Consumer medicine information

Panadol Children Suppositories

Paracetamol

BRAND INFORMATION

Brand name

Panadol (Children) Suppositories

Active ingredient

Paracetamol

Schedule

S2

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Panadol Children Suppositories.

What is in this leaflet

This leaflet answers some common questions about PANADOL CHILDREN SUPPOSITORIES. 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 PANADOL CHILDREN SUPPOSITORIES are used for

The active ingredient in these medicines is paracetamol. Paracetamol is used for the fast temporary relief of pain and discomfort associated with:

  • Immunisation
  • Earache
  • Cold & flu symptoms
  • Teething
  • Headache

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 PANADOL CHILDREN SUPPOSITORIES

When you must not use it

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

Do not use PANADOL CHILDREN SUPPOSITORIES if you have an allergy to:

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

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

Always read and follow the label.

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

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

Before you start to use it

Tell your pharmacist or doctor if your child has or has had any of the following medical conditions:

  • Liver or kidney disease
  • Underweight or malnourished
  • Has a severe infection 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 your child gets a combination of these symptoms.

Please see your doctor if your child’s symptoms do not improve.

Keep out of sight and reach of children.

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

Consider giving 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 PANADOL CHILDREN SUPPOSITORIES.

Using other medicines

Tell your pharmacist or doctor if your child is 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 use PANADOL CHILDREN SUPPOSITORIES

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 effective dose that you need to treat your symptoms and use the medicine for the shortest period of time necessary.

How much to use

PANADOL CHILDREN 6 MONTHS – 5 YEARS SUPPOSITORIES

Children 6 months to 3 years with an average weight of 8 to 14 kg:

Use 1 suppository every 4 to 6 hours. Do not use more than 4 suppositories in 24 hours.

Children 4 to 5 years with an average weight of 16 to 18 kg:

Use 2 suppositories every 4 to 6 hours. Do not use more than 4 suppositories in 24 hours.

Do not use in children below the age of 2 except on medical advice.

PANADOL CHILDREN 5 – 12 YEARS SUPPOSITORIES

Children 5 to 8 years with an average weight of 18 to 25 kg:

Use 1 suppository every 4 to 6 hours. Do not use more than 4 suppositories in 24 hours.

Children 9 to 12 years with an average weight of 28 to 41 kg:

Use 2 suppositories every 4 to 6 hours. Do not use more than 4 suppositories in 24 hours.

Do not use in children below the age of 5 except on medical advice.

How to use it

For ease of insertion, the suppository can be moistened just before insertion.

If possible, ask your children to go to the toilet and empty their bowels before using the suppository. Suppositories work best if the bowels are emptied.

Follow these steps to use a suppository:

  1. Wash your hands thoroughly with soap and water.
  2. Put on a disposable glove, if desired. They are available from pharmacies.
  3. Moisten the suppository by dipping it briefly in cool water.
  4. Lie your child on their side and raise their knee to their chest.
  5. Push the suppository gently, blunt end first, into their rectum, or back passage.
  6. Keep your child lying down for a few minutes so that the suppository dissolves.
  7. Throw away used materials and wash your hands thoroughly.

How long to use it

Only give paracetamol to children for up to 48 hours unless a doctor has told you to give it for longer.

If you use too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you think that your child or anyone else may have taken too much PANADOL CHILDREN SUPPOSITORIES. Do this even if there are no signs of discomfort or poisoning because of the risk of liver failure. They need urgent medical attention.

While you are using PANADOL CHILDREN SUPPOSITORIES

Things you must do

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

Things you must not do

Do not give PANADOL CHILDREN SUPPOSITORIES for more than 48 hours unless a doctor has told you to.

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

Do not use PANADOL CHILDREN SUPPOSITORIES to treat any other complaints unless your pharmacist or doctor tells you to.

Side Effects

Tell your pharmacist or doctor as soon as possible if you do not feel well while they are taking PANADOL CHILDREN SUPPOSITORIES.

These medicines help 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. Your child 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 your child may not experience any of them.

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

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

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

The above list includes very serious side effects. Your child 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 your child feel unwell.

