Ramipril 10mg capsules

Pajjiż: Ingilterra

Lingwa: Ingliż

Sors: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredjent attiv:

Ramipril

Disponibbli minn:

Teva UK Ltd

Kodiċi ATC:

C09AA05

INN (Isem Internazzjonali):

Ramipril

Dożaġġ:

10mg

Għamla farmaċewtika:

Oral capsule

Rotta amministrattiva:

Oral

Klassi:

No Controlled Drug Status

Tip ta 'preskrizzjoni:

Valid as a prescribable product

Sommarju tal-prodott:

BNF: 02050501; GTIN: 5017007023753

Fuljett ta 'informazzjoni

UK & Ireland Artwork Department
RAMIPRIL 1.25 MG, 2.5 MG, 5 MG
AND 10 MG CAPSULES
ramipril
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.
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
WHAT RAMIPRIL IS AND WHAT IT IS USED FOR
Ramipril 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 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.
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 other ingredients of
this medicine (listed in section 6)
•
if you have 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

Karatteristiċi tal-prodott

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ramipril 10 mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 10 mg of ramipril.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Capsule, hard.
Opaque blue cap and opaque white body hard gelatin capsules (No. 4),
printed
in black ink 93 and 7212 on opposing cap and body portions of the
capsules.
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, 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
≥
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
_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 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 (see section 4.4).
In hypertensive patients in whom the diuretic is not discontinued,
therapy with
Ramipril should be initiated with a 1.25 mg dose. Ren