Consumer medicine information

Osteomol 665 Paracetamol

Paracetamol

BRAND INFORMATION

Brand name

Osteomol 665 Paracetamol

Active ingredient

Paracetamol

Schedule

S3

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Osteomol 665 Paracetamol.

What is in this leaflet

This leaflet answers some common questions about OSTEOMOL 665 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 OSTEOMOL 665 PARACETAMOL is used for

OSTEOMOL 665 PARACETAMOL is effective for the relief of persistent pain associated with:

  • Osteoarthritis
  • Muscle aches and pains such as backache

OSTEOMOL 665 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 OSTEOMOL 665 PARACETAMOL

When you must not use it

Do not use OSTEOMOL 665 PARACETAMOL if you have an allergy to:

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

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

  • Liver or kidney disease

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.

If you have not told your pharmacist or doctor about any of the above, tell them before you use OSTEOMOL 665 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
  • Alcohol

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 use OSTEOMOL 665 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.

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.

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: Do not take this medicine for longer than a few days at a time unless advised to by a doctor.

Children and adolescents 12-17 years of age: Do not give this medicine for longer than 48 hours at a time unless advised to by a doctor.

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 OSTEOMOL 665 PARACETAMOL. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

While you are using OSTEOMOL 665 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

Adults: Do not take this medicine for longer than a few days at a time unless advised to by a doctor.

Children and adolescents 12-17 years of age: Do not give this medicine for longer than 48 hours at a time unless advised to by a doctor.

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

Do not use OSTEOMOL 665 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 taking paracetamol. Drinking large quantities of alcohol while taking 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 you are using OSTEOMOL 665 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.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

  • Nausea or dyspepsia

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, itching or hives on the skin
  • 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.

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 OSTEOMOL 665 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 OSTEOMOL 665 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

OSTEOMOL 665 PARACETAMOL tablets are a white to off-white, bevelled shaped, biconvex, film-coated tablets, plain on both sides. They come in blister packs of 96 tablets.

Ingredients

OSTEOMOL 665 PARACETAMOL tablets contain 665 mg of paracetamol as the active ingredient.

They also contain:

  • Povidone
  • Magnesium stearate
  • Cellulose - Microcrystalline
  • Hypromellose
  • Colloidal Anhydrous Silica
  • Ethyl Cellulose
  • Sodium Starch Glycolate
  • Instacoat Universal IC-U-1308
  • Purified Water

Manufacturer/Supplier

OSTEOMOL 665 PARACETAMOL tablets are supplied in Australia by:

Pharmacor Pty Ltd
Suite 401, 7 Oaks Avenue
Dee Why, NSW, 2099
Australia

The Australian Registration number is: AUST R 227076

This leaflet was prepared in: March 2014

Published by MIMS April 2019

BRAND INFORMATION

Brand name

Osteomol 665 Paracetamol

Active ingredient

Paracetamol

Schedule

S3

 

Name of the medicine

Paracetamol.

Excipients.

Microcrystalline cellulose, hypromellose, povidone, colloidal anhydrous silica, magnesium stearate, ethyl cellulose, sodium starch glycolate and Instacoat Universal IC-U-1308 (White).

Description

Molecular Formula: C8H9NO2. Molecular Weight: 151.2. CAS Registry Number: 103-90-2.
Paracetamol is an almost white to white crystalline powder. It is sparingly soluble in water, freely soluble in alcohol, very slightly soluble in methylene chloride.
Osteomol 665 Paracetamol tablets are white to off white, bevelled shaped, biconvex, film coated tablets, plain on both sides. The Osteomol 665 Paracetamol modified release tablets contain 665 mg of paracetamol. They also contain cellulose - microcrystalline, hypromellose, povidone, colloidal anhydrous silica, magnesium stearate, ethyl cellulose, sodium starch glycolate and Instacoat Universal IC-U-1308 (White).
Osteomol 665 Paracetamol tablets contain no sugar, lactose or gluten.

Pharmacology

Pharmacodynamics.

Paracetamol is a para-aminophenol derivative that exhibits analgesic and antipyretic 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 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.
Osteomol 665 Paracetamol modified release tablets provide pain relief, which may last up to 8 hours.

Absorption.

Paracetamol was rapidly absorbed after administration of Osteomol 665 Paracetamol and was generally measurable in plasma within 15 minutes in fasted subjects.

