NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.
PANADOL® SINUS RELIEF ORIGINAL FORMULA
ORIGINAL FORMULA
Paracetamol 500 mg and Pseudoephedrine Hydrochloride 30 mg
Consumer Medicine Information
Please read this information before you start using this medicine.
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 is a white, capsule shaped tablet with flat edges One face marking PANADOL, SINUS on the other 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:
GlaxoSmithKline
Consumer Healthcare
82 Hughes Avenue,
Ermington, NSW 2115
ACN 008 399 415
The Australian Registration number is:
AUST R 35521
Date of preparation: December 2017
PANADOL® is a registered trade mark of the GlaxoSmithKline group of companies.
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