Perindopril erbumine 8mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Perindopril erbumine

Available from:

Actavis UK 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: 5012617017383

Patient Information leaflet

ACTAVIS LOGO
PERINDOPRIL 2MG, 4MG AND 8MG 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 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 PERINDOPRIL TABLETS ARE AND WHAT THEY ARE 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
1. WHAT PERINDOPRIL TABLETS ARE AND WHAT THEY ARE USED FOR
Perindopril contains the active substance perindopril tert-butylamine
which belongs to a
group of medicines called ACE inhibitors. These work by widening the
blood vessels.
This makes it easier for your heart to pump blood through the body.
Perindopril 2mg or 4mg tablets are used to:
•
treat high blood pressure (hypertension)
•
treat heart failure (a condition where the heart is unable to pump
enough blood to meet
the body’s needs)
• 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.
Perindopril 8mg tablets are used to:
•
treat high blood pressure (hypertension)
•
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/o

Summary of Product characteristics

OBJECT 1
PERINDOPRIL 8MG TABLETS
Summary of Product Characteristics Updated 07-Jan-2015 | Accord-UK Ltd
1. Name of the medicinal product
Perindopril 8mg 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:
Each tablet contains 125.56 mg of lactose monohydrate
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet
White, circular, biconvex tablets with 'PP' debossed on one side and
'8' on the other.
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
_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, the diuretic should be discontinued 2 to 3 days before
beginning therapy with Perindopril (see
section 4.4 “Special warnings and precautions for use“).
In hypertensive patients in whom the diuretic cannot be discontinued,
therapy w