PHYLLOCONTIN CONTINUS Prolonged release tablets (2017)
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Περιεχόμενα
1. Name of the medicinal product
PHYLLOCONTIN CONTINUS 225 mg Prolonged Release Tablets.
2. Qualitative and quantitative composition
Each tablet contains aminophylline hydrate 225 mg. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Prolonged release tablets. Pale yellow, round, film-coated tablet with the Napp logo marked on one side and SA on the other.
4.1. Therapeutic indications
For the treatment and prophylaxis of bronchospasm and inflammation associated with asthma, emphysema and chronic bronchitis. Also indicated in adults for the treatment of cardiac asthma and left ventricular ...
4.2. Posology and method of administration
Posology Adults and the elderly The usual maintenance dose is one PHYLLOCONTIN CONTINUS tablet 225 mg twice daily. This may be titrated to higher dosage as required. Paediatric population aged 6 years ...
4.3. Contraindications
Hypersensitivity to xanthines, ethylenediamine or any of the excipients listed in section 6.1. Concomitant use with ephedrine in children less than 6 years of age (or less than 22 kg). Porphyria. Aminophylline ...
4.4. 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 clearance, dose reduction and monitoring of serum theophylline ...
4.5. 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 of aminophylline to ensure a therapeutic effect: aminoglutethimide, carbamazepine, isoprenaline, phenytoin, ...
4.6. Pregnancy and lactation
Pregnancy There are no adequate data from well controlled studies of the use of theophylline/aminophylline in pregnant women. Theophylline has been reported to give rise to teratogenic effects in mice, ...
4.7. Effects on ability to drive and use machines
PHYLLOCONTIN CONTINUS tablets have no or negligible influence on the ability to drive and use machines.
4.8. Undesirable effects
The following adverse drug reactions have been reported in the post-marketing setting for aminophylline. Frequencies of not known have been assigned as accurate frequencies cannot be estimated from the ...
4.9. 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. ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Drugs for obstructive airways disease, xanthines <b>ATC code:</b> R03DA05 Aminophylline (theophylline) is a bronchodilator. In addition it affects the function of a number ...
5.2. Pharmacokinetic properties
Absorption Following oral administration of PHYLLOCONTIN CONTINUS tablets, the delivery of theophylline is controlled and at steady state, peak concentrations are typically seen after approximately 5 hours. ...
5.3. Preclinical safety data
Genotoxicity and carcinogenicity In vitro and in vivo assays have shown both positive and negative genotoxic results for theophylline. However, oral theophylline administered daily to rats and mice for ...
6.1. List of excipients
Hydroxyethylcellulose Cetostearyl alcohol Talc Magnesium stearate Povidone (K25) <u>Film coating:</u> Hypromellose Titanium dioxide (E171) Iron oxide (E172) Macrogol 400
6.2. Incompatibilities
Not applicable.
6.3. Shelf life
3 years.
6.4. Special precautions for storage
Do not store above 25°C.
6.5. Nature and contents of container
Polypropylene containers with polyethylene lids containing 50, 56, 250 or 1000 tablets. Aluminium foil backed PVC blister strips in cardboard cartons containing 10, 56 or 60 tablets. Not all pack sizes ...
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Mundipharma Pharmaceuticals Limited, Millbank House, Arkle Road, Sandyford, Dublin 18, Ireland
8. Marketing authorization number(s)
PA 1688/008/001
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 01 April 1984 Date of last of last renewal: 01 April 2004
10. Date of revision of the text
May 2017
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