TRITACE 1.25 MG

Ülke: İsrail

Dil: İngilizce

Kaynak: Ministry of Health

Aktif bileşen:

RAMIPRIL

Mevcut itibaren:

SANOFI ISRAEL LTD

ATC kodu:

C09AA

Farmasötik formu:

TABLETS

Kompozisyon:

RAMIPRIL 1.25 MG

Uygulama yolu:

PER OS

Reçete türü:

Required

Tarafından üretildi:

SANOFI S.P.A., ITALY

Terapötik grubu:

ACE INHIBITORS, PLAIN

Terapötik endikasyonlar:

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.

Yetkilendirme tarihi:

2022-01-31

Bilgilendirme broşürü

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
.يلديصلا وأ ةيبناجلا ضارعلأا )4
.نيلمعتسملا ضعب ىدل ةيبناج
ً
اضارعأ ببسي دق سياتيرت لامعتسإ نإ
،ءاود لكب امك
.اهنم
ً
ايأ يناعت لاأ زئاجلا نم .ةيبناجلا
ضارعلأا ةمئاق نم شهدنت لا ىدحإب رعشت تنك اذإ
ً
اروف بيبطلا عجارو سياتيرت ـب جلاعلا نع
فقوت
.لجعتسم يبط جلاعل جاتحت نأ زئاجلا نم ـ
ةيلاتلا ةديدشلا ةيبناجلا ضارعلأا
علبلا يف تابوعص ىلإ يدؤي يذلا ةرجنحلا
يف وأ نيتفشلا يف ،هجولا يف خافتنإ
-
لعف درل تاملاع نوكت نأ نكمي روملأا هذه
ـ حفطو زخو كلذكو ،سفنتلا وأ
.سياتيرت ـل ديدش يسسحت
،مئاق يدلج ضرم مقافت ،مفلا يف تاحرقت
،حفط لمشي ديدش يدلج لعف در -
Stevens
نوسنوج ـ سنڤيتس ةمزلاتم لثم( دلجلا
خلاسنإ وأ تلاصيوح ،رارمحإ
toxic epidermal necrolysis
ي
ّ
مسلا يرخنلا ةرشبلا للاحنإ ،
Johnson
.)
erythema multiforme
لاكشلأا ةددعتم ىمامحلا وأ :ةيلاتلا ةيبناجلا ضارعلأا ىدحإب رعشت
تنك اذإ
ً
اروف بيبطلا غ
ّ
لب
يف ملأ ،)
palpitations
( ةمظتنم ريغ وأ ةديدش بلق تابرض ،بلقلا
مظن ديازت -
.ةتكس وأ ةيبلق ةبون لثم رطخأ ةلكشم وأ
ردصلا يف طغض ،ردصلا
.نيتئرلا

Ürün özellikleri

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