AUSTELL PARACETAMOL: Uses,Dose,Side-effects,Precautions

It is a pain-relief and fever-reducing medicine for short-term use in adults and in children from 6 years of age. It helps with common problems like headaches, toothache, and the aches and fever you may get with colds or flu.

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What it is and what it is used for

Active ingredient and class

• Paracetamol 500 mg per tablet. Paracetamol is a widely used analgesic (pain-reliever) and antipyretic (fever-reducer).

Indications (uses) — exactly as per the source

• Relief of mild to moderate pain and fever, such as:
  • Headaches
  • Toothache
  • Pain and fever associated with colds and flu
• Intended for adults and children older than 6 years.

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How it works

When you have pain or fever, your body releases chemicals that increase pain signalling and raise your internal “thermostat” in the brain. Paracetamol works centrally (mainly in the brain) to dampen pain signals and reset the body’s temperature control, so aches ease and fever comes down. It does not reduce swelling like anti-inflammatory medicines do, but it is effective for everyday pain and fever when taken at the correct dose.

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Who should NOT use this medicine

Do not use AUSTELL PARACETAMOL if:

• You are allergic to paracetamol or any of the ingredients listed in this leaflet.
• You have any liver problem.

Children under 6 years: Do not give AUSTELL PARACETAMOL to children younger than 6 years.

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Warnings and precautions (Read before use)

Talk to your doctor or pharmacist before use if:

• You have liver disease or a history of liver problems.
• You have kidney disease.

Important use reminders

• Do not take this product together with any other medicine that contains paracetamol, as this can lead to accidental overdose.
• If your symptoms worsen or do not improve after 7 days (adults) or 3 days (children), seek medical advice.
• Keep to the maximum daily dose and spacing between doses (see dosing sections below).

Driving and using machines
People react differently to medicines. It is not always possible to predict how AUSTELL PARACETAMOL will affect your ability to drive or use machines. Wait to see how you feel before doing tasks that require full attention.

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Pregnancy, planning pregnancy, and breastfeeding

Speak to your doctor or pharmacist before use.

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Interactions

Always tell your healthcare provider about all medicines you are taking. Speak to your doctor or pharmacist before using AUSTELL PARACETAMOL if you take:

• Antibiotics: e.g., chloramphenicol.
• Anti-sickness medicines: e.g., metoclopramide, domperidone.
• Medicines for diarrhoea caused by gall bladder disease (not further specified in the source).
• Lipid-lowering agent: cholestyramine.
• Medicine that increases uric acid in urine: probenecid.
• Liver enzyme inducers: carbamazepine, phenytoin, phenobarbitone, rifampicin.
• Anticoagulant: warfarin (a medicine that reduces blood clotting).

Food and drinks

• The source reports no known interaction with food and drinks. You may take AUSTELL PARACETAMOL with meals, with beverages, or independently of meals.

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How to take (Step-by-step)

General guidance

1. Check the strength (these tablets are 500 mg).
2. Confirm eligibility: adults and children 6 years and older only.
3. Measure the dose from the table below.
4. Spacing: leave 4 to 6 hours between doses; do not exceed the maximum stated for 24 hours.
5. Swallow with water: take with a full glass of water.
6. With or without food: take with meals, with beverages, or independently of meals. If you have a sensitive stomach, taking the dose after food may be more comfortable.
7. Do not combine with any other medicine containing paracetamol.

Adult dosing (18 years and older)

• 1 to 2 tablets (500–1,000 mg) every 4 to 6 hours as needed.
• Maximum: Do not take more than 8 tablets in 24 hours.

Paediatric dosing (6–12 years)

• ½ to 1 tablet (250–500 mg) every 4 to 6 hours as needed.
• Maximum: Do not take more than 4 tablets in 24 hours.

Children under 6 years

• Do not use AUSTELL PARACETAMOL tablets.

Missed dose

• If you forget a dose, do not take a double dose to make up for it. Take the next dose at the usual time, respecting the 4–6 hour interval.

Overdose

• Emergency: If too much has been taken, seek medical help immediately. Contact your doctor, pharmacist, the nearest hospital emergency unit, or a poison centre. Early treatment is important.

Practical tips for adherence (based on the source instructions)

• Keep a simple dose log with times, especially when dosing for fever.
• Use a timer or phone reminder to maintain the 4–6 hour spacing.
• Check labels of other cold/flu remedies to make sure they do not contain paracetamol.

