Active ingredients:
Pseudoephedrine sulfate and chlorphenamine maleate
Consumer Medicine Information (CMI)
This leaflet provides important information about using Demazin Original 6 hour Relief
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 a combination of two active ingredients pseudoephedrine sulfate and
chlorphenamine maleate.
Pseudoephedrine sulfate is a decongestant. 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 is an antihistamine. Antihistamines help reduce allergic
symptoms such as sneezing or watery, itchy 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 provides relief from:
runny nose
blocked nose and sinus
sneezing
watery, itchy eyes
associated with the common cold, nasal allergy, hayfever and sinusitis.
2. What should I know before I take Demazin?
Warnings
Do not take Demazin if you:
are allergic to pseudoephedrine or 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 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)
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:
narrow angle glaucoma (high pressure in the eyes)
high blood pressure
heart disease
stomach obstruction, including due to a peptic ulcer
enlarged prostate
bladder obstruction
diabetes
overactive thyroid.
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.
Demazin should only be taken during pregnancy if the benefits of taking it outweigh
the potential risks to your developing baby.
Talk to your doctor or pharmacist if you are breastfeeding or intend to breastfeed.
Demazin may pass into breast milk.
Use in children
This medicine should not be given to children under 12 years of age, including newborn
and premature babies.
Chlorphenamine can cause restlessness and excitability in children.
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.
Medicines that may
increase
the effect of Demazin include:
medicines used to treat depression, especially monoamine oxidase inhibitors (MAOIs)
and tricyclic antidepressants
medicines used to help you sleep or relax (sedatives and hypnotics)
opioid analgesics used to relieve pain.
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
Take 1 tablet every 6 hours, when required.
Follow the instructions provided with the medicine.
Do not exceed the recommended dosage.
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.
When to take Demazin
Demazin should not be used more than once every 6 hours.
Avoid taking Demazin close to bedtime. Demazin can cause sleeplessness if taken up
to several hours before going to bed.
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.
5. What should I know while taking Demazin?
Things you should do
Remind any doctor, dentist or pharmacist you visit that you are using Demazin.
See your doctor or pharmacist if symptoms persist for more than a few days.
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.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Demazin
affects you.
Demazin may cause dizziness and/or sleepiness in some people. If this happens, 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 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.
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
|
Serious side effects
|
What to do
|
|
Sudden, severe abdominal pain, especially if accompanied by blood in your stools.
Signs of an allergic reaction including:
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.
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
|
Active ingredients
(main ingredients)
|
Pseudoephedrine sulfate
Chlorphenamine maleate
|
|
Other ingredients
(inactive ingredients)
|
Brilliant Blue CFC
Starch maize
Magnesium stearate
Povidone
Lactose
|
|
Potential allergens
|
Lactose
|
Do not take this medicine if you are allergic to any of these ingredients.
What Demazin looks like
Demazin is a round, convex, blue tablet, plain on one side and with a score line on
the other side.
Registration number: AUST R 18815
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