Consumer medicine information

Chemists' Own Osteo Relief Paracetamol Bottle

Paracetamol

BRAND INFORMATION

Brand name

Chemists' Own Osteo Relief Paracetamol Bottle

Active ingredient

Paracetamol

Schedule

S3

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Chemists' Own Osteo Relief Paracetamol Bottle.

What is in this leaflet

This leaflet answers some common questions about CHEMISTS’ OWN OSTEO RELIEF PARACETAMOL. It does not contain all the available information.

It does not take the place of talking to your pharmacist or doctor.

All medicines have risks and benefits.

If you have any concerns about using this medicine, ask your pharmacist or doctor.

Keep this leaflet with the medicine. You may need to read it again.

What CHEMISTS’ OWN OSTEO RELIEF PARACETAMOL is used for

CHEMISTS’ OWN OSTEO RELIEF PARACETAMOL is effective for the relief of persistent pain associated with:

  • Osteoarthritis
  • Muscle aches and pains such as backache

CHEMISTS’ OWN OSTEO RELIEF PARACETAMOL is also used for the fast effective temporary relief of pain and discomfort associated with:

  • Headache
  • Tension headache
  • Period pain
  • Toothache and pain after dental procedures
  • Colds and flu

Paracetamol also reduces fever.

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

Ask your pharmacist or doctor if you have any questions about this medicine. Your pharmacist or doctor may have recommended it for another reason.

Before you use CHEMISTS’ OWN OSTEO RELIEF PARACETAMOL

Do not take more than the recommended dose as it may cause serious harm to your liver.

When you must not use it

Do not use CHEMISTS’ OWN OSTEO RELIEF PARACETAMOL if you have an allergy to:

  • Any medicine containing paracetamol
  • Any of the ingredients listed at the end of this leaflet

Do not take this medicine if you are taking other prescription or non-prescription medicines containing paracetamol to treat pain, fever, symptoms of cold and flu, or to aid sleep.

Always read and follow the label.

Do not use this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.

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

Before you start to use it

Tell your pharmacist of doctor if you have or have had any of the following medical conditions:

  • Liver or kidney disease
  • Are underweight or malnourished
  • Regularly drink alcohol. You may need to avoid using this product altogether or limit the amount of paracetamol that you take.
  • You have a severe infection, are severely malnourished or are a chronic heavy alcohol user as this may increase the risk of metabolic acidosis:
    Signs of metabolic acidosis include:
    - Deep, rapid, difficult breathing
    - Feeling sick (nausea), being sick (vomiting)
    - Loss of appetite
    Contact a doctor immediately if you get a combination of these symptoms.

Please see your doctor if your symptoms do not improve.

Keep out of sight and reach of children.

Ask your pharmacist or doctor about using paracetamol if you are pregnant or plan to become pregnant, or breastfeeding. Paracetamol may be used during pregnancy and if you are breastfeeding, but you should always consult your doctor first.

Consider taking the lowest effective dose for the shortest period of time.

If you have not told your pharmacist or doctor about any of the above, tell them before you use CHEMISTS’ OWN OSTEO RELIEF PARACETAMOL.

Using other medicines

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

Some medicines and paracetamol may interfere with each other. These include:

  • Warfarin, a medicine used to prevent blood clots
  • Metoclopramide, a medicine used to control nausea and vomiting
  • Medicines used to treat epilepsy or fits
  • Chloramphenicol, an antibiotic used to treat ear and eye infections
  • Probenecid, a medicine used to treat gout or sometimes given with an antibiotic
  • Colestyramine, a medicine used to treat high cholesterol levels in the blood

Your pharmacist and doctor will have more information on these and other medicines to be careful with or avoid while using the medicine.

How to use CHEMISTS’ OWN OSTEO RELIEF PARACETAMOL

Follow all directions given to you by your pharmacist or doctor carefully. They may differ from the information contained in this leaflet.

If you do not understand the instructions on the box, ask your pharmacist or doctor for help.

Do not exceed the stated dose.

Use the smallest dose that you need to treat your symptoms and use the medicines for the shortest period of time necessary.

How much to use

Adults and children aged 12 years and over: Take 2 tablets three times a day, every six to eight hours as needed. Do not take more than 6 tablets in 24 hours.

Not recommended for children under 12 years.

How to use it

Swallow the tablets whole with water or other fluid.

Do not crush the tablets. They can be taken with or without food.

Try to space the doses at equal intervals throughout the day.

How long to use it

Adults and children aged 12 years and over: Only take paracetamol for a few days at a time unless your doctor tells you to take it for longer.

If you use too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much CHEMISTS’ OWN OSTEO RELIEF PARACETAMOL.

Do this even if there are no signs of discomfort or poisoning because of the risk of liver failure. You may need urgent medical attention.

While you are using CHEMISTS’ OWN OSTEO RELIEF PARACETAMOL

Things you must do

Talk to your pharmacist or doctor if your symptoms do not improve. Your pharmacist or doctor will assess your condition and decide if you should continue to take the medicine.

