Consumer medicine information

PANADOL COLD AND FLU PLUS DECONGESTANT

Paracetamol; Phenylephrine hydrochloride

BRAND INFORMATION

Brand name

Panadol Cold & Flu + Decongestant

Active ingredient

Paracetamol; Phenylephrine hydrochloride

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using PANADOL COLD AND FLU PLUS DECONGESTANT.

What is in this leaflet

This leaflet answers some common questions about PANADOL Cold & Flu Plus Decongestant. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you taking PANADOL Cold & Flu Plus Decongestant against the benefits they expect it will have for you.

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

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

What PANADOL Cold & Flu Plus Decongestant is used for

PANADOL Cold & Flu Plus Decongestant caplets are used for the temporary relief of cold & flu symptoms including headache, body aches & pain, blocked or runny nose, sore throat. It also reduces fever.

PANADOL Cold & Flu Plus Decongestant contains the active ingredients paracetamol and phenylephrine hydrochloride.

Paracetamol works to stop the pain messages from getting through to the brain.

Phenylephrine hydrochloride works to reduce nasal stuffiness.

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

This medicine is not addictive.

This medicine may cause dizziness. If affected, do not drive or operate machinery.

Before you take/give PANADOL Cold & Flu Plus Decongestant

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

When you must not take it

Do not take PANADOL Cold & Flu Plus Decongestant if you have an allergy to:

  • any medicine containing paracetamol or phenylephrine 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, throat or other parts of the body
  • rash, peeling, itching or hives on the skin or mouth ulcers.

Do not give this medicine to a child under the age of 12 years. Safety and effectiveness in children younger than 12 years have not been established.

Always read and follow the label.

Do not take 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.
  • Within several hours of going to bed as it may cause sleeplessness.
  • For more than 48 hours (in children 12-17 years) or more than a few days (adults), except on medical advice.
  • If you are taking or have taken in the past 14 days, medicines called monoamine oxidase inhibitors (MAOIs) usually used to treat depression.
  • If you are taking other medicines for the relief of colds & flu, congestion or blocked nose, appetite suppressants or stimulant drugs called amphetamines (sometimes used for attention deficit disorder).
  • If you have very high blood pressure or severe coronary artery disease (heart disease caused by poor blood flow or narrowing of the blood vessels of the heart).

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 doctor.

Before you start to take it

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

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

  • high blood pressure
  • heart disease or
  • blood vessel disease (e.g. Raynaud's phenomenon)
  • diabetes
  • overactive thyroid
  • glaucoma
  • phaeochromocytoma (a tumour near the kidney)
  • prostate problems or difficulty urinating
  • liver or kidney 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.
    Sign 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.

Tell your doctor if you are pregnant or plan to become pregnant or are breast-feeding. Your doctor can discuss with you the risks and benefits involved.

If you have not told your doctor about any of the above, tell him/her before you start taking PANADOL Cold & Flu Plus Decongestant.

Taking other medicines

Tell your doctor or pharmacist 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 Cold & Flu Plus Decongestant may interfere with each other. These include:

  • Medicines to treat depression such as MAOIs or tricyclic antidepressants
  • Medicines to treat anxiety or help you sleep
  • Other medicines for the relief of colds & flu, congestion or blocked nose, appetite suppressants or stimulants
  • Warfarin or similar medicines used to thin the blood
  • Medicines to control your blood pressure, such as beta-blockers
  • Digoxin or similar medicines for heart disease
  • Metoclopramide, a medicine used to control nausea and vomiting
  • Anticonvulsants, medicines used to treat epilepsy or fits
  • Chloramphenicol, an antibiotic used to treat ear and eye infections
  • Alcohol
  • Cholestyramine, a medicine used to lower cholesterol levels in the blood
  • Probenecid, a medicine used to treat gout
  • Medicines used to treat behavioural disorders

These medicines may be affected by PANADOL Cold & Flu Plus Decongestant 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 have more information on medicines to be careful with or avoid while taking this medicine.

