Ramipril 5mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ramipril

Available from:

Genus Pharmaceuticals Ltd

ATC code:

C09AA05

INN (International Name):

Ramipril

Dosage:

5mg

Pharmaceutical form:

Oral capsule

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02050501

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
RAMIPRIL 5 MG, 10 MG HARD 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, 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 the 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 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,

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ramipril 5 mg Capsules.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 5 mg Ramipril.
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Capsule, hard
Light grey and green gelatin capsules; marked with “R” on the cap
and “5” on
the body.
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
_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. Renal function and
serum
potassium should be monitored. The subsequent d