If you have been prescribed PAINOGESIC CO, you are taking a pain medicine that contains two active ingredients: tramadol hydrochloride 37,5 mg and paracetamol 325 mg in each film-coated tablet. It is used to help manage moderate to moderately severe pain. In South Africa, this medicine is listed as Schedule 5, which means it must be used carefully and only as prescribed.
What it is and what it is used for
PAINOGESIC CO is a combination pain medicine. Each tablet contains:
- Tramadol hydrochloride 37,5 mg
- Paracetamol 325 mg
Tramadol is an opioid painkiller. It acts on the central nervous system, which includes your brain and spinal cord. Paracetamol also helps relieve pain and has centrally acting analgesic effects.
If you are taking PAINOGESIC CO, it has been prescribed for:
- Management of moderate to moderately severe pain
This medicine is meant for you personally. You should not give it to a friend, family member, neighbour, or anyone else. It may harm them, even if they appear to have the same symptoms.
How it works
PAINOGESIC CO helps reduce pain using two different pain-relieving ingredients.
The tramadol part works in your central nervous system. In simple terms, it changes the way your body receives and responds to pain signals. Because tramadol is an opioid, you need to take it exactly as instructed and not increase your dose on your own.
The paracetamol part also helps with pain relief. Together, tramadol and paracetamol are used when your pain needs a stronger approach than some pain medicines used alone.
This medicine helps with pain control, but it does not necessarily treat the cause of your pain. You should still follow your doctor’s advice about the condition or injury causing the pain.
Who should NOT use this medicine
Do not use PAINOGESIC CO if you:
- Are allergic to tramadol.
- Are allergic to paracetamol.
- Are allergic to any of the other ingredients in PAINOGESIC CO.
- Are allergic to other opioids, such as codeine.
- Have acute alcohol poisoning.
- Are taking sleeping tablets.
- Are taking pain relievers or medicines that affect mood and emotions.
- Are taking moclobemide or tranylcypromine.
- Have taken moclobemide or tranylcypromine in the last 14 days.
- Have a severe liver disorder.
- Need treatment for withdrawal from narcotics or addictive substances.
- Have severe breathing problems.
- Have increased pressure inside your skull.
- Have central nervous system depression, which may involve slow breathing, a slow heart rate, or loss of consciousness.
- Have fits that are not controlled.
- Are pregnant.
- Are breastfeeding.
Warning: PAINOGESIC CO must not be used to treat withdrawal from narcotics or addictive substances.
Warnings and precautions
Before you take your tablets
Speak to your doctor or pharmacist before using PAINOGESIC CO if you:
- Take any other medicine containing paracetamol.
- Take any other medicine containing tramadol.
- Have liver problems or liver disease.
- Notice yellowing of your skin or eyes, which may suggest jaundice.
- Have kidney problems.
- Recently had a head injury.
- Recently experienced shock.
- Have severe headaches with vomiting.
- Are dependent on another medicine, such as morphine.
- Have epilepsy.
- Have had fits or seizures before.
- Have sleep-related breathing disorders.
If you are unsure whether another medicine contains paracetamol or tramadol, ask your pharmacist. This is especially important because many pain, cold and flu medicines may contain pain-relieving ingredients.
Breathing problems
Some people process tramadol more quickly and completely than others. If this happens, you may be more likely to experience serious side effects.
Stop taking PAINOGESIC CO and contact your doctor immediately if you notice:
- Slow breathing.
- Shallow breathing.
- Difficulty breathing.
Low sodium levels
PAINOGESIC CO may cause low sodium levels in your blood. This is called hyponatraemia.
You may notice:
- Nausea.
- Vomiting.
- Headache.
- Confusion.
- Extreme tiredness.
- Restlessness.
- Irritability.
- Muscle weakness.
- Muscle spasms or cramps.
- Seizures.
Older people and people taking other medicines that lower sodium levels may be more at risk. If these symptoms happen while you are taking PAINOGESIC CO, contact your doctor immediately.
Skin rash and allergy warning
PAINOGESIC CO contains paracetamol. If you are allergic to paracetamol, you may develop a severe skin rash.
Stop taking PAINOGESIC CO at the first sign of:
- A rash.
- Itching.
- Any other allergic reaction.
The source also mentions SCAR, a severe skin rash that may be life-threatening.
Cravings and dependence
Tell your doctor if you start craving PAINOGESIC CO. Drug dependence is listed as a possible side effect.