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

After using PANADOL CHILDREN SUPPOSITORIES

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 PANADOL CHILDREN SUPPOSITORIES 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

PANADOL CHILDREN 6 MONTHS - 5 YEARS SUPPOSITORIES are an off-white to ivory coloured, opaque, tear-shaped, soft gelatin capsule containing a milky white, viscous liquid. They come in bottles of 20 suppositories.

PANADOL CHILDREN 5 - 12 YEARS SUPPOSITORIES are an off-white to ivory coloured, opaque, tear-shaped, soft gelatin capsule containing a milky white, viscous liquid. They come in bottles of 20 suppositories.

Ingredients

PANADOL CHILDREN 6 MONTHS - 5 YEARS SUPPOSITORIES contain 125 mg of paracetamol as the active ingredient.

They also contain:

  • Macrogol 400
  • Gelatin
  • Glycerol
  • Water-purified
  • Macrogol 8000
  • Titanium dioxide
  • Methyl hydroxybenzoate
  • Vanillin
  • Propyl hydroxyl benzoate

PANADOL CHILDREN 5 – 12 YEARS SUPPOSITORIES contain 250 mg of paracetamol as the active ingredient.

They also contain:

  • Macrogol 400
  • Gelatin
  • Glycerol
  • Water-purified
  • Macrogol 8000
  • Titanium dioxide
  • Methyl hydroxybenzoate
  • Vanillin
  • Propyl hydroxyl benzoate

Manufacturer/Supplier

Marketed by:

GlaxoSmithKline Consumer Healthcare,
82 Hughes Avenue, Ermington NSW

AUST R 15486 (PANADOL CHILDREN 6 MONTHS – 5 YEARS SUPPOSITORIES)

AUST R 15487 (PANADOL CHILDREN 5 – 12 YEARS SUPPOSITORIES)

Date of preparation: November 2017

Trademarks are owned by or licenced to the GSK group of companies.

© 2017 GSK group of companies or its licensor.

Published by MIMS December 2018

BRAND INFORMATION

Brand name

Panadol (Children) Suppositories

Active ingredient

Paracetamol

Schedule

S2

 

1 Name of Medicine

Paracetamol.

2 Qualitative and Quantitative Composition

Active ingredient.

Paracetamol.

Panadol Children 1 month to 1 year Colourfree Baby Drops.

Active ingredient.

Paracetamol 100 mg/mL.

Contains.

Saccharin, hydroxybenzoates.

Panadol Children 1 to 5 years Colourfree Suspension.

Active ingredient.

Paracetamol 24 mg/mL.

Contains.

Hydrozybenzoates, sucralose, sorbitol (11.96 mg/104 mL) and maltitol (38.58 mg/104 mL) which may have a laxative effect or cause diarrhoea.

Panadol Children 5 to 12 years Elixir.

Active ingredient.

Paracetamol 48 mg/mL.

Contains.

Hydroxybenzoates, saccharin, benzoic acid, potassium sorbate and sorbitol (7.28 g/52 mL) which may have a laxative effect or cause diarrhoea.

Panadol Children 5 to 12 years Colourfree Suspension.

Active ingredient.

Paracetamol 48 mg/mL.

Contains.

Hydroxybenzoates, sucralose, sorbitol (5.98 g/52 mL) and maltitol (19.29 g/52 mL) which may have a laxative effect or cause diarrhoea.

Panadol Children Chewable 3+ years Tablets.

Active ingredient.

Paracetamol 120 mg/tablet.

Contains.

Saccharin, mannitol (6.4 g/20 tablets) which may have a laxative effect or cause diarrhoea.

Panadol Children Soluble 7+ years Tablets.

Active ingredient.

Paracetamol 250 mg/tablet.

Contains.

Saccharin, aspartame. Each tablet contains sodium 213 mg (9.2 mmol) - this should be taken into account by those on a low sodium diet.

Panadol Children 6 months to 5 years Suppositories.

Active ingredient.

Paracetamol 125 mg/suppository.

Panadol Children 5 to 12 years Suppositories.

Active ingredient.

Paracetamol 250 mg/suppository.

Excipients.

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

3 Pharmaceutical Form

Panadol Children 1 month to 1 year Colourfree Baby Drops.

