Ramipril 1.25mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Ramipril

Available from:

Teva UK Ltd

ATC code:

C09AA05

INN (International Name):

Ramipril

Dosage:

1.25mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02050501; GTIN: 5017007023807

Patient Information leaflet

_RAMIPRIL 1.25 MG, 2.5 MG, 5 MG_
_AND 10 MG 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.
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
WHAT RAMIPRIL IS AND WHAT IT IS USED FOR
Ramipril Tablets 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.
WHAT YOU NEED TO KNOW BEFORE YOU
TAKE RAMIPRIL TABLETS
DO NOT TAKE RAMIPRIL TABLETS
•
if you are allergic to ramipril, any other ACE
inhibitor medicine or any of the other
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, throat

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ramipril 1.25 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Ramipril 1.25 mg
Excipient with known effect:
Each tablet contains 79.4 mg lactose monohydrate
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
Yellow, oblong, biplane tablets, 8.0 mm x 4.00 mm.
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
_Adults _
Diuretic-treated patients
Hypotension may occur following initiation of therapy with Ramipril
Tablets; 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 Tablets (see section 4.4).
In hypertensive patients in whom the diuretic is not discontinued,
therapy with
Ramipril Tablets should be initiated with a 1.25 mg dose. Renal
function an