Ramipril 10mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ramipril

Available from:

Kent Pharma (UK) Ltd

ATC code:

C09AA05

INN (International Name):

Ramipril

Dosage:

10mg

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

IXXXXX
SAME SIZE ARTWORK
430 x 160 mm
Front side
Package leaflet: Information for the user
Ramipril 1.25mg Capsules/ Ramipril 2.5mg Capsules/
Ramipril 5mg Capsules/ Ramipril 10mg 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
Ramipril Capsules contain the active ingredient Ramipril. Ramipril
belongs to a group of
medicines called Angiotensin Converting Enzyme (ACE) inhibitors, which
act on heart and
blood vessels. It 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 Capsules 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 rami

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ramipril 10mg Capsules
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 10mg 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 dark green cap.
Marked R on the cap and 10 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,