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ZOFENIL is a brand name for Zofenopril. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Hypertension ZOFENIL is indicated for the treatment of mild to moderate essential hypertension. Acute Myocardial Infarction ZOFENIL is indicated for the treatment initiated within the first 24 hours of patients with acute myocardial infarction with or without signs and symptoms of heart failure, who are…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Hypertension Adults The need for dosage titration should be determined by measurement of blood pressure just before the next dose. The dose should be increased at an interval of four weeks. Patients without volume or salt depletion Treatment should be started with 15 mg once daily and titrated upwards to achieve optimal blood pressure control.
The usual effective dose is 30 mg once daily. The maximum dose is 60 mg once daily. 1). Patients suspected of volume or salt depletion First-dose hypotension may occur in high risk patients (see Special warnings and precautions for use).
Initiation of therapy with ACE inhibitors requires correction of salt and/or volume deficiencies, discontinuation of an existing diuretic therapy for two to three days before ACE inhibition and a starting dose of 15 mg daily. 5 mg daily.
Patients at high risk for severe acute hypotension should be monitored closely preferably in hospital, for as long as the maximal effect is expected after administration of the first dose and whenever the dose of ACE inhibitor and/or diuretic is increased.
This also applies to patients with angina pectoris or cerebrovascular disease in whom excessive hypotension could result in a myocardial infarction or cerebrovascular accident. ) the same dose level and once-daily regimen for ZOFENIL can be employed as for patients with normal renal function.
) should be given one-half the therapeutic dose of ZOFENIL; the once-daily dosage regimen does not require modification. The starting dose and the dosage regimen of ZOFENIL for hypertensive patients maintained on dialysis should be one-quarter the dose used for patients with normal renal function.
Recent clinical observations have shown a high incidence of anaphylactoid-like reactions in patients on ACE inhibitors during haemodialysis with high-flux dialysis membranes or during LDL apheresis (see section
Tabulated list of adverse reactions The table below shows all the adverse reactions that have been reported during clinical practice in patients treated with ZOFENIL. 5) Rare The following adverse reactions have been observed associated with ACE inhibitors therapy.
Blood and lymphatic system disorders In a few patients agranulocytosis and pancytopenia may occur. There are reports of haemolytic anaemia in patients with glucose-6-phosphate dehydrogenase deficiency. Metabolism and nutrition disorders Very rare hypoglycaemia Endocrine disorders Not known, inappropriate antidiuretic hormone secretion.
Psychiatric disorders Rarely, depression, mood altered, sleep disorders, confusional state. Nervous system disorders Occasionally paraesthesia, dysgeusia, balance disorder. Eye disorders Rarely, vision blurred. Ear and labyrinth disorders Rarely, tinnitus.
Cardiac disorders Individual cases of tachycardia, arrhythmias, angina pectoris, myocardial infarction have been reported for ACE inhibitors in association with hypotension. Vascular Disorders Severe hypotension has occurred after initiation or increase of therapy.
This occurs especially in certain risk groups (see Special warnings and precautions for use). In association with hypotension, symptoms like dizziness, feeling of weakness, impaired vision. Rarely flushing occurs. Respiratory, thoracic and mediastinal disorders Rarely dyspnoea, sinusitis, rhinitis, glossitis, bronchitis and bronchospasm have been reported.
ACE inhibitors have been associated with the onset of angioneurotic oedema in a small subset of patients involving the face and oropharyngeal tissues. In isolated cases angioneurotic oedema involving the upper airways has caused fatal airway obstruction.
Gastro-intestinal disorders Occasionally, abdominal pain, diarrhoea, constipation and dry mouth can occur. Individual cases of pancreatitis and ileus have been described in association with ACE inhibitors. Very rare small bowel angioedema Hepatobiliary disorders Individual cases of cholestatic jaundice and hepatitis have been described in association with ACE inhibitors.
4 Special warnings and precaution for use). Elderly (over 65 years) In the elderly with normal creatinine clearance no adjustment is necessary. In the elderly with reduced creatinine clearance (less than 45 ml/min) half of the daily dose is recommended.
Creatinine clearance may be estimated from serum creatinine by the following formula: Clearance (140-age) X weight (Kg) Creatinine (ml/min) = _________________________ Serum Cr. (mg/dl) X 72 The above method provides creatinine clearance in males.
85. Hepatic impairment In hypertensive patients with mild to moderate hepatic impairment, the starting dose of ZOFENIL is half of the dose for patients with normal hepatic function. In hypertensive patients with severe liver impairment ZOFENIL is contraindicated Paediatric population The safety and efficacy of ZOFENIL in children and adolescents below 18 years has not been established.
Therefore its use is not recommended. Acute myocardial infarction Adults Treatment with ZOFENIL should begin within 24 hours after the onset of symptoms of acute myocardial infarction and continued for six weeks. 5 mg every 12 hours 3rd and 4th day: 15 mg every 12 hours from 5th day and onwards: 30 mg every 12 hours In the event of low systolic blood pressure (≤120mmHg) at the start of treatment or during the first three days following myocardial infarction, the daily dose should not be increased.
