TRAMACET® Tablets combine two pain-relieving medicines—tramadol hydrochloride (37,5 mg) and paracetamol (325 mg)—in a single tablet. It is prescribed for the management of moderate to moderately severe pain. Because it contains tramadol (an opioid pain-reliever) and is a Schedule 5 (S5) medicine in South Africa, it should be used exactly as directed by your doctor or pharmacist.
What it is and what it is used for
Active ingredients and class
- Tramadol hydrochloride is a painkiller in the opioid class that acts on the central nervous system.
- Paracetamol is a widely used pain-reliever with centrally acting analgesic effects.
Indications
- TRAMACET is used for the management of moderate to moderately severe pain, as prescribed by a healthcare professional.
How it works
TRAMACET reduces pain through two complementary actions:
- Tramadol works on pain pathways in the brain and spinal cord (central nervous system). It needs to be metabolised (converted) in the body to become active. Some people convert tramadol faster (“ultra-rapid metabolisers”), which can raise the risk of side effects like slow or shallow breathing.
- Paracetamol helps reduce pain by acting within the central nervous system.
Using these two agents together can provide pain relief for moderate to moderately severe pain as directed by your doctor.
Who should NOT use this medicine
Do not take TRAMACET if any of the following apply to you:
- You are allergic to tramadol, paracetamol, or any of the other tablet ingredients (see What the medicine contains).
- You are experiencing acute poisoning from alcohol, sleeping tablets, pain relievers, or other psychotropic medicines (medicines that affect mood and emotions).
- You are taking monoamine oxidase inhibitors (MAOIs)—medicines used for depression—or have used them in the last 14 days.
Important: TRAMACET is prescribed for you personally. Do not share it with anyone else, even if their symptoms appear similar.
Warnings and precautions
Speak to your doctor or pharmacist before taking TRAMACET if any of the following apply:
- History of opioid use or dependence: Use with caution if you think you are addicted to other opioid pain relievers.
- Reduced alertness or fainting tendency: If you have consciousness disorders or feel like you might faint.
- Shock: Signs include cold, clammy skin.
- Raised pressure in the skull/brain problems: For example, after a head injury or due to brain disease.
- Breathing difficulties: Any respiratory problems need careful monitoring.
- Epilepsy or seizure tendency: TRAMACET may increase the risk of fits; extra caution is required.
- Liver or kidney disease: Dose adjustments or monitoring may be necessary (see dosing for renal impairment).
- Ultra-rapid metaboliser of tramadol: If you metabolise tramadol more rapidly, you may be at greater risk of serious side effects, such as slow or shallow breathing. Stop the medicine and contact your doctor immediately if you notice such symptoms.
- Risk of low blood sodium (hyponatraemia): You may experience nausea/vomiting, headache, confusion, severe tiredness, restlessness or irritability, muscle weakness/spasms/cramps, or seizures. This risk is higher in older people and in those taking other medicines that lower sodium levels. Seek medical advice right away if these occur.
- Serious skin reactions (paracetamol-related): Rare but severe reactions such as generalised exanthematous pustulosis (AGEP), Stevens–Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN) have been reported with paracetamol. Stop TRAMACET at the first sign of a rash or any allergy sign and seek medical help.
Alcohol
- Do not drink alcohol while using TRAMACET. Alcohol can intensify the effects of TRAMACET and increase the risk of side effects.
Driving and using machinery
- TRAMACET may affect your reactions. If you feel drowsy, dizzy, or less alert, do not drive, use power tools, or operate machinery.
Overdose—urgent action is required
- In the event of overdose or suspected overdose, contact the nearest doctor, hospital, or Poison Centre immediately, even if no symptoms are present.
Pregnancy, planning pregnancy, and breastfeeding
- whether TRAMACET is safe to use in pregnancy or while breastfeeding. The leaflet states that the safe use has not been demonstrated.
- Speak to your doctor, pharmacist, or another healthcare professional for personalised advice before using TRAMACET if you are pregnant, planning a pregnancy, or breastfeeding.
Interactions
Tell your doctor or pharmacist about all medicines you are taking, including complementary or traditional medicines. The following interactions are highlighted:
- MAO inhibitors (for depression): Do not take TRAMACET with MAOIs or if you have used them in the past 14 days. Life-threatening interactions have been observed with another opioid when combined with MAOIs (affecting the central nervous system, breathing, and circulation).
- Carbamazepine (for epileptic fits): May reduce the pain-relieving effect of TRAMACET and shorten how long it works.
