Lizinopril

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

lisinopril (lisinopril dihydrate)

Available from:

Replek Farm Ltd.-Skopje

INN (International Name):

lisinopril (lisinopril dihydrate)

Dosage:

10mg

Pharmaceutical form:

tablets

Prescription type:

Prescription

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
LIZINOPRIL
Lisinopril
5 MG TABLETS 10 MG TABLETS 20 MG TABLETS
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
•
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. Do not pass it on to
others. It may
harm them, even if their symptoms are the same as yours.
•
If any of the side effects get serious, or if you notice any side
effects not listed in
this leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What LIZINOPRIL is and what it is used for
2.
Before you take LIZINOPRIL
3.
How to take LIZINOPRIL
4.
Possible side effects
5.
How to store LIZINOPRIL
6.
Further information
1. WHAT LIZINOPRIL IS AND WHAT IT IS USED FOR
LIZINOPRIL belongs to a group of medicines called ACE inhibitors.
LIZINOPRIL 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.
LIZINOPRIL 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. BEFORE YOU TAKE LIZINOPRIL
DO NOT TAKE LIZINOPRIL IF:
•
You are allergic (hypersensitive) to Lisinopril or any of the other
ingredients of
LIZINOPRIL tablets (listed in Section 6: Further information).
•
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).
•
A member of your family has had severe allergic reactions (angioedema)
to an ACE
inhibitor or you have had severe allergic reactions (angioedema)
without a known
cause.
•
If you are more than 3 months pregnant. (It is also

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF MEDICINAL PRODUCT
LIZINOPRIL
lisinopril
5 MG TABLETS
10 MG TABLETS
20 MG TABLETS
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains lisinopril dihydrate equivalent to 5 mg
lisinopril, excipients.
Each tablet contains lisinopril dihydrate equivalent to 10 mg
lisinopril, excipients.
Each tablet contains lisinopril dihydrate equivalent to 20 mg
lisinopril, excipients.
* For full list of excipients see section 6.1
3. PHARMACEUTICAL FORM
Tablet
LIZINOPRIL 5 mg tablets are uniform, round, slightly biconvex, pale
orange tablets with a
score line on one side.
LIZINOPRIL 10 mg tablets are uniform, round, slightly biconvex, pale
yellow tablets with
a score line on one side.
LIZINOPRIL 20 mg tablets are uniform, round, slightly biconvex, white
tablets with a
score line on one side.
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.
- 1 -
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 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 tablets is not affected by food.
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.
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
depl