Because this medicine contains tramadol, an opioid-type pain medicine, it must be used only as prescribed. Do not take extra tablets or use it more often than your doctor has told you.
Stopping suddenly
Do not stop PAINOGESIC CO suddenly unless your doctor tells you to. Stopping abruptly may cause withdrawal symptoms.
You may experience:
- Panic attacks.
- Severe anxiety.
- Hallucinations, such as hearing or seeing things that are not there.
- Tingling, burning or prickling feelings.
- Ringing or buzzing in your ears.
- Difficulty sleeping.
- Tremor.
- Gastrointestinal symptoms.
Your doctor may gradually reduce your dose to help prevent these effects.
Driving and using machines
Do not drive until you know how PAINOGESIC CO affects you.
This medicine may make you:
- Sleepy.
- Dizzy.
- Drowsy.
If this happens, do not drive, use tools, or operate machinery.
Alcohol
Do not drink alcohol while taking PAINOGESIC CO. Alcohol and PAINOGESIC CO may intensify each other’s effects.
This can increase the risk of dangerous side effects, including drowsiness and breathing problems.
Pregnancy, planning pregnancy, and breastfeeding
Do not take PAINOGESIC CO during pregnancy.
Do not take PAINOGESIC CO while breastfeeding. The source states that safety information during breastfeeding is not available.
If you are pregnant, breastfeeding, think you may be pregnant, or are planning to have a baby, speak to your doctor, pharmacist or another healthcare professional before taking this medicine.
Warning: PAINOGESIC CO must not be used during pregnancy or breastfeeding.
Interactions
Always tell your doctor, pharmacist, nurse or healthcare provider about all medicines you are taking. This includes prescription medicines, pharmacy medicines, complementary medicines and traditional medicines.
Medicines you should not take with PAINOGESIC CO
Do not take PAINOGESIC CO with medicines called monoamine oxidase inhibitors, also known as MAOIs.
Examples include:
- Moclobemide.
- Tranylcypromine.
These are used to treat depression. You should also not take PAINOGESIC CO if you have used these medicines in the last 14 days.
Taking these together may cause:
- Diarrhoea.
- Irregular heartbeat.
- Excessive sweating.
- Trembling.
- Confusion.
- Coma.
PAINOGESIC CO should also not be used with:
- Carbamazepine, used to treat seizures, because it may reduce how well tramadol works and shorten its effect.
- Buprenorphine, nalbuphine or pentazocine, which are opioid-type pain relievers, because their effects may be reduced.
Medicines that need extra caution
Tell your doctor if you take medicines that may increase the risk of convulsions when combined with tramadol.
These include:
- Citalopram.
- Escitalopram.
- Paroxetine.
- Duloxetine.
- Venlafaxine.
- Amitriptyline.
- Antipsychotics.
- Bupropion.
- Mirtazapine.
- Tetrahydrocannabinol.
Serotonin toxicity
Some medicine combinations may cause serotonin toxicity. This is a serious reaction linked to too much serotonin activity in the body.
Medicines mentioned in the source include:
- Citalopram.
- Escitalopram.
- Paroxetine.
- Duloxetine.
- Venlafaxine.
- Amitriptyline.
- Moclobemide.
- Tranylcypromine.
- Mirtazapine.
Symptoms may include:
- Involuntary rhythmic muscle contractions.
- Eye muscle movements you cannot control.
- Agitation.
- Excessive sweating.
- Tremor.
- Overactive reflexes.
- Increased muscle tension.
- Body temperature above 38 °C.
Seek medical help if these symptoms occur.
Medicines that may increase drowsiness or breathing problems
Be careful if PAINOGESIC CO is taken with medicines that can make you sleepy or slow your breathing.
These include:
- Morphine.
- Codeine, including codeine in cough medicine.
- Baclofen.
- Medicines used to lower blood pressure.
- Medicines used for allergies.
- Benzodiazepines, such as:
- Alprazolam.
- Diazepam.
- Lorazepam.
- Related sedative medicines.
Using these with PAINOGESIC CO may increase the risk of:
- Drowsiness.
- Breathing difficulties.
- Respiratory depression.
- Coma.
- Life-threatening effects.
Other medicines mentioned
Tell your healthcare provider if you take:
- Warfarin, used to thin the blood, because its effect may change and bleeding may occur.
- Digoxin, used for heart problems.
- Diflunisal, used for pain.
- Ondansetron, used for vomiting.
Food and drink
The source does not specify whether PAINOGESIC CO must be taken with food or without food.