How to take PANADOL Cold & Flu Plus Decongestant

Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.

If you do not understand the instructions on the box, ask your doctor or pharmacist 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 (capsule-shaped tablets) with water every 4 to 6 hours if required. Do not take more than 8 caplets in a 24 hour period. It does not matter if you take this medicine before or after food.

How long to take it

Adults:
Only take PANADOL Cold & Flu Plus Decongestant 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 old.

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 Cold & Flu Plus Decongestant. Seek medical advice immediately even if there are no signs of discomfort or poisoning because of the risk of liver failure. You may need urgent medical attention.

Taking too much paracetamol can lead to delayed, serious liver damage.

While you are using PANADOL Cold & Flu Plus Decongestant

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: Do not give to children under the age of 12 years.

Adults: Do not take 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 take PANADOL Cold & Flu Plus Decongestant to treat any other complaints unless your doctor tells you to.

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

Keep out of sight and reach of children.

Things to be careful of

Be careful driving or operating machinery until you know how PANADOL Cold & Flu Plus Decongestant affects you. This medicine may cause drowsiness, dizziness or blurred vision in some people. If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous.

Be careful when drinking alcohol while you are taking this medicine.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking PANADOL Cold & Flu Plus Decongestant.

This medicine helps most people with the relief of sinus congestion and pain, nasal congestion or runny nose but it 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 doctor or pharmacist to answer any questions you may have.

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

  • Headache
  • Dizziness
  • Nervousness
  • Difficulty sleeping
  • Increased blood pressure
  • Nausea
  • Vomiting.

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:

  • If you experience allergic reactions such as:
    - skin rash or itching
    - breathing problems
    - swelling of the lips, tongue, throat or face
    - skin rash or peeling or mouth ulcers.
  • If you have previously experienced breathing problems with aspirin or non-steroidal anti-inflammatories and experience a similar reaction with this product.
  • If you experience unexplained bruising or bleeding.
  • If you experience an unusually fast pulse rate or a sensation of an unusually fast or irregular heartbeat.
  • If you experience loss of vision, which may be due to abnormally high blood pressure in the eye. This is more likely to occur in those with glaucoma.
  • If you experience difficulty in passing water. This is more likely to occur in men with enlarged prostate gland.

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 doctor or pharmacist 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 Cold & Flu Plus Decongestant

Storage

Keep your tablets in the original pack until it is time to take them.

Keep your tablets in a cool dry place where the temperature stays below 30°C.

Do not store PANADOL Cold & Flu Plus Decongestant 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

If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

Product description

What it looks like

PANADOL Cold & Flu Plus Decongestant is white capsule-shaped tablet (caplet) with flat edges, 17.7 mm x 7.1 mm, one face is embossed with the sun graphic within an oval.

Blister packs of 20 caplets.

Ingredients

PANADOL Cold & Flu Plus Decongestant contains 500 mg of paracetamol and 5 mg of phenylephrine hydrochloride as the active ingredients.

It also contains:

  • Cellulose - microcrystalline
  • Potassium sorbate
  • Povidone
  • Sodium lauryl sulphate
  • Starch - maize
  • Starch - pregelatinised maize
  • Stearic acid
  • Talc - purified.

Manufacturer/Distributor/Supplier

PANADOL Cold & Flu Plus Decongestant is supplied in Australia by:

GlaxoSmithKline Consumer Healthcare
82 Hughes Avenue, Ermington,
NSW

This leaflet was prepared in September 2015.

AUST R number 156874

PANADOL is a registered trademark of the GSK group of companies or its licensor.

Published by MIMS November 2016

BRAND INFORMATION

Brand name

Panadol Cold & Flu + Decongestant

Active ingredient

Paracetamol; Phenylephrine hydrochloride

Schedule

Unscheduled

 

Name of the medicine

Paracetamol 500 mg, phenylephrine hydrochloride 5 mg.

