Enalapril maleate Accord 10mg tablets

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

Enalapril maleate

متاح من:

Accord Healthcare Ireland Ltd.

ATC رمز:

C09AA02

INN (الاسم الدولي):

Enalapril maleate

الشكل الصيدلاني:

Tablet

المجال العلاجي:

enalapril

الوضع إذن:

Marketed

تاريخ الترخيص:

2022-02-18

نشرة المعلومات

PACKAGE LEAFLET: INFORMATION FOR THE USER
ENALAPRIL MALEATE ACCORD 5 MG TABLETS
ENALAPRIL MALEATE ACCORD 10 MG TABLETS
ENALAPRIL MALEATE ACCORD 20 MG TABLETS
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, pharmacist or
nurse.

This medicine has been prescribed for you only. 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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.

The full name of this medicine is Enalapril maleate Accord 2.5 mg, 5
mg, 10 mg, 20 mg
tablets but within this leaflet it will be referred to as Enalapril
maleate Accord tablets.
WHAT IS IN THIS LEAFLET
1.
What Enalapril maleate Accord tablets are and what they are used for
2.
What you need to know before you take Enalapril maleate Accord tablets
3.
How to take Enalapril maleate Accord tablets
4.
Possible side effects
5.
How to store Enalapril maleate Accord tablets
6.
Contents of the pack and other information
1.
WHAT ENALAPRIL MALEATE ACCORD TABLETS ARE AND WHAT THEY ARE USED FOR
Enalapril maleate Accord tablets contain an active substance called
Enalapril maleate Accord. These
belong to the group of medicines called ACE inhibitors (angiotensin
converting enzyme inhibitors).
Enalapril maleate Accord tablets are used to:

treat high blood pressure (hypertension)

treat heart failure (weakening of heart function). It can lower the
need to go to hospital and
can help some patients live longer

prevent the signs of heart failure. The signs include shortness of
breath, tiredness after light
physical activity such as walking, or swelling of the ankles and feet.
This medicine works by widening your blood vessels. This lowers your
blood pressure. The
medicine usually starts to work within an hour

خصائص المنتج

Health Products Regulatory Authority
21 February 2022
CRN009JS6
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Enalapril maleate Accord 10mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg of enalapril maleate
Excipient(s) with known effect
This medicine contains 57.35-60.49 mg of lactose monohydrate per
tablet.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
Light Pink to Pink coloured, triangular shaped (6.50 mm diameter),
biconvex uncoated tablets with mottled appearance,
debossed with "IS3" on one side and BREAKLINE on other 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 Hypertension
Treatment of Symptomatic Heart Failure
Prevention of Symptomatic Heart Failure in patients with Asymptomatic
Left
Ventricular Dysfunction (ejection fraction ≤35%)
(See section 5.1.)
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dose should be individualized according to patient profile (see
section 4.4) and blood pressure response.
_ _
_Hypertension_
The initial dose is 5 to maximally 20 mg, depending on the degree of
hypertension and the condition of the patient (see below).
Enalapril maleate Accord is given once daily. In mild hypertension,
the recommended initial dose is 5 to 10 mg. Patients with a
strongly activated renin-angiotensin-aldosterone system (e.g.,
renovascular hypertension, salt and/or volume depletion, cardiac
decompensation, or severe hypertension) may experience an excessive
blood pressure fall following the initial dose. A starting
dose of 5 mg or lower is recommended in such patients and the
initiation of treatment should take place under medical
supervision.
Prior treatment with high dose diuretics may result in volume
depletion and a risk of hypotension when initiating therapy with
enalapril. A starting dose of 5 mg or lower is recommended in such
patients. If possible, diureti