You must not drink alcohol during treatment.
How to take
Step-by-step instructions
Take PAINOGESIC CO exactly as your doctor has told you.
You should:
- Swallow the tablets whole.
- Take them with enough liquid.
- Not break the tablets.
- Not chew the tablets.
- Not take more than your prescribed dose.
- Not take more than 8 tablets in one day.
- Not share your medicine with anyone else.
Your doctor will tell you how long to take PAINOGESIC CO. If you feel the medicine is too strong or too weak, speak to your doctor or pharmacist.
Adults
The recommended adult dose is:
- 1 or 2 tablets every 4 to 6 hours, unless your doctor has prescribed something different.
If you need further doses, take them only as instructed by your doctor.
Do not take more than:
- 8 tablets per day
Children
Not specified in the source.
If you take too much
If you take more PAINOGESIC CO than you should, contact your doctor or pharmacist.
If you cannot reach them, contact:
- Your nearest hospital.
- A poison centre.
Get medical advice immediately after an overdose, even if you feel well. Too much paracetamol can cause delayed, serious liver damage. Kidney damage may also happen, even without liver damage.
Warning: Do not wait for symptoms after taking too much. Get help straight away.
If you forget a dose
If you forget to take a dose, take it as soon as you remember.
If it is nearly time for your next dose, skip the missed dose and continue with your normal dosing schedule.
Do not take a double dose to make up for a missed dose.
If you stop taking it
If you stop PAINOGESIC CO suddenly, you may experience withdrawal symptoms.
These may include:
- Anxiety.
- Nervous excitement.
- Difficulty sleeping.
- Excessive abnormal movements.
- Tremor.
- Gastrointestinal symptoms.
- Panic attacks.
- Severe anxiety.
- Hallucinations.
- Tingling or prickling sensations.
- Ringing in the ears.
Speak to your doctor before stopping, especially if you have been taking it for some time.
Practical tips while taking PAINOGESIC CO
- Keep a simple record of each dose so you do not accidentally take too much.
- Check all other medicines for paracetamol or tramadol.
- Ask your pharmacist before using cold, flu, cough or pain medicines.
- Avoid alcohol completely while taking PAINOGESIC CO.
- Keep the tablets in their original packaging until you need them.
Dosing table
| Age or weight | Dose | Frequency | Maximum daily dose |
|---|---|---|---|
| Adults | 1 or 2 tablets | Every 4 to 6 hours, unless otherwise prescribed by your doctor | 8 tablets per day |
| Children | Not specified in the source | Not specified in the source | Not specified in the source |
Possible side effects
PAINOGESIC CO can cause side effects. Not everyone will get them.
Some side effects may be manageable, while others need urgent medical attention. If your general health gets worse or you notice any unwanted effects, speak to your healthcare provider.
Common side effects
Tell your doctor if you notice:
- Confusion.
- Sleep problems.
- Mood changes.
- Anxiety.
- Nervousness.
- Feeling unusually high-spirited.
- Dizziness.
- Excessive sleepiness.
- Headache.
- Trembling.
- Nausea.
- Vomiting.
- Constipation.
- Dry mouth.
- Diarrhoea.
- Stomach pain.
- Indigestion.
- Stomach gas.
Less common side effects
Less common side effects may include:
- Depression.
- Seeing, hearing, smelling, tasting or imagining things that are not there.
- Nightmares.
- Involuntary muscle contractions.
- Tingling or prickling sensations.
- Memory loss.
- Ringing in the ears.
- Rapid, strong or irregular heartbeat.
- Very fast heartbeat.
- Heart rhythm problems.
- Difficulty swallowing.
- Blood in the faeces.
- Chills.
- Chest pain.
- Problems passing urine.
- Difficulty breathing.
- Increased blood pressure.
- Hot flushes.
- Low blood sugar.
- Drug dependence.
- Mental confusion and emotional disruption.
- Convulsions.
- Fainting.
- Speech problems.
- Slurred speech.
- Stumbling.
- Blurred vision.
- Small pupils.
- Very large pupils.
- Severe skin rash.
Serious — seek urgent help
Stop taking PAINOGESIC CO and contact your doctor immediately, or go to the casualty department at your nearest hospital, if you notice:
- Rash or itching all over your body.
- Allergic reactions with breathing problems.
- A feeling that your throat is closing.
- Increased bleeding time.
These are very serious side effects and may need urgent medical attention.
You should also get urgent help if you notice:
- A much faster, stronger or irregular heartbeat than usual.
