Consumer medicine information

Nuelin Syrup

Theophylline

BRAND INFORMATION

Brand name

Nuelin Syrup

Active ingredient

Theophylline

Schedule

S3

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Nuelin Syrup.

FULL CMI

NUELIN® Syrup

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?
2. Before taking Nuelin Syrup?
3. Taking other medicines?
4. How to take Nuelin Syrup
5. While taking Nuelin Syrup?
6. Are there any side effects?
7. Product details

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.
AgeDosageHow Often
Adults & children over 12 years25 mLEvery 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 effectsWhat 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 effectsWhat 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 allergensMethyl 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.

Published by MIMS February 2023

BRAND INFORMATION

Brand name

Nuelin Syrup

Active ingredient

Theophylline

Schedule

S3

 

1 Name of Medicine

Theophylline.

2 Qualitative and Quantitative Composition

Nuelin SR Tablets contain 200 mg, 250 mg or 300 mg anhydrous theophylline in the form of sustained release tablets. Nuelin SR Tablets also contain guar gum, magnesium stearate and purified water.
Nuelin Syrup contains 133.3 mg anhydrous theophylline per 25 mL in immediate release form. Nuelin Syrup also contains methyl hydroxybenzoate, propyl hydroxybenzoate, sorbitol, berry citrus flavouring, sucrose and purified water.

3 Pharmaceutical Form

Nuelin SR 200 theophylline 200 mg tablet bottle - white round biconvex tablet N/L on one side and 200 on the other.
Nuelin SR 250 theophylline 250 mg tablet bottle - white, round biconvex tablets marked N/L 250.
Nuelin SR 300 theophylline 300 mg tablet bottle - white round biconvex tablet N/L on one side and 300 on the other.
Nuelin Syrup theophylline 26.67 mg/5 mL bottle - clear liquid, berry flavour.

4 Clinical Particulars

4.1 Therapeutic Indications

For the relief and prophylaxis of reversible bronchospasm associated with bronchial asthma, bronchitis, emphysema and related conditions.

4.2 Dose and Method of Administration

Desirable therapeutic levels are considered to be between 10-20 microgram/mL (55-110 micromol/L). Higher levels may produce toxic effects. Toxic effects may also occur at therapeutic levels. When maximum response is required, dose levels should be individually titrated. Serum theophylline may be monitored to confirm that levels are within the therapeutic range. Monitoring is particularly recommended when dose levels exceed 1 g daily in adults or 24 mg/kg daily in children.
Appropriate dosage adjustments should be made for smoking, heart failure, acute pulmonary oedema, chronic alcohol ingestion, established hepatic cirrhosis, severe airways obstruction, severe pneumonia, severe hypoxia, thyroid function, adolescence (12-18 years), children (8-12 years) and concomitant use of interacting drugs. (See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
Children have rapid clearance of theophylline and may require a dosage increase that should be controlled by measurement of serum theophylline.

Elderly.

In patients aged over 65 years theophylline clearance is decreased by approximately 25%.

Nuelin SR Tablets.

Adults.

200 to 300 mg (one tablet) every twelve hours. This dose can be gradually increased or decreased by half a tablet if sufficient therapeutic effect is not achieved or if side effects occur.

Children.

Nuelin SR Tablets are not recommended for administration to children under 2 years of age.
For children over 2 years, administration as advised by the physician. The daily dose should be adjusted according to bodyweight, usually on the basis of up to 10 mg/kg bodyweight every twelve hours. As a guideline, a child from 12 kg to 25 kg bodyweight (2-7 years) usually requires 125 mg bid (twice a day) and a child over 25 kg, 250 mg bid (twice a day).

Note.

For children taking Nuelin SR Tablets, Nuelin Syrup may be considered as an alternative.

Note.

Nuelin SR Tablets should be taken every twelve hours. On no account should the tablets be chewed or crushed.

Nuelin Syrup.

Not recommended for children under 2 years except on the advice of a doctor. See Table 1.
Nuelin Syrup is best taken an hour before meals with a glass of water, or if necessary with or immediately after meals to lessen gastro-intestinal irritation.

4.3 Contraindications

Nuelin SR Tablets and Nuelin Syrup should not be used where hypersensitivity to its constituents or to xanthines generally is known or has been demonstrated.

4.4 Special Warnings and Precautions for Use

As there is a correlation between plasma levels of theophylline and therapeutic effect, and as patient response can vary considerably due to variable rates of elimination, monitoring plasma levels in individual patients is strongly recommended (see Section 4.9 Overdose, Theophylline monitoring). Dosage should be individualised if optimal therapeutic effect is to be achieved. However, individual patients also have a widely variable tolerance to adverse effects and so symptomatology should be considered, as well as monitored levels.
Acute symptoms of asthma requiring rapid treatment: sustained release products are therapeutically inappropriate for acute asthma requiring prompt treatment.
Theophylline should not be administered concurrently with other xanthine medications and caution should be exercised when sympathomimetic agents are also part of the regimen.
Theophylline clearance decreases in patients with reduced thyroid function, congestive heart failure, acute pulmonary oedema, chronic obstructive pulmonary disease, severe hypoxia, pneumonia, acute febrile episodes and during acute viral infection.
Because of its cardiac side effects, use theophylline with caution in patients with cardiac arrhythmias, coronary artery disease, unstable angina, cardiomyopathy and severe hypertension. Theophylline increases gastric acid secretion and should be used with caution in patients with peptic ulcer or gastro-oesophageal reflux.
Smoking may increase theophylline clearance and increased doses of theophylline may be required (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
Xanthine containing beverages (e.g. tea, coffee, cola, cocoa) may interfere with some serum theophylline assays.

