Zopiclone Side Effects

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

What is zopiclone?

Zopiclone contains the active ingredient ZOPICLONE.

• Active ingredient — ZOPICLONE
• Registration number — 32/2.2/0487
• Registration holder — Sandoz SA (Pty) Ltd

It is approved for:

• SANDOZ ZOPICLONE 7,5 belongs to group of medicines called hypnotics
• It works by acting on your brain to help you sleep
• SANDOZ ZOPICLONE 7,5 is only used when the problem is severe or causing too much stress SANDOZ ZOPICLONE 7,5 is used to treat short term lack of sleep problems in adults SANDOZ ZOPICLONE 7,5 is not meant to be used every day for long periods of time or to treat depression

Common side effects of zopiclone

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

• You have an allergic reaction. The signs may include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue. Tell your doctor as soon as possible if you have any of the following side effects:
• Poor memory since taking SANDOZ ZOPICLONE 7,5 (amnesia). By having 7-8 hours of uninterrupted sleep after taking SANDOZ ZOPICLONE 7,5, this is less likely to cause you a problem
• Seeing or hearing things that are not real (hallucinations)
• Falling, especially in the elderly
• Thinking things that are not true (delusions)
• Feeling low or sad (depressed mood)
• Abnormal behaviour Tell your doctor or pharmacist if any of the following side effects get serious or lasts longer than a few days:
• A mild bitter or metallic taste in your mouth or a dry mouth
• Feeling drowsy or sleepy
• Feeling sick (nausea) or being sick (vomiting)
• Feeling dizzy
• Headache
• Nightmares
• Feeling physically or mentally tired : : : Each tablet contains 7,5 mg Zopiclone Submission date: 22 June 2022
• Agitation
• Feeling confused
• Lacking or being without any emotions
• Itchy, lumpy rash (urticaria)
• Feeling irritable or aggressive
• Reduced sex drive
• Feeling restless or angry
• Feeling light headed or having problems with your coordination
• Double vision
• Moving unsteadily or staggering
• Muscular weakness
• Indigestion
• Becoming dependent on SANDOZ ZOPICLONE 7,5
• Changes in blood tests that show how well your liver is working
• Unusual skin sensations such as numbness, tingling, pricking, burning or creeping on the skin (paraesthesia)
• Difficulty paying attention
• Disrupted normal speech
• Shortness of breath
• Slower breathing (respiratory depression)
• Sleepwalking
• Withdrawal syndrome If you notice any side effects not listed in this leaflet, please inform your doctor or pharmacist. : : : Each tablet contains 7,5 mg Zopiclone Submission date: 22 June 2022

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 zopiclone or any of the other ingredients in SANDOZ ZOPICLONE 7,5 (listed in section 6)
• If you have a problem that causes severe muscle weakness (myasthenia gravis)
• If your lungs do not work properly (respiratory failure)
• If you have a problem where you stop breathing for short periods at night (sleep apnoea)
• If you have severe liver problems
• If you are under the age of 18. The safety and efficacy of SANDOZ ZOPICLONE 7,5 in children and adolescents aged less than 18 years have not been established
• The safety in pregnancy and lactation has not been established
• Pre-existing depression or coma and lung problems that occur for a short time

Use with care, and tell your doctor, if

• If you have recently taken SANDOZ ZOPICLONE 7,5 or other similar medicines for more than four weeks. : : : Each tablet contains 7,5 mg Zopiclone Submission date: 22 June 2022
• If you do not feel you will ever be able to stop taking SANDOZ ZOPICLONE 7,5 or other medicines used to treat sleep problems
• If you have a history of alcohol or drug abuse
• You have any kidney problems, your doctor may need to give you a lower dose of SANDOZ ZOPICLONE 7,5
• You suffer from breathing problems, your doctor will decide if you should receive SANDOZ ZOPICLONE 7,5
• If you are elderly, your doctor may need to give you a lower dose of SANDOZ ZOPICLONE 7,5
• You have been told by a doctor that you have a personality disorder
• Before taking SANDOZ ZOPICLONE 7,5 it is important to make sure that you can have at least 7 to 8 hours of sleep to help reduce the risk of some side effects
• SANDOZ ZOPICLONE 7,5 may sometimes provoke seizures in patients with a disease called epilepsy. You may experience seizures if you stop taking SANDOZ ZOPICLONE 7.5 suddenly
• If lack of sleep in not treated after 7-10 days of treatment, there might be other conditions
• If SANDOZ ZOPICLONE 7,5 is taken with strong pain medicines called opioids, it can cause drowsiness, problems in breathing, coma and death
• SANDOZ ZOPICLONE 7,5 and opioids should only be used together, when other treatment options are not enough. Sleep-Driving and other strange behaviour: There have been some reports of people doing things while asleep that they do not remember when waking up after taking a sleep medicine. This includes sleep-driving and sleep walking. Alcohol and some medicines for depression or anxiety can increase the chance that this serious effect will happen. : : : Each tablet contains 7,5 mg Zopiclone Submission date: 22 June 2022 If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking SANDOZ ZOPICLONE 7,5. Children and adolescents SANDOZ ZOPICLONE 7,5 should not be used in children and adolescents less than 18 years. The safety and efficacy of SANDOZ ZOPICLONE 7,5 in children and adolescents aged less than 18 years have not been established

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
• SANDOZ ZOPICLONE 7,5 must not be used if you are pregnant or if you are planning to get pregnant
• Do not take SANDOZ ZOPICLONE 7,5 during pregnancy or during labour because it may be harmful to your baby
• Do not breastfeed if you are taking SANDOZ ZOPICLONE 7,5
• This is because small amounts may pass into mother’s milk
• : : : Each tablet contains 7,5 mg Zopiclone Submission date: 22 June 2022

Interactions and medicines to check

The approved leaflet names these interactions.

• Medicines for mental problems (antipsychotics)
• Medicines for depression
• Medicines for epilepsy (anticonvulsants)
• Medicines used in surgery (anaesthetics)
• Medicines to calm or reduce anxiety or for sleep problems (hypnotics)
• Medicines for hay fever, rashes or other allergies that can make you sleepy (sedative antihistamines) such as chlorphenamine or promethazine
• Some medicines for moderate to severe pain (narcotic analgesics or opioids) such as codeine, methadone, morphine, oxycodone, pethidine or tramadol The following medicines can increase the chance of you getting side effects when taken with SANDOZ ZOPICLONE 7,5. To make this less likely, your doctor may decide to lower your dose of SANDOZ ZOPICLONE 7,5:
• Some antibiotics such as clarithromycin or erythromycin
• Some medicines for fungal infections such as ketoconazole and itraconazole : : : Each tablet contains 7,5 mg Zopiclone Submission date: 22 June 2022
• Some medicines used for the treatment of HIV called protease inhibitors such as ritonavir
• Muscle relaxants The following medicines can make SANDOZ ZOPICLONE 7,5 work less well:
• Some medicines for epilepsy such as carbamazepine, phenobarbital or phenytoin
• Rifampicin (an antibiotic) – for infections, including TB
• St John’s Wort (a herbal medicine) – for mood swings and depression SANDOZ ZOPICLONE 7,5 with food, drink and alcohol Do not drink alcohol while you are taking SANDOZ ZOPICLONE 7,5. Alcohol can increase the effects of SANDOZ ZOPICLONE 7,5 and make you sleep very deeply so that you do not breathe properly or have difficulty waking

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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