EDARBYCLOR TABLETS 40MG/25MG
Country: Singapore
Language: English
Source: HSA (Health Sciences Authority)
Patient Information leaflet
(PIL)
15-07-2014
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Active ingredient:
Azilsartan medoxomil potassium 42.68mg eqv Azilsartan medoxomil
Available from:
TAKEDA PHARMACEUTICALS (ASIA PACIFIC) PTE. LTD.
Dosage:
40mg
Pharmaceutical form:
TABLET
Administration route:
ORAL
Prescription type:
Prescription Only
Manufactured by:
Takeda Pharmaceutical Company Limited (Osaka Plant)
Authorization date:
2014-07-15
Patient Information leaflet
1
FULL PRESCRIBING INFORMATION
1.
NAME OF THE MEDICINAL PRODUCT
Edarbyclor 40mg/ 12.5mg Tablets
Edarbyclor 40mg/ 25mg Tablets
2.
NAME AND STRENGTH OF ACTIVE SUBSTANCES
Edarbyclor is available in two dosage strengths: 40mg/ 12.5mg and 40mg/ 25mg, per tablet. Each tablet contains
40mg azilsartan medoxomil and 12.5mg of chlorthalidone or 25mg
of chlorthalidone
3.
PRODUCT DESCRIPTION
Edarbyclor is supplied as fixed dose combination tablets that are round, biconvex, film-coated and 9.7 mm in
diameter.
• 40mg/ 12.5mg tablets – pale
red with both “A/C” and “40/12.5” printed on one
side
• 40mg/ 25mg tablets – light
red with both “A/C” and “40/25” printed on one
side
4.
INDICATION
Edarbyclor is indicated for the treatment of hypertension. Edarbyclor may be used in patients whose blood pressure
is not adequately controlled on monotherapy or used as initial therapy if a patient is likely to need multiple drugs to
achieve blood pressure goals.
The choice of Edarbyclor as initial therapy for hypertension should be based on an assessment of potential benefits
and risks including whether the patient is likely to
tolerate the starting dose of Edarbyclor.
5.
DOSAGE AND ADMINISTRATION
5.1 RECOMMENDED DOSE
The recommended starting dose of Edarbyclor is 40/12.5 mg taken orally once daily. Most of the
antihypertensive effect is apparent within 1 to 2 weeks. The dosage may be increased to 40/25 mg after 2 to 4
weeks as needed to achieve blood pressure goals. Edarbyclor
40/25mg is the maximum recommended dose.
Refer to Section 9 USE IN SPECIFIC POPULATIONS.
Edarbyclor may be used to provide additional blood pressure low
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