ALDACTONE Film-coated tablets (2019)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή
Περιεχόμενα
Name of the medicinal product
Aldactone 25 mg Film-coated Tablets.
Qualitative and quantitative composition
Each tablet contains 25 mg spironolactone. For the full list of excipients, see section 6.1.
Pharmaceutical form
Film-coated Tablets. Buff film-coated tablets with SEARLE 39 engraved on one side.
Therapeutic indications
Congestive cardiac failure. Hepatic cirrhosis with ascites and oedema. Malignant ascites. Nephrotic syndrome. Diagnosis and treatment of primary aldosteronism. Children should only be treated under guidance ...
Posology and method of administration
Posology Adults Congestive cardiac failure with oedema For management of oedema an initial daily dose of 100 mg of spironolactone administered in either single or divided doses is recommended, but may ...
Contraindications
Spironolactone is contraindicated in adult and paediatric patients with the following: Acute renal insufficiency, significant renal compromise, anuria. Addisons disease. Hyperkalaemia. Hypersensitivity ...
Special warnings and precautions for use
Fluid and electrolyte balance Fluid and electrolyte status should be regularly monitored particularly in the elderly, in those with significant renal and hepatic impairment. Hyperkalaemia may occur in ...
Interaction with other medicinal products and other forms of interaction
Concomitant use of drugs known to cause hyperkalaemia with spironolactone may result in severe hyperkalaemia. In addition, concomitant use of trimethoprim/sulfamethoxazole (co-trimoxazole) with spironolactone ...
Pregnancy and lactation
Pregnancy Spironolactone or its metabolites may cross the placental barrier. With spironolactone, feminisation has been observed in male rat foetuses. The use of Aldactone in pregnant women requires that ...
Effects on ability to drive and use machines
Somnolence and dizziness have been reported to occur in some patients. Caution is advised when driving or operating machinery until the response to initial treatment has been determined.
Undesirable effects
Gynaecomastia may develop in association with the use of spironolactone. Development appears to be related to both dosage level and duration of therapy and is normally reversible when the drug is discontinued. ...
Overdose
Acute overdosage may be manifested by drowsiness, mental confusion, nausea, vomiting, dizziness or diarrhoea. Hyponatraemia, or hyperkalaemia may be induced, but these effects are unlikely to be associated ...
Pharmacodynamic properties
Pharmacotherapeutic group: potassium-sparing agents ATC code: C03DA01 Mechanism of action Spironolactone, as a competitive aldosterone antagonist, increases sodium excretion whilst reducing potassium loss ...
Pharmacokinetic properties
Spironolactone is well absorbed orally and is principally metabolised to active metabolites: sulfur containing metabolites (80%) and partly canrenone (20%). Although the plasma half-life of spironolactone ...
Preclinical safety data
Carcinogenicity Spironolactone has been shown to produce tumours in rats when administered at high doses over a long period of time. The significance of these findings with respect to clinical use is not ...
List of excipients
Calcium sulfate dihydrate Corn starch Polyvinyl pyrrolidone Magnesium stearate Felocofix peppermint Hypromellose Polyethylene glycol Opaspray yellow (contains E171 and E172)
Incompatibilities
Not applicable.
Shelf life
Shelf life: 5 years.
Special precautions for storage
Do not store above 30°C.
Nature and contents of container
Amber glass or plastic bottles containing 100 or 500 tablets. HDPE containers of 50 or 1,000 tablets. PVC/foil blister packs containing 100 or 500 tablets and PVC/foil blister calendar pack of 28 tablets. ...
Special precautions for disposal and other handling
No special requirements for disposal. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom
Marketing authorization number(s)
PL 00057/0928
Date of first authorization / renewal of the authorization
Date of change of ownership: 16 September 2014 Date of latest renewal: 10 February 2002
Date of revision of the text
05/2019
Πηγαίο έγγραφο
Το πηγαίο έγγραφο για αυτήν την βιβλιογραφική αναφορά είναι διαθέσιμο προς μεταφόρτωση:
