TERAXANS Film Coated Tablet 10 / 2.5 Milligram
देश: आयरलैंड
भाषा: अंग्रेज़ी
स्रोत: HPRA (Health Products Regulatory Authority)
उत्पाद विशेषताएं
(SPC)
03-05-2024
इस उत्पाद के लिए कुछ दस्तावेज़ वर्तमान में उपलब्ध नहीं हैं, आप हमारी ग्राहक सेवा को अनुरोध भेज सकते हैं और जैसे ही हम उन्हें प्राप्त करने में सक्षम होंगे, हम आपको सूचित करेंगे।
अनुरोध भेजा।
अनुरोध भेजा।
सक्रिय संघटक:
PERINDOPRIL ARGININE INDAPAMIDE
थमां उपलब्ध:
Les Laboratoires Servier
डोज़:
10 / 2.5 Milligram
फार्मास्यूटिकल फॉर्म:
Film Coated Tablet
प्राधिकरण की तारीख:
2009-08-14
उत्पाद विशेषताएं
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Teraxans 10mg/2.5mg film coated tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 6.79 mg perindopril equivalent to 10 mg perindopril arginine and 2.5 mg indapamide.
Excipient : lactose monohydrate
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
White, round film-coated tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Teraxans 10mg/2.5mg is indicated as substitution therapy for treatment of essential hypertension, in patients already
controlled with perindopril and indapamide given concurrently at the same dose level.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Oral route
One Teraxans tablet per day as a single dose, preferably to be taken in the morning, and before a meal.
_Elderly (see section 4.4)_
In elderly, the plasma creatinine must be adjusted in relation to age, weight and gender. Elderly patients can be treated
if renal function is normal and after considering blood pressure response.
_Patients with renal impairment (see section 4.4)_
In severe and moderate renal impairment (creatinine clearance below 60 ml/min), treatment is contraindicated.
Usual medical follow-up will include frequent monitoring of creatinine and potassium.
_Patients with hepatic impairment (see sections 4.3, 4.4 and 5.2)_
In severe hepatic impairment, treatment is contraindicated.
In patients with moderate hepatic impairment, no dose modification is required.
_Children and adolescents_
Teraxans should not be used in children and adolescents as the efficacy and tolerability of perindopril in children and
adolescents, alone or in combination, have not been established.
4.3 CONTRAINDICATIONS
_Linked to perindopril:_
_- _Hypersensitivity to perindopril or any other
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