Consumer medicine information

Pharmacy Choice Osteo Relief Modified Release Tablets

Paracetamol

BRAND INFORMATION

Brand name

Pharmacy Choice Osteo Relief Paracetamol

Active ingredient

Paracetamol

Schedule

S3

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Pharmacy Choice Osteo Relief Modified Release Tablets.

What is in this leaflet

This leaflet answers some common questions about this medicine. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medicine against the benefits they expect it will have for you.

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

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

What this medicine is used for

Pharmacy Choice Osteo Relief Modified Release tablets are effective for the relief of persistent pain associated with:

  • osteoarthritis
  • muscle aches and pains such as backache

The active ingredient in this medicine is paracetamol, which is also used for 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.

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

There is not enough information to recommend the use of this medicine for children under the age of 12 years.

Before you take this medicine

When you must not take it

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.

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

Do not take this medicine if you have an allergy to:

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

Some of 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.

Do not take 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 taking this medicine, talk to your pharmacist or doctor.

Before you start to take it

Tell your pharmacist or doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your 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

Please see your doctor if your symptoms do not improve.

Ask your pharmacist or doctor if you are pregnant or plan to become pregnant or are 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.

Your doctor can discuss with you the risks and benefits involved.

If you have not told your pharmacist or doctor about any of the above, tell them before you start taking this medicine.

Taking other medicines

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

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

  • warfarin, used to treat to prevent blood clots
  • metoclopramide, used to control nausea and vomiting
  • propantheline, used to treat urinary incontinence
  • some antidepressants, used to treat mood disorders or narcotic analgesics, used for strong pain
  • medicines used to treat epilepsy or fits
  • chloramphenicol, an antibiotic used to treat ear and eye infections
  • alcohol
  • probenecid, used to treat gout
  • cholestyramine, used to treat high cholesterol levels in the blood

These medicines may be affected by paracetamol or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.

How to take this medicine

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

If you do not understand the directions, ask your doctor or pharmacist for help.

How much to take

Adults and children aged 12 years and over:
Take 2 tablets swallowed whole three times a day, every six to eight hours as needed.

Do not take more than 6 tablets in 24 hours.

How to take it

Swallow the tablets whole with a full glass of water.

Do not crush or chew the tablets.

They can be taken with or without food.

When to take it

Take your medicine at about the same time each day, spacing the doses at equal intervals. As this medication is a modified release tablet, taking it at the same time each day (at least 6-8 hours apart between doses) will have the best effect to prevent breakthrough pain. It will also help you remember when to take it.

How long to take it

Adults and children aged 12 years and over:
Do not take paracetamol for longer than a few days at a time, except on medical advice.

Children aged 12-17 years:
Do not use this medication for longer than 48 hours at a time, except on medical advice.

If you take 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 of this medicine. 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.

Because Pharmacy Choice Osteo Relief contains a modified release formulation of paracetamol (slow-release), it is recommended that you seek help straight away even if you feel well because of the risk of delayed, serious liver damage.

While you are using this medicine

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.

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking this medicine.

Tell any other doctors, dentists, and pharmacists who treat you that you are taking this medicine.

If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine. It may affect other medicines used during surgery.

If you are about to have any blood tests, tell your doctor that you are taking this medicine.

Keep all your doctor's appointments so that your progress can be checked. Your doctor may do some tests from time to time to make sure the medicine is working and to prevent unwanted side effects.

Things you must not do

Do not take this medicine to treat any other complaints unless your doctor or pharmacist tells you to.

Do not give your medicine to anyone else, even if they have the same condition as you.

Do not use for more than a few days at a time unless your doctor or pharmacist tells you to.

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

Things to be careful of

Only drink small quantities of alcohol (beer, wine or spirits) while using paracetamol. Drinking large quantities of alcohol whilst taking paracetamol may increase the risk of liver side effects.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking this medicine.

This medicine helps most people with various types of pain, but it may have unwanted side effects in a few people. 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 lists of side effects. You may not experience any of them.

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

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

  • unexplained bruising or bleeding
  • bloody or dark urine or stools
  • fever or body aches that may be accompanied by coughing, sensitivity to light or a sore throat
  • blisters and sores on the skin and mucus membranes of the mouth, throat, eyes or genitals
  • rash, peeling, itching or hives on the skin or mouth ulcers
  • trouble breathing (often at night, in the morning or after you exercise), or chest tightness and pressure
  • symptoms of liver problems including yellowing of the skin and eyes; dark urine; pale or bloody/tar-coloured stools; itchy skin; pain in the upper right abdomen; abdominal swelling; nausea and vomiting; disorientation or confusion; sleepiness
  • symptoms of an allergic reaction including cough, shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue, throat or other parts of the body; rash, itching or hives on the skin

The above list includes very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are very rare.

