Lisinopril 1mg/ml Oral Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Lisinopril dihydrate

Available from:

Essential Pharmaceuticals Limited

ATC code:

C09AA; C09AA03

INN (International Name):

Lisinopril dihydrate

Dosage:

1 milligram(s)/millilitre

Pharmaceutical form:

Oral solution

Therapeutic area:

ACE inhibitors, plain; lisinopril

Authorization status:

Not marketed

Authorization date:

2015-07-31

Patient Information leaflet

Lis1mgSoln-PL-IE-5
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LISINOPRIL 1 MG/ML ORAL SOLUTION
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 1 MG/ML ORAL SOLUTION IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LISINOPRIL 1 MG/ML ORAL SOLUTION
3.
HOW TO TAKE LISINOPRIL 1 MG/ML ORAL SOLUTION
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE LISINOPRIL 1 MG/ML ORAL SOLUTION
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT LISINOPRIL 1 MG/ML ORAL SOLUTION IS AND WHAT IT IS USED FOR
Lisinopril 1 mg/ml oral solution contains a medicine called
lisinopril. This belongs to a group
of medicines called ACE inhibitors.
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 caused by Type II diabetes in people with
high blood
pressure.
Lisinopril 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 1 MG/ML ORAL SOLUTION
DO NOT TAKE LISINOPRIL 1 MG/ML ORAL SOLUTION IF:
-
you are allergic (hypersensitive) to lisinopril or any of the other
ingredients of
Lisinopril 1 mg/ml oral solution (listed in Section 6)
-
you have ever had an allergic reaction to another ACE inhibitor
medicine. The allergic
reaction may have caused swelling of the hands, feet, an

Summary of Product characteristics

Health Products Regulatory Authority
01 October 2020
CRN009W2M
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lisinopril 1mg/ml Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of oral solution contains 1 mg lisinopril (as lisinopril
dihydrate).
Excipients with known effect
Each ml contains 0.24 mg of sodium and 1.5 mg of benzoate salt
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral solution.
The oral solution is clear and colourless with a sweet taste.
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
Lisinopril 1 mg/ml oral solution should be administered orally in a
single daily dose. As with all other medication taken once
daily, Lisinopril 1 mg/ml oral solution should be taken at
approximately the same time each day. The absorption of Lisinopril 1
mg/ml oral solution is not affected by food.
Mixing with food or drinks has not been studied, and any mixing with
food and drinks is therefore the responsibility of the
health care professional or the user.
The dose should be individualised according to patient profile and
blood pressure response (see section 4.4).
_HYPERTENSION_
Lisinopril 1 mg/ml oral solution 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
decompensatio