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SPC, UK: UNIPHYLLIN CONTINUS Prolonged release tablets (2017)

Αναφορές

Βιβλιογραφική αναφορά

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Περιεχόμενα

Name of the medicinal product

UNIPHYLLIN CONTINUS 200 mg, 300 mg and 400 mg prolonged release tablets.

Qualitative and quantitative composition

Each tablet contains theophylline 200 mg, 300 mg or 400 mg. For the full list of excipients, see section 6.1

Pharmaceutical form

Prolonged release tablet. 200 mg: White, capsule shaped tablet, plain on one side and marked U200 on the other. 300 mg: White, capsule shaped tablet, plain on one side and marked U300 on the other. 400 ...

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 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 kg). ...

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

Pharmacotherapeutic group: Drugs for obstructive airways diseases, xanthines ATC code: R03DA04 Theophylline is a bronchodilator. In addition it affects the function of a number of cells involved in the ...

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 In vitro and in vivo assays have ...

List of excipients

Hydroxyethylcellulose Povidone (K25) Cetostearyl alcohol Macrogol 6000 Talc Magnesium stearate

Incompatibilities

Not applicable.

Shelf life

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 µm PVC with a PVdC coating of at least 40 gsm thickness, containing 56 tablets.

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

Napp Pharmaceuticals Ltd, Cambridge Science Park, Milton Road, Cambridge CB4 0GW

Marketing authorization number(s)

PL 16950/0066-0068

Date of first authorization / renewal of the authorization

200 mg: 23 August 1979 / 15 May 2003 300 mg: 22 February 1988 / 15 May 2003 400 mg: 29 October 1982 / 15 May 2003

Date of revision of the text

15 March 2017

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