Excipients.

Microcrystalline cellulose, potassium sorbate, povidone, sodium lauryl sulphate, maize starch, pregelatinised maize starch, stearic acid, purified talc.

Description

Paracetamol.

CAS: 103-90-2.

Phenylephrine hydrochloride.

CAS: 61-76-7.

Pharmacology

Pharmacodynamics.

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.
Phenylephrine acts predominantly by a direct effect on alpha-adrenergic receptors. Phenylephrine also has an indirect effect by releasing noradrenaline from its storage sites. Phenylephrine is used as a nasal decongestant to provide symptomatic relief by causing vasoconstriction resulting in redistribution of local blood flow to reduce oedema of the nasal mucosa, thus improving ventilation, drainage and nasal stuffiness.

Pharmacokinetics.

Absorption.

Paracetamol is rapidly and almost completely absorbed from the gastrointestinal tract. Food intake delays paracetamol absorption.
Phenylephrine is irregularly absorbed from the gastrointestinal tract. Phenylephrine undergoes first-pass metabolism by monoamine oxidases in the gut and liver; orally administered phenylephrine thus has reduced bioavailability.

Distribution.

Paracetamol is distributed into most body tissues. Binding to the plasma proteins is minimal at therapeutic concentrations but increases with increasing doses.
Phenylephrine undergoes rapid distribution into peripheral tissues. The volume of distribution of phenylephrine is between 200 and 500 L, there appears to be minimal brain penetration, and does not seem to cross the placenta and does not appear to be distributed to any great extent in breast milk.

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.
Phenylephrine undergoes extensive metabolism in the intestinal wall (first-pass) and in the liver. The principal routes of metabolism involve sulfate conjugation (primarily in the intestinal wall) and oxidative deamination (by monoamine oxidase); glucuronidation also occurs to a lesser extent.

Excretion.

Paracetamol is excreted in the urine mainly as the glucuronide and sulphate conjugates. Less than 5% is excreted unchanged. Approximately 85% of a dose of paracetamol is excreted in urine as free and conjugated paracetamol within 24 hours of ingestion. Administration of paracetamol to patients with moderate to severe renal impairment may result in accumulation of paracetamol conjugates. The elimination half-life varies from one to three hours.
Phenylephrine and its metabolites are excreted mainly in urine. Following oral administration approximately 80% of the dose is excreted in urine within 48 hours principally as metabolites. Approximately 2.5% of an oral dose is excreted in the urine as unchanged drug. The elimination half-life averages 2-3 hours following oral administration.

Indications

Panadol Sinus Pain & Congestion Relief Caplets.

For the temporary relief of the pain and congestion of sinusitis.

Panadol Cold & Flu + Decongestant Caplets.

For the temporary relief of cold and flu symptoms including headache, body aches and pain, blocked or runny nose, sore throat. Reduces fever.

Contraindications

This product is contraindicated in patients with a previous history of hypersensitivity to paracetamol, phenylephrine hydrochloride or any of the excipients.
This medicine is also contraindicated in patients who are taking, or have taken within the last two weeks, monoamine oxidase inhibitors. (See Interactions with Other Medicines.)
This medicine is contraindicated in patients with severe hypertension or coronary artery disease.
This product should not be used by patients taking other sympathomimetics (such as decongestants, appetite suppressants and amphetamine-like psychostimulants). (See Interactions with Other Medicines.)

