Stilpane Side Effects

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

What is Stilpane?

Stilpane contains the active ingredient Promethazine hydrochloride, codeine phosphate and paracetamo.

• Active ingredient — Promethazine hydrochloride, codeine phosphate and paracetamo
• Registration holder — PHARMACARE LIMITED

It is approved for:

• STILPANE SYRUP is used to treat the symptoms of mild to moderate pain and fever
• It contains promethazine hydrochloride which helps with allergies, codeine phosphate to relieve pain and paracetamol for pain and fever

Common side effects of Stilpane

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

• Confusion
• sleepiness (varying from slight drowsiness to deep sleep), lack of energy (lassitude), a strong desire to sleep (somnolence)
• paradoxical stimulation (a reaction that is opposite to what would usually be expected) of the central nervous system (made up of the brain and spinal cord)
• occasional headaches, nervousness, irritability
• high blood pressure (hypertension), muscle weakness
• dizziness, lack of coordination, a slight shaking movement in a person’s body (tremors)
• nausea, vomiting, diarrhoea, constipation (difficulty in passing stools), lack/loss of appetite (anorexia) or increased appetite, pain in upper, middle region of stomach (epigastric pain)
• sweating

Less frequent side effects

• Great happiness (elation) or persistent feeling of sadness and loss of interest (depression), changes of mood, restlessness
• decrease in the size of the pupil of the eye (miosis)
• ringing in the ears (tinnitus)
• low blood pressure and low blood pressure when standing up (orthostatic hypotension)
• intestinal cramps (colic), abdominal pain, dryness of the mouth
• increased sensitivity of skin to sun (photosensitivity)
• a condition in which you have high levels of white blood cells or pus in your urine (sterile pyuria)
• difficulty or pain when passing urine (difficulty in micturition, dysuria)
• weakness of the hands, muscle rigidity, facial flushing. Side effects with an unknown frequency:
• Too much sugar in the blood (hyperglycaemia)
• a chronic inflammatory disease of connective tissue, affecting the skin and various internal organs (lupus erythematous-like syndrome), temporary increase in the body’s temperature (fever)
• inability to sleep (insomnia), abuse, mental depression, nightmares, feeling uneasy (dysphoria), agitation, anxiety
• headache, nausea, vomiting, confusion, dizziness, feeling week or tired, loss of appetite and increased heartbeat due to high acidity in the body (pyroglutamic aciduria (5-oxoprolinuria) and high-anion gap metabolic acidosis)
• light-headedness and loss of balance (vertigo)
• deposition of pigment in the eyes, blurred or double vision or other changes in vision
• thickened secretions in the organs that are involved in breathing (respiratory tract), dryness of the nose
• increased stomach acid or bile irritates the food pipe lining (gastric reflux), stomach cramps
• a decrease in the amount of urine produced (antidiuretic effect)
• inhibition of the parasympathetic nervous system (antimuscarinic effects) (these effects can cause flushing, constipation, dry skin, dilatation of the pupils)
• a rise in body temperature cause by a certain medicine (medicine fever)
• weakness of hands, muscle stiffness (rigidity)
• passing abnormally large amounts of urine (polyuria), ureteric spasm, difficulty urinating and completely emptying the bladder (urinary retention)
• lowering of blood temperature (occasionally pyrexia), a general feeling of discomfort (malaise), physical and mental symptoms that occur after stopping or reducing a medicine (drug withdrawal syndrome)
• persistent, recurrent difficulty with sexual response, desire, orgasm or pain (sexual dysfunction, decreased libido/potency)
• increase in a certain enzyme as seen on blood tests (increased transaminases)
• tiredness
• a nearly irresistible urge to move the legs, typically in the evenings (restless legs syndrome)

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.

