Ramipril 2.5mg tablets

Land: Vereinigtes Königreich

Sprache: Englisch

Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)

Wirkstoff:

Ramipril

Verfügbar ab:

Sandoz Ltd

ATC-Code:

C09AA05

INN (Internationale Bezeichnung):

Ramipril

Dosierung:

2.5mg

Darreichungsform:

Oral tablet

Verabreichungsweg:

Oral

Klasse:

No Controlled Drug Status

Verschreibungstyp:

Valid as a prescribable product

Produktbesonderheiten:

BNF: 02050501; GTIN: 5015915941084

Gebrauchsinformation

●
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

Fachinformation

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Ramipril 2.5 mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.5 mg of ramipril.
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Tablet
Ramipril 2.5mg: oblong shaped tablet (15 x 6.5mm), light yellow
speckled, scoreline
on one side.
The tablet can be divided into equal doses.
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 is taken each day at the same time of
the day.
Ramipril can be taken before, with or after meals, because food intake
does not
modify its bioavailability (see section 5.2). Ramipril has 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;
this is more
likely in patients who are being treated concurrently with diuretics.
Caution is
therefore recommended since these patients may be volume and/