Active ingredients:
Day Tablet: Paracetamol, Pseudoephedrine hydrochloride
Night tablet: Paracetamol, Pseudoephedrine hydrochloride, Chlorphenamine maleate
Consumer Medicine Information (CMI)
This leaflet provides important information about using Demazin Original Cold + Flu
Relief Day + Night tablets. 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 Demazin.
Where to find information in this leaflet:
1. Why am I taking Demazin?
Demazin contains two different tablets. The white DAY tablet contains the active ingredients
paracetamol and pseudoephedrine hydrochloride. The pink NIGHT tablet contains paracetamol,
pseudoephedrine hydrochloride and chlorphenamine maleate.
Demazin is a cold and flu medicine. The Day tablets contain a decongestant and pain
reliever. The Night tablet contains a decongestant, pain reliever and antihistamine.
Pseudoephedrine hydrochloride is a decongestant and is used to relieve nasal congestion
and runny nose. It works by reducing congestion in the upper respiratory tract, including
the nose, nasal passages and sinuses, and making it easier to breathe.
Paracetamol is a pain reliever and works by blocking the pain messages from getting
through to the brain. It also acts in the brain to reduce fever.
Chlorphenamine maleate is an antihistamine. Antihistamines help reduce allergic
symptoms such as sneezing and itchy watery eyes 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.
Demazin is used to provide temporary relief from the following symptoms of cold and
flu:
runny nose
sinus pain
blocked nose and sinus
fever
headache
body aches and pain.
The NIGHT tablet also aids rest by providing relief from:
watery, itchy eyes
sneezing.
2. What should I know before I take Demazin?
Warnings
Do not take Demazin if you:
are allergic to paracetamol, pseudoephedrine, chlorphenamine, or any of the ingredients
listed at the end of this leaflet.
Always check the ingredients to make sure you can use this medicine.
have any of the following conditions:
very high blood pressure
severe coronary artery disease (heart disease caused by poor blood flow or narrowing
of the blood vessels of the heart)
narrow angle glaucoma (high pressure in the eyes)
stomach obstruction, including due to a peptic ulcer
enlarged prostate
bladder obstruction.
are taking a medicine for depression known as a monoamine oxidase inhibitor (MAOI)
or if you have taken one in the past 14 days.
Check with your doctor or pharmacist if you:
have any other medical conditions including:
high blood pressure
overactive thyroid
diabetes mellitus
heart disease
glaucoma
enlarged prostate
epilepsy
impaired kidney or liver function.
take any medicines for any other condition, especially anti-depressant medication.
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.
Your doctor can discuss the risks and benefits of taking Demazin during pregnancy.
Talk to your doctor or pharmacist if you are breastfeeding or intend to breastfeed.
Demazin should not be used when breastfeeding. Paracetamol, pseudoephedrine and chlorphenamine
pass into breast milk.
Use in children
Demazin is not recommended for children under 12 years of age.
3. 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 Demazin and affect how it works. These include:
Medicines which may increase blood pressure including:
Tricyclic antidepressants and monoamine oxidase inhibitors (MAOIs).
Decongestants used in cold medications
Beta blockers and methyldopa used to lower blood pressure
Appetite suppressants
Phenytoin used for epilepsy
Medicines which may increase the sedating effects of Demazin including:
Medicines to help you sleep or relax
Opioid pain killers
Other medicines including:
Warfarin used to prevent blood clots. Your warfarin dose may require reduction if
you use this product for a long period of time.
Probenecid used for gout
Medicines for urinary tract infections or bladder problems
Colestyramine used to lower cholesterol
Metoclopramide used to control nausea and vomiting.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Demazin.
4. How do I take Demazin?
How much to take
Follow the instructions provided with the medicine.
Take 2 white DAY tablets morning and afternoon if necessary.
Take 2 pink NIGHT tablets at bedtime if necessary.
Do not exceed the recommended dosage. The maximum dose is 6 DAY tablets and 2 NIGHT
tablets in 24 hours.
If you are over 65 years of age, talk to your pharmacist or doctor about how much
to take.
Elderly patients are more likely to have side effects from taking this medicine.
If you take too much Demazin
If you think that you have used too much Demazin, 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 because of
the risk of delayed, serious liver damage.
5. What should I know while taking Demazin?
Things you should do
If symptoms persist, see your doctor or pharmacist.
Unless advised by your doctor, Demazin should not be used for more than a few days
at a time in adults and in children aged between 12 and 17 years for more than 48
hours.
Remind any doctor, dentist or pharmacist you visit that you are using Demazin.
Things you should not do
Do not take Demazin with any other cold and flu medicines unless your doctor or pharmacist
has advised you to.
Do not take Demazin with any other paracetamol containing products unless your doctor
or pharmacist has advised you to.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Demazin
affects you.
The NIGHT tablets may cause drowsiness and may increase the effects of alcohol. Drowsiness
may continue the following day. If you are affected do not drive or operate machinery.
Drinking alcohol
Tell your doctor or pharmacist if you drink alcohol.
Alcohol may increase the sedative effects of this medicine making you more drowsy.
Looking after your medicine
Store below 30°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.
6. 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
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.
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.
7. Product details
This medicine is available over-the-counter without a doctor's prescription.
What Demazin contains
Day Tablet
|
Active ingredients
(main ingredients)
|
Paracetamol
Pseudoephedrine hydrochloride
|
|
Other ingredients
(inactive ingredients)
|
Microcrystalline cellulose
Crospovidone
Magnesium stearate
Povidone
Pregelatinised maize starch
Stearic acid
|
Night Tablet
|
Active ingredients
(main ingredients)
|
Paracetamol
Pseudoephedrine hydrochloride
Chlorphenamine maleate
|
|
Other ingredients
(inactive ingredients)
|
Microcrystalline cellulose
Crospovidone
Magnesium stearate
Povidone
Pregelatinised maize starch
Stearic acid
Erythrosine
|
Do not take this medicine if you are allergic to any of these ingredients.
What Demazin looks like
Demazin Original Cold + Flu Relief Day + Night contains a Day tablet and a Night tablet.
The Day tablet is a white round tablet with a break line.
The Night tablet is a pink round tablet with a break line.
Each pack contains 16 day tablets and 8 night tablets.
Registration number: AUST R 286002.
Who distributes Demazin
iNova Pharmaceuticals (Australia) Pty Limited
Level 10, 12 Help Street
Chatswood NSW 2067
Tel: 1800 630 056
This leaflet was prepared in December 2022.