Codeine Side Effects

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

What is codeine?

Codeine contains the active ingredient Paracetamol and 8 mg codeine phosphate.

• Active ingredient — Paracetamol and 8 mg codeine phosphate
• Registration number — 37/2.8/0261
• Registration holder — LeBasi Pharmaceuticals (Pty) Ltd

It is approved for:

• Paracetamol and codeine phosphate are the active substances in VARIPAN CO
• Paracetamol acts as an analgesic (painkiller) and an antipyretic (lowers body temperature) and codeine phosphate is also a painkiller
• VARIPAN CO is used for the relief of mild to moderate pain and fever

Common side effects of codeine

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

• Drowsiness
• Constipation

Less frequent side effects

• Dizziness, headache, uncontrolled shaking (tremors)
• Restlessness, confusion
• Decline in mental ability (memory/thinking), abnormal thinking, hallucinations (seeing or hearing things that are not real)
• Insomnia (difficulty falling/staying asleep)
• Loss of appetite
• Blurred or double vision
• Low blood pressure (dizziness)
• Dry mouth, stomach pain, nausea, vomiting
• Muscle stiffness
• Unusual tiredness or weakness, general feeling of discomfort
• Allergic skin rash

Frequency unknown side effects

• Raised, itchy rash (urticaria)
• Skin redness
• Changes in your white/red blood cells or platelet count when tests are done
• Changes in your mood (feeling happy or irritated/unhappy)
• Light-headedness
• Increased blood pressure (dizziness, headache)
• Reddening of your face, neck or upper chest (flushing)
• Postural hypotension (a form of low blood pressure that happens when standing up from sitting or lying down, which may cause dizziness or light-headedness)
• Spinning sensation (vertigo)
• Narrowing of your pupils
• Drop in your body temperature
• Ringing or buzzing in your ears

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 paracetamol or codeine phosphate, or to any of the other ingredients of VARIPAN CO (listed in section 6)
• If you have problems to breathe, especially if you have a bluish discolouration of your skin (due to decreased oxygen) or have excessive mucus
• If you suffer from asthma or any other lung disease
• If you are an alcoholic or addicted to any substance
• If you have a gallbladder disease, gallstones or recently had an operation on your gallbladder or bile duct
• If you have any liver problems
• If you have any kidney problems or recently had an operation on your kidneys, bladder or urethra
• If you have an infection in your pancreas
• If you don’t have enough fluid (blood) volume circulating in your body, caused by vomiting, diarrhoea or excessive bleeding, which may lead to shock (symptoms include weakness, fatigue, dizziness and fainting)
• If you have an irregular heartbeat
• If you suffer from Addison’s disease (a disorder in which your adrenal glands don’t produce enough hormones)
• If you have a history of convulsions (fits)
• If you suffer from any stomach conditions, including diarrhoea, or recently had surgery on your stomach or intestines
• If you are emotionally unstable
• If you have an enlarged prostate gland (difficulty passing urine)
• If you suffer from a spinal condition which causes an abnormal curve of your spine
• If you have an underactive thyroid
• If you have growing pressure inside your skull (headache, blurred vision, weakness), e.g. following a head injury
• If you have heart failure secondary to a lung disease (shortness of breath, swollen legs, irregular heartbeat, fatigue)
• If you have been told that you are a CYP2D6 ultra-rapid metabolisers
• In children that are having their tonsils and/or adenoids removed due to difficult/disturbed breathing during sleep
• If you have been using antidepressants called monoamine oxidase inhibitors or have just stopped using these medicines in the last 2 weeks