A clear, colourless to very light pink semi-viscous liquid, free from black specks, precipitate or other foreign matter.

Panadol Children 1 to 5 years Colourfree Suspension.

An opaque, white, viscous suspension with small white crystals dispersed uniformly throughout the suspension.

Panadol Children 5 to 12 years Elixir.

A clear, light, red coloured syrupy liquid.

Panadol Children 5 to 12 years Colourfree Suspension.

An opaque, white viscous suspension with small white crystals dispersed uniformly throughout the suspension.

Panadol Children Chewable 3+ years Tablets.

White to off-white, cherry flavoured tablets with "PANADOL" marking on one side and breakline on the other side, free from foreign matter.

Panadol Children Soluble 7+ years Tablets.

A large, round, white, flat tablet, 16 mm diameter bevelled-edged. Plain on both faces.

Panadol Children 6 months to 5 years Suppositories.

Clean white mass moulded into a cylindrical suppository with rounded top.

Panadol Children 5 to 12 years Suppositories.

Clean white mass moulded into a cylindrical suppository with rounded top.

4 Clinical Particulars

4.1 Therapeutic Indications

For the effective temporary relief of pain and discomfort associated with teething, headache, earache, immunisation, toothache, cold and flu symptoms. Reduces fever.

4.2 Dose and Method of Administration

Panadol Children 1 month to 1 year Colourfree Baby Drops.

See Table 1.
Seek medical advice before giving to children under 6 months.

Maximum daily dose.

60 mg/kg presented in divided doses of 10-15 mg/kg throughout the 24 hour period.
Check dropper/syringe markings carefully before use.
Initial dose as per dosage Table 1.
Repeat 4-6 hourly up to 4 times per day if required. No more than 4 doses in any 24 hour period.
Should not be used for more than 48 hours at a time except on medical advice.
If your child is above 12 kg, dose at 15 mg of paracetamol per kg of bodyweight.
May be given in water or fruit juice.
Shake thoroughly before use.
Take with water or other fluid.
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.
Do not use in infants under 1 month.

Minimum dosing interval.

4 hours.

Panadol Children 1 to 5 years Colourfree Suspension.

See Table 2.

Maximum daily dose.

60 mg/kg presented in divided doses of 10-15 mg/kg throughout the 24 hour period.
Initial dose as per dosage Table 2.
Repeat 4-6 hourly up to 4 times per day if required.
Should not be used for more than 48 hours at a time except on medical advice.
The lowest dose necessary to achieve efficacy should be used for the shortest duration of treatment.
May be given in water or fruit juice.
Shake thoroughly before use.
Take with water or other fluid.
Do not exceed the stated dose.
Should not be used with other paracetamol containing products.

Minimum dosing interval.

4 hours.

Panadol Children 5 to 12 years Elixir and Panadol Children 5 to 12 years Colourfree Suspension.

See Table 3.

Maximum daily dose.

60 mg/kg presented in divided doses of 10-15 mg/kg throughout the 24 hour period.
Initial dose as per dosage Table 3.
Repeat 4-6 hourly up to 4 times per day if required. No more than 4 doses in any 24 hour period.
Should not be used for more than 48 hours at a time except on medical advice.
May be given in water or fruit juice.
Shake thoroughly before use.
Take with water or other fluid.
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.

4 hours.

Panadol Children Chewable 3+ years Tablets.

See Table 4.

Maximum daily dose.

60 mg/kg presented in divided doses of 10-15 mg/kg throughout the 24 hour period.
Take every 4-6 hours as necessary up to a maximum of 4 doses per 24 hours.
Taste is improved if the tablet is not chewed but simply dissolved in the mouth.
Should not be used for more than 48 hours at a time except on medical advice.
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.
Do not use in children below the age of 3.

Minimum dosing interval.

4 hours.

Panadol Children Soluble 7+ years Tablets.

See Table 5.

Maximum daily dose.

60 mg/kg presented in divided doses of 10-15 mg/kg throughout the 24 hour period.
Take every 4-6 hours as necessary up to a maximum of 4 doses per 24 hours.
Dissolve the tablet in a glass of water at room temperature.
Can be taken with fruit juice.
Should not be used for more than 48 hours at a time except on medical advice.
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.
Do not use in children below the age of 7 except on medical advice.
Do not use if you are a phenylketonuric.

