PERINDOPRIL TERT-BUTYLAMINE SERVIER 2 Milligram Tablets

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

PERINDOPRIL TERT-BUTYLAMINE SALT

Dostopno od:

Les Laboratoires Servier

INN (mednarodno ime):

PERINDOPRIL TERT-BUTYLAMINE SALT

Odmerek:

2 Milligram

Farmacevtska oblika:

Tablets

Tip zastaranja:

Product subject to prescription which may be renewed (B)

Status dovoljenje:

Withdrawn

Datum dovoljenje:

2014-07-11

Navodilo za uporabo

     
1 

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT 

PERINDOPRIL TERT-BUTYLAMINE SERVIER 2 MG TABLETS 
perindopril tert-butylamine 

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 any get any of the side effects, talk to your doctor, or
pharmacist or nurse. This includes any 
possible side effects not listed in this leaflet. See section 4. 

WHAT IS IN THIS LEAFLET:  
1. 
What   Perindopril tert-butylamine Servier is and what it is used
for 
2. 
What you need to know before you take Perindopril tert-butylamine
Servier  
3. 
How to take Perindopril tert-butylamine Servier 
4. 
Possible side effects 
5. 
How to store Perindopril tert-butylamine Servier 
6. 
Content of the pack and other information 

1. 
 WHAT PERINDOPRIL TERT-BUTYLAMINE SERVIER IS AND WHAT IT IS USED
FOR 

Perindopril tert-butylamine Servier is an angiotensin
converting enzyme (ACE) inhibitor. These work by 
widening the blood vessels, which makes it easier for your heart
to pump blood through them. 

Perindopril tert-butylamine Servier is used: 
- 
to treat _HIGH BLOOD PRESSURE_ (hypertension),  
- 
to treat _HEART FAILURE_ (a condition where the heart is unable to
pump enough blood to meet the body’s 
needs), 
- 
to reduce the risk of cardiac events, such as heart attack, in
patients with _STABLE CORONARY ARTERY DISEASE_ 
(a condition where the blood supply to the heart is reduced or
blocked) and who have already had a heart 
attack and/or an operation to improve the blood supply to the heart
by widening the vessels that supply it. 

2. 
WHAT YOU NEED TO KNOW

Lastnosti izdelka

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Perindopril tert-butylamine Servier 2 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Perindopril tert-butylamine.
One tablet contains 1.669 mg perindopril corresponding to 2 mg perindopril tert-butylamine.
Excipient with known effect: lactose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
White, round tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hypertension
Treatment of hypertension
Heart failure
Treatment of symptomatic heart failure
Stable coronary artery disease
Reduction of risk of cardiac events in patients with a history of myocardial infarction and/or revascularisation.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose should be individualised according to the patient profile (see section 4.4) and blood pressure response.
Hypertension
Perindopril tert-butylamine Servier may be used in monotherapy or in combination with other classes of
antihypertensive therapy.
The recommended starting dose is 4 mg given once daily in the morning.
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 drop in blood
pressure following the initial dose. A starting dose of 2 mg is recommended in such patients and the initiation of
treatment should take place under medical supervision.
The dose may be increased to 8 mg once daily after one month of treatment.
Symptomatic hypotension may occur following initiation of therapy with Perindopril tert-butylamine Servier; this is
more likely in patients who are being treated concurrently with diuretics. Caution is therefore recommended since these
patients may be volume and/or