Consumer medicine information

Panadol Sinus Relief Original Formula

Paracetamol; Pseudoephedrine hydrochloride

BRAND INFORMATION

Brand name

Panadol Sinus Relief Original Formula

Active ingredient

Paracetamol; Pseudoephedrine hydrochloride

Schedule

What is in this leaflet

This leaflet answers some common questions about PANADOL SINUS RELIEF ORIGINAL FORMULA.

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. Your pharmacist or doctor has weighed the risks of you taking PANADOL SINUS RELIEF ORIGINAL FORMULA against the benefits they expect it will have for you.

If you have any concerns about taking this medicine, ask your pharmacist or doctor.

Keep this leaflet with the medicine. You may need to read it again.

What PANADOL SINUS RELIEF ORIGINAL FORMULA is used for

PANADOL SINUS RELIEF ORIGINAL FORMULA is used for the temporary relief of sinus congestion and pain, nasal congestion and runny nose.

PANADOL SINUS RELIEF ORIGINAL FORMULA caplets® contain the active ingredients paracetamol and pseudoephedrine hydrochloride.

Paracetamol works to stop the pain messages from getting through to the brain. It also acts in the brain to reduce fever.

Pseudoephedrine hydrochloride belongs to a group of medicines called sympathomimetic decongestants.

It works by reducing congestion in the upper respiratory tract, including the nose, nasal passages and sinuses, and making it easier to breathe.

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

This medicine is not addictive.

It is only available from your pharmacist.

Before you take/give PANADOL SINUS RELIEF ORIGINAL FORMULA

Taking too much paracetamol can cause serious harm to your liver.

When you must not take it

Do not take PANADOL SINUS RELIEF ORIGINAL FORMULA if you have an allergy to:

any medicine containing paracetamol or pseudoephedrine hydrochloride
any of the ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction may include:

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

Do not take this medicine if you:

have high blood pressure
have heart disease or problems with your blood vessels
have kidney disease unless your doctor says you can
have taken monoamine oxidase inhibitors, medicines used to treat depression, in the last 14 days
are taking other medicines such as decongestants, appetite suppressants and amphetamine-like psychostimulants.

Do not give to children under 12 years of age.

Do not take this medicine if you are pregnant or plan to become pregnant. It may affect your developing baby if you take it during pregnancy. Your pharmacist or doctor will discuss the benefits and possible risks of taking the medicine during pregnancy.

Do not take 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 taking this medicine, talk to your pharmacist or doctor.

Before you start to take it

Tell your pharmacist or doctor if you have allergies to any other medicines, foods, preservatives or dyes.

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

liver disease
kidney disease
heart problems
high blood pressure
overactive thyroid gland
diabetes
heart disease and poor blood flow in the blood vessels of the heart
glaucoma (high pressure in the eyes)
prostate problems
irregular heart beat
a rare tumour of the adrenal gland (phaechromocytoma)
occlusive vascular disease (poor blood flow or narrowing of the blood vessels e.g. Raynaud's Phenomenon)
Epilepsy
asthma, bronchitis, chronic lung disorder, or other respiratory problems
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
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 you get a combination of these symptoms

Ask your pharmacist or doctor about taking PANADOL SINUS RELIEF ORIGINAL FORMULA if you are pregnant or plan to become pregnant, or breastfeeding. Your pharmacist or doctor will discuss the potential benefits and risks of taking the medicine if you are pregnant or breastfeeding.

If you have not told your pharmacist or doctor about any of the above, tell him/her before you start taking PANADOL SINUS RELIEF ORIGINAL FORMULA.

Taking other medicines

Tell your pharmacist or doctor if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and PANADOL SINUS RELIEF ORIGINAL FORMULA may interfere with each other. These include:

warfarin, a medicine used to prevent blood clots or similar medicines used to thin the blood
pain relievers or medicines to treat anxiety, or help you sleep or relax (sedatives and hypnotics)
metoclopramide, a medicine used to control nausea and vomiting
anti-convulsants
medicines used to treat epilepsy or fits such as phenytoin
chloramphenicol, an antibiotic used to treat ear and eye infections
alcohol
medicines used to treat depression such as monoamine oxidase inhibitors (MAOIs)
medicines used to treat heart conditions such as digoxin or similar medicines
medicines used to treat high blood pressure such as beta-blockers
medicines used to treat urinary tract infections and bladder problems
medicines used to treat behavioural disorders
phenylephrine, a medicine used to treat congestion
appetite suppressants
other decongestants or cough and cold medicines

These medicines may be affected by PANADOL SINUS RELIEF ORIGINAL FORMULA or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.

Your doctor and pharmacist will have more information on these and other medicines to be careful with or avoid while taking this medicine.