Minimum dosing interval.

4 hours.

Panadol Children 6 months to 5 years Suppositories.

See Table 6.

Maximum daily dose.

60 mg/kg presented in divided doses of 10-15 mg/kg throughout the 24 hour period.
Insert in the rectum every 4-6 hours as required. No more than 4 doses in any 24 hour period.
For ease of insertion, the suppository can be moistened just before insertion.
Insert the large or thick end first.
Should not be used for more than 48 hours at a time except on medical advice.
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.
Do not use in children below the age of 2 except on medical advice.

Minimum dosing interval.

4 hours.

Panadol Children 5 to 12 years Suppositories.

See Table 7.

Maximum daily dose.

60 mg/kg presented in divided doses of 10-15 mg/kg throughout the 24 hour period.
Insert in the rectum every 4-6 hours as required. No more than 4 doses in any 24 hour period.
For ease of insertion, the suppository can be moistened just before insertion.
Insert the large or thick end first.
Should not be used for more than 48 hours at a time except on medical advice.
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.
Do not use in children below the age of 5 except on medical advice.

Minimum dosing interval.

4 hours.

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.
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.
Keep out of sight and reach of children.
Panadol Children 1 month to 1 year Colourfree Baby Drops contains methyl and propyl hydroxybenzoates that may cause allergic reactions (possibly delayed).
Panadol Children 1 to 5 years Colourfree Suspension contains maltitol and sorbitol liquid. Patients with rare hereditary problems of fructose intolerance should not take this medicine. Contains 115 mg/mL sorbitol.
Panadol Children 5 to 12 years Elixir contains 140 mg/mL sorbitol. Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Each Panadol Children 5 - 12 years Colourfree Suspension contains maltitol and sorbitol liquid. Patients with rare hereditary problems of fructose intolerance should not take this medicine. Contains 371 mg/mL sorbitol.
Each Panadol Children Soluble 7+ years Tablet contains 213 mg (9.2 mmol) sodium which should be taken into consideration by patients on a controlled sodium diet.
Each Panadol Children Soluble 7+ years Tablet contains aspartame, a source of phenylalanine. Patients with phenylketonuria should not take this medicine.

Use in hepatic impairment.

Paracetamol overdose may cause liver failure which may require liver transplant or lead to death.
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 or kidney 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 or are chronic heavy users of alcohol or have sepsis.

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 liver or kidney impairment must seek medical advice before taking this medication.

Use in the elderly.

No data available.

Paediatric use.

No data available.

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 small amounts (< 0.2%) in breast milk. Maternal ingestion of paracetamol in usual analgesic doses does not appear to present a risk to the breastfed infants.
Available published data do not contradict breastfeeding.

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 postmarketing experience at therapeutic/labelled dose in adults and children and considered attributable are tabulated in Table 8 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.

4.9 Overdose

If an overdose is taken or suspected, the Poisons Information Centre should be contacted immediately for advice (131 126), or the patient should be taken to hospital straight away, even if they feel well, because of the risk of delayed, serious liver damage.
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.

Treatment.

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.
Activated charcoal may reduce absorption of paracetamol 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 antipyretic activity. It does not possess anti-inflammatory activity. Its mechanism of action is believed to include inhibition of prostaglandin synthesis, primarily within the central nervous system. It is given by mouth or rectally (suppositories) for mild to moderate pain and to reduce fever.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract with peak plasma concentration occurring about 10 to 60 minutes after oral administration. Food intake delays paracetamol absorption. Following rectal administration of paracetamol, there is considerable variation in peak plasma concentrations attained, and time to reach peak plasma concentrations is substantially longer than after oral administration.

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 infants and children compared to adults, the sulphate conjugate being predominant.

Excretion.

Paracetamol is excreted in the urine mainly as the inactive glucuronide and sulphate conjugates. Less than 5% is excreted unchanged. The elimination half-life varies from about one to three hours. Approximately 85% of a dose of paracetamol is excreted in urine as free and conjugated paracetamol within 24 hours after ingestion.

