UNIPHYLLIN CONTINUS Prolonged release tablet (2023)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
UNIPHYLLIN CONTINUS 200mg prolonged release tablets.
Qualitative and quantitative composition
Each prolonged-release tablet contains 200 mg theophylline as 220 mg theophylline monohydrate. For the full list of excipients, see section 6.1.
Pharmaceutical form
Prolonged release tablet. White, capsule shaped tablet, plain on one side and marked U200 on the other.
Therapeutic indications
For the treatment and prophylaxis of bronchospasm associated with asthma, chronic obstructive pulmonary disease and chronic bronchitis. Also indicated for the treatment of left ventricular and congestive ...
Posology and method of administration
Posology Adults and the elderly The usual maintenance dose is 200 mg 12 hourly. This may be titrated to either 300 mg or 400 mg dependent on the therapeutic response. Paediatric population aged 6 years ...
Contraindications
Hypersensitivity to xanthines or to any of the excipients listed in section 6.1. Patients with porphyria. Concomitant administration with ephedrine in children less than 6 years of age (or less than 22 ...
Special warnings and precautions for use
The patients response to therapy should be carefully monitored – worsening of asthma symptoms requires medical attention. Due to potential decreased theophylline clearance, dose reduction and monitoring ...
Interaction with other medicinal products and other forms of interaction
The following increase clearance of theophylline and it may therefore be necessary to increase dosage to ensure a therapeutic effect: aminoglutethimide, carbamazepine, isoprenaline, phenytoin, rifampicin, ...
Pregnancy and lactation
Pregnancy There are no adequate data from well controlled studies of the use of theophylline in pregnant women. Theophylline has been reported to give rise to teratogenic effects in mice, rats and rabbits ...
Effects on ability to drive and use machines
UNIPHYLLIN CONTINUS tablets have no or negligible influence on the ability to drive and use machines.
Undesirable effects
The following adverse drug reactions have been reported in the post-marketing setting for theophylline. Frequencies of not known have been assigned as accurate frequencies cannot be estimated from the ...
Overdose
Theophylline has a low therapeutic index. Theophylline toxicity is most likely to occur when serum concentrations exceed 20 micrograms/ml and becomes progressively more severe at higher serum concentrations. ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Drugs for obstructive airways diseases, xanthines <b>ATC code:</b> R03DA04 Theophylline is a bronchodilator. In addition it affects the function of a number of cells involved ...
Pharmacokinetic properties
Absorption Following oral administration, theophylline is efficiently absorbed and is associated with an absolute bioavailability approximating 100%. Following oral administration of UNIPHYLLIN CONTINUS ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology and repeated dose toxicity. Genotoxicity and carcinogenicity <em>In vitro</em> and <em>in vivo ...
List of excipients
Hydroxyethylcellulose Povidone (K25) Cetostearyl alcohol Macrogol 6000 Talc Magnesium stearate
Incompatibilities
Not applicable.
Shelf life
Three years.
Special precautions for storage
Do not store above 25°C.
Nature and contents of container
Blister packs consisting of aluminium foil sealed to 250 µ m PVC with a PVdC coating of at least 40 gsm thickness, containing 8 or 56 tablets. Polypropylene containers containing 60, 100, 250 or 1000 tablets. ...
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Ennogen Healthcare Ltd, Unit G4, Riverside Industrial Estate, Riverside Way, Dartford, DA1 5BS, UK
Marketing authorization number(s)
PL 40739/0328
Date of first authorization / renewal of the authorization
23 August 1979 / 15 May 2003
Date of revision of the text
24/01/2023
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