URACTONUM Tablet (2016)
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Περιεχόμενα
1. Name of the medicinal product
Uractonum 25 mg tablets. Uractonum 100 mg tablets.
2. Qualitative and quantitative composition
Uractonum 25 mg: Each tablet contains 25 mg of spironolactone. Uractonum 100 mg: Each tablet contains 100 mg of spironolactone. <u>Excipient with known effect:</u> lactose. Each 25 mg tablet contains 145.00 ...
3. Pharmaceutical form
Tablet. Uractonum 25 mg are white, round, flat, scored tablets, with a diameter of 8.5 mm. Uractonum 100 mg are white, round, flat, scored tablets, with a diameter of 9.5 mm.
4.1. Therapeutic indications
Uractonum 25 mg and 100 mg tablets are indicated for: Congestive cardiac failure; Hepatic cirrhosis with ascites and oedema; Malignant ascites; Nephrotic syndrome; Diagnosis and treatment of primary aldosteronism. ...
4.2. 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 ...
4.3. Contraindications
Spironolactone is contraindicated in adult and paediatric patients with the following: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Acute renal insufficiency, ...
4.4. 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 ...
4.5. 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 to other medicinal products known to cause hyperkalaemia concomitant use of trimethoprim/sulfamethoxazole ...
4.6. 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 spironolactone in pregnant women requires ...
4.7. 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.
4.8. 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. ...
4.9. Overdose
Symptoms 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 ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> potassium-sparing agents <b>ATC code:</b> C03DA01 Mechanism of action Spironolactone, as a competitive aldosterone antagonist, increases sodium excretion whilst reducing ...
5.2. Pharmacokinetic properties
Spironolactone is well absorbed orally and is principally metabolised to active metabolites: sulphur containing metabolites (80%) and partly canrenone (20%). Although the plasma half-life of spironolactone ...
5.3. 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 ...
6.1. List of excipients
<u>Tablets (25 mg and 100 mg) also contain:</u> Lactose Maize starch Croscarmellose sodium Povidone Sodium lauryl sulphate Magnesium stearate Peppermint flavour
6.2. Incompatibilities
None stated.
6.3. Shelf life
60 months.
6.4. Special precautions for storage
This medicinal product does not require any special storage conditions.
6.5. Nature and contents of container
<u>Uractonum 25mg tablets:</u> Blisters of polyvinylchloride and aluminium, of ten tablets. Packs of 20, 50 and 100 are available. Polypropylene securitainers with polyethylene caps containing 100, 250, ...
6.6. Special precautions for disposal and other handling
No special requirements for disposal.
7. Marketing authorization holder
MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
8. Marketing authorization number(s)
Uractonum 25 mg: 6832 Uractonum 100 mg: 8523
9. Date of first authorization / renewal of the authorization
Uractonum 25 mg: 20.10.1978 / 17.02.2010 Uractonum 100 mg: 22.10.1982 / 03.03.2010
10. Date of revision of the text
05/2016
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