Consumer medicine information

Parapane Osteo

Paracetamol

BRAND INFORMATION

Brand name

Parapane Osteo

Active ingredient

Paracetamol

Schedule

S3

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Parapane Osteo.

FULL CMI

PARAPANE OSTEO

Active ingredient(s): paracetamol

Consumer Medicine Information (CMI)

This leaflet provides important information about using PARAPANE OSTEO. 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 PARAPANE OSTEO.

Where to find information in this leaflet:

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

1. Why am I using PARAPANE OSTEO?

PARAPANE OSTEO contains the active ingredient Paracetamol. PARAPANE OSTEO is an analgesic, used for the relief of pain and reduces fever. Paracetamol works to stop the pain messages from getting through to the brain. It also acts in the brain to reduce fever.

PARAPANE OSTEO 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.

2. What should I know before I use PARAPANE OSTEO?

Warnings

Do not use PARAPANE OSTEO 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.
  • 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.

Check with your doctor or pharmacist if you:

  • Have any other 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 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

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.

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.

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 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.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect PARAPANE OSTEO.

4. How do I use PARAPANE OSTEO?

How much to take / use

  • 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.
  • 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 in children under 12 years.
  • Follow the instructions provided with the medicine.
  • Do not exceed the recommended dosage.

When to take / use PARAPANE OSTEO

  • 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

How to use PARAPANE OSTEO

  • 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.

If you use too much PARAPANE OSTEO

If you think that you have used too much PARAPANE OSTEO, you may need urgent medical attention.

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 PARAPANE OSTEO?

Things you should 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.

Remind any doctor, dentist or pharmacist you visit that you are using PARAPANE OSTEO.

Things you should 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 PARAPANE OSTEO to treat any other complaints unless your pharmacist or doctor tells you to.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how PARAPANE OSTEO affects you.

Drinking alcohol

Tell your doctor or pharmacist if you drink alcohol.

Only drink small quantities of alcohol (beer, wine, or spirits) while using PARAPANE OSTEO. Alcohol may increase the risk of liver side effects.

Looking after your medicine

  • Keep your medicine in the original pack until it is time to take it
  • Store below 30°C.

Follow the instructions in 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.

A locked cupboard at least one and a half metres above the ground is a good place to store medicines.

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.

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

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions.

Serious side effects

Serious side effectsWhat to do
  • 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
These side effects are very rare for low doses of this medicine and when used for a short period of time.		Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these 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 PARAPANE OSTEO contains

Active ingredient
(main ingredient)		Paracetamol 665mg
Other ingredients
(inactive ingredients)		Hyetellose, microcrystalline cellulose, povidone, pregelatinized starch,
magnesium stearate,
maize starch,
sodium starch glycolate
stearic acid,
OPADRY KB low viscosity film coating system 310A180023 White, Carnauba wax
Potential allergensNil

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

What PARAPANE OSTEO looks like

PARAPANE OSTEO is a bi-layer white colored capsule shaped film coated tablet, engraved BPL on one side and plain on the other.

They come in blister packs of 96 tablets or bottles of 96, 192 and 1000 tablets.

Who distributes PARAPANE OSTEO

Beximco Pharmaceuticals Australia
4 Miami Key, Broadbeach Waters, QLD, 4218

This leaflet was prepared in April 2022.

Published by MIMS September 2023

BRAND INFORMATION

Brand name

Parapane Osteo

Active ingredient

Paracetamol

Schedule

S3

 

1 Name of Medicine

Paracetamol.

2 Qualitative and Quantitative Composition

Active ingredient.

Paracetamol 665 mg/tablet.

Excipients.

For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Parapane Osteo is a bi-layer white colored capsule shaped film coated tablet, engraved BPL on one side and plain on the other.

4 Clinical Particulars

4.1 Therapeutic Indications

Parapane 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. Parapane Osteo also 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: 2 tablets swallowed whole three 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 for children 12 years of age to adults: 4000 mg.

4.3 Contraindications

Contraindicated in patients with a previous history of hypersensitivity to paracetamol or to any of the excipients.

4.4 Special Warnings and Precautions for Use

Identified precautions.

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.

Paracetamol should be used with caution in patients with impaired liver 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 medication.
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.

Use in renal impairment.

Paracetamol should be used with caution in patients with impaired kidney function: administration of paracetamol to patients with moderate to severe renal impairment may result in accumulation of paracetamol conjugates.
Patients who have been diagnosed with kidney impairment must seek medical advice before taking this medication.

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 Parapane 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)

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.
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 post-marketing data.

4.9 Overdose

If an overdose is taken or suspected, 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)).
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).
Because Parapane Osteo is a sustained-release formulation of paracetamol, absorption will be prolonged in overdose. It is recommended that for the management of overdose, where Parapane Osteo 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 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.

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 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.
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 (three times daily) was clinically equivalent to standard immediate release paracetamol (four 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.
Parapane Osteo is a unique 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.
Parapane Osteo releases drug at a rate which ensures that therapeutically active plasma paracetamol concentrations are rapidly attained and maintained until up to 8 hours after administration.
Food had little effect on the extent of paracetamol absorption from Parapane Osteo demonstrating that Parapane Osteo is suitable to be taken with or without meals. Paracetamol was rapidly absorbed after administration of Parapane Osteo 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.

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 sulphate 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 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 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

The tablets contain hyetellose, microcrystalline cellulose, povidone, pregelatinized starch, magnesium stearate, maize starch, sodium starch glycolate, stearic acid, Opadry KB low viscosity film coating system 310A180023 White and carnauba wax.
The tablets are sugar, lactose and gluten free.

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 30°C.

6.5 Nature and Contents of Container

Alu-PVDC blister packs of 24, 48 and 96 tablets.
HDPE bottles of 96 tablets with child resistant closure.
HDPE bottles for dispensing by pharmacists only of 192 and 1000 tablets.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Active ingredients.

Paracetamol.

Chemical structure.


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

CAS number.

103-90-2.

7 Medicine Schedule (Poisons Standard)

S3 - Pharmacist only medicine.

Summary Table of Changes