SINOPREN Tablet Ref.[115267] Active ingredients: Lisinopril

Absorption of SINOPREN is not affected by food, and tablets may be administered before, during or after meals. SINOPREN should be administered in a single dose. SINOPREN should be taken at approximately the same time each day.

Mild to Moderate Hypertension

The recommended starting dose is 10 mg. The usual effective maintenance dosage is 20 mg administered in a single daily dose. Dosage should be adjusted according to blood pressure response.

A maximum dose of 40 mg a day in hypertension is recommended.

If the desired therapeutic effect cannot be achieved in a period of 2 to 4 weeks on a certain dose level, the dose can further be increased.

Diuretic-treated Patients

Symptomatic hypotension may occur following initiation of therapy with SINOPREN; this is more likely in patients who are being treated concurrently with diuretics. Caution is recommended in all patients who may be volume- and/or salt-depleted. The diuretic should be discontinued 2 to 3 days before beginning therapy with SINOPREN (see Section 4.4). In hypertensive patients in whom the diuretic cannot be discontinued, therapy with SINOPREN should be initiated with a 5 mg dose. The subsequent dosage of SINOPREN should be adjusted according to blood pressure response. If required, diuretic therapy may be resumed.

Dosage Adjustment in Renal Impairment

A lower dose is required in the presence of renal impairment, in patients in whom diuretic therapy cannot be discontinued and in patients who are volume- and/or salt depleted for any reason. Dosage in patients with renal impairment should be based on creatinine clearance as outlined below:

Safety has not been established in patients with creatinine clearance below 30 ml/min. The dosage may be titrated upward until blood pressure is controlled or to a maximum of 20 mg daily.

Renovascular Hypertension

Special care is to be exercised in patients with renovascular hypertension because of the possibility of exaggerated response.

The dosage should be lowered to 2,5 mg or 5 mg and the patient should be monitored.

Congestive Heart Failure

In patients not adequately controlled by digoxin and/or diuretics, SINOPREN may be added in a starting dose of 2,5 mg once a day. This may be increased at 4 week intervals in patients requiring an additional therapeutic effect. Dose adjustment should be based on the clinical response of the individual patients. The usual effective dosage range is 5 to 20 mg per day administered in a single daily dose.

Patients at high risk of symptomatic hypotension, e.g. patients with salt depletion with or without hyponatraemia, patients with hypovolaemia or patients who have been receiving vigorous diuretic therapy, should have these conditions corrected, prior to therapy with SINOPREN. The effect of the starting dosage of SINOPREN on blood pressure should be monitored carefully.

Acute Myocardial Infarction

Treatment with SINOPREN may be started within 24 hours of the onset of symptoms. The first dose of SINOPREN is 5 mg given orally, followed by 5 mg after 24 hours, 10 mg after 48 hours and then 10 mg once daily thereafter. Patients with a low systolic blood pressure (120 mmHg or less) should be given a lower dose, 2,5 mg orally (see Section 4.4). If hypotension occurs (systolic blood pressure less than or equal to 100 mmHg) a daily maintenance dose of 5 mg may be given with temporary reduction to 2,5 mg if needed. If prolonged hypotension occurs (systolic blood pressure less than 90 mmHg for more than 1 hour), SINOPREN should be withdrawn.

Dosing should continue for 6 weeks. The benefit appears to be greatest in patients with large myocardial infarctions and evidence of impaired left ventricular function. Patients who develop symptoms of heart failure should continue with SINOPREN (see Congestive Heart Failure above).

SINOPREN is compatible with intravenous or transdermal glyceryl trinitrate.

Paediatric Use

Safety and effectiveness of SINOPREN in children has not been established.

Use in the Elderly

There are no age-related changes in the efficacy or safety profile of SINOPREN. When advanced age is associated with a decrease in renal function, however, the guidelines set out in the dose adjustment table (see Renal Impairment above) should be used to determine the starting dose of SINOPREN. Thereafter, the dosage should be adjusted according to the blood pressure response.

The symptoms of overdosage may include severe hypotension, circulatory shock, electrolyte disturbances hyperventilation, tachycardia, palpitations, bradycardia, dizziness, anxiety and cough renal failure. Treatment is symptomatic and supportive. The recommended treatment of overdose is intravenous infusion of normal saline solution. If hypotension occurs, the patient should be placed in the shock position. If available, treatment with angiotensin II infusion and/or intravenous catecholamines may also be considered. If ingestion is recent, take measures aimed at eliminating lisinopril (e.g. emesis, gastric lavage, administration of absorbents and sodium sulphate).

Lisinopril may be removed from the general circulation by haemodialysis. Pacemaker therapy is indicated for therapy-resistant bradycardia. Vital signs, serum electrolytes and creatinine concentrations should be monitored frequently.

24 Months.

Store at or below 25°C, protected from light and moisture.

Sinopren 5 Tablets: Carton containing three PVdC-coated PVC blister strips of 10 tablets each.

Sinopren 10 Tablets: Carton containing three PVdC-coated PVC blister strips of 10 tablets each.

Sinopren 20 Tablets: Carton containing three PVdC-coated PVC blister strips of 10 tablets each.

Return all unused or expired medicines to your pharmacist for safe disposal. Do not dispose of unused medicines in drains or sewerage systems (e.g. toilets).