ZESGER

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

LISINOPRIL

Available from:

McDermott Laboratories Ltd t/a Gerard Laboratories

ATC code:

C09AA03

INN (International Name):

LISINOPRIL

Dosage:

5mg Milligram

Pharmaceutical form:

Tablets

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

lisinopril

Authorization status:

Marketed

Authorization date:

2001-02-08

Patient Information leaflet

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ZESGER 5 MG, 10 MG AND 20 MG TABLETS
lisinopril dihydrate
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 Zesger is and what it is used for
2.
What you need to know before you take Zesger
3.
How to take Zesger
4.
Possible side effects
5.
How to store Zesger
6.
Contents of the pack and other information
1. WHAT ZESGER IS AND WHAT IT IS USED FOR
Zesger contains lisinopril, which belongs to a group of medicines
called Angiotensin Converting
Enzyme (ACE) inhibitors. ACE inhibitors reduce blood pressure and
widen blood vessels, this allows
the blood to flow more easily and reduces the effort needed to pump
blood around the body. Lisinopril
is used to treat high blood pressure (hypertension), heart failure,
and along with other medicine, may be
given following a heart attack. Lisinopril can also be given to treat
kidney problems in diabetic patients
with high blood pressure (hypertension).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ZESGER
DO NOT TAKE ZESGER:
•
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 previously been treated with an ACE inhibitor and have
suffered an allergic reaction.
Signs may include swelling of the face, lips, tongue and/or throat
with difficulty swallowing or
breathing (angioedema).
•
if you or a family member have a history of angioedema.
•
if y

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zesger 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.
5 mg tablets are white or almost white, round, bevelled edge tablets,
debossed with 5 on one side and a breakline on the
other.
The tablet can be divided into 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
Zesger tablets 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
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