ZESTRIL 20MG 28 TABLETS

Package leaflet: Information for the patient ZESTRIL® 5 mg Tablets ZESTRIL® 10 mg Tablets ZESTRIL® 20 mg Tablets lisinopril Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.  Keep this leaflet. You may need to read it again.  If you have any further questions, ask your doctor or pharmacist.  This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.  If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. What is in this leaflet: 1. What Zestril is and what it is used for 2. What you need to know before you take Zestril 3. How to take Zestril 4. Possible side effects 5. How to store Zestril 6. Contents of the pack and other information 1. What Zestril is and what it is used for Zestril contains a medicine called lisinopril. This belongs to a group of medicines called ACE inhibitors. Zestril can be used for the following conditions:  To treat high blood pressure (hypertension).  To treat heart failure.  If you have recently had a heart attack (myocardial infarction).  To treat kidney problems caused by Type II diabetes in people with high blood pressure. Zestril works by making your blood vessels widen. This helps to lower your blood pressure. It also makes it easier for your heart to pump blood to all parts of your body. 2. What you need to know before you take Zestril Do not take Zestril:  If you are allergic to lisinopril or any of the other ingredients of this medicine (listed in Section 6).  If you have ever had an allergic reaction to another ACE inhibitor medicine. The allergic reaction may have caused swelling of the hands, feet, ankles, face, lips, tongue or throat. It may also have made it difficult to swallow or breathe (angioedema).  If a member of your family has had severe allergic reactions (angioedema) to an ACE inhibitor or you have had severe allergic reactions (angioedema) without a known cause.  If you are more than 3 months pregnant. (It is also better to avoid Zestril in early pregnancy - see Pregnancy section).  If you have diabetes or impaired kidney function and you are treated with a blood pressure lowering medicine containing aliskiren. If you are not sure if any of these apply to you, talk to your doctor or pharmacist before taking Zestril. If you develop a dry cough which is persistent for a long time after starting treatment with Zestril, talk to your doctor
 
1. Name of the medicinal product
Zestril 5 mg, 10 mg, and 20 mg tablets.
2. Qualitative and quantitative composition
Each tablet contains lisinopril dihydrate equivalent to 5 mg, 10 mg, or 20 mg anhydrous lisinopril.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
5 mg tablets: round, pink, uncoated, biconvex tablet with “♥ 5” on one side and bisected on the other side. Diameter 6 mm.
The tablet can be divided into equal doses.
10 mg tablets: round, pink, uncoated, biconvex tablet with “♥ 10” on one side and plain on the other side. Diameter 8 mm.
20 mg tablets: round, brownish-red, uncoated, biconvex tablet with “♥ 20” on one side and plain on the other side. Diameter 8 mm.
4. Clinical particulars
4.1 Therapeutic indications
Hypertension
Treatment of hypertension.
Heart failure
Treatment of symptomatic heart failure.
Acute myocardial infarction
Short-term (6 weeks) treatment of haemodynamically stable patients within 24 hours of an acute myocardial infarction.
Renal complications of diabetes mellitus
Treatment of renal disease in hypertensive patients with Type 2 diabetes mellitus and incipient nephropathy (see section 5.1).
4.2 Posology and method of administration
Zestril should be administered orally in a single daily dose. As with all other medication taken once daily, Zestril should be taken at approximately the same time each day. The absorption of Zestril tablets is not affected by food.
The dose should be individualised according to patient profile and blood pressure response (see section 4.4).
Hypertension
Zestril may be used as monotherapy or in combination with other classes of antihypertensive therapy (see sections 4.3, 4.4, 4.5 and 5.1).
Starting dose
In patients with hypertension the usual recommended starting dose is 10 mg. Patients with a strongly activated renin-angiotensin-aldosterone system (in particular, renovascular hypertension, salt and /or volume depletion, cardiac decompensation, or severe hypertension) may experience an excessive blood pressure fall following the initial dose. A starting dose of 2.5-5 mg is recommended in such patients and the initiation of treatment should take place under medical supervision. A lower starting dose is required in the presence of renal impairment (see Table 1 below).
Maintenance dose
The usual effective maintenance dosage is 20 mg administered in a single daily dose. In general, if the desired therapeutic effect cannot be achieved in a period of 2 to 4 weeks on a certain dose level, the dose can be further increased. The maximum dose used in long-term, controlled clinical trials was 80 mg/day.
Diuretic-treated patients
Symptomatic hypotension may occur following initiation of therapy with Zestril. This is more likely in patients who are being treated currently with diuretics. Caution is recommended therefore, since these patients may be volume and/or salt depleted. If possible, the diuretic should be discontinued 2 to 3 days before beginning therapy with Zestril. In hypertensive patients in whom the diuretic cannot be discontinued, therapy with Zestril should be initiated with a 5 mg dose. Renal function and serum potassium should be monitored. The subsequent dosage of Zestril should be adjusted according to blood pressure response. If required, diuretic therapy may be resumed (see section 4.4 and section 4.5).
Dosage adjustment in renal impairment
Dosage in patients with renal impairment should be based on creatinine clearance as outlined in Table 1 below.
Table 1 Dosage adjustment in renal impairment
 
 
Creatinine Clearance (ml/min)
Starting Dose (mg/day)
Less than 10 ml/min (including patients on dialysis)
2.5 mg*
10-30 ml/min
2.5-5 mg
31-80 ml/min
5-10 mg