SUMMARY CMI

APOHEALTH PARACETAMOL PAIN RELIEF

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using APOHEALTH Paracetamol Pain Relief?

This medicine contains the active ingredient paracetamol. This medicine is used for the temporary relief of pain associated with headache, migraine headache, neuralgia, muscular aches and pains, cold and flu symptoms, arthritis, osteoarthritis, toothache, sore throat, period pain, rheumatic pain. Reduces fever.

For more information, see Section 1. Why am I using APOHEALTH Paracetamol Pain Relief? in the full CMI.

2. What should I know before I use APOHEALTH Paracetamol Pain Relief?

Do not use if you have ever had an allergic reaction to paracetamol or any of the ingredients listed at the end of the CMI.
Talk to your doctor or pharmacist if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section 2. What should I know before I use APOHEALTH Paracetamol Pain Relief? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with APOHEALTH Paracetamol Pain Relief and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use APOHEALTH Paracetamol Pain Relief?

• The label on the pack will tell you how to take your medicine and how often. If you are unsure about the directions, ask your pharmacist or doctor.

More instructions can be found in Section 4. How do I use APOHEALTH Paracetamol Pain Relief? in the full CMI.

5. What should I know while using APOHEALTH Paracetamol Pain Relief?

For more information, see Section 5. What should I know while using APOHEALTH Paracetamol Pain Relief? in the full CMI.

6. Are there any side effects?

• Less serious side effects include nausea and stomach pain.
• Tell your doctor or pharmacist immediately if you notice any of the following side effects shortness of breath, wheezing or difficulty breathing, swelling of the face, lips, tongue, or other parts of the body, rash, itching or hives on the skin. This may be the signs of an allergic reaction.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

FULL CMI

APOHEALTH PARACETAMOL PAIN RELIEF

Active ingredient: paracetamol

Consumer Medicine Information (CMI)

This leaflet provides important information about using this medicine. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using this medicine.

Where to find information in this leaflet:

1. Why am I using APOHEALTH Paracetamol Pain Relief?
2. What should I know before I use APOHEALTH Paracetamol Pain Relief?
3. What if I am taking other medicines?
4. How do I use APOHEALTH Paracetamol Pain Relief?
5. What should I know while using APOHEALTH Paracetamol Pain Relief?
6. Are there any side effects?
7. Product details

1. Why am I using APOHEALTH Paracetamol Pain Relief?

This medicine contains the active ingredient Paracetamol.
This medicine is an analgesic.

Temporary relief of pain associated with headache, migraine headache, neuralgia, muscular aches and pains, cold and flu symptoms, arthritis, osteoarthritis, toothache, sore throat, period pain, rheumatic pain. Reduces fever.

2. What should I know before I use APOHEALTH Paracetamol Pain Relief?

Warnings

Do not use this medicine if:

• you are allergic to paracetamol, or any of the ingredients listed at the end of this leaflet. The symptoms of an allergic reaction may include:
  - shortness of breath wheezing or difficulty breathing
  - swelling of the face, lips, tongue, or other parts of the body
  - rash, itching or hives on the skin.
• Always check the ingredients to make sure you can use this medicine.
• Do not take this medicine if you have liver or kidney problems.
• Do not take this medicine if you have glucose-6-phosphate-dehydrogenase deficiency (an enzyme deficiency)
• Do not use this medicine if the packaging is torn or shows signs of tampering.
• Do not use this medicine after the expiry date (EXP) printed on the pack. If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start taking this medicine, talk to your pharmacist or doctor.

Check with your doctor or pharmacist if you:

• Have allergies to any ingredients listed under Product Details at the end of this leaflet
• Have allergies to aspirin or any other NSAID medicine
• Have liver or kidney problems
• Have low glutathione reserves
• Have Gilbert's syndrome
• Have acute breathing difficulties such as bronchitis, unstable asthma or emphysema
• Drink large quantities of alcohol
• take any medicines for any other condition

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor or pharmacist if you are pregnant or intend to become pregnant or if you are breastfeeding or intend to breastfeed.

This medicine may be used during pregnancy and if you are breastfeeding. However, it is recommended that non-drug therapy such as rest and massage be tried first. If this medicine is needed during pregnancy, it should be used at the lowest effective dose for the shortest possible time and at the lowest possible frequency.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with APOHEALTH Paracetamol Pain Relief and affect how it works.

