Ramipril 5mg capsules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ramipril

Available from:

Wockhardt UK 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; GTIN: 5012727912202

Patient Information leaflet

CHANGE CONTROL : Version changes due to change in:
Size/Layout Regulatory Non-Regulatory
Changes in detail:
• New regulatory text
ART WORK CHECK BOX
PRODUCT :
Ramipril 1.25mg; 2.5mg; 5mg; 10mg Capsules
CUSTOMER :
Wockhardt UK
FP CODE:
—
PLANT LOCATION :
UK supply
DIMENSIONS :
(w) 148 x (h) 550mm
TEXT FONT SIZE :
9pt.
FILE NAME :
Ramipril_Leaflet_107593-3.ai
SOFTWARE :
Adobe Illustrator CS5
TYPEFACES :
Myriad Pro Regular / Bold
ARTWORK (DETAILS)
31st May, 2017
RECEIVED ON :
PROOF REVISION :
R 1st PDF sent on
- 7TH JUNE 2017
R 2nd PDF sent on - 8TH JUNE 2017
R 3rd PDF sent on
- 27TH JULY 2017
Process
Black
PREFOLDED SIZE : 148 X 300MM
20000XXXX
FRONT
_PAPER SHOULD BE BIBLE (40 GSM) _
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 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 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 ramipril, any other ACE
inhibitor medicine or any of the ingredients
of this medici

Summary of Product characteristics

OBJECT 1
RAMIPRIL 5MG CAPSULES, HARD
Summary of Product Characteristics Updated 03-Oct-2017 | Wockhardt UK
Ltd
1. Name of the medicinal product
Ramipril 5mg Capsules, hard
2. Qualitative and quantitative composition
Each capsule, hard contains 5mg ramipril.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Capsule, hard
Red opaque body and red opaque cap. The body has “RP 5” printed in
black.
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 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