SUMMARY CMI

NUELIN-SR^® Tablets

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.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

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.

More instructions can be found in Section 4. How do I take Nuelin-SR? in the full CMI.

5. What should I know while taking Nuelin-SR?

For more information, see Section 5. What should I know while taking Nuelin-SR? in the full CMI.

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.

FULL CMI

NUELIN-SR^® Tablets (new-lin s r tab-lets)

Active ingredient: Theophylline (thee-off-o-lin)

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?
2. What should I know before I take Nuelin-SR?
3. What if I am taking other medicines?
4. How do I take Nuelin-SR?
5. What should I know while taking Nuelin-SR?
6. Are there any side effects?
7. Product details

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

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.

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

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.

Published by MIMS January 2023

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.

Nuelin SR Tablets.

Adults.

Children.

Note.

Note.

Nuelin Syrup.

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.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

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.

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.

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.

Treatment.

Gastric decontamination.

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

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

Theophylline monitoring.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Relationship to other drugs.

Clinical trials.

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.

Distribution.

Metabolism.

Excretion.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

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.

Nuelin Syrup.

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.

7 Medicine Schedule (Poisons Standard)

Nuelin SR Tablets: S4; Nuelin Syrup: S3.

Summary Table of Changes