Ramipril 2.5mg tablets
Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Patient Information leaflet
(PIL)
01-01-2020
Summary of Product characteristics
(SPC)
21-05-2020
Public Assessment Report
(PAR)
05-04-2006
Active ingredient:
Ramipril
Available from:
IVAX Pharmaceuticals UK Ltd
ATC code:
C09AA05
INN (International Name):
Ramipril
Dosage:
2.5mg
Pharmaceutical form:
Oral tablet
Administration route:
Oral
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 02050501
Patient Information leaflet
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RAMIPRIL 1.25MG 2.5MG 5MG & 10MG 28 TABLETS PIL - UK
Black
BBBA7422
C.Grant
27/01/2020
28/01/2020
C.Grant
190x600
10pt
Teva Bulgaria Dupnitsa
27/01/2020
02
Version 6
12.12.2019
German GTIN 14
(incorporating PZN):
Cartons and label leaflets only
(labels only when specified)
RAMIPRIL 1.25MG, 2.5MG, 5MG
AND 10MG TABLETS
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 TABLETS ARE AND WHAT
THEY ARE USED FOR
2 WHAT YOU NEED TO KNOW BEFORE YOU TAKE
RAMIPRIL TABLETS
3
HOW TO TAKE RAMIPRIL TABLETS
4
POSSIBLE SIDE EFFECTS
5
HOW TO STORE RAMIPRIL TABLETS
6
CONTENTS OF THE PACK AND OTHER
INFORMATION
1
WHAT RAMIPRIL TABLETS ARE AND WHAT
THEY ARE USED FOR
Ramipril tablets contain the active ingredient
ramipril. This belongs to a group of medicines
called ACE inhibitors (Angiotensin Converting
Enzyme Inhibitors).
RAMIPRIL TABLETS WORK BY:
• decreasing your body’s production of substances
that could raise your blood pressure
• making your blood vessels relax and widen
• making it easier
Read the complete document
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ramipril 2.5mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ramipril 2.5 mg: one tablet contains 2.5 mg ramipril
Excipient with known effect: lactose monohydrate 158.8 mg
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablets.
Ramipril 2.5 mg: yellow, capsule-shaped, uncoated, flat tablets, 10.0
x 5.0
mm, scored on one side and side walls, marked R2.
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
≥
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 is taken each day at the same time of
the day.
Ramipril tablets can be taken before, with or after meals, because
food intake
does not modify its bioavailability (see section 5.2). Ramipril
tablets have to
be swallowed with liquid.
_ _
_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 1.25mg d
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