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

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

Some of these side effects can only be found when your doctor does tests from time to time to check your progress.

Storage and Disposal

Storage

Keep your tablets in their original blister pack until it is time to take them. If you take the tablets out of the blister pack, they may not keep well.

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

Do not store this medicine or any other medicine in the bathroom or near a sink. Do not leave it on a windowsill or in the 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

If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

Product description

What it looks like

Pharmacy Choice Osteo Relief Modified Release Tablets
White to off-white caplet shaped coated tablets with 665 debossed on one side and plain on other side. AUST R 227108.

Ingredients

This medicine contains 665 mg of paracetamol as the active ingredient.

This medicine also contains the following:

  • maize starch
  • sodium starch glycollate type A
  • colloidal anhydrous silica
  • povidone
  • magnesium stearate
  • pregelatinised maize starch
  • hypromellose
  • microcrystalline cellulose
  • macrogol 6000
  • purified talc
  • titanium dioxide

This medicine does not contain lactose, sucrose, tartrazine or any other azo dyes.

Sponsor

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

This leaflet was prepared in November 2022.

Published by MIMS October 2023

BRAND INFORMATION

Brand name

Pharmacy Choice Osteo Relief Paracetamol

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

Modified release tablets; white to off-white caplet shaped coated tablets with 665 debossed on one side and plain on other side.

4 Clinical Particulars

4.1 Therapeutic Indications

Pharmacy Choice Osteo Relief Paracetamol 665 mg provides effective relief from persistent pain for up to 8 hours. Effective for the relief of persistent pain associated with osteoarthritis and muscle aches and pains such as backache. Pharmacy Choice Osteo Relief Paracetamol 665 mg also provides effective, temporary relief of pain and discomfort associated with headache, tension headache, period pain, toothache and pain after dental procedures, and cold and flu. Reduces fever.

4.2 Dose and Method of Administration

Dosage.

Adults and children aged 12 years and over.

2 tablets swallowed whole three times a day, every six to eight hours. Maximum of 6 tablets in 24 hours.
Adults: Not to be used for longer than a few days at a time except on medical advice.
Children and adolescents (12-17 years): Not to be used for longer than 48 hours at a time except on medical advice.
The tablets must not be crushed. Take with water or other fluid. Tablets can be taken with or without food. Do not exceed the stated dose. Not to be taken with other medicines containing paracetamol unless advised to do so by a doctor or pharmacist.

Children under 12 years.

Not recommended for children under 12 years.

Renal and hepatic impairment.

Patients who have been diagnosed with liver or kidney impairment must seek medical advice before taking this medication. The restrictions related to the use of paracetamol products in patients with hepatic impairment are primarily a consequence of the paracetamol content of the drug (see Section 4.4 Special Warnings and Precautions for Use).

4.3 Contraindications

Hypersensitivity to paracetamol or to any of the excipients.

4.4 Special Warnings and Precautions for Use

If symptoms persist, medical advice must be sought. Keep out of sight and reach of children.

Renal impairment.

Paracetamol should be used with caution in patients with impaired renal function. Patients who have been diagnosed with kidney impairment must seek medical advice before taking this medicine.

Hepatic impairment.

Paracetamol should be used with caution in patients with impaired hepatic function. Underlying liver disease increases the risk of paracetamol related liver damage. Patients who have been diagnosed with liver impairment must seek medical advice before taking this medicine.
The restrictions related to the use of paracetamol products in patients with hepatic impairment are primarily a consequence of the paracetamol content of the drug.
Cases of hepatic dysfunction/failure have been reported in patients with depleted glutathione levels, such as those who are severely malnourished, anorexic, have a low body mass index, are chronic heavy users of alcohol or have sepsis.
If patients with glutathione depleted states, the use of paracetamol may increase the risk of metabolic acidosis.
If symptoms persist, medical advice must be sought.

Use in the elderly.

No data available.

Paediatric use.

