Blopress 16 mg Tablet

Country: Philippines

Language: English

Source: FDA (Food And Drug Administration)

Active ingredient:

Candesartan Cilexetil

Available from:

N/A; Importer: Celltrion Healthcare Philippines, Inc.; Distributor: N/A

INN (International Name):

Candesartan Cilexetil

Dosage:

16 mg

Pharmaceutical form:

Tablet

Units in package:

Alu/PVC/PVDC Blister pack x 7's (Box of 7's and 28's), PP/Alu Blister Pack x 7's (Box of 7's and 28's), Blister Pack x 7's; (Box

Manufactured by:

Delpharm Novara S.R.L., Italy

Authorization date:

2023-10-19

Summary of Product characteristics

CANDESARTAN cilexetil
BLOPRESS
®
8MG TABLET
16MG TABLET
ANGIOTENSIN II RECEPTOR ANTAGONIST
FORMULATION
Candesartan cilexetil (Blopress) tablets (8mg, 16mg)
Each tablet contains 8mg or 16mg candesartan cilexetil.
INDICATIONS
Hypertension
Treatment of patients with heart failure and impaired left ventricle
systolic function.
DOSAGE AND ADMINISTRATION
Usual adult dose is 8 or 16mg, orally administered once daily and
could be adjusted by the physician according
to patient’s condition. For heart failure, up-titration to target
dose of 32mg once daily.
Candesartan cilexetil (Blopress) tablet may be administered with other
antihypertensive agents.
Candesartan cilexetil (Blopress) tablet may be administered with or
without food.
In elderly patients and patients with impaired renal and hepatic
functions, a lower dose should be considered and
adjust according to response. Due to limited experience, not
recommended in very severe/end-stage renal
impairment.
CONTRAINDICATIONS
Candesartan cilexetil (Blopress) Tablet is contraindicated in the
following patients –
(1)
Patients with a history of hypersensitivity to any of the ingredients
of this drug.
(2)
Pregnant women or women having possibilities of being pregnant.
(3)
Patients with diabetes on aliskerin fumarate (excluding patients with
significantly uncontrolled blood
pressure despite treatment with other antihypertensive therapy)
[Increased risks of non-fatal stroke,
renal dysfunction, hyperkalemia or hypotension has been reported].
(See Important Precautions.)
PRECAUTIONS
1.
CAREFUL ADMINISTRATION (CANDESARTAN CILEXETIL (BLOPRESS) TABLET SHOULD
BE ADMINISTERED WITH CARE IN
THE FOLLOWING PATIENTS).
(1)
Patients with a history of drug hypersensitivity.
(2)
Patients with hepatic dysfunction

Hepatic dysfunction may be aggravated. Since a decrease in the
clearance of the active metabolite candesartan is predicted, this drug
should be administered carefully,
taking such measures as starting with a lower dose

(3)
Patients with renal dysfunction

Since renal dysfu