Sudafed Sinus + Allergy & Pain Relief Tablets

NOTICE: This Consumer Medicine Information (CMI) is intended for persons living in Australia.

Active ingredient(s): Paracetamol, Pseudoephedrine hydrochloride and Triprolidine hydrochloride
Consumer Medicine Information (CMI)
This leaflet provides important information about using Sudafed Sinus + Allergy & Pain Relief. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Sudafed Sinus + Allergy & Pain Relief.
Where to find information in this leaflet:

Why am I using Sudafed Sinus + Allergy & Pain Relief?

Sudafed Sinus + Allergy & Pain Relief contains the active ingredient Paracetamol, Pseudoephedrine hydrochloride and Triprolidine hydrochloride. Paracetamol is an analgesic. It 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. 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.
Sudafed Sinus + Allergy & Pain Relief is used for the temporary relief of severe sinus pain & congestion, nasal congestion, headache & pain, allergic symptoms such as sneezing, itching and water eyes.

What should I know before I use Sudafed Sinus + Allergy & Pain Relief?

Warnings

Do not use Sudafed Sinus + Allergy & Pain Relief if:

you are allergic to Paracetamol, Pseudoephedrine hydrochloride, Triprolidine hydrocholoride or other antihistamines, or any of the ingredients listed at the end of this leaflet.
Always check the ingredients to make sure you can use this medicine.
you are younger than 12 years
have very high blood pressure
have severe coronary artery disease (heart disease caused by poor blood flow or narrowing of the blood vessels of the heart)
have taken other products containing paracetamol
have taken antihistamines
have taken monoamine oxidase inhibitors, medicines used to treat depression, in the last 14 days.

Check with your doctor or pharmacist if you:

have any other 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
take sedatives
take any medicines for any other condition
During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor or pharmacist if you are pregnant or intend to become pregnant.
Talk to your doctor or pharmacist if you are breastfeeding or intend to breastfeed.
Small amounts of pseudoephedrine pass into the breast milk. Your pharmacist or doctor will discuss the potential benefits and risks of taking the medicine if you are breastfeeding.

What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.
Some medicines may interfere with Sudafed Sinus + Allergy & Pain Relief and affect how it works.
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 behavioral 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
alcohol
medicines used to help you sleep or relax (sedatives and hypnotics)
opioid analgesics, medicines used to treat pain
flucloxacillin, an antibiotic used to treat skin infections.
You may need different amounts of your medicines, or you may need to take different medicines.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Sudafed Sinus + Allergy & Pain Relief.

How do I use Sudafed Sinus + Allergy & Pain Relief?

How much to take

The recommended dose of Sudafed Sinus + Allergy & Pain Relief for adults and children over 12 years is 2 tablets 3 to 4 times a day, as necessary.
Follow the instructions provided with the medicine.
Do not exceed 8 tablets in 24 hours.
Do not exceed the recommended dosage.

When to take Sudafed Sinus + Allergy & Pain Relief

Sudafed Sinus + Allergy & Pain Relief should be taken 3 to 4 times a day, as necessary.

How to take Sudafed Sinus + Allergy & Pain Relief

Swallow the tablets whole.
Do not use for more than a few days at a time except on medical advice.
Follow all directions given to you by your pharmacist or doctor carefully. This may differ from the information contained in this leaflet.
If you forget to take it and 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.
If you do not understand the instructions on the pack, ask your pharmacist or doctor for help.

If you use too much Sudafed Sinus + Allergy & Pain Relief

If you think that you have used too much Sudafed Sinus + Allergy & Pain Relief, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling 13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.

What should I know while using Sudafed Sinus + Allergy & Pain Relief?

Things you should do

Stop use and talk to your doctor or pharmacist if your symptoms persist, worsen, or if new symptoms occur. Your doctor or pharmacist will assess your condition and decide if you should continue to take the medicine.
Remind any doctor, dentist or pharmacist you visit that you are using Sudafed Sinus + Allergy & Pain Relief.

Things you should not do

Do not take Sudafed Sinus + Allergy & Pain 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 pharmacist or doctor tells you to.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Sudafed Sinus + Allergy & Pain Relief affects you.
Sudafed Sinus + Allergy & Pain Relief may cause dizziness in some people.
If this happens, do not drive or operate machinery.

Drinking alcohol

Tell your doctor or pharmacist if you drink alcohol.
Do not drink alcohol while taking Sudafed Sinus + Allergy & Pain Relief. The sedative effects of alcohol may be increased.

Looking after your medicine

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 25°C.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.
Do not use this medicine after the expiry date.

Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions.

Less serious side effects

Less serious side effects
What to do
nausea or dyspepsia
stomach discomfort
diarrhoea
pain when passing urine
vomiting
constipation
drowsiness or sleepiness
dizziness
insomnia
difficulty sleeping
nervousness
excitability
feeling of extreme happiness
restlessness
fear or anxiety
twitching or jerking muscles
dry mouth, nose and throat
nose bleed
rapid or irregular heart beat
tremor
headache
hallucinations
rectal bleeding
small bumps on the skin with or without fever or reddening of the skin
Speak to your doctor or pharmacist if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effects
What to do
urine retention
pain when passing urine
seizures (fits)
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
Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.
Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.
Other side effects not listed here may occur in some people. Children and people over 65 years if age may have an increased chance of getting side effects.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of this medicine.

Product details

This medicine is available over-the-counter without a doctor's prescription.

What Sudafed Sinus + Allergy & Pain Relief contains

Active ingredient
(main ingredient)
Paracetamol
Pseudoephedrine hydrochloride
Triprolidine hydrochloride
Other ingredients
(inactive ingredients)
Brilliant blue FCF
Ethanol
Hyprolose
Magnesium stearate
Microcrystalline cellulose
Povidone
Purified water
Quinoline yellow
Do not take this medicine if you are allergic to any of these ingredients.

What Sudafed Sinus + Allergy & Pain Relief looks like

Turquoise, bevelled, capsule-shaped, flat tablets. Scored on face and coded "S3F" each side of the score. Plain on the other face.
(Aust R 40335).

Who distributes Sudafed Sinus + Allergy & Pain Relief

Johnson & Johnson Pacific
45 Jones Street
Ultimo NSW 2007
Australia
Phone: 1800 029979
This leaflet was prepared in May 2022.