Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am I taking Nuelin-SR?
Nuelin-SR tablets contain the active ingredient theophylline which causes the muscle
lining of the airways to relax. Nuelin-SR is a slow-release medicine, which means
each tablet works for about 12 hours. Nuelin-SR tablets are used to treat asthma and
other conditions where breathing is difficult. It also helps to prevent asthma attacks.
For more information, see Section
1. Why am I taking Nuelin-SR? in the full CMI.
2. What should I know before I take Nuelin-SR?
Do not use if you have ever had an allergic reaction to Nuelin-SR tablets, theophylline,
aminophylline, caffeine or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section
2. What should I know before I take Nuelin-SR? in the full CMI.
3. What if I am taking other medicines?
Some medicines may interfere with Nuelin-SR tablets and affect how it works.
4. How do I take Nuelin-SR?
Adults: the usual dose is one tablet every 12 hours. Your doctor may vary the dose, so follow
their instructions exactly.
Children over 2 years: the dose depends on the child’s body weight, so follow your doctor's instructions
exactly.
Take Nuelin-SR every 12 hours with or immediately after food and continue taking it
until your doctor tells you to stop.
5. What should I know while taking Nuelin-SR?
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Things you should do
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If you are having an asthma attack, use your relieving inhaler to help with your asthma.
Nuelin-SR tablets will not give you relief during an asthma attack
When starting on any new medicines or having a blood test or surgery; remind your
doctor, dentist, pharmacist, surgeon or anaesthetist you are taking Nuelin-SR tablets.
Tell your doctor or pharmacist if you drink alcohol; smoke cigarettes or marijuana
or are taking any cold and flu medication or products containing St John's wort.
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Things you should not do
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Do not stop taking Nuelin-SR tablets or lower the dose without consulting with your
doctor.
Do not crush or chew the tablets.
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Driving or using machines
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Make sure you know how you react to Nuelin-SR before driving or operating machinery.
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Drinking alcohol
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Do not drink alcohol while taking Nuelin-SR tablets.
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Looking after your medicine
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Store in the bottle below 30°C until you are ready to take them
Store it in a cool dry place away from moisture, heat or sunlight.
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6. Are there any side effects?
Common side effects include nausea and vomiting, stomach pains, headaches, a loss
of appetite, feeling restless, nervous or irritable and difficulty sleeping. Serious
side effects include heart rhythm disturbances and fits.
For more information, including what to do if you have any side effects, see Section
6. Are there any side effects? in the full CMI.
Active ingredient:
Theophylline (thee-off-o-lin)
Full Consumer Medicine Information (CMI)
This leaflet provides important information when taking Nuelin-SR 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 Nuelin-SR Tablets.
Where to find information in this leaflet:
1. Why am I taking Nuelin-SR?
Nuelin-SR Tablets contain the active ingredient theophylline, which causes the muscle
lining of the airways to relax. Nuelin-SR is a slow-release medicine, which means each tablet works for about 12 hours.
Nuelin-SR is used to treat asthma and other conditions where breathing is difficult.
It also helps to prevent asthma attacks.
2. What should I know before I take Nuelin-SR?
Warnings
Do not take Nuelin-SR:
If you are allergic to any medicines containing theophylline, aminophylline or 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 you can use this medicine
Do not use Nuelin-SR if the packaging is torn or shows signs of tampering.
Check with your doctor if you:
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-SR check with your doctor if you are pregnant or intend to become
pregnant. Nuelin-SR 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-SR passes into breast milk. Irritability has been reported in infants of
nursing mothers taking theophylline.
Use in Children
Do not give Nuelin-SR tablets to children under 2 years of age.
Nuelin-SR Syrup is available as an alternative to tablets for use in children 2 years
and over.
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 Nuelin-SR and affect how it works.
Drugs that may
increase
the effect of Nuelin-SR 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-SR 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)
Tell your doctor if you 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-SR at the same time may affect how each medication
works.
Your doctor may wish to monitor your theophylline blood levels you while you are taking
Nuelin-SR.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Nuelin-SR.
4. How do I take Nuelin-SR?
How much Nuelin-SR to take
Follow the dosage instructions on your Nuelin-SR tablets bottle label. The dosage may differ from the advice provided in this leaflet
Adults: the usual dose of Nuelin-SR is one tablet every 12 hours. However, this dose may
be increased or decreased by your doctor
Children over 2 years: the dose depends on the body weight of the child. Follow all instructions from your
doctor when giving Nuelin-SR tablets to children
Follow your doctor's instructions exactly. Never change the dose yourself. Continue
taking Nuelin-SR until your doctor tells you to stop taking it.
When to take Nuelin-SR
Take Nuelin-SR as your doctor has told you to, even if you are not suffering any asthma
symptoms
Take Nuelin-SR tablets every 12 hours, with or immediately after food so that it does
not upset your stomach
Nuelin-SR works best when there is a certain amount of theophylline in your blood.
Your doctor may sometimes need to take samples of your blood to check the level of
theophylline.
How to take Nuelin-SR
Take Nuelin-SR with a full glass of water. DO NOT chew or crush the tablets.
If you forget to take Nuelin-SR
Take the tablets regularly at the same time each day. 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-SR
If you take too many tablets you may 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 have taken too much Nuelin-SR, 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 Nuelin-SR?
Things you should do
If you have an asthma attack, use your relieving inhaler to help with your asthma.
Nuelin-SR 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-SR tablets.
If you are going to have surgery, tell the surgeon or anaesthetist that you are taking
Nuelin-SR. 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-SR.
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 asthma is getting worse or if you suffer asthma attacks
Become pregnant while taking Nuelin-SR.
Remind any doctor, dentist or pharmacist you visit that you are taking Nuelin-SR.
Things you should not do:
Do not take Nuelin-SR tablets to treat any other complaints unless your doctor tells
you to
Do not give your medicine to anyone else, even if they have the same condition as
you
Do not stop taking your medicine or lower 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-SR
affects you.
Drinking alcohol
Tell your doctor if you drink alcohol.
Alcohol may increase the effects of Nuelin-SR tablets.
Looking after your medicine
Store below 30°C.
Store Nuelin-SR tablets in the bottle until it is time to take them.
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 about side effects.
Less serious side effects
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Less serious side effects
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What to do
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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
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Speak to your doctor if you have any of these less serious side effects and they worry
you.
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Serious side effects
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Serious side effects
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What to do
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Changes in your heart rhythm
Fits
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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.
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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.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What Nuelin-SR Tablets contain
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Active ingredient
(main ingredient)
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Theophylline
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Other ingredients
(inactive ingredients)
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Guar gum
Magnesium stearate
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Potential allergens
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None
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Do not take this medicine if you are allergic to any of these ingredients.
What Nuelin-SR looks like:
Nuelin-SR 200 mg tablets are small white tablets marked N/L on one side and 200 on
the other and come in a bottle of 100 tablets (Registration number: AUST R 59526).
Nuelin-SR 250 mg tablets are small white tablets marked N/L on one side and 250 on
the other and come in a bottle of 100 tablets (Registration number: AUST R 46069).
Nuelin-SR 300 mg tablets are small white tablets marked N/L on one side and 300 on
the other and come in a bottle of 100 tablets (Registration number: AUST R 59527).
Who distributes Nuelin-SR:
iNova Pharmaceuticals (Australia) Pty Limited
Level 10, 12 Help Street
Chatswood NSW 2067
Tel: 1800 630 056
This leaflet was prepared in November 2022.