Enalapril 10mg tablets

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)

מרכיב פעיל:

Enalapril maleate

זמין מ:

Mawdsley-Brooks & Company Ltd

קוד ATC:

C09AA02

INN (שם בינלאומי):

Enalapril maleate

כמות:

10mg

טופס פרצבטיות:

Oral tablet

מסלול נתינה (של תרופות):

Oral

סיווג:

No Controlled Drug Status

סוג מרשם:

Valid as a prescribable product

leaflet_short:

BNF: 02050501

עלון מידע

Black
Keyline
AW.CRC.74.01.V12
156x590 mm
Grasshopper Sistemas de Informação
[e-mail]
www.gsiportugal.com
NO GOOD FOR COLOR PROOF
ENALAPRIL MALEATE 2.5mg, 5mg, 10mg and 20mg
TABLETS
(Package leaflet EN)
Code
Date
Customer
Description
Notes
Colours
Size
2017-07-05
1
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
ENALAPRIL MALEATE 2.5mg, 5mg,
10mg and 20mg
TABLETS
enalapril maleate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Ÿ
KEEP THIS LEAFLET. YOU MAY NEED TO READ IT AGAIN.
Ÿ
IF YOU HAVE ANY FURTHER QUESTIONS, ASK YOUR DOCTOR OR PHARMACIST.
Ÿ
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.
Ÿ
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 Enalapril Tablets are and what they
are used for
2.
What you need to know before you take
Enalapril Tablets
3.
How to take Enalapril Tablets
4.
Possible side effects
5.
How to store Enalapril Tablets
6.
Contents of the pack and other information
1.
WHAT ENALAPRIL TABLETS ARE AND
WHAT THEY ARE USED FOR
The full name of your medicine is Enalapril
Maleate 2.5mg, 5mg, 10mg or 20mg Tablets,
but within the leaflet it will be referred to as
Enalapril Tablets.
This medicine contains an active substance
called enalapril maleate. This belongs to the
group of medicines called ACE inhibitors
(Angiotensin Converting Enzyme Inhibitors).
ENALAPRIL TABLETS ARE USED:
Ÿ
to treat high blood pressure (hypertension)
Ÿ
to treat heart failure (weakening of heart
function). It can lower the need to go to
hospital and can help some patients live
longer
Ÿ
to 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

מאפייני מוצר

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Enalapril maleate 10 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 10 mg of Enalapril maleate.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
White circular biplanar uncoated tablets with 10 embossed on one face
and
score line on the other.
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
The absorption of Enalapril Tablets is not affected by food.
The dose should be individualised according to patient profile (see
4.4) and
blood pressure response.
Hypertension
Enalapril can be used alone or in combination with other
antihypertensive agents (see
sections 4.3, 4.4, 4.5 and 5.1).
The initial dose is 5 to maximally 20 mg, depending on the degree of
hypertension and the condition of the patient (see below). Enalapril
Tablets are
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, diuretic
therapy
should
be
discontinued
for
2-3
days
prior
to
initiation
of
therapy
with
enalapril. Renal function and serum potassium should be monitored.
The usual maintenance dose is 20 mg daily. The maximum maintenance
dose
is 40 mg daily.