Bifril Plus 30 mg/12.5 mg film-coated tablets

Country: Irlanda

Lingwa: Ingliż

Sors: HPRA (Health Products Regulatory Authority)

Ingredjent attiv:

ZOFENOPRIL CALCIUM; Hydrochlorothiazide

Disponibbli minn:

Menarini International Operations Luxembourg S.A.

Kodiċi ATC:

C09BA; C09BA15

INN (Isem Internazzjonali):

ZOFENOPRIL CALCIUM; Hydrochlorothiazide

Dożaġġ:

30 mg/12.5 milligram(s)

Għamla farmaċewtika:

Film-coated tablet

Tip ta 'preskrizzjoni:

Product subject to prescription which may be renewed (B)

Żona terapewtika:

ACE inhibitors and diuretics; zofenopril and diuretics

L-istatus ta 'awtorizzazzjoni:

Not marketed

Data ta 'l-awtorizzazzjoni:

2005-05-13

Fuljett ta 'informazzjoni

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
BIFRIL PLUS 30 mg /12.5 mg film-coated tablets
(zofenopril calcium / hydrochlorothiazide)
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 Plus is and what it is used for
2. What you need to know before you take Bifril Plus
3. How to take Bifril Plus
4. Possible side effects
5. How to store Bifril Plus
6. Content of the pack and other information
1. WHAT BIFRIL PLUS IS AND WHAT IT IS USED FOR
Bifril Plus contains zofenopril calcium 30 mg and hydrochlorothiazide
12.5 mg as the active ingredients.

Zofenopril calcium is a cardiovascular drug which belongs to a group
of blood pressure lowering
medicines called angiotensin converting enzyme (ACE) inhibitors.

Hydrochlorothiazide is a diuretic, that acts by increasing the amount
of urine you produce.
Bifril Plus is used to treat mild to moderate high blood pressure
(hypertension), when this is not adequately
controlled by taking zofenopril alone.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BIFRIL PLUS
DO NOT TAKE BIFRIL PLUS IF YOU:

are more than 3 months pregnant (It is also better to avoid Bifril
Plus in early pregnancy - see
“pregnancy section”).

are allergic to zofenopril calcium or to hydrochlorothiazide or to any
of the other ingredients of this
medicine (listed in section 6)

are
allergic
to
other
sulphonamide-derived
substances
(like
hydrochlorothiazide,
which
is
a
sulphonamide-derived drug)

have had any previous allergic reaction to any other ACE inhibitor
such as captopril o

Karatteristiċi tal-prodott

Health Products Regulatory Authority
10 November 2019
CRN008Y6G
Page 1 of 18
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bifril Plus 30 mg/12.5 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 28.7 mg of zofenopril as 30 mg of
zofenopril calcium and 12.5 mg of hydrochlorothiazide.
Excipients with known effect:
Each film-coated tablet contains 56.20 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Pastel-red, round, slightly bi-convex tablets of 9 mm with a score
line on one side.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of mild to moderate essential hypertension.
This fixed dose combination is indicated in patients whose blood
pressure is not adequately controlled on zofenopril alone.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
_Adults_
Dose titration with the individual components (i.e. zofenopril and
hydrochlorothiazide) is recommended before changing to
the fixed dose combination.
When clinically appropriate direct change from monotherapy to the
fixed combination may be considered.
_Patients without volume or salt depletion_
The usual effective dose is one tablet once daily.
_Patients suspected of volume or salt depletion_
The use of Bifril Plusis not recommended.
_Elderly (over 65 years)_
In the elderly with normal creatinine clearance no dose adjustment is
necessary.
In the elderly with reduced creatinine clearance (less than 45 mL/min)
the use of Bifril Plusis not recommended.
Creatinine clearance may be estimated from serum creatinine by the
following
Cockroft-Gault formula:
[(140-age) * weight (Kg)]
CrCl (mL/min) = _______________________________________
72 *serum Cr (mg/dL)
The above method provides creatinine clearance in males. For females
the value obtained should be multiplied by 0.85.
Health Products Regulatory Authority
10 N