ZOFENIL 7.5 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Zofenopril calcium

Available from:

Menarini International Operations Luxembourg S.A.

ATC code:

C09AA; C09AA15

INN (International Name):

Zofenopril calcium

Dosage:

7.5 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

ACE inhibitors, plain; zofenopril

Authorization status:

Marketed

Authorization date:

1999-03-04

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZOFENIL 7.5 MG AND 30 MG
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 Zofenil is and what it is used for
2. What you need to know before you take Zofenil
3. How to take Zofenil
4. Possible side effects
5. How to store Zofenil
6. Contents of the pack and other information
1. WHAT ZOFENIL IS AND WHAT IT IS USED FOR
Zofenil contains zofenopril calcium 7.5 mg or 30 mg which belongs to a
group of blood pressure
lowering medicines called angiotensin converting enzyme (ACE)
inhibitors.
Zofenil 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 ZOFENIL
DO NOT TAKE ZOFENIL 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 medicine

Summary of Product characteristics

Health Products Regulatory Authority
29 September 2021
CRN00C75Q
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
ZOFENIL 7.5 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ZOFENIL 7.5 mg tablet contains 7.5 mg of zofenopril calcium as
7.2 mg of zofenopril.
Excipients with known effect:
Each ZOFENIL 7.5 mg film-coated tablet contains 17.35 mg of lactose
monohydrate
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
White round film-coated tablets with convex faces.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_Hypertension_
ZOFENILis indicated for the treatment of mild to moderate essential
hypertension.
_Acute Myocardial Infarction_
ZOFENIL 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_
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 existing diuretic therapy for
two to three days before ACE inhibition and a starting dose of 15 mg
daily. If this is