Precautions

Contains paracetamol. Do not use with any other paracetamol containing products, decongestants, or cold and flu medicines. The concomitant use with other products containing paracetamol may lead to an overdose. Paracetamol overdose may cause liver failure which can lead to liver transplant or death.
Caution should be exercised in patients with kidney impairment and in those with hepatic impairment due to the paracetamol content of the product.
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.
Underlying liver disease increases the risk of paracetamol related liver damage.
Caution should be exercised in patients with glutathione depleted states such as sepsis, the use of paracetamol may increase the risk of metabolic acidosis.
Caution should be exercised in patients with cardiovascular disease, hypertension, diabetes, hyperthyroidism, prostatic enlargement, raised intraocular pressure (i.e. glaucoma), phaeochromocytoma and occlusive vascular disease (e.g. Raynaud's phenomenon).
Due to the phenylephrine content of this product, Panadol Sinus Pain & Congestion Relief and Panadol Cold & Flu + Decongestant should be used with caution in patients taking beta-blockers or other antihypertensives.
Due to the phenylephrine content of this product, Panadol Sinus Pain & Congestion Relief and Panadol Cold & Flu + Decongestant should be used with caution in patients taking tricyclic antidepressants.
This product should not be used by patients taking other sympathomimetics (such as decongestants, appetite suppressants and amphetamine like psychostimulants).
If symptoms persist, medical advice must be sought.
Keep out of sight and reach of children.

Use in pregnancy.

(Category B2)
Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of foetal damage.
This product should not be used during pregnancy without medical advice.

Use in lactation.

This product should not be used whilst breastfeeding without medical advice.
Paracetamol is excreted in breast milk. Maternal ingestion of paracetamol in usual analgesic doses does not appear to present a risk to the breastfed infants.
Phenylephrine may be excreted in breast milk.

Use in children.

Do not give to children under 12 years of age.

Effects on ability to drive and use machinery.

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

Interactions

The following interactions with paracetamol have been noted.

Coumarins (including warfarin).

Anticoagulant effect may be enhanced by prolonged regular daily use of paracetamol with increased risk of bleeding. Anticoagulant dosage may require reduction if treatment with paracetamol containing medication is prolonged.

Substances that increase gastric emptying (e.g. metoclopramide).

These substances increase paracetamol absorption.

Substances that decrease gastric emptying (e.g. propantheline, antidepressants with anticholinergic properties, narcotic analgesics).

These substances decrease paracetamol absorption.

Chloramphenicol.

Concentrations may be increased by paracetamol.

Potentially hepatotoxic drugs or drugs that induce liver microsomal enzymes (e.g. alcohol, anticonvulsants).

Risk of paracetamol toxicity may be increased.

Probenecid.

May affect paracetamol excretion and alter paracetamol plasma concentrations.

Colestyramine.

Reduces the absorption of paracetamol if given within one hour of paracetamol.
Phenylephrine should be used with caution in combination with the following drugs as interactions have been reported.

Monoamine oxidase inhibitors.

Hypertensive crisis or a serious increase in blood pressure may occur between phenylephrine and monoamine oxidase inhibitors (see Contraindications).

Sympathomimetic amines such as other decongestants, appetite suppressants and amphetamine-like psychostimulants.

Concomitant use of phenylephrine with other sympathomimetic amines can increase the risk of cardiovascular side effects and other additive effects (see Precautions).

Beta-blockers and other antihypertensives (including debrisoquine, guanethidine, reserpine, methyldopa).

Phenylephrine may reduce the efficacy of beta-blocking drugs and antihypertensive drugs. The risk of hypertension and other cardiovascular side effects may be increased. (See Precautions.)

Tricyclic antidepressants (e.g. amitriptyline).

May increase the risk of cardiovascular side effects with phenylephrine (see Precautions).
Hypertensive crisis may also occur.

Digoxin and cardiac glycosides.

Increase the risk of irregular heartbeat or heart attack.

Adverse Effects

Adverse events from historical clinical trial data are both infrequent and from small patient exposure. Accordingly, events reported from extensive postmarketing experience at therapeutic/ labelled doses and considered attributable are listed below by system organ class and frequency.
The following convention has been utilised for the classification of undesirable effects: very common (≥ 1/10), common (≥ 1/100, < 1/10), uncommon (≥ 1/1,000, < 1/100), rare (≥ 1/10,000, < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from available data).
Adverse event frequencies have been estimated from spontaneous reports received through postmarketing data.

