Lisinopril Grindeks 5 mg tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Lisinopril Dihydrate

Available from:

AS Grindeks

ATC code:

C09AA03

INN (International Name):

Lisinopril Dihydrate

Pharmaceutical form:

Tablet

Therapeutic area:

lisinopril

Authorization status:

Not marketed

Authorization date:

2023-05-19

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LISINOPRIL GRINDEKS 5 MG TABLETS
LISINOPRIL GRINDEKS 10 MG TABLETS
LISINOPRIL GRINDEKS 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 Grindeks is and what it is used for
2.
What you need to know before you take Lisinopril Grindeks
3.
How to take Lisinopril Grindeks
4.
Possible side effects
5.
How to store Lisinopril Grindeks
6.
Contents of the pack and other information
1.
WHAT LISINOPRIL GRINDEKS IS AND WHAT IT IS USED FOR
Lisinopril Grindeks contains a medicine called lisinopril. This
belongs to a group of medicines called
ACE inhibitors.
Lisinopril Grindeks can be used for the following conditions:
•
To treat high blood pressure (hypertension) in adults, adolescents and
children aged 6 years and
older.
•
To treat heart failure in adults.
•
If you have recently had a heart attack (myocardial infarction) in
adults.
•
To treat kidney problems caused by Type 2 diabetes in adults with high
blood pressure.
Lisinopril Grindeks 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 LISINOPRIL GRINDEKS
_ _
DO NOT TAKE LISINOPRIL GRINDEKS
•
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 caus

Summary of Product characteristics

Health Products Regulatory Authority
22 May 2023
CRN00CQ6Z
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lisinopril Grindeks 5 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg lisinopril (as dihydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
White, round plain uncoated tablets with bevelled edges. Dimensions of
tablet: diameter 6 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
HYPERTENSION
Treatment of hypertension in adults, adolescents and children aged 6
years and older.
HEART FAILURE
Treatment of symptomatic heart failure in adults.
ACUTE MYOCARDIAL INFARCTION
Short-term (6 weeks) treatment of haemodynamically stable patients
within 24 hours of an acute myocardial infarction in
adults.
RENAL COMPLICATIONS OF DIABETES MELLITUS
Treatment of renal disease in hypertensive adult patients with Type 2
diabetes mellitus and incipient nephropathy (see
section 5.1).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The dose should be individualised according to patient profile and
blood pressure response (see section 4.4).
Posology
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).
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 a