BIFRIL TABLET 30 mg

Nazione: Singapore

Lingua: inglese

Fonte: HSA (Health Sciences Authority)

Principio attivo:

ZOFENOPRIL CALCIUM

Commercializzato da:

A. MENARINI SINGAPORE PTE. LTD.

Codice ATC:

C09AA15

Dosaggio:

30 mg

Forma farmaceutica:

TABLET, FILM COATED

Composizione:

ZOFENOPRIL CALCIUM 30 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

Prescription Only

Prodotto da:

A MENARINI MANUFACTURING LOGISTICS AND SERVICES SRL

Stato dell'autorizzazione:

ACTIVE

Data dell'autorizzazione:

2004-02-10

Foglio illustrativo

BIFRIL
®
Zofenopril calcium 30 mg
COMPOSITION
Each BIFRIL 30 mg coated tablet contains:
ACTIVE INGREDIENT: Zofenopril calcium 30 mg
EXCIPIENTS:
CORE: microcrystalline cellulose, lactose monohydrate, maize starch, magnesium stearate, colloidal anhydrous silica.
COAT: hydroxypropylmethyl cellulose (hypromellose), titanium dioxide (E171), macrogol 400, macrogol 6000.
INDICATIONS
HYPERTENSION
BIFRIL is indicated for the treatment of mild to moderate essential hypertension.
ACUTE MYOCARDIAL INFARCTION
BIFRIL is indicated for the treatment initiated within the first 24 hours of patients with acute myocardial infarction with or without signs and symptoms of heart failure, who are haemo-
dynamically stable and have not received thrombolytic therapy.
CONTRAINDICATIONS
• Hypersensitivity to zofenopril calcium or any other ACE inhibitor.
• History of angioneurotic oedema associated with previous ACE inhibitor therapy.
• Hereditary/idiopathic angioneurotic oedema.
• Severe hepatic impairment.
• Pregnancy.
• Lactation period.
• Women of child-bearing potential unless protected by effective contraception.
• Bilateral renal artery stenoses or unilateral renal artery stenosis in cases of a solitary single kidney.
PRECAUTIONS
HYPOTENSION:
As with other ACE inhibitors, BIFRIL may cause a profound fall in blood pressure especially after the first dose.Symptomatic hypotension is rare in uncomplicated hypertensive patients.
It is more likely to occur in patients who have been volume depleted by diuretic therapy, dietary salt restriction, dialysis, diarrhoea or vomiting. It has been reported mainly in patients
with severe heart failure with or without associated renal insufficiency. This is more likely in patients on high doses of loop diuretics, or those with hyponatraemia or functional renal
impairmen

Scheda tecnica

BIFRIL®
Zofenopril calcium 30 mg
COMPOSITION
Each BIFRIL 30 mg coated tablet contains:
ACTIVE INGREDIENT: Zofenopril calcium 30 mg
EXCIPIENTS:
CORE: microcrystalline cellulose, lactose monohydrate, maize starch,
magnesium stearate, colloidal anhydrous
silica.
COAT: hydroxypropylmethyl cellulose (hypromellose), titanium dioxide
(E171), macrogol 400, macrogol 6000.
INDICATIONS
HYPERTENSION
BIFRIL is indicated for the treatment of mild to moderate essential
hypertension.
ACUTE MYOCARDIAL INFARCTION
BIFRIL is indicated for the treatment initiated within the first 24
hours of patients with acute myocardial
infarction with or without signs and symptoms of heart failure, who
are haemodynamically stable and have not
received thrombolytic therapy.
CONTRAINDICATIONS
• Hypersensitivity to zofenopril calcium or any other ACE inhibitor.
• History of angioneurotic oedema associated with previous ACE
inhibitor therapy.
• Hereditary/idiopathic angioneurotic oedema.
• Severe hepatic impairment.
• Pregnancy.
• Lactation period.
• Women of child-bearing potential unless protected by effective
contraception.
• Bilateral renal artery stenoses or unilateral renal artery
stenosis in cases of a solitary single kidney.
• The concomitant use of BIFRIL with aliskiren-containing products
is contraindicated in patients with diabetes
mellitus or renal impairment (GFR < 60 ml/min/1.73m
2
) (see Interactions).
PRECAUTIONS
HYPOTENSION:
As with other ACE inhibitors, BIFRIL may cause a profound fall in
blood pressure especially after the first dose.
Symptomatic hypotension is rare in uncomplicated hypertensive
patients. It is more likely to occur in patients
who have been volume depleted by diuretic therapy, dietary salt
restriction, dialysis, diarrhoea or vomiting. It
has been reported mainly in patients with severe heart failure with or
without associated renal insufficiency.
This is more likely in patients on high doses of loop diuretics, or
those with hyponatraemia or functional renal
impairment. In these patients treatment