Things you must not do

Do not take this medicine for longer than a few days at a time unless your doctor tells you to.

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

Do not use CHEMISTS’ OWN OSTEO RELIEF PARACETAMOL to treat any other complaints unless your pharmacist or doctor tells you to.

Only drink small quantities of alcohol (beer, wine or spirits) while using CHEMISTS’ OWN OSTEO RELIEF PARACETAMOL. Drinking large quantities of alcohol while taking CHEMISTS’ OWN OSTEO RELIEF PARACETAMOL may increase the risk of liver side effects.

Side Effects

Tell your pharmacist or doctor as soon as possible if you do not feel well while using CHEMISTS’ OWN OSTEO RELIEF PARACETAMOL.

This medicine helps most people with various types of pain but it may have unwanted side effects. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

Do not be alarmed by the following list of side effects. These side effects are rare and you may not experience any of them.

Ask your pharmacist or doctor to answer any questions you may have.

If any of the following happen, stop using the product and tell your pharmacist or doctor immediately or go to Accident and Emergency at your nearest hospital:

  • Shortness of breath
  • Wheezing or difficulty breathing
  • Swelling of the face, lips, tongue or other parts of the body
  • Rash, peeling, itching or hives on the skin or mouth ulcers
  • Unexplained bruising or bleeding

The above list includes very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are very rare for low doses of this medicine and when used for a short period of time.

Tell your pharmacist or doctor if you notice anything that is making you feel unwell.

Other side effects not listed above may also occur in some people.

After using CHEMISTS’ OWN OSTEO RELIEF PARACETAMOL

Storage

Keep your medicine in the original pack until it is time to take it.

Keep your medicine in a cool dry place where the temperature stays below 25°C.

Do not store CHEMISTS’ OWN OSTEO RELIEF PARACETAMOL or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in a car. Heat and dampness can destroy some medicines.

Keep it where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

Ask your pharmacist what to do with any medicine that is left over, or if the expiry date has passed.

Product Description

What it looks like

CHEMISTS’ OWN OSTEO RELIEF PARACETAMOL tablet are a white to off-white, film-coated capsule shaped coated tablets with 665 debossed on one side and plain on the other side. They come in bottle packs of 100 and 1000 tablets.

*Not all pack sizes are marketed

Ingredients

CHEMISTS’ OWN OSTEO RELIEF PARACETAMOL tablets contain 665 mg of paracetamol as the active ingredient.

They also contain:

  • Hypromellose
  • microcrystalline cellulose
  • Povidone
  • Magnesium stearate
  • Colloidal anhydrous silica
  • Macrogol 6000
  • Maize starch
  • Pregelatinised maize starch
  • Purified talc
  • Sodium starch glycollate type A
  • Titanium dioxide

Manufacturer/Supplier

CHEMISTS’ OWN OSTEO RELIEF PARACETAMOL tablets are supplied in Australia by:

Arrotex Pharmaceuticals Pty Ltd
15 – 17 Chapel Street
Cremorne VIC 3121

AUST R 227117

Date of preparation: November 2022

Published by MIMS January 2023

BRAND INFORMATION

Brand name

Chemists' Own Osteo Relief Paracetamol Bottle

Active ingredient

Paracetamol

Schedule

S3

 

1 Name of Medicine

Paracetamol.

2 Qualitative and Quantitative Composition

Each modified release tablet contains 665 mg paracetamol.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Paracetamol 665 mg modified release tablets; white to off-white capsule shaped coated tablets with 665 debossed on one side and plain on other side.

4 Clinical Particulars

4.9 Overdose

If an overdose is taken or suspected, contact the Poisons Information Centre immediately for advice (131 126), or the patient should go to the nearest hospital straight away. This should be done even if they feel well because of the risk of delayed, serious liver damage (see Section 4.8 Adverse Effect (Undesirable Effects)).
Because Chemists' Own Osteo Relief Paracetamol contains a sustained release formulation of paracetamol, absorption will be prolonged in overdose. It is recommended that for the management of overdose, where Chemists' Own Osteo Relief Paracetamol is suspected, that an additional plasma paracetamol level be obtained four to six hours after the initial measurement. If either level is above or close to the treatment line on the paracetamol overdose nomogram, administration of antidote would be indicated.
Treatment. Paracetamol overdose may cause liver failure. Immediate medical management is required in the event of an overdose, even if the symptoms of overdose are not present.
Administration of acetylcysteine may be required.
In cases of overdosage, methods of reducing absorption of ingested drug are important. Activated charcoal may reduce absorption of the medicine if given within one hour after ingestion. In patients who are not fully conscious or have impaired gag reflex, consideration should be given to administering activated charcoal via a nasogastric tube, once the airway is protected.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. No data available.
Carcinogenicity. No data available.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure. The chemical name for paracetamol is N-acetyl-p-aminophenol. Its structural formula is:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSPARCET.gif C8H9NO2.
Molecular weight: 151.17.
CAS number. 103-90-2.

7 Medicine Schedule (Poisons Standard)

Pharmacist Only Medicine - S3.

Summary Table of Changes

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