Consumer medicine information

Panadol Extra

Paracetamol + Caffeine

BRAND INFORMATION

Brand name

Panadol Extra

Active ingredient

Paracetamol + Caffeine

Schedule

S2; Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Panadol Extra.

What is in this leaflet

This leaflet answers some common questions about PANADOL EXTRA. 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 EXTRA is used for

The active ingredients in this medicine are paracetamol and caffeine. Paracetamol is used for the fast effective temporary relief of pain and discomfort associated with

  • Headache
  • Muscular aches
  • Period pain
  • Arthritis/Osteoarthritis
  • Toothache
  • Migraine headache
  • Colds and flu
  • Tension headache
  • Sinus pain/headache
  • Backache

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.

Caffeine acts on paracetamol to increase its effectiveness.

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

Before you use PANADOL EXTRA

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

When you must not use it

Do not use PANADOL EXTRA if you have an allergy to:

  • Any of the ingredients listed at the end of this leaflet

Do not use this medicine if you are taking any 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 you have or have had any of the following medical conditions:

  • Liver or kidney disease
  • Are underweight or malnourished
  • Regularly drink alcohol
    You may need to avoid using this product altogether or limit the amount of paracetamol that you take.
  • You have a severe infection, are severely malnourished or are a chronic heavy alcohol user as this may increase the risk of metabolic acidosis.
    Signs of metabolic acidosis include:
    - deep, rapid, difficult breathing
    - feeling sick (nausea), being sick (vomiting)
    - loss of appetite
    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 this medicine if you are pregnant or plan to become pregnant, or breastfeeding. Your pharmacist or doctor will discuss the benefits and possible risks of taking this medicine during pregnancy.

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 PANADOL EXTRA.

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
  • 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 EXTRA

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 use

Adults and children aged 12 years and over: Take 2 caplets every four to six hours as needed. Do not take more than 8 caplets in 24 hours.

Children under 12 years: Not recommended for children under 12 years of age.

Swallow with water or other fluid.

How long to use it

Adults:
Only take this medicine for a few days at a time unless your doctor tells you to take it for longer.

Children 12 to 17 years:
Only give this medicine 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 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 PANADOL EXTRA. 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 using PANADOL EXTRA

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

Children 12 to 17 years:

Do not give this medicine for more than 48 hours unless a doctor has told you to.

Adults:

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 PANADOL EXTRA 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 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 PANADOL EXTRA. 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 lists of side effects. You may not experience any of them.

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

If any of the following happen, 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, throat 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.

If you have drinks or food containing caffeine while you are taking this medicine, you may experience caffeine-related side effects such as:

  • Sleeplessness
  • Restlessness
  • Anxiety
  • Irritability
  • Headaches
  • Stomach upsets
  • Fast heartbeats

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 PANADOL EXTRA

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 25ºC.

Do not store PANADOL EXTRA 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 EXTRA are white to off-white, film-coated tablets. On one side they are marked “xPx” with the “P” inside a circle. There are no markings on the other side. They come in blister packs of 10, 20 and 40 caplets.

Ingredients

PANADOL EXTRA contain 500 mg of paracetamol and 65 mg of caffeine as the active ingredients.

They also contain:

  • Alginic acid
  • Calcium carbonate
  • Carnauba wax
  • Crospovidone
  • Magnesium stearate
  • White colouring (Opadry YS-1R-7003)
  • Povidone
  • Sodium ethyl hydroxybenzoate
  • Sodium methyl hydroxybenzoate
  • Sodium propyl hydroxybenzoate
  • Starch – pregelatinised maize
  • Water - purified

Manufacturer/Supplier

PANADOL EXTRA is supplied in Australia and New Zealand by:

GlaxoSmithKline Consumer
Healthcare Australia Pty Ltd
82 Hughes Avenue, Ermington
NSW and Auckland, New Zealand

AUST R 203990

Date of preparation: August 2017

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

Published by MIMS November 2018

BRAND INFORMATION

Brand name

Panadol Extra

Active ingredient

Paracetamol + Caffeine

Schedule

S2; Unscheduled

 

1 Name of Medicine

Paracetamol and caffeine.

6.7 Physicochemical Properties

Chemical structure.

Paracetamol.


Caffeine.


CAS number.

Paracetamol.

103-90-2.

Caffeine.

58-08-2.

2 Qualitative and Quantitative Composition

Active ingredients.

Paracetamol 500 mg and caffeine 65 mg/tablet.

Excipients.

Panadol Extra soluble tablets.

Each tablet contains:
426 mg of sodium per tablet (854 mg of sodium per 2 tablet dose). To be taken into consideration by patients on a controlled sodium diet.
50 mg of sorbitol powder (E420). Patients with rare hereditary problems of fructose intolerance should not take this medicine.
Saccharin sodium, which may cause allergic reactions.

