NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.
SUDAFED SINUS DAY + NIGHT RELIEF TABLETS
Pseudoephedrine hydrochloride, Paracetamol, Triprolidine hydrochloride
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about Sudafed Sinus Day + Night Relief Tablets. 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 Sudafed Sinus Day + Night Relief 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 Sudafed Sinus Day + Night Relief is used for
Sudafed Sinus Day + Night Relief provides fast and effective relief from sinus pain and congestion, day and night.
Pseudoephedrine 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.
Paracetamol works to stop the pain messages from getting through to the brain. It also acts in the brain to
reduce fever.
Triprolidine 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 only available from your pharmacist.
Before you take Sudafed Sinus Day + Night Relief
When you must not take it
Do not take Sudafed Sinus Day + Night Relief if you have an allergy to:
any medicine containing pseudoephedrine
any medicine containing paracetamol
any medicine containing triprolidine 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 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).
Do not take this medicine if you have or have had any of the following medical conditions:
glaucoma (high pressure in the eyes)
stomach or duodenal ulcer, or other stomach problems
prostate problems
bladder problems.
Do not take this medicine if you are also taking monoamine oxidase inhibitors (a type of medicine used to treat depression), or if you have taken monoamine oxidase inhibitors in the last 14 days.
Do not give this medicine to newborn or premature babies.
Do not take this medicine after the expiry date (EXP) 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:
respiratory condition (such as emphysema, chronic bronchitis or acute or chronic bronchial asthma)
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
liver or kidney disease
alcohol dependence
epilepsy.
Tell your pharmacist or doctor if you take sedatives.
Tell your pharmacist or doctor if you are pregnant or plan to become pregnant.
Your pharmacist or doctor will discuss the benefits and possible risks of taking the medicine during pregnancy.
Tell your pharmacist or doctor if you are breastfeeding or plan to breastfeed.
Your pharmacist or doctor will discuss the benefits and possible risks of taking the medicine while breastfeeding.
If you have not told your pharmacist or doctor about any of the above, tell him/her before you start taking Sudafed Sinus Day + Night Relief.
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 Sudafed Sinus Day + Night Relief may interfere with each other. These include:
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
medicines used to treat behavioural disorders
phenylephrine, a medicine used to treat congestion
appetite suppressants
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
medicines used to help you sleep or relax (sedatives and hypnotics)
opioid analgesics, medicines used to treat pain
alcohol.
These medicines may be affected by Sudafed Sinus Day + Night Relief 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 Sudafed Sinus Day + Night Relief
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
The recommended dose of Sudafed Sinus Day + Night Relief for adults and children 12 years and over is:
Day time: 2 DAY tablets in the morning and 2 tablets in the afternoon.
Night time: 2 NIGHT tablets in the evening at bedtime.
Children under 12 years of age should not take this medicine.
Do not take more than the recommended dose.
If you are over 65 years of age, talk to you pharmacist or doctor about how much to take.
You may have an increased chance of getting side effects.
How long to take it
As Sudafed Sinus Day + Night Relief contains paracetamol, take only for a few days at a time unless your doctor tells you to take it for longer.
If you forget to take it
If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.
Otherwise, you may take a dose as soon as you remember if you think you need it.
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 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 Sudafed Sinus Day + Night Relief. Do this even if there are no signs of discomfort or poisoning.
While you are using Sudafed Sinus Day + Night Relief
Things you must do
Talk to your pharmacist or doctor if your symptoms do not improve, worsen, or if new symptoms appear.
Your pharmacist or doctor will assess your condition and decide if you should continue to take the medicine.
Things you must not do
Do not take for more than a few days at a time unless your doctor tells you to.
Do not drink alcohol while taking Sudafed Sinus Day + Night Relief.
The sedative effects of alcohol may be increased.
Drinking large quantities of alcohol while taking this medicine may also increase the risk of liver side effects.
Do not take Sudafed Sinus Day + Night Relief 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 take more than the recommended dose unless your doctor tells you to.
Things to be careful of
Be careful driving or operating machinery until you know how Sudafed Sinus Day + Night Relief affects you.
This medicine may cause dizziness or sleepiness in some people.If this happens, do not drive or operate machinery.
Side effects
Tell your pharmacist or doctor as soon as possible if you do not feel well while you are taking Sudafed Sinus Day + Night Relief.
This medicine helps most people with sinus pain and congestion, 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 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
constipation
drowsiness or sleepiness
dizziness
difficulty sleeping
nervousness and irritability
excitability
restlessness
fear or anxiety
twitching or jerking muscles
dry mouth, nose and throat
rapid heart beat
tremor
hallucinations
rectal bleeding
small bumps on the skin with or without fever or reddening of the skin.
The above list includes the more common side effects of your medicine.They are usually mild and short-lived.
Children and people over 65 years of age may have an increased chance of getting side effects.
Tell your doctor as soon as possible if you notice any of the following:
difficult or painful urination
seizures (fits).
The above list includes serious side effects that may require medical attention.These side effects are rare.
If any of the following happen, tell your pharmacist or doctor immediately or go to Accident and Emergency at your nearest hospital:
urine retention
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.
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 Sudafed Sinus Day + Night Relief
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 Sudafed Sinus Day + Night Relief 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 your medicine 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
Sudafed Sinus Day + Night Relief contain two types of tablets:
The DAY tablets which are white, round, flat and uncoated with wide bevelled edges. They are scored and coded ‘P3F’ on one face, and plain on the other face.
The NIGHT tablets are turquoise, bevelled, capsule-shaped, flat and uncoated. They are scored on one face and coded ‘S3F’ each side of the score, and plain on the other face.
Sudafed Sinus Day + Night Relief tablets are available in blister packs of 24 tablets (16 DAY tablets and 8 NIGHT tablets).
Ingredients
The DAY tablets contain 30 mg of pseudoephedrine hydrochloride and 500 mg of paracetamol as the active ingredients.
The DAY tablets also contain the following inactive ingredients:
microcrystalline cellulose
hydroxypropylcellulose
magnesium stearate
sodium starch glycollate
pregelatinised wheat starch
stearic acid.
The NIGHT tablets contain 30 mg of pseudoephedrine hydrochloride, 500 mg of paracetamol and 1.25 mg of triprolidine hydrochloride as the active ingredients.
The NIGHT tablets also contain the following inactive ingredients:
brilliant blue FCF
microcrystalline cellulose
hydroxypropylcellulose
magnesium stearate
povidone
quinoline yellow.
This medicine does not contain lactose, sucrose, tartrazine or any other azo dyes.
Name and Address of Sponsor
Johnson & Johnson Pacific
45 Jones Street
Ultimo NSW 2007
AUSTRALIA
SUDAFED is a registered trademark.
This leaflet was prepared in September 2018.
Australian Register Number:
AUST R 46869
Source: Read Full Article