Tramazac Side Effects

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

What is Tramazac?

Tramazac contains the active ingredient Tramadol hydrochloride.

• Active ingredient — Tramadol hydrochloride
• Registration number — A39/2.9/0415
• Registration holder — Zydus Healthcare SA (Pty) Ltd

It is approved for:

• Tramadol, the active substance in TRAMAZAC 50, is a painkiller belonging to a class of medicines called opioids, that acts on the central nervous system
• TRAMAZAC 50 is used for the management of moderate to moderately severe pain

Common side effects of Tramazac

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

• TRAMAZAC 50 should not be given to children below 12 years of age
• TRAMAZAC 50 should not be given to children below 18 years of age after an operation to remove their tonsils or adenoids for pain or airflow blockage during sleep (obstructive sleep apnoea)
• TRAMAZAC 50 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. Other medicines and TRAMAZAC 50 Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines.) Tell your doctor or pharmacist if you are currently taking:
• Monoamine oxidase inhibitors (used to treat depression) or have taken them in the last 14 days before treatment with TRAMAZAC 50
• Sedatives or tranquillisers, also known as central nervous system (CNS) depressants, such as barbiturates and benzodiazepines (used to treat anxiety, panic attacks, insomnia or trouble sleeping)
• Serotonergic medicines (medicines that may increase serotonin levels in your body) such as selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs) and tricyclic antidepressants (used to treat depression)
• Medicines which may cause seizures/fits such as certain antidepressants or antipsychotics (used to treat depression or a psychotic disorder). The risk of having a seizure/fit may increase if you use TRAMAZAC 50 at the same time
• Anticoagulants such as warfarin (used to thin your blood)
• Medicines which may reduce a certain enzyme known as CYP3A4 in your body such as ketoconazole (used to treat a fungal infection) and erythromycin (used to treat a bacterial infection)
• Carbamazepine (used to treat seizures/fits)
• Ondansetron (used to prevent nausea and vomiting)
• Analgesics, including opioids, such as morphine (used to treat pain)
• Cimetidine (used to treat heartburn and stomach ulcers). TRAMAZAC 50 with alcohol Do not drink alcohol during treatment with TRAMAZAC 50 as it may have additive sedative effects. Pregnancy, breastfeeding and fertility 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 you take TRAMAZAC 50. Do not take TRAMAZAC 50 if you are pregnant or breastfeeding your baby. Driving and using machines TRAMAZAC 50 may cause drowsiness and dizziness and affect your ability to drive a vehicle or use machinery
• This is particularly in conjunction with other medicines that may affect your mental state, behaviour or mood, including alcohol. It is not always possible to predict to what extent TRAMAZAC 50 may interfere with your daily activities. Do not engage in the above activities until you are aware of the measure to which TRAMAZAC 50 affects you

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 tramadol hydrochloride, other opioid pain-relieving medicines or any of the other ingredients of TRAMAZAC 50 (listed in section 6)
• If you have drunk enough alcohol to make you feel woozy or drunk or if you have taken more than the prescribed dose of your sleeping tablets, other painkillers or psychotropic medicines (medicines that affect your mood and emotions), which can slow down your breathing and reactions
• If you are taking monoamine oxidase (MAO) inhibitors (medicine used to treat depression) or have taken them in the last 14 days before treatment with TRAMAZAC 50
• If you have problems to breathe, if you have a bluish discoloration of your skin (due to decreased oxygen) or have excessive mucus
• If you have growing pressure inside your skull (headache, blurred vision, weakness) or central nervous system depression due to a head injury or a disorder that affect blood supply to your brain
• If you or your child are younger than 12 years of age
• If you or your child are younger than 18 years of age and you or your child have had an operation to remove your tonsils or adenoids
• If you suffer from epilepsy (fits)
• If you are pregnant or breastfeeding your baby
• You should not receive TRAMAZAC 50 for the treatment of withdrawal symptoms caused by narcotics/drugs

Use with care, and tell your doctor, if

• If you are taking medicines which may cause seizures/fits such as neuroleptics/antipsychotics (used to treat depression or a psychotic disorder). The risk of having a seizure/fit may increase if you use TRAMAZAC 50 at the same time
• If you are in a state of shock (cold sweat may be a sign)
• 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

Interactions and medicines to check

The approved leaflet names these interactions.

• If you are addicted to other opioids, as TRAMAZAC 50 is not a suitable substitute to suppress withdrawal symptoms
• If you are sensitive to opioid pain relievers
• If you have any liver or kidney problems. Sleep-related breathing disorders TRAMAZAC 50 contains the active substance, tramadol, that belongs to the group of opioids. Opioids can cause sleep-related breathing disorders, for example central sleep apnoea (shallow/pause of breathing during sleep) and sleep related hypoxemia (low levels of oxygen in the blood). The symptoms can include breathing pauses during sleep, night awakening due to shortness of breath, difficulties to maintain sleep or excessive drowsiness during the day. If you or another person observe these symptoms, contact your doctor. The risk of experiencing central sleep apnoea is dependent on the dose of opioids. Your doctor may consider decreasing your dosage if you experience central sleep apnoea. Serotonin syndrome You may experience serotonin syndrome (a serious condition where your body has too much of a chemical called serotonin) after taking TRAMAZAC 50 in combination with certain antidepressants or TRAMAZAC 50 alone. Consult your doctor immediately if you have any of the symptoms related to this condition. Dependence/addiction and tolerance TRAMAZAC 50 may lead to dependence/addiction, especially with long-term use. If you have a tendency towards medicine abuse or dependence, you should only use TRAMAZAC 50 for short periods and under strict medical supervision. If you find that treatment with TRAMAZAC 50 is less effective after long-term use, it could be a sign that you have developed tolerance. If this happens, speak to your doctor about your treatment. Withdrawal symptoms You may experience withdrawal symptoms if treatment with TRAMAZAC 50 is suddenly stopped. Withdrawal symptoms can include agitation, anxiety, nervousness, difficulty sleeping, restlessness, tremor (uncontrolled shaking) and gastrointestinal (stomach) symptoms. Your doctor will discuss with you how to gradually reduce your dose of TRAMAZAC 50 before stopping. Increased sensitivity to pain If you have been taking TRAMAZAC 50 for a long time and present with increased pain, consult your doctor for advice. TRAMAZAC 50 metabolism Tramadol, as in TRAMAZAC 50, 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

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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