Panadol Extra Optizorb caplets.

Each caplet contains: parahydroxybenzoates (sodium methyl, sodium ethyl, sodium propyl), which may cause allergic reactions.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Panadol Extra caplets.

White film coated, capsule-shaped tablet (caplet) with flat edges. “PANADOL EXTRA” is embossed on one face of the caplet.

Panadol Extra soluble tablets.

Flat, white tablets with bevelled edges, packed in a laminate strip. They effervesce vigorously when placed in water and dissolve to give a clear, odourless solution with a slightly sweet taste.

Panadol Extra Optizorb caplets.

White to off-white, oval shaped film coated tablet, debossed with a logo “P” in a circle on one side and a deep score line on the other side.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Paracetamol is a para-aminophenol derivative that exhibits analgesic and antipyretic activity. It inhibits prostaglandin synthetase in the hypothalamus, prevents synthesis of spinal prostaglandin and inhibits inducible nitric oxide synthesis in macrophages. Paracetamol has minimal anti-inflammatory action. Caffeine acts as an analgesic adjuvant which enhances the efficacy of paracetamol.

Clinical trials.

A meta-analysis to determine the analgesic effect of the combined dosage of paracetamol (1000 mg) and caffeine (130 mg) versus paracetamol (1000 mg) alone has been undertaken. The primary outcome of the meta-analysis was to determine whether the use of paracetamol plus caffeine provided significantly superior analgesia over paracetamol alone in acute pain states.
Inclusion criteria were full journal publications reporting the results of randomised, controlled, double blind trials comparing the two treatments.
The clinical measure selected was the > 50% maxTOTPAR (i.e. the number of patients in the two groups who achieved at least 50% of the maximal pain relief). The dichotomous descriptor of > 50% maxTOTPAR was chosen because it is a simple clinical end point of half pain relieved. It is a well defined clinical measure of pain relief and can be used to evaluate the comparative benefit of contrasting medications.
Of the seven papers describing double blind trials, four papers met the inclusion criteria for the meta-analysis and contained eight separate studies. These eight studies spanned a number of different pain states; postpartum pain (n = 3), headache (n = 2), dental pain (n = 2) and dysmenorrhoea (n = 1).
All of the eight studies included in the meta-analysis provided efficacy results as mean TOTPAR values over 0-4 hours. The total number of patients evaluated was 1265 (paracetamol plus caffeine) and 1268 (paracetamol alone). Using the endpoint of at least half pain relief achieved (at least 50% maxTOTPAR), the odds ratio of a greater likelihood of effect of the paracetamol/ caffeine combination compared to paracetamol alone is 1.34 (95% CI 1.14, 1.58). This corresponds to a relative benefit of 1.12 (95% CI 1.05-1.19). Analgesic efficacy has also been determined as the number needed to treat (NNT). For the comparison of the paracetamol/ caffeine combination with paracetamol alone, the NNT for at least 50% pain relief achieved over 0-4 hours is 14.
Compared with placebo, the relative benefit for the paracetamol/ caffeine combination is 1.42 (95% CI 1.29-1.56) and the NNT for at least 50% pain relief achieved over 0-4 hours is 5. For paracetamol alone compared with placebo, the relative benefit is 1.27 (95% CI 1.15-1.40) and the NNT is 81.
The meta-analysis indicated that the combination of paracetamol and caffeine has an added benefit in analgesic activity compared to paracetamol alone.
Time effect curves for pain relief were presented in all eight of the studies included in the meta-analysis. Overall, these studies suggested that combining paracetamol with caffeine results in an earlier analgesic effect than is achieved with paracetamol alone.

