Consumer medicine information

Pharmacy Action Paracetamol Osteo 665

Paracetamol

BRAND INFORMATION

Brand name

Pharmacy Action Paracetamol Osteo 665

Active ingredient

Paracetamol

Schedule

S3

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Pharmacy Action Paracetamol Osteo 665.

What is in this leaflet

This leaflet answers some common questions about PHARMACY ACTION Paracetamol Osteo 665. 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 PHARMACY ACTION Osteo 665 is used for

PHARMACY ACTION Paracetamol Osteo 665 is effective for the relief of persistent pain associated with:

  • Osteoarthritis.
  • Muscle aches and pains such as backache.

Paracetamol, the active ingredient in this medicine, 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 take PHARMACY ACTION Osteo 665

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

When you must not take it

Do not use PHARMACY ACTION Paracetamol Osteo 665 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 take it

Tell your pharmacist or 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 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 breast-feeding 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 PHARMACY ACTION Paracetamol Osteo 665.

Taking 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;
  • alcohol;
  • probenecid, a medicine used to treat gout or sometimes given with an antibiotic;
  • cholestyramine, 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 this medicine.

How to take PHARMACY ACTION Paracetamol Osteo 665

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 medicine for the shortest period of time necessary.

How much to take

Adults and children aged 12 years and over: Take 2 tablets 3 times a day, every 6 to 8 hours as needed. Do not take more than 6 tablets in 24 hours.

Not recommended in children under 12 years of age.

How to take it

Swallow the tablets whole with water or other fluid. Do not crush the tablets. They can be taken with or without food.

When to take it

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

How long to take 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 take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26 for Australia, 0800 764 766 for New Zealand) 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 PHARMACY ACTION Paracetamol Osteo 665. 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 taking PHARMACY ACTION Paracetamol Osteo 665

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 use for more 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 PHARMACY ACTION Paracetamol Osteo 665 to treat any other complaints unless your pharmacist or doctor tells you to.

Things to be careful of

Only drink small quantities of alcohol (beer, wine or spirits) while using PHARMACY ACTION Paracetamol Osteo 665. Drinking large quantities of alcohol whilst taking PHARMACY ACTION Paracetamol Osteo 665 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 you are using PHARMACY ACTION Paracetamol Osteo 665.

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 (paracetamol) modified release tablet 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 taking PHARMACY ACTION Paracetamol Osteo 665

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 PHARMACY ACTION Paracetamol Osteo 665 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

PHARMACY ACTION Paracetamol Osteo 665 modified release tablets are a white to off-white, film-coated, capsule-shaped biconvex tablets debossed with “PT” on one side and “665” on the other side.

They come in blister packs of 96 tablets.

Ingredients

Active ingredient

PHARMACY ACTION Paracetamol Osteo 665 tablets contain 665 mg of paracetamol as the active ingredient.

Other ingredients

  • hypromellose;
  • pregelatinised maize starch;
  • microcrystalline cellulose;
  • povidone;
  • silicon dioxide;
  • croscarmellose sodium;
  • magnesium stearate;
  • Opadry complete film coating system 02F38986 WHITE (PI 111210) (as film-coating);
  • purified water.

Australian Registration Numbers

PHARMACY ACTION Paracetamol Osteo 665: AUST R 302801.

Distributor

PHARMACY ACTION Paracetamol Osteo 665 tablets are supplied in Australia by:

Generic Health Pty Ltd
Suite 2, Level 2
19-23 Prospect Street
Box Hill, VIC, 3128
Australia
Email: [email protected]
Telephone: +61 3 9809 7900
Website: www.generichealth.com.au

This leaflet was prepared in March 2021.

Published by MIMS September 2021

BRAND INFORMATION

Brand name

Pharmacy Action Paracetamol Osteo 665

Active ingredient

Paracetamol

Schedule

S3

 

Notes

Distributed by Generic Health Pty Ltd

1 Name of Medicine

Paracetamol.

2 Qualitative and Quantitative Composition

Pharmacy Action Paracetamol Osteo 665 modified release tablets contain 665 mg of paracetamol.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Pharmacy Action Paracetamol 665 modified release tablets are white to off-white film coated capsule shaped biconvex tablets debossed with "PT" on one side and "665" on the other side.

4 Clinical Particulars

4.1 Therapeutic Indications

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

4.2 Dose and Method of Administration

Adults and children aged 12 years and over.

Two tablets swallowed whole 3 times a day every 6 to 8 hours. Do not chew or suck, as it impairs the sustained release properties. Maximum of 6 tablets in 24 hours.
Do not use for more than a few days at a time in adults except on medical advice.

Children under 12 years.

Not recommended for children under the age of 12 years.
Should not be used for more than 48 hours for children aged 12-17 years except on medical advice.
Take with water or other fluid. Can be taken with or without food.
Doses should be equally spaced throughout the day. The tablets must not be crushed.
Do not exceed the stated dose.
The lowest dose necessary to achieve efficacy should be used for the shortest duration of treatment. Should not be used with other paracetamol-containing products.

Minimum dosing interval.

6 hours.

Maximum daily dose.

4000 mg.

4.3 Contraindications

Pharmacy Action Paracetamol Osteo 665 is contraindicated in patients with a previous history of hypersensitivity to paracetamol or any of the excipients.

4.4 Special Warnings and Precautions for Use

Contains paracetamol. Do not use with any other paracetamol-containing products. The concomitant use with other products containing paracetamol may lead to an overdose.
Paracetamol overdose may cause liver failure which may require liver transplant or lead to death.
If symptoms persist, medical advice must be sought. Keep out of sight and reach of children.

Use in hepatic impairment.