How to take PANADOL SINUS RELIEF ORIGINAL FORMULA

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 or frequency of dosing.

Always use the lowest effective dose to relieve your symptoms

How much to take

Adults and children 12 years and over: Take 2 caplets. Do not take more than 8 caplets in 24 hours.

Do not take more than the recommended dose.

How to take it

Take 2 caplets of PANADOL SINUS RELIEF ORIGINAL FORMULA by mouth with water.

When to take it

Every 6 hours as necessary

Maximum 8 caplets in 24 hours.

How long to take it

Adults:
Only take PANADOL SINUS RELIEF ORIGINAL FORMULA for a few days at a time except on medical advice.

Children aged 12 to 17 years:
Do not take for more than 48 hours except on medical advice.

Do not use in children below 12 years of age.

If you forget to take it

If it is less than 1 hour before your next dose, skip the dose you missed and take your next dose when you are meant to.

Otherwise, take it as soon as you remember, and then go back to taking your medicine as you would normally.

Do not take a double dose to make up for the dose that you missed. This may increase the chance of you getting an unwanted side effect.

If you are not sure what to do, ask your pharmacist or doctor.

If you have trouble remembering to take your medicine, ask your pharmacist for some hints.

If you take 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 PANADOL SINUS RELIEF ORIGINAL FORMULA.

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

While you are using PANADOL SINUS RELIEF ORIGINAL FORMULA

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 PANADOL SINUS RELIEF ORIGINAL FORMULA for more than 48 hours unless a doctor has told you to.

Adults:

Do not take for more than a few days at a time unless your doctor tells you to.

Do not give to children under 12 years of age.

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

Do not take PANADOL SINUS RELIEF ORIGINAL FORMULA to treat any other complaints unless your pharmacist or doctor tells you to.

Do not give your medicine to anyone else, even if they have the same condition as you.

Things to be careful of

Avoid drinking alcohol (beer, wine or spirits) while taking PANADOL SINUS RELIEF ORIGINAL FORMULA. Drinking alcohol while taking PANADOL SINUS RELIEF ORIGINAL FORMULA may increase the risk of liver side effects.

Be careful driving or operating machinery until you know how PANADOL SINUS RELIEF ORIGINAL FORMULA affects you. This medicine may cause dizziness in some people. If this happens, do not drive, use or operate machinery.

Side effects

Tell your pharmacist or doctor as soon as possible if you do not feel well while you are taking PANADOL SINUS RELIEF ORIGINAL FORMULA. This medicine helps most people with the relief of sinus congestion and pain, nasal congestion and runny nose but there may have unwanted side effects in a few people.

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.

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

nausea or dyspepsia
drowsiness
difficulty sleeping
nervousness
agitation
restlessness
dizziness
fear or anxiety
rapid heart beat
tremor
increased blood pressure
hallucinations
trouble urinating (more likely to occur if you have enlarged prostate)

If any of the following happen, stop using the product, 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
rapid or irregular heartbeat
urinary retention
severe headache
sudden abdominal pain or blood in your stools

The above list includes very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are very rare for low doses of this medicine and when used for a short period of time.

Tell your pharmacist or doctor if you notice anything that is making you feel unwell.

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

After using PANADOL SINUS RELIEF ORIGINAL FORMULA

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 30°C.

Do not store PANADOL SINUS RELIEF ORIGINAL FORMULA or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the 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 SINUS RELIEF ORIGINAL FORMULA are white, capsule shaped tablets with flat edges
debossed with I-I on one side.

A pack contains 24 tablets.

Ingredients

PANADOL SINUS RELIEF ORIGINAL FORMULA contains 500 mg of Paracetamol and 30 mg of Pseudoephedrine Hydrochloride as the active ingredients.

It also contains:

Talc - purified
Starch - Maize
Starch - pregelatinised maize
Stearic acid
Povidone
Sodium benzoate

Manufacturer/Supplier

PANADOL SINUS RELIEF ORIGINAL FORMULA is manufactured and supplied in Australia by:

Haleon Australia Pty Ltd
ACN 008 399 415

The Australian Registration number is:

AUST R 35521

Date of preparation: March 2023

Trademarks are owned by or licensed to the Haleon Group of Companies.

Published by MIMS May 2023

BRAND INFORMATION

Brand name

Panadol Sinus Relief Original Formula

Active ingredient

Paracetamol; Pseudoephedrine hydrochloride

Schedule

1 Name of Medicine

Paracetamol.
Pseudoephedrine hydrochloride.

2 Qualitative and Quantitative Composition

Panadol Sinus Relief Original Formula Tablets contain pseudoephedrine hydrochloride 30 mg and paracetamol 500 mg.

