Day tablet – Paracetamol 500 mg and Pseudoephedrine Hydrochloride 30 mg; Night tablet – Paracetamol 500 mg, Pseudoephedrine Hydrochloride 30 mg and Chlorpheniramine Maleate 2 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 DAY & NIGHT 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 DAY & NIGHT 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 DAY & NIGHT ORIGINAL FORMULA is used for
PANADOL SINUS RELIEF DAY & NIGHT ORIGINAL FORMULA is used for the fast effective temporary relief of sinus pain and congestion day and night. It also reduces fever. The NIGHT formula also relieves runny nose, sneezing, itchy and watery eyes and allows rest by providing effective temporary relief from these symptoms.
PANADOL SINUS RELIEF DAY ORIGINAL FORMULA caplets® contain the active ingredients paracetamol and pseudoephedrine hydrochloride.
PANADOL SINUS RELIEF NIGHT ORIGINAL FORMULA tablets contain the active ingredients paracetamol, pseudoephedrine 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.
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.
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 from your pharmacist.
Before you take/give PANADOL SINUS RELIEF DAY & NIGHT ORIGINAL FORMULA
When you must not take it
Do not take PANADOL SINUS RELIEF DAY & NIGHT ORIGINAL FORMULA if you have an allergy to:
- any medicine containing paracetamol, pseudoephedrine hydrochloride, chlorpheniramine maleate 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 or other parts of the body
- rash, itching or hives on the skin
Do not use this medicine if you:
- have high blood pressure
- have heart disease
- have kidney disease unless your doctor says you can
- have taken monoamine oxidase inhibitors, medicines used to treat depression, in the last 14 days
- you are taking other medicines for the relief of colds and flu, congestion or blocked nose, stimulant drugs called amphetamines (sometimes used to treat attention deficit disorders), or appetite suppressants, or other medicines containing antihistamines (sometimes used to treat allergy)
- are breastfeeding
- have glaucoma (high pressure in the eyes)
- have stomach or duodenal ulcer, or other stomach problems
- have prostate problems
- have bladder problems
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 problems
- kidney problems
- You are taking medicines to control your blood pressure e.g. medicines called beta blockers
- overactive thyroid gland
- irregular heartbeat
- diabetes
- glaucoma (high pressure in the eyes)
- prostate problems
- epilepsy
- phaeochromocytoma
- You have asthma, bronchitis or a chronic lung disorder
- You are taking warfarin or similar medicines used to thin the blood
- You are taking medicines to treat anxiety or help you sleep
- You are taking medicines containing phenytoin for epilepsy (fits)
Ask your pharmacist or doctor about taking PANADOL SINUS RELIEF DAY & NIGHT 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.
This medicine should not be taken if you are pregnant or breastfeeding unless your doctor has told you to.
If you have not told your pharmacist or doctor about any of the above, tell him/her before you start taking PANADOL SINUS RELIEF DAY & NIGHT 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 DAY & NIGHT 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 especially monoamine oxidase inhibitors and tricyclic antidepressants
- medicines used to treat heart conditions
- medicines used to treat high blood pressure
- medicines used to treat urinary tract infections and bladder problems
- other decongestant or cough and cold medicines
- medicines used to treat behavioural disorders
- phenylephrine, a medicine used to treat congestion
- appetite suppressants
- medicines used to help you sleep or relax (sedatives and hypnotics)
- opioid analgesics, medicines used to treat pain
- phenytoin, a medicine used to treat epilepsy
These medicines may be affected by PANADOL SINUS RELIEF DAY & NIGHT 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 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 SINUS RELIEF DAY & NIGHT 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:
- DAY caplet:
Take 2 caplets. Do not take more than 6 DAY caplets in 24 hours. - NIGHT tablets:
Take 2 tablets at bedtime. Do not take more than 2 NIGHT tablets in 24 hours.
Do not take more than the recommended dose.
How to take it
Take 2 caplets/tablets of PANADOL SINUS RELIEF DAY & NIGHT ORIGINAL FORMULA by mouth with fluid as necessary. Swallow with water or other fluid.
When to take it
Adults and children 12 years and over:
- DAY: Take 2 DAY caplets every 6 hours with water as necessary.
Maximum 6 DAY caplets in 24 hours. - NIGHT: At bedtime, take 2 NIGHT tablets with water as necessary.
Maximum 2 NIGHT tablets in 24 hours.
Do not take PANADOL SINUS RELIEF DAY ORIGINAL FORMULA within 6 hours of PANADOL SINUS RELIEF NIGHT ORIGINAL FORMULA.
How long to take it
Adults:
Only take PANADOL SINUS RELIEF DAY & NIGHT 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 old.
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 DAY & NIGHT 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 DAY & NIGHT 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 DAY & NIGHT 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 DAY & NIGHT 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.
Do not drink alcohol while taking PANADOL SINUS RELIEF DAY & NIGHT. The sedation effects of alcohol may be increased.
Things to be careful of
Avoid drinking alcohol (beer, wine or spirits) while taking PANADOL SINUS RELIEF DAY & NIGHT ORIGINAL FORMULA. Drinking alcohol while taking PANADOL SINUS RELIEF DAY & NIGHT ORIGINAL FORMULA may increase the risk of liver side effects.
Be careful driving or operating machinery until you know how PANADOL SINUS RELIEF DAY & NIGHT ORIGINAL FORMULA affects you. This medicine may cause dizziness or sleepiness in some people. If this happens, do not drive or use 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 DAY & NIGHT 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.
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
- hallucinations (this is rare but more likely in children)
- dry mouth nose and throat
- nervousness and irritability
- twitching or jerking muscles
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
- difficult or painful urination (this is most likely to occur if you have an enlarged prostate)
- unexplained bruising or bleeding
- rapid or irregular heartbeat
- 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 DAY & NIGHT 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 DAY & NIGHT 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 DAY ORIGINAL FORMULA caplet is a white, film-coated capsule-shaped tablet with flat edges, front and back faces marked with DAY.
- PANADOL SINUS RELIEF NIGHT ORIGINAL FORMULA tablet is a white, film-coated round tablet with bevelled edges, front and back faces marked with NIGHT.
A pack contains 24 tablets.
Ingredients
PANADOL SINUS RELIEF DAY ORIGINAL FORMULA caplet contains 500 mg of Paracetamol and 30 mg of Pseudoephedrine Hydrochloride as the active ingredients.
The DAY tablet also contains:
- Talc – purified
- Starch – Maize
- Starch – pregelatinised maize
- Stearic acid
- Povidone
- Sodium benzoate
- Hypromellose
- Glycerol triacetate
- Titanium dioxide
- Carnauba wax
- Water – purified
PANADOL SINUS RELIEF NIGHT ORIGINAL FORMULA tablet contains 500 mg of Paracetamol, 30 mg of Pseudoephedrine Hydrochloride and 2 mg of Chlorpheniramine Maleate as the active ingredients.
The NIGHT tablet also contains:
- Starch – Maize
- Starch – pregelatinised
- Povidone
- Sodium Benzoate
- Talc-purified
- Silica – colloidal anhydrous
- Stearic acid
- Hypromellose
- Glycerol triacetate
- Titanium dioxide
- Carnauba wax
- Water – purified
Manufacturer/Supplier
PANADOL SINUS RELIEF DAY & NIGHT 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 50361
Date of preparation: May 2014
PANADOL® is a registered trade mark of the GlaxoSmithKline group of companies.
Published by MIMS September 2014
