Ramipril 1.25mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ramipril

Available from:

Bristol Laboratories Ltd

ATC code:

C09AA05

INN (International Name):

Ramipril

Dosage:

1.25mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02050501; GTIN: 5060013942525

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR USER
RAMIPRIL 1.25 MG CAPSULES
RAMIPRIL 2.5 MG CAPSULES
RAMIPRIL 5 MG CAPSULES
RAMIPRIL 10 MG CAPSULES
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 CAPSULES ARE AND WHAT THEY ARE USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RAMIPRIL CAPSULES
3. HOW TO TAKE RAMIPRIL CAPSULES
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE RAMIPRIL CAPSULES
6. CONTENTS OF THE PACK AND OTHER INFORMATION.
1. WHAT RAMIPRIL CAPSULES ARE AND WHAT THEY ARE USED FOR
The name of your medicine is Ramipril 1.25 mg or 2.5 mg or 5 mg or 10
mg capsules. The active
substance is Ramipril and 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 CAPSULES
DO NOT TAKE RAMIPRIL CAPSULES:
•
If you are allergic to ramipril, any other ACE inhibitor medi

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ramipril 1.25 mg capsules, hard
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 1.25mg of Ramipril
Excipients with known effect: Also contains methyl parahydroxybenzoate
(E218) and propyl parahydroxybenzoate (E216).
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Capsule, Hard
Yellow/ white coloured gelatin capsules of size "4"
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 _
_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. Rena