ZESTRIL 20 Milligram Tablets

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

LISINOPRIL

Disponível em:

LTT Pharma Limited

DCI (Denominação Comum Internacional):

LISINOPRIL

Dosagem:

20 Milligram

Forma farmacêutica:

Tablets

Tipo de prescrição:

Product subject to prescription which may be renewed (B)

Status de autorização:

Withdrawn

Data de autorização:

2014-02-19

Folheto informativo - Bula

PATIENT INFORMATION LEAFLET
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:
What Zestril is and what it is used for
Before you take Zestril
How to take Zestril
Possible side effects
How to store Zestril
Further Information
WHAT ZESTRIL IS AND WHAT IT IS USED FOR 
Zestril contains a medicine called lisinopril. This belongs to a
group of 
medicines called ACE inhibitors.
Zestril 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.
Zestril 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.
BEFORE YOU TAKE ZESTRIL
DO NOT TAKE ZESTRIL IF:
*
You are allergic (hypersensitive) to lisinopril or any of the other
ingredients 
of Zestril (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 better to avoid
Zestril in 
early pregnancy - see Pregnancy section).

Características técnicas

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Zestril 20mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains lisinopril dihydrate equivalent to 20mg anhydrous lisinopril
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablets
_Product imported from _the UK:
Round, brownish-red, uncoated, biconvex tablets with “ 20” on one side and plain on the other side.
Diameter 8mm.
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
Zestril should be administered orally in a single daily dose. As with all other medication taken once daily, Zestril
should be taken at approximately the same time each day. The absorption of Zestril tablets is not affected by food.
The dose should be individualised according to patient profile and blood pressure response
(see section 4.4 ).
HYPERTENSION
Zestril 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 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 patien