Excipient with known effect.

Sodium benzoate as a preservative.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Panadol Sinus Relief Original Formula Tablets are white, capsule-shaped tablets with flat edges debossed with I - I on one side.

4 Clinical Particulars

4.1 Therapeutic Indications

Panadol Sinus Relief Original Formula Tablets are used for the temporary relief of sinus congestion and pain, nasal congestion and runny nose.

4.2 Dose and Method of Administration

Adults and children 12 years and over.

2 capsule shaped tablets (caplets) taken with water every 6 hours as necessary, maximum 8 caplets within 24 hours.

Use in adults.

Paracetamol should not be taken for more than a few days at a time except on medical advice.

Use in children aged 12 to 17 years.

Paracetamol should not be taken for more than 48 hours except on medical advice. Do not use in children below 12 years of age.
Do not exceed the stated dose or frequency of dosing.
Minimum dosage interval: 6 hours.
Do not use with other paracetamol containing or decongestant products including cough and cold preparations.
Seek medical advice if symptoms persist for more than 7 days.

4.3 Contraindications

This product is contraindicated for use in patients:
with known hypersensitivity or idiosyncratic reaction to paracetamol, pseudoephedrine or any of the other ingredients in the product;
with severe hypertension or severe coronary artery disease;
who are receiving other sympathomimetics (such as decongestants, appetite suppressants and amphetamine-like psychostimulants);
who are receiving monoamine oxidase inhibitors (MAOIs) or for two weeks after stopping a MAOI drug;
with severe renal impairment.
See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions for additional information.

4.4 Special Warnings and Precautions for Use

Identified precautions.

This product should be used with caution in patients with: cardiovascular disease; arrhythmias; hypertension; prostatic enlargement; phaeochromocytoma; hyperthyroidism; diabetes mellitus; raised intraocular pressure including glaucoma; epilepsy; bronchitis; bronchiectasis; bronchial asthma.

Liver and kidney impairment.

Caution should be exercised in patients with kidney impairment and in those with hepatic impairment due to the paracetamol content of this medicine. 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.
In patients with glutathione depleted states such as sepsis, the use of paracetamol may increase the risk of metabolic acidosis.
Use with caution in patients taking beta-blockers or other antihypertensives because of the pseudoephedrine content (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
There have been reports of acute systemic vasoconstrictive events with pseudoephedrine. Significant examples include:
Acute coronary syndrome (ACS): symptoms include sudden chest pain, tightness, heavy sweating and dyspnoea at rest.
Ischaemic colitis: symptoms included sudden abdominal pain and rectal bleeding.
Posterior reversible encephalopathy (PRES)/reversible cerebral vasoconstriction syndrome (RCVS): symptoms include sudden onset of severe headache, nausea, vomiting, and visual disturbances. Most cases improved or resolved within a few days following appropriate treatment.
Pseudoephedrine should be discontinued immediately and medical advice sought if any signs/symptoms of vasoconstrictive events develop.
Medical advice should be sought if the symptoms persist, or is accompanied by a high fever, skin rash or persistent headache.
If symptoms persist, medical advice must be sought.
Keep out of sight and reach of children.
Patients should be advised not to drive or operate machinery if affected by dizziness.
See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions for additional information.

Use in hepatic impairment.

Caution should be exercised in patients with hepatic impairment due to the paracetamol content of this medicine.
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.

Use in renal impairment.

Caution should be exercised in patients with kidney impairment due to the paracetamol content of this medicine.
Patients who have been diagnosed with kidney impairment must seek medical advice before taking this medication.
This product is contraindicated for use in patients with severe renal impairment.

Use in the elderly.

No data available.

Paediatric use.

Do not give to children under 12 years of age.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Paracetamol.

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 containing products with increased risk of bleeding; occasional doses have no significant effect.
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.

Pseudoephedrine.

The following interactions with pseudoephedrine have been noted.
Antidepressant medication, e.g. tricyclic antidepressants and monoamine oxidase inhibitors (MAOIs), may cause a serious increase in blood pressure or hypertensive crisis.
Concomitant administration of pseudoephedrine and MAOIs (or within two weeks of stopping of MAOI) may lead to hypertensive crisis (see Section 4.3 Contraindications).
Other sympathomimetic agents, such as decongestants, appetite suppressants and amphetamine-like psychostimulants which interfere with the catabolism of sympathomimetic amines may occasionally cause a rise in blood pressure (see Section 4.3 Contraindications).
Pseudoephedrine may antagonise the effect of certain classes of antihypertensives (e.g. β-blockers, methyldopa, reserpine, debrisoquine, guanethidine) (see Section 4.4 Special Warnings and Precautions for Use).
Methyldopa and β-blockers may cause an increase in blood pressure.
Urinary acidifiers enhance elimination of pseudoephedrine.
Urinary alkalinisers decrease elimination of pseudoephedrine.
Pseudoephedrine-containing products may antagonise the effect of certain classes of antihypertensives.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category B2)

Pseudoephedrine.

Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human foetus having been observed. Studies in animals are inadequate or may be lacking, but available data shows no evidence of an increased occurrence of foetal damage.

Paracetamol.

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 foetus having been observed.
This product should be used in pregnancy only if the potential benefits to the patient are weighed against the possible risk to the foetus.
This product should not be used in pregnancy without medical advice.
This product should not be used whilst breastfeeding without medical advice.
Paracetamol is excreted in small amounts (< 0.2%) in breast milk but the effect of this on breastfed infants is unknown. Maternal ingestion of paracetamol in usual analgesic doses does not appear to present a risk to the breastfed infants.
Pseudoephedrine is secreted in breast milk in small amounts. It has been estimated that 0.5% to 0.7% of a single dose of pseudoephedrine ingested by the mother will be excreted in the breast milk over 24 hours. Therefore it is not recommended for breastfeeding mothers unless the potential benefits to the patient are weighed against the possible risk to the infant.

4.7 Effects on Ability to Drive and Use Machines

Patients should be advised not to drive or operate machinery if affected by dizziness.

4.8 Adverse Effects (Undesirable Effects)

Adverse events from extensive postmarketing experience at therapeutic/ labelled dose 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 (≥ 1/1000, < 1/100), rare (≥ 1/10,000, < 1/1000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Adverse event frequencies have been estimated from spontaneous reports received through postmarketing data.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

Poisons information centre.

If an overdose is taken or suspected, immediately contact the Poisons Information Centre (in Australia, call 131 126) for advice, or the patient should go to the 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).

Treatment-paracetamol.

Paracetamol overdose may cause liver failure which can lead to liver transplant or death. Acute pancreatitis has been observed with hepatic dysfunction.
Immediate medical management is required in the event of overdose, even if symptoms of overdose are not present.
Administration of N-acetylcysteine or methionine may be required.

Treatment-pseudoephedrine.

Pseudoephedrine overdose may result in symptoms due to central nervous system and cardiovascular stimulation, e.g. excitement, restlessness, hallucinations, hypertension and arrhythmias. In severe cases, psychosis, convulsions, coma and hypertensive crisis may occur. Serum potassium levels may be low due to the extracellular to intracellular shifts in potassium.
Treatment should consist of standard supportive measures.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Paracetamol is a p-aminophenol derivative that exhibits analgesic and antipyretic activity. It does not possess anti-inflammatory activity. Paracetamol is thought to produce analgesia through a central inhibition of prostaglandin synthesis.
Pseudoephedrine has direct and indirect sympathomimetic activity and is an effective decongestant in the upper respiratory tract. It is a stereoisomer of ephedrine and has a similar action, but has been found to have less pressor activity and fewer central nervous system (CNS) effects.
Sympathomimetic agents are used as nasal decongestants to provide symptomatic relief. They act by causing vasoconstriction resulting in redistribution of local blood flow to reduce oedema of the nasal mucosa, thus improving ventilation, drainage and nasal stuffiness.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Paracetamol.

Paracetamol is readily absorbed from the gastrointestinal tract with peak plasma concentrations occurring about 10 to 60 minutes after oral administration. Paracetamol is distributed into most body tissues. Plasma protein binding is negligible at usual therapeutic doses but increases with increasing doses. The elimination half-life varies from about 1 to 3 hours.
Paracetamol is metabolised extensively in the liver and excreted in the urine mainly as inactive glucuronide and sulphate conjugates. Less than 5% is excreted unchanged. 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.

Pseudoephedrine.

Pseudoephedrine is readily absorbed from the gastrointestinal tract. It is largely excreted unchanged in the urine together with small amounts of its hepatic metabolite. It has a half-life of about 5-8 hours; elimination is enhanced and half-life reduced accordingly in acid urine. Small amounts are distributed into breast milk.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Panadol Sinus Original Formula Tablets contain the excipients: purified talc, maize starch, pregelatinised maize starch, stearic acid, povidone, sodium benzoate.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine. See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions.

6.3 Shelf Life

3 years.

6.4 Special Precautions for Storage

Store below 30°C.

6.5 Nature and Contents of Container

Panadol Sinus Original Formula Tablets are available in blister packs of the following sizes: 24 tablets.

6.6 Special Precautions for Disposal

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

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Consumer medicine information

Panadol Sinus Relief Original Formula

Paracetamol; Pseudoephedrine hydrochloride

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BRAND INFORMATION