General Information
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about Nuelin-SR tablets. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. If you need any more information about Nuelin-SR tablets, please ask your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the risk of you taking Nuelin-SR against the benefits it can have for you. If you have any concerns about taking this medicine, ask your doctor or pharmacist.
Keep this leaflet with the medicine. You may want to read it again.
What NUELIN-SR is used for
Nuelin-SR is used to treat asthma and other conditions where breathing is difficult. It also helps to prevent asthma attacks. The active ingredient in Nuelin-SR is 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.
Your doctor may prescribe Nuelin-SR for another purpose. If you are not sure why you are taking this medicine, ask your doctor.
Before using NUELIN-SR
When you must not use NUELIN-SR
Do not use Nuelin-SR if you are allergic to theophylline, aminophylline or caffeine, or to any of the ingredients listed under "Product Description".
Do not use Nuelin-SR after the "use-by" date on the bottle.
Nuelin-SR is a prescription medicine and has been prescribed for you only. Do not give it to anyone else even if their condition is the same as yours.
Do not use Nuelin-SR to treat an asthma attack. Use a reliever inhaler such as Airomir instead.
Before you start to use NUELIN-SR
Tell your doctor if you have a stomach ulcer or reflux; an irregular or rapid heartbeat or any other heart disease; very high blood pressure; any viral infections or lung infections; or any liver disease; thyroid disease or lung disease.
Tell your doctor if you are pregnant, planning to become pregnant or are breastfeeding.
Your doctor or pharmacist can discuss with you the risks and benefits involved.
Tell your doctor if you are taking any other medicines for your asthma.
Some medicines may affect the way Nuelin SR works. Tell your doctor if you are taking any other medication, in particular:
Antibiotics such as erythromycin (Eryc and others), clarithromycin (Klacid), ciprofloxacin (Ciproxin), enoxacin (Enoxin) or rifampicin (Rifadin and others)
Cimetidine (Tagamet and Magicul)
Allopurinol (Zyloprim and others)
Propranolol (Inderal and others)
Verapamil (Isoptin and others)
Mexiletine (Mexitil)
Phenytoin (Dilantin), phenobarbitone or carbamazepine (Tegretol and others)
Tacrine (Cognex)
Lithium
Thiabendazole (Mintezol)
Oral contraceptives (the Pill)
Flu vaccine
Interferon
Any remedies that you buy without a prescription, especially cold and flu medicines and products containing St John's wort.
Also tell your doctor if you drink any alcohol or if you smoke cigarettes or marijuana.
Using NUELIN-SR
How to take NUELIN-SR
Take this medicine only as directed by your doctor or pharmacist. The dose for adults is usually one tablet twice a day. However, this dose may be increased or decreased by your doctor.
For children over 2 years old, the dose of Nuelin-SR depends on the weight of the child. Nuelin-SR is not suitable for children younger than 2 years of age.
Nuelin-SR tablets should be taken every 12 hours. Take Nuelin-SR with a full glass of water and DO NOT chew or crush the tablets. You can take Nuelin-SR with or immediately after food so that it does not upset your stomach.
While you are using NUELIN-SR
Nuelin-SR helps to prevent asthma attacks. Always take Nuelin-SR regularly, as your doctor has told you to, even if you are not suffering any asthma symptoms. If you think your asthma is getting worse or if you suffer asthma attacks, please consult your doctor immediately.
Nuelin-SR will not give you relief during an asthma attack. If you have an asthma attack, please use your relieving inhaler (such as Airomir, Ventolin, Asmol or Bricanyl). Nuelin-SR works best when there is a certain amount of theophylline, the active ingredient, in your blood. Your doctor may sometimes need to take samples of your blood to check the level of theophylline.
If you forget to take NUELIN-SR
If you forget to take Nuelin-SR, take it as soon as you remember. However, if it is more than 4 hours late, skip the dose that you missed. Take your next dose at the normal time. Never take a double dose to make up for a dose you have missed.
If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.
If you take too much NUELIN-SR
Telephone your doctor or immediately go to casualty at your nearest hospital if you think that you or anyone else may have taken too much Nuelin-SR even if there are no signs of discomfort or poisoning. If you take too much Nuelin-SR you may feel sick and vomit. You may feel irritable, agitated or anxious. You may be unable to sleep. In severe cases, your heart may beat faster and irregularly and you may have a high body temperature, be very thirsty, be very confused and have fits.
Side Effects
All medicines can have side effects and this may occur with the normal use of Nuelin-SR. Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking Nuelin-SR.
The more common side effects of Nuelin-SR include:
nausea, vomiting, stomach pain, loss of appetite
fast or irregular heartbeat
headache
difficulty sleeping
feeling restless, nervous or irritable
tremor
Less common side effects include:
diarrhoea
worsening of a stomach ulcer
blood in the vomit
abnormal heartbeat
low blood pressure
flushing, skin rash
rapid breathing
increased or decreased urine flow
blood in the urine
high blood glucose
hair loss
Very rare side effects include:
very irregular or faster heartbeat
fits
If you have any side effect, even if it is not listed above, please tell your doctor.
Storage Conditions
Keep Nuelin-SR tablets in a cool dry place where the temperature stays below 30°C.
Keep Nuelin-SR tablets where children cannot reach them. A locked cupboard one-and-a-half metres above the ground is a good place to store medicine.
Product Description
What NUELIN-SR tablets look like
Each bottle of Nuelin-SR contains 100 tablets.
Nuelin-SR 200 mg tablets (AUST R 59526) are small white tablets marked N/L on one side and 3M 200 on the other.
Nuelin-SR 250 mg tablets (AUST R 46069) are small white tablets marked N/L on one side and 3M 250 on the other.
Nuelin-SR 300 mg tablets (AUST R 59527) are small white tablets marked N/L on one side and 3M 300 on the other.
Ingredients
Nuelin-SR tablets contain 200mg, 250mg or 300mg of the active ingredient, theophylline. Nuelin-SR also contains the following inactive ingredients:
guar gum
magnesium stearate Nuelin-SR tablets do not contain gluten.
Sponsor
Nuelin-SR is made and supplied by:
iNova Pharmaceuticals (Aust) Pty Ltd
(ABN 88 000 222 408)
9-15 Chilvers Road
Thornleigh NSW 2120
AUSTRALIA
Distributor
Nuelin Syrup is distributed in New Zealand by:
Douglas Pharmaceuticals Ltd
Central Park Drive, Lincoln
Auckland 0610
NEW ZEALAND
This leaflet was prepared in August 2008.