Lisinopril Crescent 5mg Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

LISINOPRIL

Available from:

Crescent Pharma International Limited 260, Triq San Albert, Gzira GZR 1150, Malta

ATC code:

C09AA03

INN (International Name):

LISINOPRIL 5 mg

Pharmaceutical form:

TABLET

Composition:

LISINOPRIL 5 mg

Prescription type:

POM

Therapeutic area:

AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM

Authorization status:

Withdrawn

Authorization date:

2019-05-02

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LISINOPRIL CRESCENT 5 MG, 10 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 Tablets are and what they are used for
2.
What you need to know before you take Lisinopril Tablets
3.
How to take Lisinopril Tablets
4.
Possible side effects
5.
How to store Lisinopril Tablets
6.
Contents of the pack and other information
1.
WHAT LISINOPRIL TABLETS ARE AND WHAT THEY ARE USED FOR
The full name of your medicine is Lisinopril Crescent 5 mg or 10 mg
tablets, but within the leaflet it
will be referred to as Lisinopril Tablets.
Lisinopril 5 mg or 10 mg tablets contains a medicine called
lisinopril. This belongs to the group of
medicines called ACE inhibitors (Angiotensin Converting Enzyme
Inhibitors).
Lisinopril Tablets can be used for he following conditions:
•
To treat high blood pressure (hypertension).
•
To treat heart failure (weakening of heart function).
•
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
lowers your blood pressure. It
also makes easier for your heart to pump blood to all parts of your
body.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LISINOPRIL TABLETS
DO NOT TAKE LISINOPRIL TABLETS:
-
if you are allergic (hypersensitive) to lisinopril or any of the other
ingredients of this medicine
(listed in section 6).
-
if you have ev

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Lisinopril Crescent 5 mg Tablets
Lisinopril Crescent 10 mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains: 5.44 mg lisinopril dihydrate, equivalent to 5 mg
lisinopril
One tablet contains: 10.89 mg lisinopril dihydrate, equivalent to 10
mg lisinopril
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablet
The tablets are round, convex, slightly red and with a score notch on
one side, diameter 5.5 mm.
The tablets are round, convex, slightly red and with a score notch on
one side, diameter 7 mm.
The tablet can be divided into equal halves.
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
Lisinopril should be administered orally in a single daily dose. As
with all other medication taken
once daily, lisinopril should be taken at approximately the same time
each day. The absorption of
lisinopril is not affected by food.
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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 pre