- Signs of liver problems, such as:
- Abdominal pain.
- Dark urine.
- Pale stools.
- Weakness.
- Fatigue.
Other side effects reported with tramadol-only or paracetamol-only medicines
The source also mentions side effects reported in people using medicines that contain only tramadol or only paracetamol.
These include:
- Feeling faint when standing up from sitting or lying down.
- Slow heart rate.
- Fainting.
- Changes in appetite.
- Muscle weakness.
- Slower or weaker breathing.
- Mood changes.
- Changes in activity.
- Changes in perception.
- Worsening of existing asthma.
- Severe skin rash.
Reporting side effects
If you get side effects, speak to your doctor, pharmacist or nurse. This includes side effects not listed here.
In South Africa, side effects can also be reported to SAHPRA. Reporting side effects helps improve information about medicine safety.
Storage and disposal
Store PAINOGESIC CO safely.
You should:
- Keep it in the original packaging.
- Keep the blisters in the carton until you need to use them.
- Store it at or below 30 °C.
- Protect it from light.
- Protect it from moisture.
- Keep it out of reach of children.
- Not use it after the expiry date on the label and carton.
Return unused medicine to your pharmacist.
Do not throw unused medicine into drains, toilets or sewerage systems.
What the medicine contains
Each PAINOGESIC CO film-coated tablet contains:
| Ingredient type | Ingredient | Amount |
|---|---|---|
| Active ingredient | Tramadol hydrochloride | 37,5 mg |
| Active ingredient | Paracetamol | 325 mg |
| Other stated content | Sodium | 0,035 mmol |
| Sugar content | Sugar free | Not applicable |
Other ingredients are:
- Sodium starch glycolate.
- Maize starch.
- Pre-gelatinised starch.
- Colloidal silicon dioxide.
- Magnesium stearate.
- Opadry white Y-1-7000.
The source states that each tablet contains less than 1 mmol sodium, or less than 23 mg, meaning it is essentially sodium-free.
Pack information and appearance
PAINOGESIC CO tablets are:
- White to off-white.
- Round.
- Biconvex, meaning curved on both sides.
- Film-coated.
- Plain on both surfaces.
The available strength is:
- PAINOGESIC CO 37,5 mg/325 mg film-coated tablets
The tablets come in PVC/PVDC–aluminium blister strips of 10 tablets per blister strip.
Carton sizes are:
- 20 tablets.
- 30 tablets.
- 60 tablets.
- 100 tablets.
The holder of the certificate of registration is Innovata Pharmaceuticals (Pty) Ltd in Johannesburg, South Africa.
Registration number:
- A 49/2.9/0774
Practical FAQs
Can I drink alcohol while taking PAINOGESIC CO?
No. You should not drink alcohol while taking PAINOGESIC CO. Alcohol and this medicine may intensify each other’s effects.
Can I drive after taking PAINOGESIC CO?
Do not drive until you know how the medicine affects you. If you feel sleepy, dizzy or drowsy, do not drive, use tools or operate machinery.
Can I take PAINOGESIC CO with other pain medicines?
You must be careful. Do not take other medicines containing tramadol or paracetamol unless your doctor or pharmacist says it is safe.
What should I do if I miss a dose?
Take the missed dose when you remember, unless it is almost time for your next dose. Do not take a double dose.
What should I do if I take too many tablets?
Get medical help immediately, even if you feel well. Contact your doctor, pharmacist, nearest hospital or poison centre.
Why must I get help after an overdose if I feel fine?
Too much paracetamol can cause delayed, serious liver damage. Kidney damage may also happen even if there is no liver damage.
Can I stop PAINOGESIC CO suddenly?
Stopping suddenly may cause withdrawal symptoms. Speak to your doctor before stopping, especially if you have been taking it for some time.
Can I take PAINOGESIC CO during pregnancy?
No. PAINOGESIC CO must not be taken during pregnancy.
Can I breastfeed while taking PAINOGESIC CO?
No. PAINOGESIC CO must not be taken during breastfeeding because safety information during breastfeeding is not available in the source.
Is PAINOGESIC CO sugar free?
Yes. PAINOGESIC CO is sugar free.
Sources :
Written by: RxZest Editorial Team
Editorial review: Checked for readability, structure, and source alignment
Based on SAHPRA-approved information
Last updated: [01/05/2026]
https://pi-pil-repository.sahpra.org.za/wp-content/uploads/2024/05/pil-unref-3.pdf
