Panadol Flu Strength Day & Night
NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.
PANADOL® FLU STRENGTH DAY & NIGHT CAPLETS
Day caplet – Paracetamol 500mg, Dextromethorphan Hydrobromide 15mg, Phenylephrine Hydrochloride 5mg; Night caplet – Paracetamol 500mg, Dextromethorphan Hydrobromide 15mg, Phenylephrine Hydrochloride 5mg and Chlorpheniramine Maleate 2mg
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about PANADOL FLU STRENGTH DAY & NIGHT caplets.
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 FLU STRENGTH DAY & NIGHT caplets 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 FLU STRENGTH DAY & NIGHT CAPLETS are used for
PANADOL FLU STRENGTH DAY & NIGHT CAPLETS are used for the temporary relief of the following symptoms of cold and flu:headache, runny or blocked nose, sore throat, dry cough, body aches and pains.Reduces fever. The NIGHT caplet also relieves runny nose, sneezing, itchy and watery eyes and allows rest by providing effective temporary relief from these symptoms.
PANADOL FLU STRENGTH DAY caplets contain the active ingredients paracetamol, dextromethorphan hydrobromide and phenylephrine hydrochloride.
PANADOL FLU STRENGTH NIGHT caplets contain the active ingredients paracetamol, dextromethorphan hydrobromide, phenylephrine hydrochloride and chlorpheniramine maleate.
Paracetamol works to stop the pain messages from getting through to the brain.It also acts in the brain to reduce fever.
Dextromethorphan hydrobromide is a cough suppressant that is used to suppress a dry cough.
Phenylephrine HCl works to reduce nasal stuffiness.
Chlorpheniramine maleate belongs to a group of medicines called ‘antihistamines’.Antihistamines help reduce allergic symptoms by preventing the effects of a substance called histamine.Histamine is produced by the body in response to foreign substances that the body is allergic to.
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 in the pharmacy.
Before you take/give PANADOL FLU STRENGTH DAY & NIGHT CAPLETS
Taking too much paracetamol can cause serious harm to your liver.
When you must not take it
Do not take PANADOL FLU STRENGTH DAY & NIGHT CAPLETS if you have an allergy to:
any medicine containing paracetamol, dextromethorphan, phenylephrine, chlorpheniramine or other antihistamines.
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, itching or hives on the skin or mouth ulcers
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
if you have very high blood pressure, heart problems or are taking antidepressant medicines unless your doctor has told you to
if you are taking or have taken in the last 14 days, drugs called monoamine oxidase inhibitors, medicines used to treat depression
if you are taking other medicines for the relief of colds and flu, congestion or blocked nose, appetite suppressants or stimulants, or other medicines containing antihistamines (sometimes used to treat allergy)
if you are underweight or malnourished
if you regularly drink alcohol
You may need to avoid using this product altogether or limit the amount of paracetamol that you take
if you have a chest infection, worsening asthma or severe respiratory problems
if you are having an asthma attack
if you are pregnant or breastfeeding
if you have:
glaucoma (high pressure in the eyes)
stomach or duodenal ulcer, or other stomach problems
prostate problems
bladder problems
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.
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 had any of the following medical conditions:
liver or kidney disease
overactive thyroid gland
heart disease, blood vessel disease such as Raynaud’s phenomenon (which may appear as pain in the fingers or toes in response to cold or stress)
high blood pressure
irregular heartbeat
epilepsy (fits)
diabetes
glaucoma (high pressure in the eyes)
phaeochromocytoma (a tumour near the kidney)
prostate gland enlargements
long term or persistent cough
asthma, bronchitis or a chronic lung disorder or a cough with excessive phlegm
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.
Ask your pharmacist or doctor about taking PANADOL FLU STRENGTH DAY & NIGHT CAPLETS 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 FLU STRENGTH DAY & NIGHT CAPLETS.
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 FLU STRENGTH DAY & NIGHT CAPLETS may interfere with each other.These include:
warfarin, a medicine used to prevent blood clots or similar medicines used to thin the blood
medicines to treat anxiety, or help you sleep or relax (sedatives and hypnotics)
phenytoin, a medicine used to treat epilepsy (fits)
medicines to treat depression (e.g. a selective serotonin reuptake inhibitor (SSRI) such as fluoxetine, or tricyclic antidepressant (such as amitriptyline, clomipramine or imipramine)
metoclopramide, a medicine used to control nausea and vomiting
chloramphenicol, an antibiotic used to treat ear and eye infections
alcohol
monoamine oxidase inhibitors, a medicine used to treat depression, especially if taken within the last 14 days
quinidine and amiodarone, medicines used to treat abnormal or irregular heartbeat
medicines used to treat:
heart conditions
high blood pressure
urinary tract infections and bladder problems
behavioural disorders
congestion
appetite suppressants
opioid analgesics, medicines used to treat pain
These medicines may be affected by PANADOL FLU STRENGTH DAY & NIGHT CAPLETS or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.
Your pharmacist and doctor will have more information on these and other medicines to be careful with or avoid while taking this medicine.
How to take PANADOL FLU STRENGTH DAY & NIGHT
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/bottle, 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 (capsule-shaped tablets).Do not take more than 4 DAY caplets and 2 NIGHT caplets within 24 hours.
Do not take more than the recommended dose.
