NUELIN SA 175 Milligram Tablet Prolonged Release
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
01-05-2024
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Active ingredient:
THEOPHYLLINE
Available from:
Meda Health Sales Ireland Limited
INN (International Name):
THEOPHYLLINE
Dosage:
175 Milligram
Pharmaceutical form:
Tablet Prolonged Release
Prescription type:
Product subject to prescription which may be renewed (B)
Authorization status:
Withdrawn
Authorization date:
2013-01-01
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nuelin SA 175 mg Prolonged-release Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet contains 175 mg theophylline.
Excipient with known effect:
Each tablet also contains 140 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release Tablet
White, circular, biconvex tablet, 9 mm in diameter, marked ‘NLS 175’ on one side and ‘3M’ on the other.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Nuelin is indicated for the prophylaxis and treatment of reversible bronchospasm in asthma, bronchitis and
emphysema.
Theophylline is well established in the treatment of bronchospasm. It also has anti-inflammatory effects which
may be of benefit to patients with asthma.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS: A starting dose of 175 mg twice daily or 5 mg/kg/day is recommended. If well tolerated this may be
increased to 350 mg twice daily or 10 mg/kg/day. Adults weighing less than 60 kg may require a lower
maintenance dose (e.g. 250 mg twice daily) and those weighing over 80 kg (lean body mass) may require more.
The dose should not exceed 750 mg if serum theophylline monitoring is not to be carried out.
CHILDREN: 6 to 12 years (20 - 35 kg): 175 mg twice daily, preferably after food.
Regular monitoring of plasma concentrations is highly recommended. If plasma monitoring is not undertaken,
the maximum dose should not exceed 20 mg/kg/day, or 700 mg, whichever is the lesser.
ELDERLY: Elderly patients may require lower doses due to reduced theophylline clearance.
If adverse effects are experienced the dose should be reduced immediately to a level at which they no longer
occur.
Dose increases should be made, if req
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