SUMMARY CMI

Pharmacy Action Paracetamol

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 Pharmacy Action Paracetamol?

Pharmacy Action Paracetamol contains the active ingredient paracetamol. Pharmacy Action Paracetamol is used to relieve pain and fever in adults (including arthritis, headache and muscular pain) and children (including teething, earache and pain associated with immunisation).

For more information, see Section 1. Why am I using Pharmacy Action Paracetamol? in the full CMI.

2. What should I know before I use Pharmacy Action Paracetamol?

Do not use if you have ever had an allergic reaction to Pharmacy Action 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 Pharmacy Action Paracetamol? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Pharmacy Action Paracetamol 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 Pharmacy Action Paracetamol?

• 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.
• The dose will be different depending upon whether you are an adult or child.

More instructions can be found in Section 4. How do I use Pharmacy Action Paracetamol? in the full CMI.

5. What should I know while using Pharmacy Action Paracetamol?

For more information, see Section 5. What should I know while using Pharmacy Action Paracetamol? 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. They 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

Pharmacy Action Paracetamol

Active ingredient(s): paracetamol

Consumer Medicine Information (CMI)

This leaflet provides important information about using Pharmacy Action Paracetamol. 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 Pharmacy Action Paracetamol.

Where to find information in this leaflet:

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

1. Why am I using Pharmacy Action Paracetamol?

Pharmacy Action Paracetamol contains the active ingredient paracetamol. Pharmacy Action Paracetamol is an analgesic.

Pharmacy Action Paracetamol is used to relieve pain and fever in adults (including arthritis, headache and muscular pain) and children (including teething, earache and pain associated with immunisation).

Pharmacy Action Paracetamol works to stop the pain messages from getting through to the brain. Pharmacy Action Paracetamol also acts in the brain to reduce fever.

2. What should I know before I use Pharmacy Action Paracetamol?

Warnings

Do not use Pharmacy Action Paracetamol if:

• you are allergic to paracetamol, or any of the ingredients listed at the end of this leaflet.
  Always check the ingredients to make sure you can use this medicine.
  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.
• you have liver or kidney problems.
• you have glucose-6-phosphate-dehydrogenase deficiency (an enzyme deficiency).
• the expiry date (EXP) printed on the pack has passed or if the packaging is torn or shows signs of tampering.

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 non-steroidal anti-inflammatory (NSAID) medicine;
• have any other medical conditions, such as:
  - liver or kidney problems,
  - low glutathione reserves,
  - Gilbert's syndrome,
  - 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.

Talk to your doctor or pharmacist if you are breastfeeding or intend to breastfeed.

Pharmacy Action Paracetamol 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 Pharmacy Action Paracetamol 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 Pharmacy Action Paracetamol 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), eg. 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.
• colestyramine, 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 Pharmacy Action Paracetamol.

4. How do I use Pharmacy Action Paracetamol?

How much to take

• Follow the instructions provided with the medicine.
• 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.
• Do not exceed the recommended dosage.

Adults and children over 12 years:

• The usual dose is 1 to 2 tablets to be taken every 4 to 6 hours, when required, up to 4 times daily.
• You should not take more than 8 tablets in 24 hours.
• Adults: Do not take this medicine for longer than a few days at a time unless advised by a doctor.

Children (7-12 years):

• The usual dose is half to 1 tablet to be taken every 4 to 6 hours, when required, up to 4 times daily.
• Children should not take more than 4 tablets in 24 hours.
• Do not take this medicine for longer than 48 hours at a time unless advised by a doctor.
• Pharmacy Action Paracetamol tablets are not recommended for children under 7 years of age.

When to take Pharmacy Action Paracetamol

• 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.

How to take Pharmacy Action Paracetamol

• Swallow the tablets whole with a little water or other liquid.

If you use too much Pharmacy Action Paracetamol

If you think that you have used too much Pharmacy Action Paracetamol, you may need urgent medical attention.

If you take too much Pharmacy Action Paracetamol you may feel nauseous, dizzy or sweaty.

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 Pharmacy Action Paracetamol?

Things you should do

• Take Pharmacy Action Paracetamol exactly as directed.

Remind any doctor, dentist or pharmacist you visit that you are using Pharmacy Action Paracetamol.

Things you should not do

• Do not take more than the recommended dose unless your doctor tells you to.
• Do not take with other products containing paracetamol, unless advised to do so by a doctor or pharmacist.

Adults:

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

Children:

• Do not give Pharmacy Action Paracetamol for more than 48 hours unless a doctor has told you to.
• Do not give to children under 7 years of age unless a doctor has told 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 paracetamol.

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

Looking after your medicine

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

Follow the instructions on the carton 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 Pharmacy Action Paracetamol contains

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

Pharmacy Action Paracetamol tablets do not contain gluten, lactose, sucrose, tartrazine or any azo dyes.

What Pharmacy Action Paracetamol looks like

Pharmacy Action Paracetamol is a white, capsule-shaped tablet, with a breakline on one side and plain on the other side (AUST R 192004).

Who distributes Pharmacy Action Paracetamol

Generic Health Pty Ltd
Suite 2, Level 2
19-23 Prospect Street
Box Hill, VIC, 3128

  [email protected]

  +61 3 9809 7900

  www.generichealth.com.au

This leaflet was prepared in January 2025.

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

Pharmacy Action Paracetamol are white, capsule-shaped tablets, plain on one side and a breakline on the other.

4 Clinical Particulars

4.1 Therapeutic Indications

Pharmacy Action Paracetamol provides effective temporary relief of pain associated with:
headache; backache; toothache; period pain; migraine headache; muscular aches; sore throat; symptoms of cold and flu; arthritis/rheumatics/osteoarthritis.
Pharmacy Action Paracetamol also reduces fever.

4.2 Dose and Method of Administration

Adults and children over 12 years.

Adults.

Children 7 to 12 years.

4.3 Contraindications

Pharmacy Action Paracetamol is contraindicated in patients who are hypersensitive to paracetamol or to any other component of the formulation. It must not be used in patients with known glucose-6-phosphate-dehydrogenase deficiency.
Pharmacy Action Paracetamol 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 g to 15 g of paracetamol and hepatic failure is known to occur occasionally with the long term use of paracetamol.

To avoid the risk of overdose.

Identified precautions.

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 hepatotoxic 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 resin 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.
TEN, SJS, acute generalised exanthematous pustulosis, fixed drug eruption and cytolytic hepatitis, which may lead to acute hepatic failure, have also been reported (see Section 4.4 Special Warnings and Precautions for Use).
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 enzyme-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

Pharmacy Action Paracetamol tablets also contain colloidal anhydrous silica, docusate sodium, magnesium stearate, maize starch and povidone.

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

Pharmacy Action Paracetamol tablets are packed in PVC/Aluminium blister packs of 20, 24, 48, 50, 96 and 100 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

Paracetamol is a white or almost white, crystalline powder. It is sparingly soluble in water, freely soluble in alcohol and very slightly soluble in methylene chloride. It has a melting point between 168°C and 172°C.

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

(S3) Pharmacist Only Medicine - Blister of 96 and 100 tablets.
(S2) Pharmacy Medicine - Blister of 20, 24, 48 and 50 tablets.

Summary Table of Changes