Ramipril 5mg tablets
Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Patient Information leaflet
(PIL)
02-08-2019
Summary of Product characteristics
(SPC)
29-10-2019
Public Assessment Report
(PAR)
05-04-2006
Active ingredient:
Ramipril
Available from:
IVAX Pharmaceuticals UK Ltd
ATC code:
C09AA05
INN (International Name):
Ramipril
Dosage:
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
●
You have had certain types of heart problems e.g. aortic and mitral
stenosis (narrowing of the inlet valve into the left ventricle of the
heart), hypertrophic cardiomyopathy (disease of the heart muscle)
and cardiac arrhythmias (irregular heart beat).
TAKE SPECIAL CARE WITH RAMIPRIL TABLETS IF:
●
You have heart problems (particularly if you are taking medicine for
it), or if you have any kidney or liver disease. Your doctor may need
to change the dose of your medicine.
●
If you are dehydrated or have a salt imbalance.
●
You are taking diuretic medication (water tablets). Your doctor may
discontinue diuretic therapy and correct volume and/or salt depletion
before starting treatment with ramipril.
●
You have severe high blood pressure.
●
You are taking any medications which may affect your blood picture.
Your doctor can advise you of this.
●
You are taking medication for low potassium levels.
●
You are taking allopurinol and/or other immunosuppressants as this
may increase the likelihood of blood picture changes.
Alcohol can increase the effect of ramipril, this can be dangerous and
you should speak to your doctor if you are unsure.
You need to tell your doctor or dentist that you are taking ramipril
if
you are about to undergo a surgical / dental procedure where an
aesthetic might be used.
PREGNANCY:
Ramipril should not be used in the first trimester of pregnancy. When
pregnancy is planned/confirmed switch to an alternative treatment. Do
not take blood pressure lowering drugs as this may cause defects to
the unborn baby. Ask your doctor or pharmacist for advice before
taking any medicine.
LACTATION:
Ramipril Tablets should not be taken by women who are
breast-feeding as Ramipril passes into breast milk and may be
harmful to the baby.
DRIVING AND USING MACHINES:
It is not advisable to drive or operate machinery for several hours
after the first dose of Ramipril Tablets or after an increase in dose.
Do not take alcohol.You should not drive or operate machinery if you
feel dizzy or tired while takin
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Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ramipril 5mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ramipril 5 mg: one tablet contains 5 mg ramipril
Excipient with known effect: lactose monohydrate 96.47 mg
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablets.
Ramipril 5 mg: pink, capsule-shaped, un-coated, flat tablets, 8.8 x
4.4 mm,
scored on one side and side walls, marked R3.
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 dose. Renal
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