5.2 Pharmacokinetic Properties

After oral administration, paracetamol is absorbed rapidly and completely from the gastrointestinal tract; peak plasma levels occur 10 to 60 minutes after administration.
Paracetamol is uniformly distributed throughout most body fluids; the apparent volume of distribution is 1 to 1.2 L/kg. Paracetamol can cross the placenta and is excreted in breast milk. Plasma protein binding is negligible at usual therapeutic concentrations but increases with increasing concentrations.
Paracetamol is metabolised by the hepatic microsomal enzyme system. In adults at therapeutic doses, paracetamol is mainly conjugated with glucuronide (45 to 55%) or sulfate (20 to 30%). A minor proportion (less than 20%) is metabolised to catechol derivatives and mercapturic acid compounds via oxidation. Paracetamol is excreted in the urine mainly as the glucuronide and sulfate conjugates. Less than 5% is excreted as unchanged paracetamol with 85 to 90% of the administered dose eliminated in the urine within 24 hours of ingestion. The elimination half-life varies from 1 to 3 hours. Food intake delays paracetamol absorption.
Caffeine is absorbed readily after oral administration. Maximal plasma concentrations are achieved in adults within one hour and the plasma half-life is about 3 to 7 hours. Caffeine is almost completely metabolised in the liver by oxidation, demethylation and acetylation to various xanthine derivatives, which are excreted in the urine.
Regular Panadol Extra caplets and Panadol tablets are bioequivalent for AUC0-10 hr and Cmax for paracetamol. The extent of absorption (AUC) and peak plasma levels (Cmax) of paracetamol were similar for both products. The time to peak plasma level (tmax) was not significantly different, for regular Panadol Extra caplets and Panadol tablets.
For Panadol Extra soluble tablets the tmax for both paracetamol and caffeine was reached twice as fast (0.27 h, 0.32 h respectively) compared to regular Panadol Extra caplets (0.67 h, 0.65 h respectively) (p ≤ 0.043).
Panadol Extra Optizorb caplets contain a disintegrant system which optimises tablet dissolution compared to regular Panadol Extra caplets.
Human pharmacokinetic data demonstrate that paracetamol and caffeine from Panadol Extra with Optizorb Formulation caplets showed faster and greater absorption in the first 60 minutes (Tmax, AUC0-30min and AUC0-60min) compared to regular Panadol Extra.
Maximum plasma concentration of paracetamol is reached faster for Panadol Extra Optizorb caplets compared to regular Panadol Extra caplets in fasted and fed states (p < 0.01). Panadol Extra Optizorb caplets achieved tmax in the fasted state in a faster median time of 0.50 hrs versus 0.99 hrs for regular Panadol Extra. After food, Panadol Extra Optizorb caplets achieved tmax in a faster median time of 1.00 hrs versus 1.25 hours for regular Panadol Extra caplets.
Total extent of absorption of paracetamol and caffeine from Panadol Extra Optizorb caplets is equivalent to that from regular Panadol Extra caplets (AUC0-∞ and AUC0-t).
1. Palmer H, Graham G, Williams and Day R (2010). A risk-based assessment of paracetamol (acetaminophen) combined with caffeine. Pain Medicine 11: 951-965.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

4 Clinical Particulars

4.1 Therapeutic Indications

Panadol Extra is indicated for the temporary relief of pain and discomfort associated with headache, tension headache, migraine headache, osteoarthritis, arthritis, cold and flu symptoms, toothache, dental procedures, muscular aches, sore throat and period pain. Reduces fever.

4.3 Contraindications

These products are contraindicated in patients with a previous history of hypersensitivity to paracetamol, caffeine 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.
Excessive intake of caffeine (e.g. coffee, tea and some canned drinks) should be avoided while taking this product.
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 or 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 in children under the age of 12 years.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

The anticoagulant effect of warfarin and other coumarins can be enhanced by prolonged regular daily use of paracetamol with an increased risk of bleeding; occasional doses have no significant effect. Paracetamol absorption is increased by drugs which increase gastric emptying, e.g. metoclopramide, and decreased by drugs which decrease gastric emptying, e.g. propantheline, antidepressants with anticholinergic properties, narcotic analgesics. Paracetamol may increase chloramphenicol concentrations. The likelihood of paracetamol toxicity may be increased by the concomitant use of enzyme inducing agents such as alcohol or anticonvulsant drugs.
Paracetamol excretion may be affected and plasma concentrations altered when given with probenecid.
Cholestyramine reduces the absorption of paracetamol if given within 1 hour of paracetamol.
Caffeine undergoes extensive metabolism by hepatic microsomal cytochrome P450 isoenzyme CYP1A2, and is subject to numerous interactions with other drugs and substances which enhance or reduce its metabolic clearance.
No potentially hazardous interactions with caffeine have been reported. However patients who take medicines that decrease caffeine elimination may need to limit caffeine intake to avoid adverse events.
Caffeine may increase the elimination of lithium from the body. Concomitant use is therefore not recommended.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category A)
Both paracetamol and caffeine have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations.
Animal studies have shown an association between caffeine intake and foetal abnormalities, but only at very high doses that are not considered relevant to human consumption.
There is limited evidence that maternal caffeine intake during pregnancy may reduce birthweight. One review article indicated a correlation between caffeine consumption during pregnancy and a decrease in birthweight due to the vasoconstrictive effect of caffeine on placental circulation. Other reviews have found no correlation between caffeine intake in pregnancy and birthweight.
Paracetamol/ caffeine is not recommended for use during pregnancy due to the possible increased risk of spontaneous abortion associated with caffeine consumption.
 Paracetamol is exceted in breast milk. The amount available for ingestion by the infant has been reported variously as less than 0.1% of a single dose of paracetamol 500 mg and as 0.04 to 0.23% of a single 650 mg dose. Maternal ingestion of paracetamol in usual analgesic doses does not appear to present a risk to the breastfed infant.
Caffeine is excreted in breast milk. Studies examining the transfer of caffeine into breast milk after oral doses of 35 to 336 mg of caffeine have recorded peak maternal plasma concentrations of 2.4 to 4.7 microgram/mL, peak maternal saliva concentrations of 1.2 to 9.2 microgram/mL, and peak breast milk concentrations of 1.4 to 7.2 microgram/mL. At these concentrations in breast milk, the calculated daily caffeine ingestion by breastfed infants ranged from 1.3 to 3.1 mg, which was not thought to present a hazard, although irritability and a poor sleeping pattern have been reported.
The American Academy of Pediatrics states that caffeine is excreted slowly by the infant and may be associated with irritability and poor sleeping pattern when ingested by breastfeeding mothers. However, no effects occur with moderate intake of caffeinated beverages (2 to 3 cups daily) and caffeine is usually compatible with breastfeeding.
Caffeine in breast milk may potentially have a stimulating effect on breast fed infants but significant toxicity has not been observed.