5.3 Preclinical Safety Data

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Panadol Children 1 month to 1 year Colourfree Baby Drops.

Excipients.

Macrogol 400, Glycerol, Saccharin sodium, Sodium chloride, Vanilla 054468 T7, Sodium citrate, Citric acid - anhydrous, Methyl hydroxybenzoate, Cherry 51849 T7, Propyl hydroxybenzoate, Water - purified.

Panadol Children 1 to 5 years Colourfree Suspension.

Excipients.

Maltitol solution, Sorbitol solution (70 per cent) (non-crystallising), Water - purified, Carbomer 934P, Sodium Nipasept, Sodium hydroxide, Malic acid, Sucralose, Xanthan gum, Acesulfame potassium, Edetate sodium, either Strawberry 539421 T or Orange 539420 T.

Panadol Children 5 to 12 years Elixir.

Excipients.

Glycerol, Water - purified, Macrogol 1500, Sorbitol solution (70 per cent) (crystallising), Propylene glycol, Allura red AC, Saccharin sodium, Benzoic acid, Imitation candied sugar 510155U, Potassium sorbate, Raspberry flavour 21820.

Panadol Children 5 to 12 years Colourfree Suspension.

Excipients.

Maltitol solution, Sorbitol solution (70 per cent) (non-crystallising), Water - purified, Carbomer 934P, Sodium Nipasept, Sodium hydroxide, Malic acid, Sucralose, Xanthan gum, Acesulfame potassium, edetate sodium and either Orange 539420 T or strawberry 539421 T.

Panadol Children Chewable 3+ years Tablets.

Excipients.

Mannitol, Starch - maize, Ethylcellulose, Stearic acid, Saccharin sodium, Cherry Trusil Artificial flavour 5-9098 34179.

Panadol Children Soluble 7+ years Tablets.

Excipients.

Sodium bicarbonate, Citric acid - anhydrous, Sodium carbonate anhydrous, Strawberry flavour permaseal 75051-31, Sorbitol, Aspartame, Saccharin sodium, Dimethicone 200, Povidone, Imitation candied sugar flavour 650122U, Sodium lauryl sulphate.

Panadol Children 6 months to 5 years Suppositories.

Excipients.

Hard fat.

Panadol Children 5 to 12 years Suppositories.

Excipients.

Hard fat.

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

Panadol Children 1 month to 1 year Colourfree Baby Drops.

Store below 25°C.

Panadol Children 1 to 5 years Colourfree Suspension.

Store below 30°C.

Panadol Children 5 to 12 years Elixir.

Store below 30°C.

Panadol Children 5 to 12 years Colourfree Suspension.

Store below 30°C.

Panadol Children Chewable 3+ years Tablets.

Store below 30°C.

Panadol Children Soluble 7+ years Tablets.

Store below 30°C.

Panadol Children 6 months to 5 years Suppositories.

Store below 25°C.

Panadol Children 5 to 12 years Suppositories.

Store below 25°C.

6.5 Nature and Contents of Container

Panadol Children 1 month to 1 year Colourfree Baby Drops.

Bottles of 20 mL.

Panadol Children 1 to 5 years Colourfree Suspension.

Bottles of 100 mL and 200 mL.

Panadol Children 5 to 12 years Elixir.

Bottles of 100 mL and 200 mL.

Panadol Children 5 to 12 years Colourfree Suspension.

Bottles of 100 mL and 200 mL.

Panadol Children Chewable 3+ years Tablets.

Blister packs of 24 tablets.

Panadol Children Soluble 7+ years Tablets.

Strip packs of 16 tablets.

Panadol Children 6 months to 5 years Suppositories.

Blister pack of 10 suppositories.

Panadol Children 5 to 12 years Suppositories.

Blister pack of 10 suppositories.

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

Chemical structure.


CAS number.

103-90-2.

7 Medicine Schedule (Poisons Standard)

Soluble Tablets - Unscheduled.
Baby Drops, Elixir, Suspension, Chewable Tablets - S2, Pharmacy Medicine.
Suppositories - S2, Pharmacy Medicine.

Summary Table of Changes