How to take
Take 2 caplets (capsule-shaped tablets) of PANADOL FLU STRENGTH DAY & NIGHT CAPLETS by mouth with fluid as necessary.
When to take it
Adults and children 12 years and over:
DAY:
Take 2 DAY caplets every 6 hours with water as necessary.
Maximum 4 DAY caplets in 24 hours
NIGHT:
At bedtime, take 2 NIGHT caplets with water as necessary.
Maximum 2 NIGHT caplets in 24 hours.
Do not take the NIGHT caplets within 6 hours of the DAY caplets.
How long to take it
Adults and children 12 years and over:
Only take PANADOL FLU STRENGTH DAY & NIGHT CAPLETS 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 in Australia or 0800 764 766 in 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 FLU STRENGTH DAY & NIGHT CAPLETS.Seek medical advice immediately even if there are no signs or symptoms 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 FLU STRENGTH DAY & NIGHT
Things you must do
Talk to your pharmacist or doctor if your symptoms do not improve or if your cough is accompanied by high temperature, skin rash or persistent headache.
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 PANADOL FLU STRENGTH DAY & NIGHT CAPLETS 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 FLU STRENGTH DAY & NIGHT CAPLETS 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.
Keep out of sight and reach of children.
Do not drink alcohol (wine, beer, spirits) while taking PANADOL FLU STRENGTH DAY & NIGHT CAPLETS.
The sedation effects of alcohol may be increased.
Things to be careful of
Avoid drinking alcohol (beer, wine or spirits) while taking PANADOL FLU STRENGTH DAY & NIGHT CAPLETS.
Drinking alcohol while taking PANADOL FLU STRENGTH DAY & NIGHT CAPLETS may increase the risk of side effects.
This medicine may cause drowsiness, dizziness or blurred vision in some people.You should not drive or operate machinery until you are sure you are not affected.
Side effects
Tell your pharmacist or doctor as soon as possible if you do not feel well while you are taking PANADOL FLU STRENGTH DAY & NIGHT CAPLETS.
This medicine helps most people with the relief of sinus congestion and pain, nasal congestion, runny nose or dry cough 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.
Children and the elderly are more likely to develop side effects with this medicine.
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, dyspepsia or vomiting
drowsiness or sleepiness
difficulty sleeping
nervousness
fatigue
headache
blurred vision
excitability
restlessness
dizziness
difficulty concentrating
lack of co-ordination
rapid heart beat
increased blood pressure
dry mouth, nose and throat
nervousness and irritability
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:
allergic reactions such as
skin rash or peeling, or mouth ulcers
skin rash or itching, redness sometimes with breathing problems (difficulty breathing)
swelling of mouth or eyes, lips, tongue, throat or face
previously experienced breathing problems with aspirin or non-steroidal anti-inflammatories, and experience similar reactions with this product
difficulty passing water (this is most likely to occur in men with enlarged prostate gland)
unexplained bruising or bleeding
severe drowsiness or dizziness
severe excitability
unusually fast pulse rate or a sensation of an unusually fast or irregular heartbeat
tremor
hallucinations (this is rare but more likely in children)
twitching or jerking muscles
severe nausea and vomiting
experience some or all of the following symptoms:
extreme confusion
nervousness and anxiety
restlessness
sweating
shaking
shivering
sudden jerks of the muscles
increased blood pressure
These may be symptoms of a condition called serotonin syndrome, which may be rare.
loss of vision, which may be due to abnormally high blood pressure in the eye.
This is very rare but is more likely to occur in those with glaucoma.
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 FLU STRENGTH DAY & NIGHT CAPLETS
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 FLU STRENGTH DAY & NIGHT CAPLETS 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 FLU STRENGTH DAY CAPLETS are blue capsule-shaped tablet with flat edges. One face is marked with the sun within an oval.
PANADOL FLU STRENGTH NIGHT CAPLETS tablet are white capsule-shaped tablet with flat edges.One face is marked with a crescent within an oval.
A pack contains 24 caplets consisting of 16 DAY (blue) caplets and 8 NIGHT (white) caplets.
Ingredients
PANADOL FLU STRENGTH DAY CAPLET contains 500mg paracetamol, 5mg Phenylephrine Hydrochloride and 15mg Dextromethorphan Hydrobromide as the active ingredients.
The DAY caplet also contains:
Cellulose – microcrystalline
Potassium sorbate
Povidone
Sodium lauryl sulfate
Starch – maize
Starch – pregelatinised maize
Stearic acid
Talc – purified
Indigo Carmine
PANADOL FLU STRENGTH NIGHT CAPLET contains 500mg Paracetamol, 5mg Phenylephrine Hydrochloride, 15mg Dextromethorphan Hydrobromide and 2mg of Chlorpheniramine Maleate as the active ingredients.
The NIGHT caplet also contains:
Cellulose – microcrystalline
Potassium Sorbate
Povidone
Sodium Lauryl sulfate
Starch – Maize
Starch – pregelatinised maize
Stearic acid
Talc – purified
Water – purified
Manufacturer/Distributor
PANADOL FLU STRENGTH DAY & NIGHT CAPLETS is supplied in Australia and New Zealand by:
GlaxoSmithKline Consumer Healthcare
82 Hughes Avenue, Ermington, NSW and Auckland, New Zealand
This leaflet was prepared in September 2015.
AUST R 148714
PANADOL is a registered trade mark of the GSK group of companies or its licensor.
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