Not recommended for children under 12 years of age.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol with increased risk of bleeding. Anticoagulant dosage may require reduction if paracetamol and anticoagulants are taken for a prolonged period of time.
The rate of paracetamol absorption is increased by drugs which increase gastric emptying, e.g. metoclopramide.
Paracetamol absorption is decreased by drugs which decrease gastric emptying, e.g. propantheline, antidepressants with anticholinergic properties and narcotic analgesics.
Paracetamol may increase chloramphenicol concentrations.
The risk of paracetamol toxicity may be increased in patients receiving other potentially hepatotoxic drugs or drugs that induce liver microsomal enzymes such as alcohol and anticonvulsant drugs.
Co-administration of paracetamol with probenecid may cause a decrease in the plasma clearance of paracetamol (by almost 50%) due to inhibition of paracetamol glucuronidation.
Colestyramine reduces the absorption of paracetamol if given within one hour of paracetamol.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category A)
Paracetamol has been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the foetus having been observed.
As with the use of any medicine during pregnancy, pregnant women should seek medical advice before taking paracetamol. The lowest effective dose and shortest duration of treatment should be considered.
 Paracetamol is excreted in breast milk. Human studies with paracetamol have not identified any risk to lactation or the breastfed offspring. These results are based on immediate release preparations of paracetamol. There is no data available on the excretion of sustained release paracetamol preparations in breast milk. However, it is not expected that paracetamol 665 mg modified release tablets would provide any increase in the excretion of paracetamol in breast milk as this product is designed to maintain rather than increase plasma paracetamol concentrations compared to immediate release preparations. Maternal ingestion of paracetamol in usual analgesic doses does not appear to present a risk to the breastfed infant.

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)

Adverse events from historical clinical trial data are both infrequent and from a small patient exposure. Accordingly, events reported from extensive postmarketing experience at therapeutic/labeled dose and considered attributable are listed below by system organ class and frequency.
The following convention has been utilised for the classification of undesirable effects: very common (≥ 1/10), common (≥ 1/100, < 1/10), uncommon (≥ 1/1,000, < 1/100), rare (≥ 1/10,000, < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from available data).
Adverse event frequencies have been estimated from spontaneous reports received through postmarketing data.

Blood and lymphatic system disorders.

Very rare: thrombocytopenia.

Immune system disorders.

Very rare: anaphylaxis, cutaneous hypersensitivity reactions including skin rashes, angioedema, Stevens-Johnson syndrome and toxic epidermal necrolysis.

Respiratory, thoracic and mediastinal disorders.

Very rare: bronchospasm, especially in patients sensitive to aspirin and other NSAIDs.

Hepatobiliary disorders.

Very rare: hepatic dysfunction.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems and contact Apotex Medical Information Enquiries/Adverse Drug Reaction Reporting on 1800 195 055.

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 Effects (Undesirable Effects)).
Because Pharmacy Choice Osteo Relief Paracetamol 665 mg contains a sustained release formulation of paracetamol, absorption will be prolonged in overdose. It is recommended that for the management of overdose, where Pharmacy Choice Osteo Relief Paracetamol 665 mg 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 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Paracetamol is a para-aminophenol derivative that exhibits analgesic and antipyretic activity. The mechanism of action of paracetamol is believed to include the inhibition of prostaglandin synthesis, primarily within the central nervous system. It does not possess anti-inflammatory activity. It provides relief from mild to moderate pain and fever.

Clinical trials.

Chronic pain.

In patients with pain associated with osteoarthritis of the knee, paracetamol 665 mg modified release tablets (two tablets taken three times daily) and standard immediate release paracetamol (two tablets taken four times daily) were clinically equivalent at a total daily dose of 4 g based on patient global assessment after treatment for seven days.
Paracetamol 665 mg modified release tablets and standard immediate release paracetamol were not significantly different for a range of secondary efficacy parameters including pain during the day, pain on walking, pain relief, number of times woken during the night due to pain and duration or morning stiffness. Since paracetamol 665 mg modified release tablets (three times daily) was clinically equivalent to standard immediate release paracetamol (four times daily), it was concluded that paracetamol 665 mg modified release tablets provides pain relief for up to eight hours after dosing.

Acute pain.

In patients with postsurgical dental pain, a single dose of paracetamol 665 mg modified release tablets (two tablets) was therapeutically equivalent to standard immediate release paracetamol (two tablets) based on patient global assessment four hours after treatment. Onset of action was apparent 30 minutes after administration.
There was no significant difference between paracetamol 665 mg modified release tablets and standard immediate release paracetamol in either development of analgesia or peak analgesic effect. Trends in favour of paracetamol 665 mg modified release tablets were observed at the later time points. Furthermore, paracetamol 665 mg modified release tablets was significantly more effective than standard immediate release paracetamol for the summed pain intensity difference at six hours (p = 0.0344) and eight hours (p = 0.0500), as measured on a visual analogue scale.
From these results, it was concluded that paracetamol 665 mg modified release tablets has a similar time to onset of action compared to standard immediate release paracetamol and provides more prolonged analgesia than standard immediate release paracetamol. For the patient, this translates to longer lasting pain relief and the improved convenience of fewer doses. This is as expected for a formulation containing sustained release paracetamol and consistent with results from the pharmacokinetic studies.

