Active ingredient:
Theophylline (thee-off-o-lin)
Consumer Medicine Information (CMI)
This leaflet provides important information about using Nuelin Syrup. 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 Nuelin Syrup.
Where to find information in this leaflet:
1. Why take Nuelin Syrup?
Nuelin Syrup contains the active ingredient theophylline, which causes the muscle
lining of the airways to relax.
Nuelin Syrup is used to treat asthma and other conditions where breathing is difficult.
It also helps to prevent asthma attacks.
2. Before taking Nuelin Syrup?
Warnings
Do not take Nuelin Syrup:
If you or your child are allergic to any medicines containing theophylline, aminophylline,
caffeine or to 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
Always check the ingredients to make sure that you or your child can take Nuelin Syrup.
Do not take Nuelin Syrup if the packaging is torn or shows signs of tampering.
Check with your doctor or pharmacist if you or your child:
Have allergies to any medicines, foods, preservatives or dyes
Have a stomach ulcer or reflux
Have an irregular or rapid heartbeat or any other heart disease
Have very high blood pressure
Have a viral infection or a fever
Have liver, thyroid or lung disease
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
Before taking Nuelin Syrup check with your doctor if you are pregnant or intend to
become pregnant. Nuelin Syrup may affect your developing baby if you take it during
pregnancy.
Talk to your doctor if you are breastfeeding or intend to breastfeed. The active ingredient
in Nuelin Syrup passes into breast milk. Irritability has been reported in infants
of nursing mothers taking theophylline.
Use in Children
Do not give Nuelin Syrup to children under 2 years of age unless recommended by a
doctor.
3. Taking other medicines?
Tell your doctor or pharmacist if you or your child 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 Nuelin Syrup and affect how it works.
Drugs that may
increase
the effect of Nuelin Syrup include:
Cimetidine – used to treat heartburn indigestion, stomach ulcers or reflux
Allopurinol – used to treat gout
Propranolol – used to reduce anxiety, relieve tremors and prevent migraine, angina,
and high blood pressure
Antibiotics, such as erythromycin, clarithromycin, ciprofloxacin or enoxacin
Alcohol
Oral contraceptives
Mexilitene or verapamil – used to treat high blood pressure, angina or other heart
conditions
Tacrine – used to treat Alzheimer’s disease
Thiabendazole – used to treat infections caused by worms
Disulfiram – used to treat alcoholism
Interferon alpha – used to treat different types of cancer
Drugs that may
reduce
the effect of Nuelin Syrup include:
Tobacco or marijuana
Phenobarbitone, phenytoin or carbamazepine – used to treat epilepsy
Lithium
Rifampicin – used to treat tuberculosis or leprosy
Hypericum perforatum (St John's wort)
Your doctor may sometimes need to take samples of your blood to check the level of
theophylline and possibly adjust your dose of Nuelin Syrup.
Tell your doctor or pharmacist if you or your child are taking medication containing
any of the following:
Halothane
Ketamine
Ranitidine
Diltiazem
Nifedipine
Isoniazid
Frusemide
Influenza vaccine (flu vaccine)
Corticosteroids
Cold and flu medicines.
Taking these medicines and Nuelin Syrup at the same time may affect how each medication
works.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you or your child are taking and if these will affect Nuelin Syrup.
4. How to take Nuelin Syrup
How much Nuelin Syrup to take:
Dosage instructions are provided in the table below. For children 2 to 12 years of age, the dose depends on the body weight of the child.
|
Age
|
Dosage
|
How Often
|
|
Adults & children over 12 years
|
25 mL
|
Every 6 hours
|
|
Children 6-12 years
(average body weight 20-41 kg)
|
20 – 25 mL
|
|
Children 4-6 years
(average body weight 16-20 kg)
|
15 – 20 mL
|
|
Children 2-4 years
(average body weight 12-16 kg)
|
10 – 15 mL
|
Follow any instructions given to you by your doctor or pharmacist on how to take Nuelin
Syrup.