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Dosing table

Age group	Single dose	How often	Maximum in 24 hours
Adults (≥18 years)	1–2 tablets (500–1,000 mg)	Every 4–6 hours as needed	8 tablets
Children 6–12 years	½–1 tablet (250–500 mg)	Every 4–6 hours as needed	4 tablets

Note: Do not give to children under 6 years. Do not exceed the stated dose. Do not use with other paracetamol-containing products.

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Possible side effects

Not everyone gets side effects. Stop the medicine and get medical advice if you are worried about any symptom. The side effects below are reported .

Serious—seek urgent help

Stop taking AUSTELL PARACETAMOL and contact a doctor immediately or go to the emergency department if you notice:

• Swelling of the hands, feet, ankles, face, lips, mouth, or throat that may cause difficulty swallowing or breathing.
• Rash or itching with any swelling or breathing problem.
• Fainting.

These may indicate a serious allergic reaction and require urgent medical attention.

Seek medical help urgently if you develop:

• Difficulty breathing.
• Fever or sore throat suggesting recurrent infections.
• Passing much less urine than usual.
• Yellowing of the skin or eyes, dark urine, or unusual tiredness (possible liver problems).

Less common side effects reported

• Jaundice (yellowed skin and eyes) with stomach pain and swelling.
• Unusual tiredness or weakness.
• Pinpoint red spots on the skin.
• Skin rash, hives, or itching.
• Sores, ulcers, or white spots on the lips or in the mouth.
• Cloudy urine.
• Blood disorders (changes in numbers or types of blood cells). Sometimes blood may not clot well, leading to easy bruising or bleeding.
• Rarely, a severe reduction in white blood cells, which may make infections more likely.
• Bronchospasm (tight chest).
• Pancreatitis (inflammation of the pancreas).

What to do

• Serious symptoms: get urgent medical care.
• Non-urgent symptoms: speak to your doctor or pharmacist.
• You can report side effects via SAHPRA’s Adverse Drug Reaction Reporting Form (see “Publications” on the SAHPRA website).

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Storage and disposal

• Keep out of the reach of children.
• Store at or below 25 °C.
• Keep in the original package and protect from light.
• Do not store in a bathroom.
• Do not use after the expiry date on the label or carton.
• Return unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or toilets.

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What the medicine contains

• Active ingredient: Paracetamol.
• Other ingredients (excipients): Magnesium stearate, pregelatinised starch, purified water, sodium metabisulphite.
• The product is described as sugar-free in the source.

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Pack information and appearance

• Supplied in white opaque PVC/Aluminium blisters packed into cardboard cartons.
• Pack sizes: 1 × 10, 2 × 10, and 1 × 20 tablets.
• Not all pack sizes may be marketed.
• Tablet colour/shape: Not specified in the source.

Holder of Certificate of Registration

• Austell Laboratories (Pty) Ltd.

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Practical FAQs (based ONLY on the source)

Can I take AUSTELL PARACETAMOL with meals or drinks?
Yes. The source notes no known interaction with food and drinks. You can take it with meals, with beverages, or independently of meals.

How should I swallow the tablets?
Take the tablets with a sufficient quantity of liquid, such as one glass of water.

What if I have a sensitive stomach?
If your stomach is sensitive, it may be more comfortable to take the tablets after meals.

Can I give these tablets to my child?
Only to children aged 6–12 years, using the ½ to 1 tablet dose every 4–6 hours. Do not exceed 4 tablets in 24 hours. Do not give to children under 6 years.

What is the maximum dose for adults?
Adults may take 1–2 tablets every 4–6 hours as needed, up to 8 tablets in 24 hours. Do not exceed this maximum.

Can I use this medicine if I have liver or kidney problems?
Speak to your doctor or pharmacist first. Extra caution is advised if you have liver or kidney disease.

Can I take AUSTELL PARACETAMOL with my other medicines?
Tell your healthcare provider about all your medicines. In particular, check before use if you take chloramphenicol, metoclopramide, domperidone, cholestyramine, probenecid, carbamazepine, phenytoin, phenobarbitone, rifampicin, or warfarin.

When should I see a doctor?
If symptoms worsen or do not improve after 7 days (adults) or 3 days (children), or if you develop allergic symptoms, breathing difficulty, or yellowing of the skin/eyes, seek medical help.

Can I drive after taking it?
People respond differently. Wait to see how it affects you before driving or operating machinery.

What should I do if I accidentally take too much?
Treat this as an emergency. Contact your doctor, pharmacist, the nearest hospital, or a poison centre immediately.