- Other CNS depressants: Medicines that depress brain function taken with TRAMACET may increase side effects (e.g., drowsiness, breathing problems).
- Medicines that can cause seizures or lower the seizure threshold: For example, some medicines used for certain psychological conditions—combined use may increase seizure risk.
- Serotonergic medicines (used for depression): Taking these together with TRAMACET increases the risk of side effects.
- Anticoagulants (medicines that prevent abnormal blood clotting): Their effect on blood clotting may change when taken with TRAMACET, and you may notice small areas of bleeding under the skin.
- Diflunisal: Concomitant use may elevate paracetamol plasma levels.
Food interactions: Not specified in the source.
Alcohol: Do not consume alcohol with TRAMACET.
How to take
Use only as prescribed for you. Do not share your medicine.
If you are unsure about anything, ask your doctor or pharmacist.
Standard directions
- Check your dose against your doctor’s instructions and the guidance below.
- Swallow the tablets with a sufficient quantity of liquid (for example, one glass of water).
- Timing: Take every 4 to 6 hours as needed for pain relief, without exceeding the maximum daily amount.
- Alcohol: Do not take TRAMACET with alcohol.
- Driving: If you feel your reactions are affected, avoid driving and machinery.
Adults and adolescents from 16 years
- Dose: 1 to 2 tablets every 4 to 6 hours as needed for pain.
- Maximum: 8 tablets in 24 hours.
Renal impairment
- If your creatinine clearance is < 30 mL/min, increase the dosing interval so that the dose does not exceed 2 tablets every 12 hours.
Hepatic (liver) impairment
- consult your doctor for individual advice.
Missed dose
- Ask your pharmacist or doctor if you are unsure how to handle a missed dose.
Overdose
- Seek urgent medical help immediately—even if you feel well.
- Possible symptoms (tramadol): Pin-point or dilated pupils, vomiting, low blood pressure, fast heartbeat, faintness, decreased consciousness up to coma, fits (seizures), and breathing difficulties up to stopped breathing.
- Possible symptoms (paracetamol): Within the first 24 hours—pallor, nausea, vomiting, lack of appetite, abdominal pain. Between 12 to 48 hours—liver damage may become apparent.
Dosing table
Use this table as a guide only and follow your prescriber’s instructions.
| Patient group | Single dose | How often | Important limits |
|---|---|---|---|
| Adults & adolescents ≥16 years | 1–2 tablets | Every 4–6 hours as needed | Max 8 tablets in 24 hours |
| Renal impairment (creatinine clearance < 30 mL/min) | Up to 2 tablets | Do not dose more often than every 12 hours | Do not exceed 2 tablets every 12 hours |
Note: Dosing for children under 16 years is not specified in the source.
Possible side effects
Like all medicines, TRAMACET can cause side effects, although not everyone gets them. If your general health worsens or you notice any worrying symptoms, speak to your doctor or pharmacist.
Common
- Digestive: Nausea, vomiting, constipation, diarrhoea, indigestion, flatulence, stomach pain, dry mouth, loss of appetite.
- Nervous system & mental health: Dizziness, headache, tremor, sleeplessness, nervousness, anxiety, confusion, unrealistic feeling of wellbeing, lack of energy, fatigue, bad dreams, abnormal thinking, hallucinations, emotional lability, depression, amnesia, a sense that thoughts/feelings feel unreal.
- Neurological: Convulsions (seizures), increased muscle tone, involuntary muscle contractions, migraine or worsened migraine, loss of muscle coordination, tingling or pins-and-needles, reduced consciousness or sensitivity, a spinning sensation (vertigo), speech difficulties, movement disorder.
- Heart & circulation: High blood pressure, worsened high blood pressure, low blood pressure, irregular heartbeat, palpitations, increased heart rate, fainting, hot flushes.
- Breathing: Difficulty breathing.
- Skin: Itchy rash, sweating.
- Liver & lab tests: Abnormal liver test results.
- Urinary & kidneys: Urinary problems, reduced urine production, urinary retention, protein in the urine.
- Other: Chest pain, shivering or stiffness, ringing/buzzing in ears, swollen tongue, blood in stools, weight decrease, impotence, drug abuse, withdrawal syndrome, anaemia (low red blood cells).
What to do: If these symptoms are troubling or persistent, contact your healthcare professional. Stop the medicine and seek help urgently if you have breathing difficulties, severe drowsiness, fainting, or confusion.