Do not exceed the recommended dosage.
When to take Nuelin Syrup:
Take Nuelin Syrup one hour before food with a glass of water. However, it can be taken
with or immediately after food so that it does not upset your stomach
If you forget to take Nuelin Syrup
If you miss your dose at the usual time, take it as soon as you remember.
However, if it is more than 4 hours late, skip the dose that you missed and take your
next dose when you are meant to. Do not take a double dose to make up for the dose
you missed.
If you take too much Nuelin Syrup
Taking too much Nuelin Syrup may make you feel irritable, agitated, or anxious; feel
sick and vomit or are unable to sleep. More severe effects include a rapid or irregular
heartbeat, feeling very thirsty or experiencing fever, confusion or fits.
If you think that you or your child have taken too much Nuelin Syrup, urgent medical
attention may be needed.
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. While taking Nuelin Syrup?
Things you should do
If you have an asthma attack, use your relieving inhaler to help with your asthma. Nuelin Syrup will not give you relief during an asthma attack as it does not work
quickly enough.
If you are about to start on any new medicines, remind your doctor, dentist and pharmacist
that you are taking Nuelin Syrup.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking
Nuelin Syrup. It may affect other medicines used during surgery.
If you are about to have any blood tests tell your doctor that you are taking Nuelin
Syrup. It may interfere with the results of some tests.
Keep all doctor's appointments so that your progress can be checked.
Call your doctor straight away if you:
Think your or your child’s asthma is getting worse or suffer asthma attacks
Become pregnant while taking Nuelin Syrup.
Things you should not do:
Do not use Nuelin Syrup to treat any other complaints unless your doctor or pharmacist
tells you to
Give Nuelin Syrup to anyone else, even if they have the same condition as you
Stop taking Nuelin Syrup or change the dosage without checking with your doctor.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Nuelin
Syrup affects you.
Children should be careful riding bicycles or climbing on playground equipment until
you know how Nuelin Syrup affects them.
Drinking alcohol
Tell your doctor or pharmacist if you drink alcohol.
Alcohol may increase the effects of Nuelin Syrup.
Looking after your medicine
Store below 30°C. Do not refrigerate. Storage under 15°C may cause the syrup to crystallise.
Store Nuelin Syrup in the bottle until it is time to take it.
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 or your child no longer need to take 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
|
Less serious side effects
|
What to do
|
|
Common side effects
Nausea
Vomiting
Stomach pain
Reactivation of stomach ulcers
Loss of appetite
Headache
Difficulty sleeping
Feeling restless, nervous or irritable
Tremors
Heart palpitations or fast heartbeat
Blood in vomit or urine
Less common side effects
Diarrhoea
Flushing or skin rashes
Low blood pressure
Rapid breathing
Fast or irregular urine flow
High blood sugar
Hair loss
|
Speak to your doctor if you have any of these less serious side effects and they worry
you.
|
Serious side effects
|
Serious side effects
|
What to do
|
|
Changes in your heart rhythm
Fits
|
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 Nuelin Syrup contains
|
Active ingredient
(main ingredient)
|
Theophylline
|
|
Other ingredients
(inactive ingredients)
|
Berry citrus flavour
Methyl hydroxybenzoate
Propyl hydroxybenzoate
Purified water
Sucrose
Sorbitol
|
|
Potential allergens
|
Methyl hydroxybenzoate
Propyl hydroxybenzoate
Sorbitol
|
Do not take this medicine if you are allergic to any of these ingredients.
What Nuelin Syrup looks like
Nuelin Syrup is a clear, almost colourless liquid with a berry flavour and comes in
a 500 mL bottle (Registration number: AUST R 10576).
Who distributes Nuelin Syrup
iNova Pharmaceuticals (Australia) Pty Limited
Level 10, 12 Help Street
Chatswood NSW 2067
Tel: 1800 630 056
This leaflet was prepared in December 2022.