These include:

• Any medicines which thin the blood, for example warfarin
• Medicines to treat epilepsy
• Metoclopramide or domperidone, medicines used to control nausea and vomiting
• Propantheline, a drug used to treat stomach ulcers
• Other pain relief medication
• Alcohol and medicines containing alcohol (ethanol) e.g. some cough syrups
• Medicines used to treat depression
• Medicines used to aid sleep
• Chloramphenicol, an antibiotic used to treat ear and eye infections
• Flucloxacillin, zidovudine and rifampicin, drugs used to treat infections
• Probenecid, a drug used to treat high uric acid levels in the blood associated with gout
• Cholestyramine, a drug used to reduce blood cholesterol
• Chelating resin

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect this medicine.

4. How do I use APOHEALTH Paracetamol Pain Relief?

How much to take

Adults and children aged 12 years and over:

Take 1 or 2 tablets with water every 4 to 6 hours as required.

Do not take more than 8 tablets in 24 hours.

Children 7-12 years of age:

Take half to 1 tablet with water every 4 to 6 hours as required.

Do not take more than 4 tablets in 24 hours.

This medicine is not recommended for children under 7 years of age.

When to take this medicine

• The label on the pack will tell you how to take your medicine and how often. If you are unsure about the directions ask your pharmacist or doctor.

Your doctor may ask you to take a different dose. If so, you should follow the doctor's instructions.

If you are unsure what dose to take ask your pharmacist.

If you forget to use this medicine

If you miss a dose, take it as soon as you remember.

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Do not take a double dose to make up for the dose you missed.

If you use too much medicine

If you think that you have used too much medicine, you may need urgent medical attention.

You should immediately:

• phone the Poisons Information Centre
  (by calling 13 11 26), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using APOHEALTH Paracetamol Pain Relief?

Things you should do

Take this medicine exactly as directed.

Remind any doctor, dentist or pharmacist you visit that you are using this medicine.

Things you should not do

• Do not take more than the recommended dose unless your doctor tells you to.

Children:

• Do not give this medicine for more than 48 hours unless a doctor has told you to.

Adults:

• Do not take for more than a few days at a time unless your doctor tells you to.

Drinking alcohol

Tell your doctor or pharmacist if you drink alcohol.

Only drink small quantities of alcohol (beer, wine or spirits) while taking this medicine.

Drinking large quantities of alcohol while taking paracetamol may increase the risk of liver side effects.

Looking after your medicine

• Keep your tablets in the pack until it is time to take them.
• If you take the tablets out of the pack they will not keep well.
• Store below 25°C.

Follow the instructions on the pack on how to take care of your medicine properly.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

• in the bathroom or near a sink, or
• in the car or on window sills.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions.

Less serious side effects

Serious side effects

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

7. Product details

This medicine is available over-the-counter without a doctor's prescription.

What APOHEALTH Paracetamol Pain Relief contains

Do not take this medicine if you are allergic to any of these ingredients.

What APOHEALTH Paracetamol Pain Relief looks like

APOHEALTH PARACETAMOL PAIN RELIEF is white to off white, caplet shaped tablet with score notch on one side and “P” debossed on the other.

HDPE bottle - Aust R 230262

Who distributes APOHEALTH Paracetamol Pain Relief

Arrotex Pharmaceuticals Pty Ltd
15-17 Chapel Street
Cremorne, Victoria 3121
www.arrotex.com.au

This leaflet was prepared in May 2024.

Published by MIMS April 2025

1 Name of Medicine

Paracetamol.

2 Qualitative and Quantitative Composition

Each tablet contains paracetamol 500 mg.
For the full list of excipients see Section 6.1 List of Excipients.

3 Pharmaceutical Form

White to off white, caplet shaped tablet with score notch on one side and "P" debossed on the other.

4 Clinical Particulars

4.1 Therapeutic Indications

Temporary relief of pain associated with headache, migraine headache, neuralgia, muscular aches and pains, cold and flu symptoms, arthritis, osteoarthritis, toothache, sore throat, period pain, rheumatic pain. Reduces fever.

4.2 Dose and Method of Administration

Dosage.

