SPIROLON Film-coated tablet (2015)
Βιβλιογραφική αναφορά
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Περιεχόμενα
1. Name of the medicinal product
Spirolon 25 mg film-coated tablets. Spirolon 100 mg film-coated tablets.
2. Qualitative and quantitative composition
Spirolon 25 mg film-coated tablets: Each film-coated tablet contains 25 mg spironolactone. Spirolon 100 mg film-coated tablets: Each film-coated tablet contains 100 mg spironolactone. <u>Excipient(s) with ...
3. Pharmaceutical form
Film-coated tablet. <u>Spirolon 25 mg film-coated tablets:</u> Yellow, round, film-coated tablets, scored with Remedicas logo on one side and embossed with SP 25 on the other side. The score line is only ...
4.1. 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 ...
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 a single or divided doses, is recommended, but ...
4.3. Contraindications
Spironolactone is contraindicated in adult and paediatric patients with the following: Acute renal insufficiency, significant renal compromise, anuria. Addisons disease. Hyperkalaemia. Hypersensitivity ...
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 concomitant use of trimethoprim/sulfamethoxazole (co-trimoxazole) with spironolactone ...
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 Spirolon in pregnant women requires that ...
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
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 ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Diuretics; Potassium-sparing agents <b>ATC code:</b> C03DA01 Mechanism of action Spironolactone, as a competitive aldosterone antagonist, increases sodium excretion whilst ...
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
Spirolon 25 mg film-coated tablets <u>Core:</u> Starch, pregelatinised Cellulose, microcrystalline Macrogol 6000 Polysorbate 80 Sodium starch glycolate (type A) Sodium laurilsulfate Silica, colloidal anhydrous ...
6.2. Incompatibilities
None stated.
6.3. Shelf life
5 years.
6.4. Special precautions for storage
Store below 25°C. Protect from light and moisture.
6.5. Nature and contents of container
<u>Spirolon 25 mg film-coated tablets:</u> PVC/Aluminium blisters. Pack sizes of 30, 50, 100, 500 and 1000 film-coated tablets. PP containers with PE closure. Pack sizes of 50, 500 and 1000 film-coated ...
6.6. Special precautions for disposal and other handling
No special requirements for disposal.
7. Marketing authorization holder
Remedica Ltd, Aharnon St., Limassol Industrial Estate, 3056 Limassol, Cyprus
8. Marketing authorization number(s)
Spirolon 25 mg film-coated tablets: 7873 Spirolon 100 mg film-coated tablets: 8679
9. Date of first authorization / renewal of the authorization
<u>Spirolon 25 mg film-coated tablets:</u> Date of first authorization: 02 April 1981 Date of latest renewal: 25 January 2012 <u>Spirolon 100 mg film-coated tablets:</u> Date of first authorization: 07 ...
10. Date of revision of the text
11/05/2015
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