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Panadol® Cold & Flu
Original Formula

Paracetamol 500 mg, Pseudoephedrine Hydrochloride 30 mg and Dextromethorphan Hydrobromide 15 mg


Consumer Medicine Information

What is in this leaflet

This leaflet answers some common questions about PANADOL COLD & FLU 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 COLD & FLU 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 COLD & FLU ORIGINAL FORMULA is used for

PANADOL COLD & FLU ORIGINAL FORMULA is used for the fast effective temporary relief of the symptoms of cold & flu.

PANADOL COLD & FLU ORIGINAL FORMULA caplets contain the active ingredients paracetamol, pseudoephedrine hydrochloride and dextromethorphan hydrobromide.

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.

Dextromethorphan is a cough suppressant that acts on the cough centre in the brain to suppress a dry cough.

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 COLD & FLU ORIGINAL FORMULA

When you must not take it

Do not take PANADOL COLD & FLU ORIGINAL FORMULA if you have an allergy to:

  • any medicine containing paracetamol, pseudoephedrine hydrochloride and dextromethorphan hydrobromide
  • 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:

  • very high blood pressure
  • severe coronary artery disease (heart disease caused by poor blood flow or narrowing of the blood vessels of the heart)
  • Kidney problems
  • taken monoamine oxidase inhibitors, medicines used to treat depression, in the last 14 days
  • In 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 if you are having an asthma attack.

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 or kidney disease
  • 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
  • epilepsy
  • bronchitis, asthma or other respiratory problems

Ask your pharmacist or doctor about taking PANADOL COLD & FLU 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 breastfeeding.

If you have not told your pharmacist or doctor about any of the above, tell him/her before you start taking PANADOL COLD & FLU 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 COLD & FLU ORIGINAL FORMULA 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
  • medicines used to treat depression
  • medicines used to treat heart conditions
  • medicines used to treat high blood pressure
  • 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
  • monoamine oxidase inhibitors, a medicine used to treat depression, especially if taken within the last 14 days
  • Other decongestant or cough and cold medicines
  • quinidine and amiodarone, medicines used to treat abnormal or irregular heart beat
  • opioid analgesics used to treat pain
  • medicines used to help you relax, sleep or relieve anxiety, such as sedatives

These medicines may be affected by PANADOL COLD & FLU 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 COLD & FLU 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.

How much to take

Adults and children 12 years and over, take 2 caplets.

Do not take more than 8 caplets within 24 hours.

Do not take more than the recommended dose.

How to take

Take 2 caplets of PANADOL COLD & FLU ORIGINAL FORMULA by mouth with fluid.

When to take it

Every 6 hours as necessary.

How long to take it

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

Children 12 to 17 years:
Only give to children for up to 48 hours unless a doctor has told you to give it longer.

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 COLD & FLU 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 COLD & FLU 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 take PANADOL COLD & FLU 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 take more than the recommended dose unless your doctor tells you to.

Do not take PANADOL COLD & FLU 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

Only drink small quantities of alcohol (beer, wine or spirits) while taking PANADOL COLD & FLU ORIGINAL FORMULA. Drinking large quantities of alcohol while taking PANADOL COLD & FLU ORIGINAL FORMULA may increase the risk of liver side effects.

Be careful driving or operating machinery until you know how PANADOL COLD & FLU 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 COLD & FLU ORIGINAL FORMULA. This medicine helps most people with the relief of sinus congestion and pain, nasal congestion and runny nose but there may be 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
  • mild drowsiness
  • difficulty sleeping
  • nervousness
  • excitability
  • restlessness
  • dizziness
  • fear or anxiety
  • rapid heart beat
  • tremor
  • hallucinations
  • fatigue
  • nausea
  • vomiting
  • stomach discomfort
  • constipation
  • muscle spasms affecting the eyes, head, neck and body

The above list includes the more common side effects of your medicine. They are usually mild.

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:

  • excitation
  • extreme confusion
  • nervousness and anxiety
  • irritability
  • restlessness
  • severe nausea and vomiting
  • 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 COLD & FLU ORIGINAL FORMULA

Storage

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

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

Do not store PANADOL COLD & FLU 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 COLD & FLU ORIGINAL FORMULA is a white, capsule-shaped tablet with flat edges, one face marked with C & F, PANADOL on the other. A pack contains 24 tablets.

Ingredients

PANADOL COLD & FLU ORIGINAL FORMULA contains 500 mg of paracetamol, 30 mg of pseudoephedrine hydrochloride and 15 mg of dextromethorphan hydrobromide as the active ingredients.

It also contains:

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

Manufacturer/Distributor/Supplier

PANADOL COLD & FLU ORIGINAL FORMULA is manufactured and supplied in Australia by:
GlaxoSmithKline Consumer Healthcare
82 Hughes Avenue, Ermington, NSW
CAN 008 399 415

The Australian registration number is:
AUST R 10858

Date of preparation: May 2014

PANADOL is a registered trade mark of the GlaxoSmithKline group of companies.

® = Registered Trademark

Published by MIMS September 2014

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