Use with care, and tell your doctor, if

• Consult your healthcare provider if:
• No pain relief is obtained from the recommended dosage after 10 days for adults and 5 days for children
• There is no improvement in fever after 3 days
• New symptoms occur or if redness and swelling is present
• STILPANE SYRUP can lead to drowsiness and impaired concentration, which may be aggravated by the simultaneous intake of alcohol or other central nervous system depressants (such as anti-depressants, anti-anxiety medication and or medicines used to help you sleep). You are advised, particularly at the initiation of therapy, against taking charge of vehicles or machinery or performing potentially hazardous tasks where loss of concentration could lead to accidents
• STILPANE SYRUP should not be used with any other paracetamol containing medicine
• If you have a compromised ability to remove chemicals from the body (glutathione depleted states), as the use of paracetamol, as contained in STILPANE SYRUP, can increase your risk of developing a condition in which too much acid accumulates in the body (metabolic acidosis)
• If you are an elderly patient as you may be more prone to experience side effects such as dizziness, sleepiness, confusion, low blood pressure, dry mouth and urinary retention
• If you have any of the following:
• under active thyroid gland (a condition where the thyroid gland does not produce enough hormones)
• adrenocortical insufficiency (a condition where the adrenal glands do not produce enough steroid hormone)
• a hormone-secreting tumour that can occur in the adrenal glands (phaeochromocytoma)
• asthma
• narrowing of the tube connected to the bladder (urethral stricture)
• enlarged prostate gland
• low blood pressure
• a heart disease/condition
• breathing problems such as emphysema or chronic bronchitis
• problems with your liver or kidneys (also see Do not take STILPANE SYRUP)
• if you have a condition in which the skin, whites of the eyes and mucous membranes turn yellow (jaundice)
• a condition where your bladder doesn’t completely empty (urinary retention)
• a group of rare disorders that affect the skin and nervous system (porphyria)
• if you are an alcoholic
• shock (a condition where there is not enough blood flow through the body)
• pre-existing central nervous system depression
• bone marrow depression
• inflammatory or obstructive bowel disorders (a problem or blockage of your bowel)
• diseases or conditions that cause weakness of muscles around the eyes, mouth and throat (myasthenia gravis)
• increased pressure in the eye (glaucoma)
• a disorder of the central nervous system that affects movement, often including tremors (Parkinsonism)
• a disease that affects how the body uses sugar (glucose) (diabetes mellitus)
• Reye’s syndrome (a rare but serious condition that causes swelling in the liver and brain. Reye’s syndrome most often affects children and teenagers recovering from a viral infection, most commonly the flu or chickenpox)
• If you are pregnant or in labour. STILPANE SYRUP administration during labour may cause breathing problems in the new-born infant. If women take STILPANE SYRUP during pregnancy, there is a risk that their newborn infants will experience neonatal withdrawal syndrome
• Since codeine, as contained in STILPANE SYRUP, may cause a decrease in the function and activity of the brain. This effect may be increased by medicines that slow down brain activity such as alcohol, anaesthetics, calming and sleeping tablets, and phenothiazines. The prolonged use of high doses of codeine has produced addiction similar to morphine addiction. Codeine should be used with caution in patients with a history of substance abuse or mental health disorders
• If you use medicine for the treatment of diarrhoea, as concomitant use with STILPANE SYRUP can cause constipation (difficulty in passing stools)
• If you are also taking flucloxacillin (an antibiotic) as the combination with paracetamol, as contained in STILPANE SYRUP, has been associated with a condition where acid accumulates in the body (high anion gap metabolic acidosis), especially in patients with risk factors
• As STILPANE SYRUP can cause very serious skin reactions that are potentially life threatening, you should stop taking STILPANE SYRUP if you develop any skin reactions and contact your doctor
• If you are an ultra-rapid metaboliser of CYP2D6, you should not take STILPANE SYRUP. Even small doses of codeine can lead to increased formation of the active metabolite morphine resulting in clinical signs of morphine intoxication
• If you are a child and you might have compromised respiratory function, as worsened symptoms of morphine toxicity can occur
• If you are a paediatric patient and you have had your tonsils and/or adenoids removed due to obstructive sleep apnoea. Rare, but life-threating adverse events such as death can occur. Your pigments should be examined periodically by your doctor for abnormal skin pigmentation (discolourisation) or eye changes. Children STILPANE SYRUP is not recommended for children under 2 years of age

Pregnancy and breastfeeding

• You should not take STILPANE SYRUP if you are pregnant or breastfeeding your baby
• 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 STILPANE SYRUP

Interactions and medicines to check

The approved leaflet names these interactions.

