Tramacet Side Effects

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

What is Tramacet?

Tramacet contains the active ingredient Tramadol hydrochloride.

• Active ingredient — Tramadol hydrochloride
• Registration number — 52/2.9/0749
• Registration holder — Macleods Pharmaceuticals SA (Pty) Ltd

It is approved for:

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

Common side effects of Tramacet

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

• dizziness
• headaches
• drowsiness
• nausea (feeling sick urge to vomit)
• vomiting
• constipation
• dry mouth
• sweating more than is normal for you
• fatigue

Less frequent side effects

• abnormal sensations for example if you experience itching, tingling, or numbness
• trembling
• muscle twitches
• uncoordinated movement
• changes in appetite
• hallucination
• confusional state
• sleep disorders
• delirium
• anxiety
• nightmares
• changes in mood for example you may feel happy or irritated
• decreased activity
• restlessness
• changes in the way you see or view things
• blurred vision
• narrowing of the pupil
• stomach trouble (e.g. feeling of pressure in the stomach, bloating)
• diarrhoea (frequent or loose watery stools)
• weak muscles
• liver enzyme increased
• acute pancreatitis
• abdominal pain. The following side effects have been reported in post-marketing surveillance:
• speech disorder
• excessive widening of your pupils
• Stevens-Johnson syndrome – a rare, serious disorder of the skin and mucous membranes. It starts with flu-like symptoms, followed by a painful rash that spreads and blisters
• Low levels of sodium in the blood and/or inappropriate antidiuretic hormone secretion (SIADH)
• Increased risk of abdominal pain, including acute pancreatitis. Frequency: rare If any of the side effects get serious, or if you experience one of the above –mentioned serious side effects, call the nearest doctor immediately. If you experience any side effects not listed in this leaflet, please inform your doctor or pharmacist

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 allergic to tramadol or any of the other ingredients of DOLTREX 50 MG tablets.; S5
• in acute poisoning with alcohol, sleeping pills, pain relievers or other psychotropic medicines (medicines that affect mood and emotions)
• if you are taking MAO inhibitors (certain medicines used for depression) or have taken them in the last 14 days before treatment with DOLTREX 50 MG tablets
• If you have epilepsy
• As a substitute in drug withdrawal
• If you are pregnant or breastfeeding your baby

Use with care, and tell your doctor, if

• if you think that you are addicted to other pain relievers (opioids)
• if you suffer from consciousness disorders (if you have fainting spells or you feel that you are going to faint)
• if you are in a state of shock (cold sweat may be a sign of it)
• if you suffer from increased pressure in the brain (possibly after a head injury or brain disease)
• if you have difficulty in breathing
• if you have a tendency towards epilepsy or seizures because the risk of a seizure may increase; especially if the upper dose limit (400 mg) of DOLTREX 50 MG tablets is exceeded
• if you suffer from a liver or kidney disease
• Tramadol works by being converted (metabolised) into its active component. If you convert (metabolise) Tramadol to this active component more rapidly and completely than other patients you are known as an ultra-rapid metaboliser. If you are an ultra rapid metaboliser you are more likely to have serious side effects, such as breathing difficulties, with slow or shallow breathing. If you experience these types of side effects, stop taking this medicine and consult with your doctor immediately
• You may experience low levels of sodium in the blood (hyponatraemia) while taking this medicine. Symptoms of low blood sodium may include nausea and vomiting, headaches, feeling confused, feeling very tired, feeling restless, feeling irritable, muscle weakness, spasms or cramps and seizures. Elderly patients and patients taking other medicines that lower sodium in the blood are most at risk for this side effect. If you get any of these symptoms while taking DOLTREX 50 MG, consult with your doctor immediately DOLTREX 50 MG tablets can lead to psychological and physical dependence or addiction in some people, especially with long term use. The dose needed to achieve the desired effect may increase with time. DOLTREX 50 MG tablets should be used with caution, and only for short periods under strict medical supervision, in patients who are addicted to other opioid pain-killers
• DOLTREX 50 MG contains sugar (lactose monohydrate). If you have been told by our doctor that you have intolerance to some sugars, contact your doctor before taking DOLTREX 50 MG. Please also inform your doctor if any of these problems occur during DOLTREX 50 MG tablets treatment or if they applied to you in the past. Use in children DOLTREX 50 MG tablets are not suitable for children under the age of 12 years

Pregnancy and breastfeeding

• If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking DOLTREX 50 MG tablets
• If DOLTREX 50 MG tablets are used on a long term basis during pregnancy, it will lead to harm (withdrawal symptoms) in newborns
• You should not take DOLTREX 50 MG tablets if you are pregnant
• The use of DOLTREX 50 MG tablets is not recommended during breastfeeding
• DOLTREX 50 MG is excreted into breast milk
• If you are taking DOLTREX 50 MG tablets you should not breastfeed your baby

Interactions and medicines to check

The approved leaflet names these interactions.

• The pain-relieving effect of DOLTREX 50 MG tablets may be reduced and the length of time it acts may be shortened if you take medicines which contain:
• Carbamazepine (for epileptic seizures)
• Ondansetron (prevents nausea). Your doctor will tell you whether you should have DOLTREX 50 MG tablets, and at what dose. The risk of side effects increases
• If you are taking tranquilisers, sleeping pills, other pain relievers such as morphine and codeine (also as cough medicine), and alcohol while having DOLTREX 50 MG tablets. You may feel drowsier or feel that you might faint. If this happens tell your nurse or doctor
• If you are taking medicines which may cause seizures such as certain antidepressants or antipsychotics. The risk of having a seizure may increase if you take DOLTREX 50 MG tablets at the same time. Your doctor will tell you whether DOLTREX 50 MG tablets are suitable for you
• If you are taking certain antidepressants such as Selective Serotonin Reuptake Inhibitors or MAO inhibitors. DOLTREX 50 MG tablets may interact with these medicines and you may experience symptoms such as involuntary, rhythmic contractions of muscles, including muscles that control movement of the eye, agitation, excessive sweating, tremor, exaggeration of reflexes, increased muscle tension, body temperature above 38 ° C
• If you are taking warfarin together with DOLTREX 50 MG tablets. The effect of warfarin on blood clotting may be increased and bleeding may occur. DOLTREX 50 MG with food and drink: Do not drink alcohol during treatment with DOLTREX 50 MG tablets as the effects of DOLTREX 50 MG and alcohol may intensify each other. Food does not influence the effect of DOLTREX 50 MG tablets

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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