Use with care, and tell your doctor, if

• If you or a family member previously had mental health problems, characterised by a persistently low or depressed mood (major depression), feeling of fear or worry (anxiety), or misused alcohol or drugs, as it may increase the risk of addiction
• VARIPAN CO may cause severe liver damage if taken in excess
• Consult your doctor if no relief is obtained with the recommended dosage
• Do not use continuously for longer than 10 days without consulting your doctor
• If you suffer from a condition known as myasthenia gravis which weakens the muscles
• If you are elderly or weak
• You may need to reduce your dose
• If you are in a state of shock (cold sweat may be a sign)
• Exceeding the prescribed dose, together with prolonged and continuous use of VARIPAN CO, may lead to dependency and addiction
• If you develop any skin adverse reaction, such as toxic epidermal necrolysis (TEN), Steven- Johnson syndrome (SJS), acute generalised exanthematous pustulosis (AGEP), drug rash with eosinophilia and systemic symptoms (DRESS) or drug-induced hypersensitivity syndrome (DIHS) and fixed drug eruptions (FDE), treatment with VARIPAN CO must immediately be discontinued. These reactions can be life-threatening and are characterised by redness, inflamed or swollen skin, blisters, hives, itching and sometimes peeling or pain. Should you experience any of these symptoms, contact your health care provider immediately
• If you are taking sedating medicines, also known as central nervous system (CNS) depressants, such as benzodiazepines (used to treat anxiety, panic attacks and insomnia or trouble sleeping)
• Codeine, as in VARIPAN CO, is metabolised in your liver by an enzyme. Some people have a variation of this enzyme, and this can affect people in different ways. In some people, they may not get enough pain relief but other people, known as ultra-rapid metabolisers, are more likely to get serious side effects (such as breathing difficulties, with slow or shallow breathing, confusion, sleepiness, feeling or being sick, constipation and lack of appetite). If you experience any of these side effects, stop taking VARIPAN CO and consult with your doctor immediately. You should not take VARIPAN CO if you are known to be a CYP2D6 ultra-rapid metaboliser
• Do not take VARIPAN CO for longer than directed by your doctor. Taking codeine regularly for a long time can lead to addiction, which might cause you feel restless and irritable when you stop taking the tablets. Taking a painkiller for headaches too often or for too long can make them worse. Children and adolescents
• VARIPAN CO should not be given to children below 6 years of age
• VARIPAN CO should not be given to children below 18 years of age after an operation to remove their tonsils or adenoids for airflow blockage during sleep (obstructive sleep apnoea)
• VARIPAN CO is not recommended for use in children with breathing problems, including neuromuscular disorders (conditions that impair the functioning of the muscles, either directly or indirectly, through the nervous system), severe heart or lung conditions, lung infections, several serious injuries or major surgery

Pregnancy and breastfeeding

• Safe use in pregnancy and breastfeeding has not been established
• 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 VARIPAN CO

Interactions and medicines to check

The approved leaflet names these interactions.

• Sedatives or tranquillisers, also known as central nervous system (CNS) depressants, such as benzodiazepines (used to treat anxiety, panic attacks, insomnia or trouble sleeping)
• Anticoagulants such as warfarin (used to thin your blood)
• Medicines that may be harmful to your liver such as carbamazepine, phenobarbital (phenobarbital) and phenytoin (used to treat epilepsy)
• Probenecid (used to treat gout)
• Isoniazid (used to treat tuberculosis)
• Antidiarrhoeal and antiperistaltic medicines such as loperamide and kaolin (used to treat diarrhoea)
• Antimuscarinic medicines (used to treat an overactive bladder)
• Neuromuscular blocking medicines (potent muscle relaxants typically only used during surgery)
• Antihypertensive medicines such as diuretics (used to treat high blood pressure)
• Hydroxyzine (used to treat anxiety disorders and allergic conditions)
• Cimetidine (used to treat stomach ulcers or heartburn)
• Naloxone (used to treat a narcotic overdose)
• Naltrexone (used as part of a treatment program for medicine or alcohol dependence)
• Nonsteroidal anti-inflammatory drugs (NSAIDs), aspirin or other salicylates (used to treat pain, inflammation and fever)
• Medicines which may increase the CYP3A4 enzyme in your body, such as rifampicin (used to prevent and treat tuberculosis) and phenytoin (used to treat and prevent seizures/fits)
• Zidovudine (anti-retroviral therapy, used in the treatment of HIV infection)
• Metoclopramide or domperidone (used to treat nausea and vomiting)
• Colestyramine (used to lower high cholesterol levels in the blood)
• Mexiletine (used to treat irregular heartbeat)
• Cisapride (used to treat heartburn or gastro-oesophageal reflux disease)
• Other opioid painkillers (used to treat pain)
• Antitussive medicines (used to treat a cough)
• Antihistamines (used to treat allergies)
• Antipsychotics (used to treat depression or a psychotic disorder)
• Tell your doctor or pharmacist if you need to go for any laboratory tests. VARIPAN CO with alcohol Do not drink alcohol during treatment with VARIPAN CO as it may have additive sedative effects

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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