5.2 Pharmacokinetic Properties

The combination of immediate release and sustained release paracetamol provides pain relief, which may last up to 8 hours.

Absorption.

Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. Food intake delays paracetamol absorption.
Paracetamol 665 mg modified release tablets are bilayer tablets incorporating an immediate release and a sustained release dose of paracetamol.
The sustained release layer is formulated in such a manner that it rapidly hydrates to form a gel layer at the matrix periphery; the drug is then released from the matrix by a combination of diffusion and erosion of the gel layer.
Paracetamol 665 mg modified release tablets release drug at a rate which ensures that therapeutically active plasma paracetamol concentrations are rapidly attained and maintained until up to eight hours after administration.

Bioequivalence.

Paracetamol 665 mg modified release tablets and standard immediate release paracetamol were bioequivalent in volunteers with respect to dose corrected AUC(0-t) and AUC(0-∞) in both fed and fasted states following administration of a single dose. This indicates that the extent of paracetamol absorption from paracetamol 665 mg modified release tablets was equivalent to that of standard immediate release paracetamol. Food had little effect on the extent of paracetamol absorption from paracetamol 665 mg modified release tablets demonstrating that paracetamol 665 mg modified release tablets is suitable to be taken with or without meals. Paracetamol was rapidly absorbed after administration of paracetamol 665 mg modified release tablets and was generally measurable in plasma within 15 minutes in fasted subjects. Mean plasma paracetamol concentrations above the minimum level required for analgesia (> 4 microgram/mL) were maintained until up to six to seven hours after administration in fasted subjects and seven to eight hours in fed subjects.
At steady state, paracetamol 665 mg modified release tablets was bioequivalent with standard immediate release paracetamol based on the comparison of AUCs during the final 24 hour dosing period of the study. Furthermore, comparison of the pharmacokinetic parameters indicated that paracetamol 665 mg modified release tablets has the characteristics of a formulation containing sustained release paracetamol. Fluctuations in the peak and trough values for plasma paracetamol concentrations were significantly smaller for paracetamol 665 mg modified release tablets than for standard immediate release paracetamol (mean fluctuation index = 0.957 and 1.388, respectively, p < 0.001). Consequently, paracetamol 665 mg modified release tablets provided more consistent levels of paracetamol. Furthermore, the AUCs at steady state were equivalent indicating that there was no additional accumulation of paracetamol from paracetamol 665 mg modified release tablets compared to standard immediate release paracetamol.

Distribution.

Paracetamol is distributed into most body tissues. Binding to the plasma proteins is minimal at therapeutic concentrations but increases with increasing doses.

Metabolism.

Paracetamol is metabolised extensively in the liver and excreted in the urine mainly as inactive glucuronide and sulfate conjugates. The metabolites of paracetamol include a minor hydroxylated intermediate which has hepatotoxic activity. This intermediate metabolite is detoxified by conjugation with glutathione, however, it can accumulate following paracetamol overdosage (more than 150 mg/kg or 10 g total paracetamol ingested) and if left untreated can cause irreversible liver damage.
Paracetamol is metabolised differently by premature infants, newborns, infants and young children compared to adults, the sulfate conjugate being predominant.

Excretion.

Paracetamol is excreted in the urine mainly as the glucuronide and sulphate conjugates. Less than 5% is excreted unchanged. Approximately 85% of a dose of paracetamol is excreted in urine as free and conjugated paracetamol within 24 hours of ingestion. Administration of paracetamol to patients with moderate to severe renal impairment may result in accumulation of paracetamol conjugates. The elimination half-life varies from one to three hours.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Maize starch, sodium starch glycollate type A, colloidal anhydrous silica, povidone, magnesium stearate, pregelatinised maize starch, hypromellose, microcrystalline cellulose, macrogol 6000, 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

PVC/PVDC/aluminium foil blister packs of 96 tablets.

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.

Chemical name: N-acetyl-p-aminophenol.
Structural formula:
Molecular formula: C8H9NO2.
Molecular weight: 151.17.

CAS number.

103-90-2.

7 Medicine Schedule (Poisons Standard)

Pharmacist Only Medicine - S3.

Summary Table of Changes