Ramipril 5mg capsules

Kraj: Wielka Brytania

Język: angielski

Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)

Składnik aktywny:

Ramipril

Dostępny od:

Milpharm Ltd

Kod ATC:

C09AA05

INN (International Nazwa):

Ramipril

Dawkowanie:

5mg

Forma farmaceutyczna:

Oral capsule

Droga podania:

Oral

Klasa:

No Controlled Drug Status

Typ recepty:

Valid as a prescribable product

Podsumowanie produktu:

BNF: 02050501; GTIN: 08901175011704

Ulotka dla pacjenta

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 Ramipril is and what it is used for
2.
What you need to know before you
take Ramipril
3.
How to take Ramipril
4.
Possible side effects
5.
How to store Ramipril
6.
Contents of the pack and other
information
1.
WHAT RAMIPRIL IS AND WHAT IT IS
USED FOR
Ramipril contains a medicine called
ramipril. This belongs to a group
of medicines called ACE inhibitors
(Angiotensin Converting Enzyme
Inhibitors).
Ramipril works by:
•
Decreasing your body’s production of
substances that could raise your blood
pressure
•
Making your blood vessels relax and
widen
•
Making it easier for your heart to pump
blood around your body.
Ramipril can be used:
•
To treat high blood pressure
(hypertension)
•
To reduce the risk of you having a
heart attack or stroke
•
To reduce the risk or delay the
worsening of kidney problems
(whether or not you have diabetes)
•
To treat your heart when it cannot
pump enough blood to the rest of your
body (heart failure)
•
As treatment following heart attack
(myocardial infarction) complicated
with heart failure.
2.
WHAT YOU NEED TO KNOW BEFORE YOU
TAKE RAMIPRIL
DO NOT TAKE RAMIPRIL:
•
If you are allergic to ramipril, any other
ACE inhibitor medicine or any of the
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
si

Charakterystyka produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ramipril 5 mg capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains ramipril 5 mg.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Capsules, hard
Red/White size ‘4’ hard gelatin capsules imprinted with ‘D’ on
red cap and
‘42’ on white body with black edible ink filled with white to
almost white
powder.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of hypertension.
-
Cardiovascular
prevention:
reduction
of
cardiovascular
morbidity
and
mortality in patients with:
•
manifest
atherothrombotic
cardiovascular
disease
(history
of
coronary
heart disease or stroke, or peripheral vascular disease) or
•
diabetes with at least one cardiovascular risk factor (see section
5.1).
- Treatment of renal disease:
•
Incipient glomerular diabetic nephropathy as defined by the presence
of
microalbuminuria,
•
Manifest glomerular diabetic nephropathy as defined by
macroproteinuria
in patients with at least one cardiovascular risk factor (see section
5.1),
•
Manifest
glomerular
non
diabetic
nephropathy
as
defined
by
macroproteinuria
≥
3 g/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 is taken each day at the same time of
the day.
Ramipril can be taken before, with or after meals, because food intake
does
not modify its bioavailability (see section 5.2). Ramipril has 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;
this is
more likely in patients who are being treated concurrently with
diuretics.
Caution is therefore recommended since t