Lisopress 10 mg tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Lisinopril

Available from:

Gedeon Richter Plc

ATC code:

C09AA; C09AA03

INN (International Name):

Lisinopril

Dosage:

10 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

ACE inhibitors, plain; lisinopril

Authorization status:

Marketed

Authorization date:

2002-02-08

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
LISOPRESS TABLETS 2.5 MG, 5 MG, 10 MG AND 20 MG
lisinopril (as 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 Lisopress is and what it is used for
2.
What you need to know before you take Lisopress
3.
How to take Lisopress
4.
Possible side effects
5.
How to store Lisopress
6.
Contents of the pack and other information
1.
WHAT LISOPRESS IS AND WHAT IT IS USED FOR
Lisopress tablet contains an active substance called lisinopril. This
belongs to a group of medicines
called ACE inhibitors (angiotensin converting enzyme inhibitors).
Lisopress tablet 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.
Lisopress tablet works by making your blood vessels widen. This helps
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 LISOPRESS
DO NOT TAKE LISOPRESS
•
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 fa

Summary of Product characteristics

Health Products Regulatory Authority
31 August 2020
CRN009TJJ
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lisopress 10 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains 10 mg lisinopril as 10.89 mg lisinopril dihydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
10 mg tablets are white, square, debossed with 10 on one side and a
break line 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_
Lisopress 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