Underlying liver disease increases the risk of paracetamol-related liver damage. 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.
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.
In 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 following interactions with paracetamol have been noted:
The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol with increased risk of bleeding; occasional doses have no significant effect. Anticoagulant dosage may require reduction if paracetamol and anticoagulants are taken for a prolonged period of time.
Paracetamol absorption is increased by substances that increase gastric emptying, e.g. metoclopramide.
Paracetamol absorption is decreased by substances that 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 agents.
Paracetamol excretion may be affected, and plasma concentrations altered when given with probenecid.
Colestyramine reduces the absorption of paracetamol if given within 1 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 breast-fed 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 Pharmacy Action Paracetamol Osteo 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 small patient exposure. Accordingly, events reported from extensive post-marketing experience at therapeutic/labelled doses and considered attributable are tabulated in Table 1 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.

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.

4.9 Overdose

Poisons Information Centre.

If an overdose is taken or suspected, contact the Poisons Information Centre immediately for advice (13 11 26), or the patient should go to Accident and Emergency at 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 Action Paracetamol Osteo 665 is a sustained-release formulation of paracetamol, absorption will be prolonged in overdose. It is recommended that for the management of overdose, where Pharmacy Action Paracetamol Osteo 665 is suspected, that an additional plasma paracetamol level be obtained 4-6 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 which may require liver transplant or lead to death.
Acute pancreatitis has been observed, usually with hepatic dysfunction and liver toxicity.
Immediate medical management is required in the event of an overdose, even if the symptoms of overdose are not present.
Administration of N-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 (1) hour after oral 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

5.1 Pharmacodynamic Properties

Mechanism of action.

Paracetamol is a para-aminophenol derivative that exhibits analgesic and anti-pyretic activity. Its mechanism of action is believed to include 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.
The combination of immediate release and sustained release paracetamol provides pain relief, which may last up to 8 hours.

Clinical trials.

Chronic pain.

In patients with pain associated with osteoarthritis of the knee, sustained release paracetamol (2 tablets taken 3 times daily) and standard immediate release paracetamol (2 tablets taken 4 times daily) were clinically equivalent at a total daily dose of 4 g based on patient global assessment after treatment for 7 days.
Sustained release paracetamol 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 of morning stiffness.
Since sustained release paracetamol (3 times daily) was clinically equivalent to standard immediate release paracetamol (4 times daily), it was concluded that sustained release paracetamol provides pain relief for up to 8 hours after dosing.

Acute pain.

In patients with post-surgical dental pain, a single dose of sustained release paracetamol (2 tablets) was therapeutically equivalent to standard immediate release paracetamol (2 tablets) based on patient global assessment 4 hours after treatment. Onset of action was apparent 30 minutes after administration.
There was no significant difference between sustained release paracetamol and standard immediate release paracetamol in either development of analgesia or peak analgesic effect. Trends in favour of sustained release paracetamol were observed at the later time points. Furthermore, sustained release paracetamol was significantly more effective than standard immediate release paracetamol for the summed pain intensity difference at 6 hours (p = 0.0344) and 8 hours (p = 0.0500), as measured on a visual analogue scale.

Summary.

From these results, it was concluded that sustained release paracetamol 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

Absorption.

Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. Food intake delays paracetamol absorption.
Pharmacy Action Paracetamol Osteo 665 is a bi-layer tablet incorporating an immediate release and a sustained release dose of paracetamol.
The sustained release layer contains HPMC polymer, which 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.

Bioequivalence.

Pharmacy Action Paracetamol Osteo 665 releases drug at a rate which ensures that therapeutically active plasma paracetamol concentrations are rapidly attained and maintained until up to eight (8) hours after administration.
Sustained release paracetamol and standard immediate release paracetamol were bioequivalent in volunteers with respect to dose-corrected AUC(0-t) and AUC(0-inf) in both the fed and fasted states following administration of a single dose. This indicates that the extent of paracetamol absorption from sustained release paracetamol was equivalent to that of standard immediate release paracetamol. Food had little effect on the extent of paracetamol absorption from sustained release paracetamol demonstrating that sustained release paracetamol is suitable to be taken with or without meals. Paracetamol was rapidly absorbed after administration of sustained release paracetamol 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 6 to 7 hours after administration in fasted subjects and 7 to 8 hours in fed subjects.
At steady state, sustained release paracetamol 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 sustained release paracetamol 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 sustained release paracetamol than for standard immediate release paracetamol (mean fluctuation index = 0.957 and 1.388, respectively, p < 0.001). Consequently, sustained release paracetamol provided more consistent levels of paracetamol. Furthermore, the AUCs at steady state were equivalent indicating that there was no additional accumulation of paracetamol from sustained release paracetamol 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 predominant1.

Excretion.

Paracetamol is excreted in the urine mainly as the glucuronide and sulfate 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 conjugates2. The elimination half-life varies from 1 to 3 hours.
1 Core Paracetamol PI.
2 American Hospital Formulary Service Drug Information 2012.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Excipients: hypromellose, pregelatinised maize starch, microcrystalline cellulose, povidone, silicon dioxide, croscarmellose sodium, magnesium stearate, OPADRY complete film coating system 02F38986 WHITE (PI 111210) and purified water.

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 665 modified release tablets are available in PVC/Al or PVC/PVDC/Al blister packs of 96 tablets.

Australian registration numbers.

Pharmacy Action Paracetamol 665: AUST R 302801.

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-(4-hydroxyphenyl)acetamide.
Molecular Formula: C8H9NO.
Molecular Weight: 151.2.

CAS number.

103-90-2.

7 Medicine Schedule (Poisons Standard)

S3 - Pharmacist Only Medicine.

Summary Table of Changes