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.

What is in this leaflet

This leaflet answers some common questions about Nuelin Syrup. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

Throughout this leaflet we are talking about the 'patient'. By that we mean either you or your child, whoever is taking Nuelin Syrup.

All medicines have risks and benefits. Your doctor or pharmacist has weighed the risks and benefits of the patient taking Nuelin against the benefits they expect it will have for the patient.

If the have any concerns about taking this medicine or giving it to your child, ask your doctor or pharmacist.

Please read this leaflet carefully before taking this medicine or giving it to your child.

If the information in this leaflet is not clear, or if you have any questions that are not covered by this leaflet, please ask your doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

Nuelin Syrup can be bought from a pharmacy without a doctor's prescription on the advice of a pharmacist.

What NUELIN Syrup is used for

The name of the medicine is Nuelin Syrup. It is used to treat asthma and other conditions where breathing is difficult. It also helps to prevent asthma attacks. The active ingredient in Nuelin Syrup is theophylline, which causes the muscle lining of the airways to relax.

Your doctor or pharmacist may recommend Nuelin Syrup for another purpose.

If you are not sure why the patient is taking this medicine, please ask your doctor or pharmacist.

Before taking NUELIN Syrup

When the patient must not take NUELIN Syrup

Nuelin Syrup should not be taken if the patient is allergic to:

  • theophylline
  • aminophylline
  • caffeine,
  • 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

Do not give this medicine to a child under the age of 2 years unless a doctor has recommended the medicine.

Do not take this medicine or give it to a child after the expiry date printed on the pack or if the packaging shows signs of tampering.

If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether the patient should start taking this medicine, talk to your doctor or pharmacist.

Nuelin Syrup has been recommended for the patient only.

Do not give it to anyone else even if they suffer from the same condition.

Before starting to take it

Tell your doctor if the patient has allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor or pharmacist if the patient has or has had any of the following medical conditions:

  • a stomach ulcer or reflux
  • an irregular or rapid heartbeat
  • any other heart disease
  • high blood pressure
  • any viral infections or lung infections
  • any liver disease
  • thyroid disease
  • lung disease

Or else if the patient:

  • has a fever
  • is pregnant or breastfeeding
  • is taking any other medicines for asthma

Tell your doctor or pharmacist if you are pregnant or plan to become pregnant or are breast-feeding.

Your doctor or pharmacist can discuss with you the risks and benefits involved.

If you have not told your pharmacist or doctor about any of the above, tell him/her before the patient starts taking the medicine.

Taking other medicines

Tell your doctor or pharmacist if the patient is taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and Nuelin Syrup may interfere with each other. These include:

  • antibiotics such as erythromycin (Eryc and others), clarithromycin (Klacid), ciprofloxacin (Ciproxin)
  • enoxacin (Enoxin), rifampicin (Rifadin and others) or isoniazid.
  • medicines used to treat ulcers such as cimetidine (Tagamet and others), ranitidine (Zantac and others).
  • allopurinol (Zyloprim and others).
  • propranolol (Inderal and others)
  • frusemide (Lasix and others)
  • medicines used to help lower high blood pressure such as verapamil (Isoptin and others), diltiazem (Cardizem and others), nifedipine (Adalat and others)
  • mexiletine (Mexitil)
  • medicines used to treat epilepsy or fits such as phenytoin (Dilantin), phenobarbitone or carbamazepine (Tegretol and others)
  • tacrine (Cognex)
  • lithium
  • thiabendazole (Mintezol)
  • disulfiram (Antabuse)
  • oral contraceptives (the Pill)
  • corticosteroids
  • flu vaccine
  • interferon
  • any remedies that you buy without a prescription, especially cold and flu medicines and products containing St John's Wort (Hypericum perforatum)

These medicines may be affected by Nuelin Syrup or may affect how well it works. The patient may need different amounts of these medicines, or may need to take different medicines.

Also tell your doctor or pharmacist if the patient drinks any alcohol or smokes cigarettes or marijuana.

Your doctor or pharmacist may have more information on medicines to be careful with or to avoid while taking this medicine.

How to take NUELIN Syrup

Follow all directions given to you by your doctor or pharmacist carefully.

They may differ from the information contained in this leaflet.

If you do not understand the instructions on the bottle, ask your doctor or pharmacist for help.

Nuelin Syrup helps to prevent and relieve asthma attacks.

Take this medicine only as directed by your doctor or pharmacist.

How much to take

The dose for adults is usually 25mL every six hours. However, this dose may be increased or decreased by your doctor.

For children over 2 years old, the dose of Nuelin Syrup depends on the weight of the child (1mL/kg of bodyweight up to a maximum of 25mL every six hours).

  • Children 2-4 years, 12-16 kg: 10-15mL every 6 hours
  • Children 4-6 years, 16-20 kg: 15-20mL every 6 hours
  • Children 6-12 years, 20-41 kg: 20-25mL every 6 hours
  • Adults and children over 12 years: 25mL every 6 hours

Nuelin Syrup is not suitable for children younger than 2 years of age except on the advice of a doctor.

