Tritace 1.25mg tablets

Country: United Kingdom

Bahasa: Inggeris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Ramipril

Boleh didapati daripada:

Sanofi

Kod ATC:

C09AA05

INN (Nama Antarabangsa):

Ramipril

Dos:

1.25mg

Borang farmaseutikal:

Oral tablet

Laluan pentadbiran:

Oral

Kelas:

No Controlled Drug Status

Jenis preskripsi:

Valid as a prescribable product

Ringkasan produk:

BNF: 02050501; GTIN: 5013011005969

Risalah maklumat

PACKAGE LEAFLET:
INFORMATION FOR THE USER
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 is and what it is used for.
2.
What you need to know before you take ramipril.
3.
How to take ramipril.
4.
Possible side effects.
5.
How to store ramipril.
6.
Contents of the pack and other information.
1.
WHAT RAMIPRIL IS AND WHAT IT IS USED FOR
The name of your medicine is Ramipril 1.25mg, 2.5mg, 5mg or 10mg
Tablets (called
ramipril throughout this leaflet). It 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.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE RAMIPRIL
DO NOT TAKE AND TELL YOUR DOCTOR BEFORE TAKING THIS MEDICINE IF:
•
If you are allergic to ramipril, any other ACE inhibitor medicine or
any of the other
ingredients of this medicine listed in section 6.

Ciri produk

Reference: 4840 1.3.1.01 - SPC 1 - 1.25mg - 2007-04-18 1.0
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Tritace 1.25 mg Tablets
or
Ramipril 1.25mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tablets
Each tablet contains ramipril 1.25 mg.
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Tablets 1.25mg
White to almost white oblong tablet with dimensions of 8 x 4 mm with
score-
line.
Upper stamp: 1.25 & logo (
)
Lower stamp: HMN & 1.25
The score-line is only to facilitate breaking for ease of swallowing
and not to
divide 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,
Reference: 4840 1.3.1.01 - SPC 1 - 1.25mg - 2007-04-18 1.0
•
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 TRITACE is taken each day at the same time of
the day.
TRITACE can be taken before, with or after meals, because food intake
does not modify its
bioavailability (see section 5.2).
TRITACE has to be swallowed with liquid. It must not be chewed or
crushed.
_Adults _