NUELIN SR Tablet / NUELIN Syrup Ref.[50311] Active ingredients: Theophylline

Source: Pharmaceutical Benefits Scheme (AU)  Revision Year: 2019  Publisher: iNova Pharmaceuticals (Australia) Pty Limited, L10, 12 Help Street, Chatswood NSW 2067, Toll Free: 1800 630 056

Product name and form

NUELIN SR (Theophylline) Tablet.

NUELIN (Theophylline) Syrup.

Pharmaceutical Form

NUELIN SR 200 theophylline 200mg tablet bottle: White round biconvex tablet N/L on one side and 200 on the other.

NUELIN SR 250 theophylline 250mg tablet bottle: White, round biconvex tablets marked N/L 250.

NUELIN SR 300 theophylline 300mg tablet bottle: White round biconvex tablet N/L on one side and 300 on the other.

NUELIN Syrup theophylline 26.67mg/5mL bottle: Clear liquid, berry flavour.

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.

Chemical structure

Chemical name: 1,3-Dimethylxanthine, 2,6-Dihydroxy-1,3-dimethylpurine, 3,7-dihydro-1,3-dimethyl1H-purine-2,6-dione.

Molecular formula is C7H8N4O2 (molecular weight 180.16)

CAS number: 58-55-9

Active Ingredient Description
Theophylline

Theophylline is a bronchodilator. In addition it affects the function of a number of cells involved in the inflammatory processes associated with asthma and chronic obstructive airways disease. Theophylline stimulates the myocardium and produces a diminution of venous pressure in congestive heart failure leading to marked increase in cardiac output.

List of Excipients

Refer to Section 2 – Qualitative and quantitative composition.

Pack sizes and marketing

Nuelin SR Tablets: HDPE bottle, 100’s

Nuelin Syrup: Amber PET bottle; 500 mL, 100 mL*, 5 L*

* Not Marketed

Marketing authorization holder

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

Marketing authorization dates and numbers

Nuelin-SR 200 mg Tablets: 16 May 1997
Nuelin-SR 250 mg Tablets: 11 August 1993
Nuelin-SR 300 mg Tablets: 16 May 1997
Nuelin Syrup: 4 July 1991

Drugs

Drug Countries
NUELIN Australia, Hong Kong, New Zealand, Singapore, South Africa

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