Use in hepatic impairment.

Clearance is markedly decreased in patients with impaired liver function, such as hepatic cirrhosis (See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).

Use in the elderly.

There is some evidence that theophylline exhibits dose dependent kinetics, at least in sick and elderly patients. Care should be exercised by titration of dosage requirements in small increments and by monitoring serum theophylline levels.

Paediatric use.

No data available.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

The following drugs have been shown to decrease the hepatic clearance of theophylline, thus increasing its serum concentration: cimetidine, high dose allopurinol, propranolol, macrolide antibiotics (e.g. erythromycin, clarithromycin), quinolone antibiotics (e.g. ciprofloxacin and enoxacin), alcohol, oral contraceptives, mexiletine, tacrine, thiabendazole, disulfiram, interferon alfa and verapamil.
The following substances have been shown to increase the hepatic clearance of theophylline, thus lowering its serum concentration: tobacco or marijuana smoking, phenobarbitone, phenytoin, carbamazepine and rifampicin. Theoretical potential interactions of theophylline with products containing Hypericum perforatum (St. John's wort), possibly involving the CYP1A2 isoform, could result in reduced plasma levels of theophylline.
It is recommended that serum theophylline levels are monitored and dosage adjustments made if concomitant therapy with these drugs/ substances is commenced or ceased during continued theophylline therapy.
Ventricular arrhythmias have been reported when halothane is used concurrently with theophylline. Concurrent use of ketamine with theophylline may lower the seizure threshold. Theophylline has been reported to enhance the renal clearance of lithium, thus reducing serum lithium levels.
Synergism with adrenaline and other sympathomimetic amines has been reported with theophylline. Concomitant administration of a β-adrenergic agonist with methylxanthines has resulted in cardiac arrhythmias and sudden death in studies carried out in laboratory animals. The clinical significance of these findings when applied to humans is not known at present.
The effect of ranitidine, diltiazem, nifedipine, isoniazid, frusemide, influenza vaccine and corticosteroids on theophylline is uncertain, but concomitant use of these drugs should be monitored closely.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category A)
Although theophylline has a Category A rating, it does cross the placental barrier. The effect on foetal development is not known. Theophylline clearance is significantly decreased in premature infants. Therefore, if this drug is administered to the mother near the time of delivery, the neonate should be monitored closely for the pharmacological effects of theophylline. Hence the use of theophylline in pregnant women should be balanced against the risk of uncontrolled asthma.
Theophylline is excreted in breast milk and irritability has been reported in infants of nursing mothers taking theophylline. It is advisable to keep serum theophylline concentrations as low as possible in nursing mothers while maintaining adequate asthma control.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

The most common adverse reactions are gastric irritation, nausea, vomiting, anorexia, epigastric pain, reactivation of peptic ulcer, gastro-oesophageal reflux, haematemesis, tachycardia, palpitation, headache, CNS stimulation, reflex hyperexcitability, insomnia and tremor. Other possible reactions include diarrhoea, extrasystoles, flushing, hypotension, tachypnoea, potentiation of diuresis, albuminuria, haematuria, rash, hyperglycaemia, hypokalaemia, alopecia and inappropriate ADH secretion (high dose). More serious signs of high serum levels (usually above 30 microgram/mL), such as cardiac arrhythmias and convulsions, may appear rarely without prior warning.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).
Also see Section 4.8 Adverse Effects (Undesirable Effects) for possible drug effects that may be seen in overdosage.

Symptoms.

Early symptoms of toxicity such as anorexia, nausea, vomiting, headache, irritability, agitation, anxiety, insomnia, hypotension, palpitations and tachycardia may progress to sensory disturbances, confusion, hyperthermia, ventricular arrhythmias, extreme thirst, delirium and convulsions.
Every theophylline overdose should be regarded as potentially fatal and all patients should be closely monitored.

Treatment.

There is no specific antidote to theophylline. Symptomatic support is indicated. Gastric lavage and general supportive measures (e.g. to maintain circulation, respiration and fluid and electrolyte balance) are recommended. Oral activated charcoal may reduce serum theophylline levels, whilst in severe cases charcoal haemoperfusion may be required.
The important features of overdose management are:

Gastric decontamination.

