NUELIN SA 250 Milligram Tablet Prolonged Release
Država: Irska
Jezik: angleščina
Source: HPRA (Health Products Regulatory Authority)
Lastnosti izdelka
(SPC)
21-05-2024
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Aktivna sestavina:
THEOPHYLLINE
Dostopno od:
Meda Health Sales Ireland Limited
INN (mednarodno ime):
THEOPHYLLINE
Odmerek:
250 Milligram
Farmacevtska oblika:
Tablet Prolonged Release
Tip zastaranja:
Product subject to prescription which may be renewed (B)
Status dovoljenje:
Withdrawn
Datum dovoljenje:
2013-01-01
Lastnosti izdelka
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nuelin SA 250 mg Prolonged-release Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each prolonged-release tablet contains 250 mg theophylline.
Excipient with known effect:
Each tablet also contains 200 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged-release tablet
White, circular, biconvex tablet with breakline, 11 mm in diameter, marked ‘NLS 250’ 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: Nuelin SA 250 tablets are not recommended for use in children under 12 years of age.
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 incre
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