Tritace 5mg tablets

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)

מרכיב פעיל:

Ramipril

זמין מ:

Sanofi

קוד ATC:

C09AA05

INN (שם בינלאומי):

Ramipril

כמות:

5mg

טופס פרצבטיות:

Oral tablet

מסלול נתינה (של תרופות):

Oral

סיווג:

No Controlled Drug Status

סוג מרשם:

Valid as a prescribable product

leaflet_short:

BNF: 02050501; GTIN: 5013011005983

עלון מידע

795442 - 89036063 4/4
795442 - 89036063 1/4
PACKAGE LEAFLET:
INFORMATION FOR THE USER
TRITACE
® 1.25MG, 2.5MG,
5MG, 10MG TABLETS
TRITACE
® TABLETS TITRATION PACK
Ramipril
IS THIS LEAFLET HARD TO SEE
OR READ?
PHONE [phone]
FOR HELP
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 TRITACE is and what it is used for
2. What you need to know before you take TRITACE
3. How to take TRITACE
4. Possible side effects
5. How to store TRITACE
6. Contents of the pack and other information
1. WHAT TRITACE IS AND WHAT
IT IS USED FOR
TRITACE contains a medicine called ramipril. This
belongs to a group of medicines called ACE inhibitors
(Angiotensin Converting Enzyme Inhibitors).
TRITACE 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.
TRITACE 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
TRITACE
DO NOT TAKE TRITACE:
± If you are allergic to ramipril, any other ACE
inhibitor medicine or any of the ingredients of
this medicine li

מאפייני מוצר

Reference: 4931 1.3.1.01 - SPC 1 - 5mg - 2007-04-19 1.0
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Tritace 5 mg Tablets
or
Ramipril 5mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tablets
Each tablet contains ramipril 5 mg.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablets mg 5mg
Pale red oblong tablet with dimensions of 8 x 4 mm with score-line.
Upper stamp: 5 & logo (
)
Lower stamp: HMP & 5
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),
Reference: 4931 1.3.1.01 - SPC 1 - 5mg - 2007-04-19 1.0
•
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 _
_ _
Diuretic-Treated patients
Hypotension may occur following initiation of therapy with TRITA