TRITACE 1.25 MG

Land: Israel

Språk: engelsk

Kilde: Ministry of Health

Aktiv ingrediens:

RAMIPRIL

Tilgjengelig fra:

SANOFI ISRAEL LTD

ATC-kode:

C09AA

Legemiddelform:

TABLETS

Sammensetning:

RAMIPRIL 1.25 MG

Administreringsrute:

PER OS

Resept typen:

Required

Produsert av:

SANOFI S.P.A., ITALY

Terapeutisk gruppe:

ACE INHIBITORS, PLAIN

Indikasjoner:

Hypertension congestive heart failure reduction of mortality in patients after MI with left ventricular dysfunction. For reducing the risk of myocardial infarction stoke cardiovascular death or need for revascularization procedures in patients over 55 years or more who have clinical evidence of cardiovascular disease (previous MI unstable angina or multivessel CABG or multivessel PTCA) stroke or peripheral vascular disease. Also for reducing the risk of myocardial infarction stroke cardiovascular death or need for revascularization procedures in diabetic patients of 55 years or more who have one or more of the following clinical findings : hypertension (systolic blood pressure > 160 mmHg or diastolic pressure > 90 mmHg) high total cholesterol (>5.2 mmol/L) low HDL ( <0.9 mmol/L) current smoker known microalbuminuria clinical evidence of previous vascular disease. Prevention of progressive renal failure in patients with persistent proteinuria in excess of 1g/day.

Autorisasjon dato:

2022-01-31

Informasjon til brukeren

817910 89036670 2/6
817910 89036670 3/6
817910 89036670 4/6 ةعرجلا نم دكأتلاو ءاودلا عباط صيخشت
بجي !ةمتعلا يف ةيودأ لوانت زوجي لا
.كلذ رملأا مزل اذإ ةيبطلا تاراظنلا عض
.ءاود اهيف لوانتت ةرم لك يف ةيئاودلا بيبطلا رشتسإ ،ءاودلا لامعتسإ صوصخب
ةيفاضإ ةلئسأ كيدل ترفوت اذإ
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فقوت
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ةيلاتلا ةديدشلا ةيبناجلا ضارعلأا
علبلا يف تابوعص ىلإ يدؤي يذلا ةرجنحلا
يف وأ نيتفشلا يف ،هجولا يف خافتنإ
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ـ حفطو زخو كلذكو ،سفنتلا وأ
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،مئاق يدلج ضرم مقافت ،مفلا يف تاحرقت
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نوسنوج ـ سنڤيتس ةمزلاتم لثم( دلجلا
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تنك اذإ
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palpitations
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مظن ديازت -
.ةتكس وأ ةيبلق ةبون لثم رطخأ ةلكشم وأ
ردصلا يف طغض ،ردصلا
.نيتئرلا

Preparatomtale

1
_Tritace comp. version-22.0 _
Tritace Comp 2.5 mg / 12.5 mg
Tritace Comp 5 mg / 25 mg
1. NAME OF THE MEDICINAL PRODUCT
Tritace Comp 2.5 mg/12.5 mg tablets
Tritace Comp 5 mg/25 mg tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Tritace Comp 2.5 mg/12.5 mg
Each tablet contains 2.5 mg ramipril and 12.5 mg hydrochlorothiazide
Tritace Comp 5 mg/25 mg
Each tablet contains 5 mg ramipril and 25 mg hydrochlorothiazide
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablet 2.5 mg/12.5 mg
White to almost white oblong tablet with score line, both sides
embossed with HNV and
a logo. The tablet can be divided into equal halves.
Tablet 5 mg/25 mg
White to almost white oblong tablet with score line, both sides
embossed with HNW and
a logo. The tablet can be divided into equal halves.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Essential hypertension.
Tritace comp is indicated in patients whose blood pressure cannot be
adequately
lowered with ramipril alone or hydrochlorothiazide alone.
4.2 Posology and method of administration
Posology
_It is recommended that TRITACE COMP is taken once daily, at the same
time of the _
_day, usually in the morning._
TRITACE COMP can be taken before, with or after meals, because food
intake does not
modify its bioavailability (see section 5.2).
TRITACE COMP has to be swallowed with some liquid. The tablet must not
be chewed
or crushed.
2
_Adults_
The dose should be individualised according to the patient profile
(see section 4.4) and
blood pressure control. The administration of the fixed combination of
ramipril and
hydrochlorothiazide is usually recommended after dosage titration with
one of the
individual components.
TRITACE COMP should be started at the lowest possible dosage.
If necessary, the dose can be gradually increased to achieve target
blood pressure; the
maximum permitted doses are 10 mg of ramipril and 25 mg of
hydrochlorothiazide daily.
_ _
_Special populations _
_ _
_Patients treated with diuretics_
_ _
Caution should be exercised in patients on