Ramipril 5mg capsules

Land: Verenigd Koninkrijk

Taal: Engels

Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)

Werkstoffen:

Ramipril

Beschikbaar vanaf:

Sigma Pharmaceuticals Plc

ATC-code:

C09AA05

INN (Algemene Internationale Benaming):

Ramipril

Dosering:

5mg

farmaceutische vorm:

Oral capsule

Toedieningsweg:

Oral

klasse:

No Controlled Drug Status

Prescription-type:

Valid as a prescribable product

Product samenvatting:

BNF: 02050501

Bijsluiter

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, pharmacist or nurse.
!
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, pharmacist or nurse. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Artulo Capsules are and what they
are used for
2.
What you need to know before you take
Artulo Capsules
3.
How to take Artulo Capsules
4.
Possible side effects
5.
How to store Artulo Capsules
6.
Contents of the pack and other
information
Artulo Capsules contain ramipril which
belongs to a group of medicines called ACE
(angiotensin converting enzyme) inhibitors.
They work by widening the blood vessels
which makes it easier for the heart to pump
blood through them, to all parts of the body.
This helps to reduce blood pressure. It can
also help to make the heart work better if it
does not pump as well as needed.
ARTULO CAPSULES ARE USED TO:-
!
Reduce the risk of a heart attack, heart
disease and stroke and decrease the
risk of requiring surgery to increase
blood flow to the heart
!
Treat high blood pressure.
DO NOT TAKE ARTULO CAPSULES:
!
If you are allergic to ramipril, other ACE
inhibitors or any of the other ingredients
of this medicine (listed in section 6).
Signs of an allergic reaction may include
a rash, swallowing or breathing
problems, swelling of your lips, face,
throat or tongue
!
If you have ever had a serious allergic
reaction called "angioedema". The signs
include itching, hives (urticaria), red
marks on the hands, feet and throat,
swelling of the throat and tongue,
swelling around the eyes and lips,
difficulty breathing and swallowing
!
If you have taken or are currently taking
sac

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ramipril 5mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 5.0mg ramipril.
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Capsule, hard
Hard gelatin capsule (size 4), light grey body and green cap. Marked R
on the cap and 5 on the
body. The capsule contains white or almost white powder.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
- Treatment of hypertension.
- Treatment of renal disease.
o
Incipient glomerular diabetic nephropathy as defined by the presence
of
microalbuminuria,
o
Manifest glomerular diabetic nephropathy as defined by
macroproteinuria in
patients with at least one cardiovascular risk factor (see section
5.1),
o
Manifest glomerular non diabetic nephropathy as defined by
macroproteinuria
≥
3g/day (see section 5.1).
- Treatment of symptomatic heart failure.
- Secondary prevention after acute myocardial infarction: reduction of
mortality from the
acute phase of myocardial infarction in patients with clinical signs
of heart failure when
started > 48 hours following acute myocardial infarction.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Posology _
It is recommended that Ramipril Capsules are taken each day at the
same time of the day.
Ramipril Capsules can be taken before, with or after meals, because
food intake does not
modify its bioavailability (see section 5.2). Ramipril Capsules have
to be swallowed with
liquid. It must not be chewed or crushed._ _
_ _
_Adults _
_Diuretic-Treated patients: _Hypotension may occur following
initiation of therapy with
Ramipril Capsules; this is more likely in patients who are being
treated concurrently with
diuretics (see sections 4.3, 4.4, 4.5, and 5.1). 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
Ramipril Capsules (see section 4.4).
In hypertensive patients in whom the diuretic is not discontinued,
therap