Information about FOSICARD

Composition:
Fosinopril sodium10 - 20 mg tablets.
Mechanism of action: 
Fosinopril sodium is the pro-drug (ester) of the long acting active ACE inhibitor fosinoprilat. After oral administration fosinopril sodium is quickly and fully metabolised to the active fosinoprilat. Fosinopril sodium contains a phosphinic group capable of a specific binding to the active site of the angiotensin converting enzyme, preventing the conversion of angiotensin I in angiotensin II. The reduction in angiotensin II leads to a vasoconstriction reduction and a decrease in aldosterone secretion, which might induce a slight increase in serum potassium and a loss of sodium and fluid. 
Contraindications:
• Hypersensitivity to the active substance, other angiotencin-converting enzyme (ACE) inhibitors or to any of the excipients listed in section 6.1. 
• History of angioneurotic oedema.
• History of angioedema associated with previous ACE inhibitor therapy.
• Renal artery stenosis (bilateral or unilateral in single kidney).
• Cardiogenic shock. 
• Second and third trimesters of pregnancy (see sections 4.4 and 4.6). 
• The concomitant use of fosinopril sodium with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60ml/min/1.73m2). (see sections 4.5 and 5.1).
• Concomitant use with sacubitril/valsartan therapy. Fosinopril sodium must not be initiated earlier than 36 hours after the last dose of sacubitril/valsartan.
Combinations not recommended: 
Potassium sparing diuretics, potassium supplements or potassium-containing salt substitutes:
Potassium sparing diuretics (e.g. spironolactone, triamterene, or amiloride), potassium supplements, or potassium-containing salt substitutes may lead to significant increases in serum potassium. Care should also be taken when fosinopril sodium is co-administered with other agents that increase serum potassium, such as trimethoprim and cotrimoxazole (trimethoprim/sulfamethoxazole) as trimethoprim is known to act as a potassium-sparing diuretic like amiloride. Therefore, the combination of fosinopril sodium with the above-mentioned drugs is not recommended. If concomitant use is indicated, they should be used with caution and with frequent monitoring of serum potassium.
If fosinopril sodium is given with a potassium-losing diuretic, diuretic-induced hypokalaemia may be ameliorated.
Pregnancy:
The use of ACE inhibitors is not recommended during the first trimester of pregnancy. The use of ACE inhibitors is contraindicated during the second and third trimester of pregnancy.
Breast-feeding:
Because only very limited information is available regarding the use of fosinopril sodium during breastfeeding, fosinopril sodium is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant.
Overdose:
The symptoms of overdosage may include severe hypotension, circulatory shock, electrolyte disturbance, renal failure, hyperventilation tachycardia, palpitations, bradycardia, dizziness, anxiety and cough. The recommended treatment of overdose is intravenous infusion of normal saline solution. After ingestion of an overdose the patient should be kept under very close supervision preferably in an intensive care unit. Serum electrolytes and creatinine should be monitored frequently.