Less common
- Confusional state (altered awareness), excessive contraction of the pupils, prolonged pupil dilatation.
- Low blood sugar—most often in people with diabetes, kidney disease, or in the elderly.
- Low blood sodium/SIADH (see Warnings for symptoms).
What to do: Contact your doctor if these occur, especially if you are at higher risk (older age, diabetes, kidney problems, or on medicines that affect sodium levels).
Serious—seek urgent help
- Severe skin reactions (e.g., AGEP, SJS, TEN)—stop TRAMACET immediately if you notice a rash, blistering, or peeling skin, and seek emergency care.
- Seizures, severe dizziness/fainting, breathing problems (slow or shallow breathing), chest pain, sudden confusion, or severe drowsiness—seek urgent medical attention.
If you notice any side effects not listed here, inform your doctor or pharmacist.
Storage and disposal
- Store in a cool, dry place at or below 25 °C.
- Protect from light and moisture.
- Keep out of the reach of children.
- Do not use after the expiry date shown on the label.
- Return all unused medicine to your pharmacist.
- Do not dispose of medicines in drains or sewerage systems (e.g., toilets).
What the medicine contains
Each TRAMACET tablet contains:
- Tramadol hydrochloride 37,5 mg
- Paracetamol 325 mg
Other ingredients (excipients): carnauba wax, magnesium stearate, OPADRY® Light yellow, powdered cellulose, pregelatinised starch, purified water, sodium starch glycolate, and starch (corn/maize).
Pack information and appearance
- Presentation: Blister packs of 2, 10, 20, 30, 60, 100, or 500 tablets.
- Identification: Light yellow, film-coated, capsule-shaped tablets engraved “J-C” on one side and “T/P” on the other.
- Registration number: 35/2.9/0010.
- Registration holder: JANSSEN PHARMACEUTICA (Pty) Ltd, Reg No. 1980/011122/07, 2 Medical Road, Halfway House, Midrand, 1685; Tel: +27 (11) 518 7000; RA-JACZA-MedInfo@its.jnj.com.
- Scheduling status: S5 (prescription-only).
FAQs
Can I take TRAMACET with alcohol?
No. Do not drink alcohol while using TRAMACET. Alcohol can intensify the medicine’s effects and increase side-effect risks.
Can I drive or operate machinery?
TRAMACET may affect your reactions. If you feel drowsy, dizzy, or less alert, do not drive or operate machinery.
I’m on an antidepressant. Can I use TRAMACET?
Do not use TRAMACET if you are taking MAO inhibitors or have taken them in the past 14 days. If you use serotonergic medicines (for depression), the risk of side effects increases—discuss this with your doctor.
What if I take carbamazepine for epilepsy?
Carbamazepine can reduce TRAMACET’s pain-relieving effect and shorten how long it works. Your doctor may advise differently or consider alternatives.
I’m on a blood thinner—can I take TRAMACET?
TRAMACET may affect the action of medicines that prevent abnormal blood clotting and you may notice small skin bleeds/bruises. Speak to your prescriber before combining them.
Is TRAMACET suitable for people with kidney problems?
If your creatinine clearance is < 30 mL/min, your dosing interval must be increased so that you do not exceed 2 tablets every 12 hours. Always follow your doctor’s instructions.
Can teenagers use TRAMACET?
Dosing is provided for adults and children from 16 years. Use below 16 years is not specified in the source—consult your doctor.
Is it safe in pregnancy or while breastfeeding?
The safe use has not been demonstrated. Consult your doctor or pharmacist for advice.
What should I do if I notice a skin rash?
Stop TRAMACET immediately and seek medical advice, as rare but serious skin reactions have been reported with paracetamol.
What are the warning signs of low sodium?
Symptoms can include nausea, vomiting, headaches, confusion, severe tiredness, restlessness or irritability, muscle weakness/spasms/cramps, and seizures. Seek urgent medical advice if you develop these.
Manish Sharma is a Master’s graduate in Pharmaceutical Chemistry and a registered pharmacist with a passion for simplifying medical knowledge for everyday readers. Through his platform, he provides clear, easy-to-understand information about medicines — including their correct usage, benefits, and safety tips — while also addressing common myths surrounding them.
Alongside modern medicine, Manish also explores natural and herbal remedies, encouraging a balanced and healthy lifestyle. His mission is to empower people with reliable health information, helping them make informed decisions and live healthier, happier lives.