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.
Events reported from extensive post marketing experience at therapeutic/ labelled dose and considered attributable are tabulated by System Organ Class and frequency. (See Table 1.)
The following convention has been utilised for the classification of undesirable effects: very common (≥ 1/10), common (≥ 1/100, < 1/10), uncommon (≥ 1/1000, < 1/100), rare (≥ 1/10,000, < 1/1000), 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.
When the recommended Panadol Extra dosing regimen is combined with dietary caffeine intake, the resulting higher dose of caffeine may increase the potential for caffeine related adverse effects such as insomnia, restlessness, anxiety, irritability, headaches, gastrointestinal disturbances and palpitations.

4.2 Dose and Method of Administration

Panadol Extra caplets and Panadol Extra Optizorb caplets are to be administered orally, with or without food.

For adults and children 12 years and older.

2 caplets every 4 to 6 hours (as required) with water. Maximum of 8 caplets in 24 hours. Not recommended in children under the age of 12 years.
Panadol Extra soluble tablets are to be administered orally, with or without food.

For adults and children 12 years and older.

2 soluble tablets every 4 to 6 hours (as required). Maximum of 8 soluble tablets in 24 hours. Not recommended in children under the age of 12 years. Panadol Extra soluble tablets should be dissolved in at least half a glass of water.
The lowest dose necessary to achieve efficacy should be used for the shortest duration of treatment. Do not exceed the stated dose. Panadol Extra should not be used with other paracetamol containing products.

Minimum dosing interval.

4 hours.

Maximum daily dose for children 12 years of age to adults.

4000 mg/520 mg (paracetamol/caffeine).

4.7 Effects on Ability to Drive and Use Machines

Panadol Extra has no influence on the ability to drive or use machines.

4.9 Overdose

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 overdose, even if symptoms of overdose are not present.
Administration of N-acetylcysteine may be required.
If an overdose is taken or suspected, the Poisons Information Centre should be contacted immediately for advice (call 131 126), or the patient should go to a hospital straight away, even if they feel well, because of the risk of delayed, serious liver damage. (See Section 4.8 Adverse Effects (Undesirable Effects)).
Overdose of caffeine may result in epigastric pain, vomiting, diuresis, tachycardia or cardiac arrhythmia, CNS stimulation (insomnia, restlessness, excitement, agitation, anxiety, tremors and convulsions).
For clinically significant symptoms of caffeine overdose to occur, the amount ingested would be associated with serious paracetamol-related liver toxicity.

7 Medicine Schedule (Poisons Standard)

Unscheduled (10's, 20's); S2 (larger than 20).

6 Pharmaceutical Particulars

6.1 List of Excipients

Panadol Extra caplets.

Maize starch, Starch - Pregelatinised maize, Povidone, Potassium sorbate, Purified talc, Stearic acid, Croscarmellose sodium, Hypromellose, Glycerol triacetin.

Panadol Extra soluble tablets.

Sorbitol, Saccharin sodium, Sodium bicarbonate, Povidone, Sodium lauryl sulphate, Dimethicone 350, Citric acid (anhydrous), Sodium carbonate (anhydrous).

Panadol Extra Optizorb caplets.

Starch - Pregelatinised maize, Calcium carbonate, Alginic acid, Crospovidone, Povidone, Magnesium stearate, Parahydroxybenzoates (sodium methyl, sodium ethyl, sodium propyl), Opadry complete film coating system YS-1-7003 White, Carnauba wax, Water - purified.
Contains no sugar, lactose or gluten.

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

Panadol Extra caplets.

Packs of 10, 18, 36, 64 and 72 caplets.

Panadol Extra soluble tablets.

Packs of 24 soluble tablets.

Panadol Extra Optizorb caplets.

Packs of 10, 20 and 40 caplets.
Not all pack sizes may be marketed.

6.6 Special Precautions for Disposal

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

Summary Table of Changes