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 sulphate 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.

Bioequivalence.

Three clinical studies were conducted to demonstrate bioequivalence of Osteomol 665 Paracetamol to the Australian reference product (Panadol Osteo (paracetamol tablets 665 mg) of GlaxoSmithKline): Fasting (CL-104-12), Fed (CL-016-13) and Steady-State (CL061-13). All bioequivalence parameters were met in all three bioequivalence studies.
Paracetamol modified release tablets and standard immediate release paracetamol tablets have been reported as bioequivalent in volunteers with respect to dose-corrected AUC(0-t) and AUC(0-inf) in both fed and fasted states following administration of a single dose. This indicates that the extent of paracetamol absorption from the paracetamol modified release was equivalent to that of standard immediate release paracetamol.
At steady-state, paracetamol modified release tablets were reported as bioequivalent with standard immediate release paracetamol based on the comparison of AUCs during the final 24 hour dosing period of the study. Comparisons of the pharmacokinetic parameters indicated that paracetamol modified release tablets have 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 modified release tablets than for standard immediate release paracetamol.
Paracetamol modified release tablets provided more consistent levels of paracetamol. The AUCs at steady-state were equivalent indicating that there was no additional accumulation of paracetamol from modified release paracetamol tablets compared to standard immediate release paracetamol.

Clinical Trials

Chronic pain.

In a reported clinical study patients with pain associated with osteoarthritis of the knee, paracetamol modified release (2 tablets taken three 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.
In the reported clinical study paracetamol modified release 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.
Paracetamol modified release (three times daily) was clinically equivalent to standard immediate release paracetamol (four times daily), it was concluded that paracetamol modified release tablets provided pain relief for up to 8 hours after dosing.

Acute pain.

In a reported clinical trial results, patients with postsurgical dental pain, a single dose of paracetamol modified release (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.
In the clinical trial study there was no significant difference between paracetamol modified release and standard immediate release paracetamol in either development of analgesia or peak analgesic effect. Trends in favour of paracetamol modified release were observed at the later time points. Furthermore, paracetamol modified release 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.

It was concluded from the above studies that paracetamol modified release 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 modified release paracetamol and consistent with results from the pharmacokinetic studies.

Indications

Osteomol 665 Paracetamol is effective for the relief of persistent pain associated with osteoarthritis and muscle aches and pains such as backache. Osteomol 665 Paracetamol 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.

Contraindications

Osteomol 665 Paracetamol is contraindicated in patients with a previous history of hypersensitivity or idiosyncratic reaction to paracetamol or any of the excipients.

Precautions

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

Use in pregnancy.

(Category A)
Drugs which have 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 fetus having been observed.
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.

Use in lactation.

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 Osteomol 665 Paracetamol 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.

Paediatric use.

Not recommended for children under 12 years of age.

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. 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 drugs.
Paracetamol excretion may be affected and plasma concentrations altered when given with probenecid.
Colestyramine reduces the absorption of paracetamol if given within one hour of paracetamol.

Adverse Effects

Adverse events from historical clinical trial data are both infrequent and from small patient exposure. Accordingly, events reported from extensive postmarketing experience at therapeutic/ labelled 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 though postmarketing data.

Blood and lymphatic system disorders.

Very rare: thrombocytopenia.

Immune system disorders.

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

Respiratory, thoracic and mediastinal disorders.

Very rare: bronchospasm.

Hepatobiliary disorders.

Very rare: hepatic dysfunction.

Dosage and Administration

Adults and children aged 12 years and over.

Two tablets swallowed whole three times a day every 6 to 8 hours. 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. 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.
Should not be used with other paracetamol containing products.

Children under 12 years.

Not recommended for children under the age of 12 years.
Minimum dosing interval 6 hours.

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 Precautions.)

Overdosage

Poisons Information Centre. 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 Adverse Effects.)
Because Osteomol 665 Paracetamol is a sustained release formulation of paracetamol, absorption will be prolonged in overdose. It is recommended that for the management of overdose, where Osteomol 665 Paracetamol 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.
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.

Presentation

Osteomol 665 Paracetamol tablets are white to off white, bevelled shaped, biconvex, film coated tablets, plain on both sides. Available in blister packs and bottles of 96 tablets.
Blister pack - AUST R 227076.
Bottle pack - AUST R 227075.

Storage

Store below 25°C.

Poison Schedule

S2.