Lisinopril 5 mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Lisinopril (as dihydrate)

Available from:

McDermott Laboratories Ltd t/a Gerard Laboratories

ATC code:

C09AA; C09AA03

INN (International Name):

Lisinopril (as dihydrate)

Dosage:

5 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

ACE inhibitors, plain; lisinopril

Authorization status:

Not marketed

Authorization date:

2011-09-09

Patient Information leaflet

PAGE 1 OF 9
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LISINOPRIL 2.5 MG TABLETS
LISINOPRIL 5 MG TABLETS
LISINOPRIL 10 MG TABLETS
LISINOPRIL 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 Lisinopril is and what it is used for
2.
What you need to know before you take Lisinopril
3.
How to take Lisinopril
4.
Possible side effects
5.
How to store Lisinopril
6.
Contents of the pack and other information
1.
WHAT LISINOPRIL IS AND WHAT IT IS USED FOR
Lisinopril contains lisinopril, which belongs to a group of medicines
called Angiotensin Converting
Enzyme (ACE) inhibitors. ACE inhibitors lower blood pressure by
widening your blood vessels. This
allows the blood to flow more easily and reduces the effort needed to
pump blood around the body.
Lisinopril 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 in diabetic patients with high blood pressure
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LISINOPRIL
DO NOT TAKE LISINOPRIL:
-
if you are allergic to lisinopril, any other angiotensin converting
enzyme (ACE) inhibitor e.g.
-
captopril, enalapril, ramipril or any of the other ingredients of this
medicine (listed in Section 6).
-
if you have ever had a severe allergic reaction to another ACE
inhibitor. The allergic reaction
may have caused skin rashes, itchy skin and swelling of the hands,
ankles face, lips, tongue or
thro

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lisinopril 5 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains lisinopril dihydrate equivalent to 5 mg anhydrous
lisinopril.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
Light pink, mottled, round, biconvex tablet debossed with “L and
23” on either side of the breakline on one side and
“M” on the other side.
Diameter 8.7 mm.
The tablet can be divided in to equal doses.
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
Posology
The dose should be individualised according to patient profile and
blood pressure response (see section 4.4).
Hypertension
Lisinopril 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).
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