Perindopril erbumine 8mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Perindopril erbumine

Available from:

Milpharm Ltd

ATC code:

C09AA04

INN (International Name):

Perindopril erbumine

Dosage:

8mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02050501; GTIN: 8901175011582

Patient Information leaflet

PERINDOPRIL 8 MG
TABLETS
Perindopril tert-butylamine
PACKAGE LEAFLET:
INFORMATION FOR THE USER
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
The name of your medicine is Perindopril 8 mg
tablets (referred to as ‘Perindopril Tablets’ or
‘Perindopril’ throughout this leaflet).
1.
What Perindopril tablets is and what it is used
for
2.
What you need to know before you take
Perindopril tablets
3.
How to take Perindopril tablets
4.
Possible side effects
5.
How to store Perindopril tablets
6.
Contents of the pack and other information
Perindopril Tablets 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 Tablets is used:
•
to treat _HIGH BLOOD PRESSURE_ (hypertension),
•
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.
DO NOT TAKE PERINDOPRIL TABLETS
•
if you are allergic to perindopril or to any of the
other ingredients of this medicine (listed in
section 6),
•
if you are more than 3 months pregnant. (It is
also better to avoid Perindopril Tablets in early
pregnancy – see pregnancy section),
•
if you have experienced symptoms such as
wheezing, swelling of the face, tongue or throat,
intense itchin

Summary of Product characteristics

OBJECT 1
PERINDOPRIL 8 MG TABLETS
Summary of Product Characteristics Updated 02-Aug-2017 | Aurobindo
Pharma - Milpharm Ltd.
1. Name of the medicinal product
Perindopril 8 mg tablets
2. Qualitative and quantitative composition
Each tablet contains 8 mg perindopril tert-butylamine salt equivalent
to 6.676 mg perindopril.
Excipient with known effect: 118.660 mg lactose / tablet
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet
White to off-white coloured round biconvex, uncoated tablets with
debossing “D” on one side and “5” &
“9” on either side of the break line on another side. The tablet
can be divided into two equal doses.
4. Clinical particulars
4.1 Therapeutic indications
Hypertension
Treatment of hypertension
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 individualized according to the patient profile
(see section 4.4) and blood pressure
response.
Hypertension
Perindopril may be used in monotherapy or in combination with other
classes of antihypertensive therapy
(See Sections 4.3, 4.4, 4.5 and 5.1).
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; 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 salt depleted.
If possible,