Gastric lavage is recommended, especially when slow release preparations have been ingested. Note that the conscious state, gag reflex or occurrence of seizures may require the patient to be intubated before lavage is carried out. (Ipecac-induced emesis is not appropriate because it reduces the likelihood that patients will be able to tolerate oral charcoal.)

Use of activated charcoal and cathartic (either sorbitol or polyethylene glycol).

This has been shown in several studies to reduce the half-life of theophylline substantially, even when absorption has been completed. The recommended dose is 1 g/kg every 4-6 hours (or 10 g/hour) until the theophylline level has plateaued or commenced falling or is below 55 micromol/L. (This depends on the experience of the physician in managing theophylline overdose.)

Control of emesis (otherwise patients will not tolerate charcoal).

Metoclopramide, ranitidine, droperidol and possibly ondansetron can be used, but there is no controlled trial evidence for any of these.

Theophylline monitoring.

(Also see Section 4.4 Special Warnings and Precautions for Use.)
If side effects appear or if unusually high doses are required, serum theophylline should be monitored. Blood samples for monitoring should be drawn immediately before administration of the morning dose when the serum theophylline level is lowest. Another sample should be drawn 5-10 hours after administration of Nuelin SR when the theophylline level is at a maximum.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Theophylline has a direct relaxant effect on the smooth muscle of bronchial airways and pulmonary blood vessels, serving as a bronchodilator and pulmonary vasodilator. It also exhibits activities typical of xanthines such as CNS stimulation including the respiratory centre, cardiac stimulation, coronary vasodilatation, diuresis and increased gastric secretion.
The mechanism of action of theophylline in vivo has not been fully elucidated. One mechanism of smooth muscle relaxation may be inhibition of phosphodiesterase that reduces intracellular hydrolysis of cyclic AMP. Increased intracellular concentrations of cyclic AMP have been associated with relaxation of bronchial smooth muscle.
There is no evidence that tolerance develops with continued use of theophylline.

Relationship to other drugs.

Theophylline is closely related to the other xanthines, caffeine and theobromine. Generally, the xanthines relax smooth muscle, act on the kidney to produce diuresis, stimulate the central nervous system and stimulate cardiac muscle.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Nuelin SR Tablets are a sustained release formulation appropriate for long-term use. Steady-state conditions are usually achieved after 4 days' therapy.
Nuelin Syrup is an immediate release formulation.
It is now generally believed that plasma concentrations of 10-20 microgram/mL constitute a therapeutic range, although some patients may benefit from levels below this.

Absorption.

Theophylline is well absorbed throughout the gastrointestinal tract.
The bioavailability of theophylline from Nuelin SR Tablets is approximately 100%. Peak levels after administration of Nuelin SR Tablets usually occur at 4 to 6 hours post-dose. Total bioavailability is not altered by food intake. Single dose studies with Nuelin SR Tablets show that food delays the rate of absorption slightly, especially in children. In multiple dosing situations, a slower rate of theophylline absorption leads to lower peak-trough fluctuation.
Peak plasma theophylline levels occur 1.5 to 2 hours after a dose of Nuelin Syrup.
The plasma half-life of theophylline in adults varies considerably. In healthy adults, it ranges from 3 to 12 hours. The half-life is shortened by smoking.
The half-life of theophylline is prolonged by reduced hepatic function, congestive heart failure, pulmonary disease, severe hypoxia, reduced thyroid function, acute febrile states, viral infections and administration of some drugs (see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions). Patients with a prolonged half-life of theophylline, from whatever cause, require a reduced dosage.
In children aged 1-9 years, the half-life is usually significantly shorter than in adults, averaging about 3.5 hours. In newborns and neonates, clearance is extremely slow.

Distribution.

Approximately 50-70% of circulating theophylline is bound to the plasma proteins of adults, but binding is decreased to about 40% in newborn infants and in adults with hepatic cirrhosis. Theophylline partitions into saliva and breast milk and crosses the placental barrier.

Metabolism.

Theophylline is metabolised in the liver, principally to 1,3-dimethyluric acid with other metabolites being 3-methylxanthine and 1-methyluric acid. 3-Methylxanthine has some pharmacological activity, but less than theophylline.

Excretion.

Theophylline and its metabolites are excreted by the kidney. About 10% of the administered dose is excreted unchanged in the urine.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

See Section 2 Qualitative and Quantitative Composition.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 30°C.

6.5 Nature and Contents of Container

Nuelin SR Tablets.

HDPE bottle, 100's.

Nuelin Syrup.

Amber PET bottle; 500 mL, 100 mL*, 5 L*.
* Not marketed.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Chemical name: 1,3-dimethylxanthine, 2,6-dihydroxy-1,3-dimethylpurine, 3,7-dihydro-1,3-dimethyl-1H-purine-2,6-dione. Molecular formula is C7H8N4O2 (molecular weight 180.16).

Chemical structure.


CAS number.

58-55-9.

7 Medicine Schedule (Poisons Standard)

Nuelin SR Tablets: S4; Nuelin Syrup: S3.

Summary Table of Changes