In the event of hypotension (≤100mmHg), the treatment can be continued with the dose that was previously tolerated. In the event of severe hypotension (systolic blood pressure lower than 90mmHg in two consecutive measurement at least one hour apart), ZOFENIL should be discontinued.
After 6 weeks treatment patients must be re-evaluated and the treatment should be discontinued in patients without signs of left ventricular dysfunction or cardiac failure. If these signs are present, treatment might be continued long term.
1. History of angioneurotic oedema associated with previous ACE inhibitor therapy. Concomitant use with sacubitril/valsartan therapy. 5). Hereditary/idiopathic angioneurotic oedema. Severe hepatic impairment. 6). Women of child-bearing potential unless protected by effective contraception.
Bilateral renal artery stenosis or unilateral renal artery stenosis in cases of a solitary single kidney. 1).
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Skin and subcutaneous tissue disorders Occasionally allergic and hypersensitivity reactions can occur like erythema multiforme, Stevens-Johnson syndrome, toxic epidermic necrolysis, psoriasis-like efflorescences, alopecia. This can be accompanied by fever, myalgia, arthralgia, eosinophilia and/or increased ANA- titers.
Rarely hyperhidrosis occurs. Musculoskeletal and connective tissue disorders Occasionally, myalgia can occur. Renal and urinary disorders Renal insufficiency may occur or be intensified. Acute renal failure has been reported (see Special warnings and precautions for use).
Rarely micturition disorders occur. Reproductive system and breast disorders Rarely, erectile dysfunction. General disorders and administration site conditions. Very rarely oedema peripheral and chest pain. Investigations Increases in blood urea and creatinine, reversible on discontinuation may occur, especially in the presence of renal insufficiency, severe heart failure and renovascular hypertension.
In a few patients, decreases in haemoglobin, haematocrit, platelets and white-cell count have been reported. Increases in serum levels of hepatic enzymes and bilirubin have also been reported.
Reporting of suspected adverse reactions:
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme.
uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Patients should also receive, as appropriate, the standard treatment such as nitrates, aspirin or β-blockers. Elderly (over 65 years)ZOFENIL should be used with caution in myocardial infarction patients who are more than 75 years of age.
Renal impairment and dialysis The efficacy and safety of ZOFENIL in myocardial infarction patients with renal impairment or who are undergoing dialysis has not been established. Therefore, ZOFENIL should not be used in these patients.
Hepatic impairment The efficacy and safety of ZOFENIL in myocardial infarction patients with hepatic impairment has not been established. Therefore, it should not be used in these patients. Method of administration Zofenil can be taken before, during or after meals.
Dosage must be titrated according to the therapeutic response of the patient. 1. History of angioneurotic oedema associated with previous ACE inhibitor therapy. Concomitant use with sacubitril/valsartan therapy. 5). Hereditary/idiopathic angioneurotic oedema.
Severe hepatic impairment. 6). Women of child-bearing potential unless protected by effective contraception. Bilateral renal artery stenosis or unilateral renal artery stenosis in cases of a solitary single kidney. 1). 4 Special warnings and precautions for use Hypotension: As with other ACE inhibitors, ZOFENIL may cause a profound fall in blood pressure especially after the first dose, although.
symptomatic hypotension is seen rarely in uncomplicated hypertensive patients. 8). In patients with heart failure, with or without associated renal insufficiency, symptomatic hypotension has been observed. This is more likely to occur in those patients with more severe degrees of heart failure, as reflected by the use of high doses of loop diuretics, hyponatraemia or functional renal impairment.
In patients at increased risk of symptomatic hypotension, treatment should be started under close medical supervision preferably in the hospital, with low doses and careful dose titration. If possible, diuretic treatment should be discontinued temporarily when therapy with ZOFENIL is initiated.
Such considerations apply also to patients with angina pectoris or cerebrovascular disease in whom an excessive fall in blood pressure could result in myocardial infarction or cerebrovascular accident. If hypotension develops, the patient should be placed in a supine position.
Volume repletion with intravenous normal saline may be required. The appearance of hypotension after the initial dose does not preclude subsequent careful dose titration with drug after effective management. In some patients with heart failure who have normal or low blood pressure, additional lowering of systemic blood pressure may occur with ZOFENIL.
This effect is anticipated and is not usually a reason to discontinue treatment. If hypotension becomes symptomatic, a reduction of dose or discontinuation of ZOFENIL may be necessary.
Hypotension in acute myocardial infarction:
Treatment with ZOFENIL must not be initiated in acute myocardial infarction patients if there is a risk of additional serious heamodynamic depression following treatment with a vasodilator. These are patients with a systolic blood pressure of <100mmHg or […]