce sleep) or other central nervous depressants (to treat anxiety, panic attacks, seizures, insomnia (trouble to sleep), etc.). The medicines prescribed to reduce seizures have been associated with a rare but serious reaction called Drug Reaction with Eosinophilia and Systemic Symptoms, or DRESS. This serious sensitivity is a reaction of the immune system that can cause severe swelling (inflammation) throughout the body, or injury to organs, including the liver, kidneys, lungs, heart, or pancreas. It can lead to hospitalisation and damage or failure of these organs and may progress to death, especially if treatment is delayed. Do not stop taking CLOBAZAM ADCO without first talking to your healthcare professional. Stopping CLOBAZAM ADCO suddenly can cause uncontrolled seizures. Call your healthcare professional and seek immediate medical attention if you develop any of the following symptoms at any time while taking CLOBAZAM ADCO:
• Fever
• Swollen lymph nodes
• Sore throat
• Skin rash (may or may not be present)
• Swelling of your face or eyes
• Painful sores in the mouth or around the eyes
• Trouble swallowing or breathing
• Yellowing of your skin or eyes
• Unusual bruising or bleeding
• Severe fatigue and weakness
• Shortness of breath or exercise intolerance
• Severe muscle pain

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 health care provider for advice before taking CLOBAZAM ADCO
• CLOBAZAM ADCO is not recommended during the first trimester of pregnancy and in women of childbearing potential not using contraception
• Since CLOBAZAM ADCO is found in the breastmilk, CLOBAZAM ADCO should not be given to breastfeeding mothers
• Fertility No human data available

Interactions and medicines to check

The approved leaflet names these interactions.

• Antipsychotics (such as chlorpromazine, haloperidol, clozapine and pimozide)
• Hypnotics, anxiolytics/sedative (medicines that work on the central nervous system to relieve anxiety, aid sleep, or have a calming effect)
• Antidepressant agents (such as Monoamine Oxidase Inhibitors (MAOIs) or tricyclic anti- depressants such as trazodone, or Selective Serotonin Re-uptake Inhibitors (SSRIs) such as fluvoxamine or paroxetine)
• Narcotic analgesics and opioids (medicines containing codeine, dihydrocodeine, morphine, fentanyl, oxycodone and, methadone)
• Anti-convulsant medicines (such as phenytoin, carbamazepine, stiripentol or valproic acid)
• Anaesthetics (medicine that is administered during an operation)
• Sedative antihistamines (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))
• Muscle relaxants (such as baclofen) and nitrous oxide (laughing gas)
• CYP2C19 inhibitors (such as fluconazole (used to treat fungal conditions), fluvoxamine (SSRI, used to treat depression) and ticlopidine (an antiplatelet medication used in patients with an increased risk of stroke)
• CYP2D6 substrates such as Dextromethorphan (used to relieve dry, irritating coughs), pimozide (used to treat severe mental illness), paroxetine (SSRI, used to treat depression), nebivolol (used to treat high blood pressure). CLOBAZAM ADCO with food and drink Be careful how much alcohol you drink. Due to the combined effect of CLOBAZAM ADCO and alcohol it can increase the effects of CLOBAZAM ADCO e.g., sedation

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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