Neulyn: Each film-coated Sustained Release Tablet contains Theophylline BP 400 mg.

Theophylline is a bronchodilator, structurally classified as a Methylxanthine.
Theophylline relaxes bronchial smooth muscle, relieves bronchospasm, and has a
stimulant effect on respiration. It stimulates the myocardium and CNS, decreases
peripheral resistance and venous pressure, and causes diuresis.

Neulyn is used to control of acute asthma, management of chronic asthma (both
symptomatic and prophylactic treatment), controlling of nocturnal asthma and early
morning wheezing and to control of apnea of pre-maturity.

Adult: 1 tablet 12 hourly or as directed by the physicians.

Neulyn is contraindicated to any known hypersensitivity to xanthine derivatives. It is
also contraindicated in patients with active peptic ulcer diseases and in individuals
with underlying seizure disorders (unless receiving appropriate anti-convulsing
medication).

Theophylline should be given with caution to patients with hyperthyroidism, viral
infection, congestive heart failure, hypertension, cardiac arrhythmias or other
cardiovascular diseases, or epilepsy, as these conditions may be exacerbated. They
should also be given with caution to patients with heart failure, hepatic dysfunction,
chronic alcoholism, acute febrile illness, since in all of these circumstances theophylline
clearance may be decreased, resulting in increases in serum-theophylline
concentrations and serum half-life. Conversely, smoking increases theophylline
clearance.

Safety in human pregnancy has not been established. Theophylline crosses the
placental barrier & is secreted in breast milk. Theophylline should be used with
caution in pregnancy & lactation.

Theophylline clearance may be reduced by interaction with other drugs including
allopurinol, some antiarrhythmics, cimetidine, disulfiram, fluvoxamine, interferonalfa,
macrolide antibacterials and quinolones, oral contraceptives, and the dose may
need to be reduced. Phenytoin and some other antiepileptics, ritonavir, rifampicin, and
sulfinpyrazone may increase theophylline clearance, and require an increase in dose or
dosing frequency.

Theophylline may cause nausea, vomiting, abdominal pain, diarrhoea, gastrooesophageal
reflux, and other gastrointestinal disturbances, insomnia, headache,
anxiety, restlessness, dizziness, tremor, and palpitations. Overdosage may also lead to
agitation, diuresis and repeated vomiting (sometimes haematemesis) and consequent
dehydration, cardiac arrhythmias including tachycardia, hypotension, and electrolyte
disturbances including profound hypokalaemia, hyperglycaemia, metabolic acidosis,
convulsions, and death. Convulsions, cardiac arrhythmias, and hypotension may
follow intravenous injection, particularly if the injection is too rapid, and sudden
deaths have been reported; the drug is too irritating for intramuscular use.

Store in a cool and dry place, away from direct light. Keep out of the reach of the
children.

Each box contains 10X10\'s tablets in blister pack.