BIFRIL 60 mg film-coated tablets

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

ZOFENOPRIL CALCIUM

Διαθέσιμο από:

Menarini International Operations Luxembourg S.A.

Φαρμακολογική κατηγορία (ATC):

C09AA; C09AA15

INN (Διεθνής Όνομα):

ZOFENOPRIL CALCIUM

Δοσολογία:

60 milligram(s)

Φαρμακοτεχνική μορφή:

Film-coated tablet

Τρόπος διάθεσης:

Product subject to prescription which may be renewed (B)

Θεραπευτική περιοχή:

ACE inhibitors, plain; zofenopril

Καθεστώς αδειοδότησης:

Not marketed

Ημερομηνία της άδειας:

1999-03-04

Φύλλο οδηγιών χρήσης

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
BIFRIL 30MG 7.5MG 15MG 60MG
film-coated tablets
(zofenopril calcium)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their
signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Bifril is and what it is used for
2. What you need to know before you take Bifril
3. How to take Bifril
4. Possible side effects
5. How to store Bifril
6. Contents of the pack and other information
1. WHAT BIFRIL IS AND WHAT IT IS USED FOR
Bifril contains zofenopril calcium 30 mg 7.5 mg 15 mg 60 mg which
belongs to a group of blood
pressure lowering medicines called angiotensin converting enzyme (ACE)
inhibitors.
Bifril is used to treat the following conditions:

high blood pressure (hypertension).

heart attack (acute myocardial infarction) in people who may or may
not show signs and symptoms
of heart failure, and who have not received treatment that helps
dissolve blood clots (thrombolytic
therapy).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BIFRIL
DO NOT TAKE BIFRIL IF YOU:

are allergic to zofenopril calcium or any of the other ingredients of
this medicine (listed in
section 6)

have had any previous allergic reaction to any other ACE inhibitor
such as captopril or enalapril

have a history of severe swelling and itching around the face, nose
and throat (angioneurotic
edema) associated with previous ACE inhibitor therapy, or if you
suffer from
hereditary/idiopathic angioneurotic oedema (rapid swelling of the
skin, tissues, digestive tract
and other organs)

have taken or are currently taking sacubitril/valsartan, a medici

Αρχείο Π.Χ.Π.

Health Products Regulatory Authority
25 July 2019
CRN008Y3R
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
BIFRIL 60 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each BIFRIL 60 mg tablet contains 60 mg of zofenopril calcium as 57.3
mg of zofenopril.
Excipients with known effect:
Each BIFRIL 60 mg film-coated tablet contains 138.8 mg of lactose
monohydrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
White oblong film coated tablets with a breakline. The tablet can be
divided into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC 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.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Posology_
_ _
HYPERTENSION
_ _
_Adults_
The need for dosage titration should be determined by measurement of
blood pressure just before the next dose. The dose
should be increased at an interval of four weeks.
_Patients without volume or salt depletion:_
Treatment should be started with 15 mg once daily and titrated upwards
to achieve optimal blood pressure control.
The usual effective dose is 30 mg once daily.
The maximum dose is 60 mg per day administered in a single or two
divided doses.
In case of inadequate response, other antihypertensive agents such as
diuretics may be added (see Sections 4.3, 4.4, 4.5 and
5.1).
_ _
_Patients suspected of volumeor salt depletion_
Health Products Regulatory Authority
25 July 2019
CRN008Y3R
Page 2 of 14
First-dose hypotension may occur in high risk patients (see Special
warnings and precautions for use). Initiation of therapy
with ACE inhibitors requires correction of salt and/or volume
deficiencies, discontinuation of an existi