How to take it

It is best to take Nuelin Syrup one hour before food with a glass of water. However if it upsets the patient's stomach it should be taken with or immediately after food.

While the patient is taking NUELIN Syrup

Nuelin Syrup works best when there is a certain amount of theophylline, the active ingredient, in the blood. Your doctor may sometimes need to take samples of blood to check the level of theophylline.

If the patient forgets to take NUELIN Syrup

If the patient forgets to take Nuelin Syrup, take it as soon as you remember. However, if it is more than 4 hours late, skip the dose that the patient missed. Take the next dose at the normal time.

Never take a double dose to make up for a missed dose.

If the patient has trouble remembering when to take the medicine, ask your pharmacist for some hints.

If you or your child take too much NUELIN Syrup

If you think that you or anyone else may have taken too much Nuelin Syrup telephone your doctor or pharmacist or the Poisons Information Centre (in Australia call 131126; in New Zealand phone toll free 0800 POISON or 0800 764 766) or go to Accident and Emergency at your nearest hospital IMMEDIATELY. Do this even if there are no signs of discomfort or poisoning.

If you or your child has taken too much Nuelin Syrup 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.

While you are using Nuelin Syrup

Things you must do

If the patient is about to be started on any new medicine remind your doctor and pharmacist that the patient is taking Nuelin Syrup.

Tell any other doctors, dentists and pharmacists who treat the patient that they are taking this medicine

If the patient is going to have surgery, tell the surgeon or anaesthetist that the patient is taking this medicine.

It may affect other medicines used during surgery.

If the patient becomes pregnant while taking this medicine, tell your doctor immediately.

Things you must not do

The patient must not take Nuelin Syrup to treat any other complaints unless the doctor or pharmacists tells them to.

Do not give this medicine to anyone else, even if they have the same condition as the patient.

The patient should not stop taking the medicine or lower the dosage without checking with the pharmacist or doctor.

Things to be careful of

Be careful when drinking alcohol or smoking cigarettes or marijuana, these can interfere with how well Nuelin Syrup works.

Side Effects

Tell your doctor or pharmacist as soon as possible if the patient does not feel well while taking Nuelin Syrup.

This medicine helps most people with asthma and other conditions where breathing is difficult or to prevent asthma attacks, but it may have unwanted side effects in a few people.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

  • nausea, vomiting, stomach pain, loss of appetite
  • heartburn
  • headache
  • difficulty sleeping
  • feeling restless, nervous or irritable

Tell your doctor or pharmacist as soon as possible if you notice any of the following:

  • diarrhoea
  • abnormal heartbeat
  • low blood pressure
  • flushing, skin rash
  • rapid breathing
  • increased or decreased urine flow
  • blood in the urine
  • high blood glucose
  • hair loss
  • worsening of a stomach ulcer
  • fast or irregular heartbeat
  • tremor

The above list includes serious side effects that may require medical attention. Serious side effects are rare.

If any of the following happens, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:

  • very irregular or faster heartbeat
  • fits
  • blood in the vomit

The above list includes very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are very rare.

Tell your doctor or pharmacist if you notice anything that is making the patient feel unwell.

Other side effects not listed above may also occur in some people.

If the patient has any side effect, whether it is listed above or not, please tell your doctor or pharmacist.

After Using Nuelin Syrup

Storage

Keep your syrup in the bottle until it is time to take it.

If you take the syrup out of the bottle it may not keep well.

Keep Nuelin Syrup in a cool dry place where the temperature stays below 30°C.

Do not refrigerate it.

Do not store Nuelin Syrup or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car.

Heat and dampness can destroy some medicines.

Keep Nuelin Syrup where children cannot reach it.

A locked cupboard one-and-a-half metres above the ground is a good place to store medicine.

Disposal

If your doctor or pharmacist tells the patient to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

Product Description

What NUELIN Syrup looks like

Nuelin Syrup is a clear, almost colourless liquid with a berry like flavour contained in a 500mL bottle.

Ingredients

Each 25mL of Nuelin Syrup contains 133.3mg of the active ingredient theophylline.

Nuelin Syrup also contains:

  • sucrose
  • sorbitol
  • berry citrus flavouring
  • purified water.

Methyl hydroxybenzoate and propyl hydroxybenzoate are used as preservatives.

Nuelin Syrup does not contain gluten.

Sponsor

iNova Pharmaceuticals (Australia) Pty Limited
ABN 13 617 871 539
L10, 12 Help Street
Chatswood, NSW 2067, Australia
Toll Free: 1800 630 056

New Zealand Toll Free: 0508 375 394

Australian Register Number: AUST R 10576

™ = Trademark

This leaflet was prepared in August 2008 and updated in November 2017.

BRAND INFORMATION

Brand name

Nuelin Syrup

Active ingredient

Theophylline

Schedule

S3

 

1 Name of Medicine

Theophylline.

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.

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.

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.

4 Clinical Particulars

4.1 Therapeutic Indications

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

4.3 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.

4.8 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.

4.2 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.

4.7 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.

4.9 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.

7 Medicine Schedule (Poisons Standard)

Nuelin SR Tablets: S4; Nuelin Syrup: S3.

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.

Summary Table of Changes