Contromet Side Effects

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

What is Contromet?

Contromet contains the active ingredient Metoclopramide.

• Active ingredient — Metoclopramide
• Registration number — P/5.7.2/53
• Registration holder — Adcock Ingram Limited

It is approved for:

• Digestive disorders
• Feeling sick (nausea) and being sick (vomiting)
• Delayed nausea and vomiting after radiology treatment (Diagnostic radiology)
• Emptying of duodenal content for treatment procedures (Duodenal intubation)
• In young adults and children CLOPAMON INJECTION 20mg/2ml is restricted to vomiting that is difficult to control and to aid gastrointestinal intubation (passing a tube through the nose or mouth into the stomach or small intestine) and diagnostic radiology (special medical procedure)

Common side effects of Contromet

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

• depression
• uncontrollable movements such as tics, shaking, twisting movements or muscle contracture (stiffness, rigidity)
• symptoms similar to Parkinson’s disease (rigidity, tremor)
• feeling restless
• decrease in blood pressure (particularly with intravenous route)
• diarrhoea, constipation
• feeling drowsy, feeling weak (asthenia)

Less frequent side effects

• raised levels of a hormone called prolactin in the blood which may cause milk production in men and in women who are not breastfeeding
• irregular periods
• visual disturbances and involuntary upward deviation of eyeball
• hallucination (seeing or hearing things that are not there), confusional state
• decreased level of consciousness, Side effects with an unknown frequency:
• abnormal blood pigment levels, which may change the colour of your skin
• abnormal development of breasts (gynaecomastia)
• involuntary muscle spasms after prolonged use, particularly in elderly patients
• sudden increase in blood pressure in patients with tumour of the adrenal gland (phaeochromocytoma)
• very high blood pressure
• urinary incontinence
• retention of fluid in the body
• pain at site of injection. If you notice any side effects not listed in this leaflet, please consult your doctor, pharmacist or other health care professional for advice

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 metoclopramide or any other ingredients of CLOPAMON INJECTION 10 mg/2 ml (listed in section 6)
• if you are on antipsychotic treatment (Phenothiazines)
• if you have or have had bleeding, perforation or blockage of the stomach or intestines, or if you have had an operation on your stomach or intestines recently
• if you have or may have a rare tumour of the adrenal gland, which sits near the kidney (phaeochromocytoma)
• if you have epilepsy (CLOPAMON INJECTION 10 mg/2 ml may increase the risk of having a seizure)
• if you suffer from a rare inherited blood disease (porphyria)
• if you are pregnant

Use with care, and tell your doctor, if

• if you are elderly as there is an increased risk of extrapyramidal reactions (extreme restlessness, involuntary movements, and uncontrollable speech). These reactions usually at the beginning of the treatment and can occur after a single administration. CLOPAMON INJECTION 10 mg/2 ml should be discontinued immediately in the event of the above-mentioned symptoms
• if you are using CLOPAMON INJECTION 10 mg/2 ml for longer than 12 weeks. As tardive dyskinesia, a potentially irreversible and disfiguring disorder which causes involuntary movements of the face, tongue or extremities may develop with prolonged treatment especially in the elderly. Do not exceed 3 months treatment because of the risk of involuntary muscle spasms
• if vomiting persists you should be reassessed to exclude any underlying disorder
• if you are receiving CLOPAMON INJECTION 10 mg/2 ml for delayed gastric emptying, then your treatment should be reviewed at an early stage for responsiveness
• if you have kidney or liver problems. Patients with kidney or liver impairment should receive a reduced dosage
• if you are breastfeeding
• if you have a history of abnormal heart beats (QT interval prolongation) or any other heart problems
• if you are using other medicines known to affect the way your heart beats
• if you have any neurological (brain) problems
• if you have Parkinson’s disease as symptoms of Parkinson’s disease may worsen with CLOPAMON INJECTION 10 mg/2 ml
• if you are taking any medicines known as serotonergic medicines, as taking these medications with CLOPAMON INJECTION 10 mg/2 ml can cause side effects (such as restlessness, loss of co-ordination, fast heartbeat and increased body temperature)
• if you have abnormal blood pigment level (methaemoglobinaemia) which could be related to NADH cytochrome b5 reductase deficiency. Your doctor may perform blood tests to check your blood pigment levels. In cases of abnormal levels (methaemoglobinaemia), the treatment should be immediately and permanently stopped
• if you have high blood pressure (hypertension)
• if you have a history of allergies, including asthma (atopy) or have a rare inherited blood disease (porphyria)
• if you are taking any other medicine by mouth. It is possible that CLOPAMON INJECTION 10 mg/2 ml may change the amount of the other medicine that gets into your body. Children and adolescents Uncontrollable movements (extrapyramidal disorders) may occur in children and young adults

Pregnancy and breastfeeding

• You should not take CLOPAMON INJECTION 10 mg/2 ml 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 this medicine CLOPAMON INJECTION 10 mg/2 ml
• CLOPAMON INJECTION 10 mg/2 ml is not recommended if you are breastfeeding because metoclopramide passes into breast milk and may affect your baby

Interactions and medicines to check

The approved leaflet names these interactions.

• levodopa or other medicines used to treat Parkinson’s disease
• alcohol as CLOPAMON INJECTION 10 mg/2 ml may increase the effect of alcohol
• phenothiazines (medicines used to treat serious mental and emotional disorders)
• anticholinergics (medicines used to relieve stomach cramps or spasms)
• morphine derivatives (medicines used to treat severe pain)
• sedative medicines
• any medicines used to treat mental health problems
• digoxin (medicine used to treat heart failure)
• cyclosporine (medicine used to prevent organ rejection after transplantation such as a liver transplant
• mivacurium and suxamethonium (medicines used to relax muscles)
• fluoxetine and paroxetine (medicine used to treat depression that boost brain serotonin levels)
• atovaquone (antibiotic used to treat pneumonia)
• neuroleptic medicines (medicines for mental illness)
• pain killers such as aspirin or paracetamol or stronger pain killers called opioids. CLOPAMON INJECTION 10 mg/2 ml with food, drink and alcohol Taking alcohol during treatment with CLOPAMON INJECTION 10 mg/2 ml may increase the sedative effect of CLOPAMON INJECTION 10 mg/2 ml

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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