Children (7-12 years).

Adults and children aged 12 years and over.

Children under 7 years.

4.3 Contraindications

This medication is contraindicated in patients who are hypersensitive to paracetamol or to any of the excipients of this medicine. It must not be used in patients with known glucose-6-phosphate-dehydrogenase deficiency. This medicine must not be used in patients with impaired liver function.

4.4 Special Warnings and Precautions for Use

This medication may be dangerous when used in large amounts or for long periods. Hepatotoxicity may occur with paracetamol even at therapeutic doses, after short treatment duration and in patients without pre-existing liver dysfunction. Hepatotoxicity may develop following as little as 10 to 15 g of paracetamol and hepatic failure is known to occur occasionally with long term use of paracetamol.

To avoid the risk of overdose.

Severe cutaneous adverse reactions (SCARs).

Use in hepatic impairment.

Use in renal impairment.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

Uric acid and blood glucose.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Paracetamol may increase the risk of bleeding in patients taking warfarin and other antivitamin K. Anticoagulant dosage may require reduction and patients should be monitored for appropriate coagulation and bleeding complications.
Paracetamol absorption is increased by drugs which increase gastric emptying e.g. metoclopramide and domperidone and decreased by drugs which decrease gastric emptying e.g. propantheline, antidepressants with anticholinergic properties, narcotic analgesics.
Paracetamol may increase chloramphenicol concentrations by slowing down excretion, entailing the risk of increased toxicity. The risk of paracetamol toxicity may be increased in patients receiving other potentially hepatoxic drugs or drugs that induce liver microsomal enzymes, such as antiepileptics (such as phenobarbital, phenytoin, carbamazepine, topiramate), barbiturates, hypnotics, rifampicin and alcohol.
Paracetamol excretion may be affected and plasma concentrations altered when given probenecid.
Cholestyramine reduces the absorption of paracetamol if given within 1 hour of paracetamol. Chelating resins can decrease the intestinal absorption of paracetamol and potentially decrease its efficacy if taken simultaneously. In general, there must be an interval of more than 2 hours between taking the resin and taking paracetamol, if possible.
Co-administration of flucloxacillin with paracetamol may lead to metabolic acidosis, particularly in patients presenting risk factors of glutathione depletion, such as sepsis, malnutrition or chronic alcoholism.
When used concurrently with zidovudine, an increased tendency for neutropenia may develop. Combination of Paracetamol and zidovudine should be avoided.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

Reports of adverse reactions are rare. Although the following reactions have been reported: dyspepsia, sweating, erythema, urticaria, anaphylactic shock, angioneurotic oedema, difficulty breathing, drop in blood pressure, nausea, allergic reactions such as skin rashes, hypersensitivity reactions and haematological reactions, including thrombocytopenia, leukopenia, neutropenia, agranulocytosis and pancytopenia. Bronchospasm may be triggered in patients having a tendency of analgesic asthma. Toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), acute generalised exanthematous pustulosis, fixed drug eruption (see Section 4.4 Special Warnings and Precautions for Use) and cytolytic hepatitis, which may lead to acute hepatic failure, have also been reported. Overdosage with paracetamol if left untreated can result in severe, sometimes fatal liver damage and rarely, acute renal tubular necrosis.
Haemolytic anaemia, particularly in patients with underlying glucose 6-phosphate-dehydrogenase deficiency has been reported. Kounis syndrome has been reported, as has pyroglutamic acidosis in patients with pre-disposing factors for glutathione depletion.

Reporting suspected adverse effects.

4.9 Overdose

Elderly persons, small children, patients with liver disorders, chronic alcohol consumption or chronic malnutrition, as well as patients concomitantly treated with enzymes-inducing drugs are at an increased risk of intoxication, including fatal outcome.

Symptoms.

Treatment.

Acetylcysteine 20% iv.

Oral methionine.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

Absorption.

Distribution.

Metabolism.

Excretion.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Hypromellose, macrogol 6000, magnesium stearate, pregelatinised maize starch, propylene glycol, purified talc, titanium dioxide.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C.

6.5 Nature and Contents of Container

HDPE bottle - 100, 500, 1000 tablets.
Not all pack sizes may be marketed.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

S3 Pharmacist Only Medicine.

Summary Table of Changes