• Medicines used to treat depression, referred to as monoamine oxidase inhibitors (such as selegiline)
• medications tending to cause involuntary movements that you cannot control (extrapyramidal reactions) and those with anticholinergic effects may be potentiated. These include medicine to treat depression know as tricyclic antidepressants, maprotiline or monoamine oxidase inhibitors (MOAIs)
• medication used to treat high blood pressure, alcohol and anaesthetics, as STILPANE SYRUP may enhance the effect of these medicines
• hypnotics and sedatives, medicines used to make you feel sleepy
• phenothiazines, used to treat schizophrenia as well as nausea and vomiting
• anti-virals (e.g. interferon alfa and zidovudine), as paracetamol enhances the antiviral effect of Interferon Alfa. Severe liver toxicity has occurred after the use of paracetamol in patients taking zidovudine and co-trimoxazole
• medicine that may cause damage to the liver or medicine that increases the metabolic activity of an enzyme (hepatotoxic or enzyme-inducing medicine), as there as is an increased risk of damage to the liver
• prolonged concurrent use of STILPANE SYRUP with salicylates (e.g. aspirin) increases the risk of kidney side-effects
• levodopa, a medicine used to treat Parkinson’s disease
• sodium oxybate, as concomitant administration of codeine and sodium oxybate may cause increased central nervous system depression and/or airway depression and/or lowered blood pressure (hypotension)
• medicine to prevent your blood from clotting (warfarin and other coumarins), since there is as an increased risk for bleeding in patient taking regular doses of paracetamol
• medicines used to treat tuberculosis, including isoniazid, as severe liver damage can occur
• anti-dysrhythmics (e.g. mexiletine, quinidine), as codeine, as contained in STILPANE SYRUP, delays the absorption of mexiletine. The pain-relieving activity of codeine, as contained in STILPANE SYRUP, is likely to be significantly impaired by quinidine which impairs the breakdown of codeine
• domperidone and metoclopramide, as the absorption of paracetamol may be accelerated. Codeine works against the effects of metoclopramide and domperidone on gastrointestinal activity
• cisapride, codeine works against the effects of cisapride on gastrointestinal activity
• cholestyramine (used to lower cholesterol levels in the blood), as it reduces the absorption of paracetamol
• probenecid (used to treat gout), as STILPANE SYRUP causes paracetamol to stay in the body for longer
• ulcer-healing medicine (such as cimetidine), as it may cause codeine, as contained in STILPANE SYRUP, to stay in the body for longer
• flucloxacillin, as concurrent intake with paracetamol has been associated acid accumulates in the body, especially in patients with risk factors
• STILPANE SYRUP may affect the results of pregnancy tests (false negative or positive)
• STILPANE SYRUP may affect the results of skin tests and should be stopped several days before these tests are done
• STILPANE SYRUP may mask the warning signs of damage caused by agents that have toxic effects on the nerve of the ear
• The plasma-paracetamol concentrations considered an indication for antidote treatment should be halved in patients receiving enzyme inducing medicines such as rifampicin (used in the treatment of tuberculosis), carbamazepine phenobarbital, phenytoin, or primidone (used in the treatment of epilepsy or as a sedative)
• Interference with laboratory tests: Opioids may interfere with gastric emptying studies. Codeine, as contained in STILPANE SYRUP, may delay the absorption of other medicines that you may be taking. STILPANE SYRUP with alcohol Do not drink alcohol when taking STILPANE SYRUP (also see Other medicines and STILPANE SYRUP)

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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