Paracetamol.

The frequency of these reactions is unknown but considered likely to be very rare.

Blood and lymphatic system disorders.

Thrombocytopenia.

Immune system disorders.

Anaphylaxis.
Cutaneous hypersensitivity reactions including skin rashes, angioedema and Stevens-Johnson syndrome.

Respiratory, thoracic and mediastinal disorders.

Bronchospasm, especially in patients sensitive to aspirin and other NSAIDs.

Hepatobiliary disorders.

Hepatic dysfunction.

Phenylephrine.

The following adverse events have been observed in clinical trials with phenylephrine and may therefore represent the most commonly occurring adverse events.

Psychiatric disorders.

Nervousness.

Nervous system disorders.

Headache, dizziness, insomnia.

Cardiac disorders.

Increased blood pressure, tachycardia or arrhythmias.

Gastrointestinal disorders.

Nausea, vomiting.

Central nervous stimulation.

Anxiety.
Adverse reactions identified during postmarketing use are listed below.

Eye disorders.

Rare: mydriasis, acute angle closure glaucoma, most likely to occur in those with closed angle glaucoma (see Precautions).

Cardiac disorders.

Rare: tachycardia, palpitations.

Skin and subcutaneous disorders.

Rare: allergic reactions (e.g. rash, urticaria, allergic dermatitis).

Renal and urinary disorders.

Rare: dysuria, urinary retention. This is most likely to occur in those with bladder outlet obstruction such as prostatic hypertrophy.

Dosage and Administration

Adults and children aged 12 years and over.

2 caplets every 4-6 hours as necessary. Maximum 8 caplets in 24 hours.
Do not use for more than a few days at a time in adults except on medical advice.
Should not be used for more than 48 hours for children aged 12-17 except on medical advice.
Do not give to children under 12 years of age.
Do not exceed the stated dose or frequency of dosing.
The lowest dose necessary to achieve efficacy should be used.
Should not be used with other paracetamol containing products, decongestants or cough and cold medicines.
Do not use within several hours of going to bed as it may cause sleeplessness.
Minimum dosing interval: 4 hours.

Renal and hepatic impairment.

Patients who have been diagnosed with liver or kidney impairment must seek medical advice before taking this medication. The restrictions related to the use of such combinations in these patients is primarily a consequence of the paracetamol content of the product. (See Precautions.)

Overdosage

Immediate medical management is required in the event of an overdose even if the symptoms of overdose are not present.
If an overdose is taken or suspected, contact the Poisons Information Centre immediately for advice (131 126) or the patient should go to the nearest hospital straight away. This should be done even if they feel well because of the risk of delayed, serious liver damage.

Paracetamol.

Symptoms and signs.

Paracetamol overdose may cause liver failure which can lead to liver transplant or death.

Treatment.

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.

Phenylephrine.

Symptoms and signs.

Overdose is likely to result in effects similar to those listed under Adverse Effects. Additional symptoms may include irritability, restlessness, hypertension, and possibly reflex bradycardia. In severe cases confusion, hallucinations, seizures and arrhythmias may occur.

Treatment.

Treatment should be as clinically appropriate. Severe hypertension may need to be treated with an alpha-blocking drug such as phentolamine.

Presentation

Panadol Sinus Pain & Congestion Relief Caplets.

Tablets, paracetamol 500 mg, phenylephrine HCl 5 mg (white, capsule shaped, flat edges, 17.7 mm x 7.1 mm, marked with sun in oval on one side): 10's, 24's (blister pack, AUST R 147590).

Panadol Cold & Flu + Decongestant Caplets.

Tablets, paracetamol 500 mg, phenylephrine HCl 5 mg (white, capsule shaped, flat edges, 17.7 mm x 7.1 mm, marked with sun in oval on one side): 20's (blister pack, AUST R 156874).

Storage

Store below 30°C.

Poison Schedule

Unscheduled.