Perindopril erbumine 8mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Perindopril erbumine

Available from:

Viatris UK Healthcare 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: 5016695001616

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR
THE PATIENT
PERINDOPRIL ERBUMINE
8 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 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 Erbumine is and what it
is used for
2.
What you need to know before you take
Perindopril Erbumine
3.
How to take Perindopril Erbumine
4.
Possible side effects
5.
How to store Perindopril Erbumine
6. Contents of the pack and other information
1. WHAT PERINDOPRIL ERBUMINE IS AND
WHAT IT IS USED FOR
Perindopril Erbumine Tablets contain the
active substance perindopril erbumine
which belongs to a group of medicines
known as angiotensin converting enzyme
(ACE) inhibitors. These work by making your
blood vessels wider, which makes it easier
for your heart to pump blood through them.
Perindopril Erbumine 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 blood vessels supplying it.
2. WHAT YOU NEED TO KNOW BEFORE
YOU TAKE PERINDOPRIL ERBUMINE
DO NOT TAKE PERINDOPRIL ERBUMINE:
•
if you are allergic to perindopril, to any
other ACE inhibitor 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 in
early pregnancy - see pregna

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Perindopril Erbumine 8 mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Perindopril Erbumine 8 mg tablets: Each tablet contains 8 mg of
perindopril _tert_-
butylamine salt, equivalent to 6.676 mg of perindopril.
Excipient with known effect:
Each 8 mg tablet also contains 108.100 mg of lactose.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
Perindopril Erbumine 8 mg tablets are green mottled, round, tablets
debossed
with “PT8” on one side of the tablet and “M” on the other
side.
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 individualised according to the patient profile
(see section 4.4)
and blood pressure response.
Hypertension
Perindopril erbumine may be used in monotherapy or in combination with
other
classes of anti-hypertensive 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
erbumine; 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