Enalapril 20mg tablets

국가: 영국

언어: 영어

출처: MHRA (Medicines & Healthcare Products Regulatory Agency)

유효 성분:

Enalapril maleate

제공처:

Zentiva Pharma UK Ltd

ATC 코드:

C09AA02

INN (국제 이름):

Enalapril maleate

복용량:

20mg

약제 형태:

Oral tablet

관리 경로:

Oral

수업:

No Controlled Drug Status

처방전 유형:

Valid as a prescribable product

제품 요약:

BNF: 02050501; GTIN: 5000283605416

환자 정보 전단

Enalapril Maleate
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 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 or
pharmacist. This includes any possible side effects
not listed in this leaflet, (see section 4).
THIS LEAFLET CONTAINS
1. What Enalapril is and what it is used for
2. What you need to know before you take Enalapril
3. How to take Enalapril
4. Possible side effects
5. How to store Enalapril
6. Contents of the pack and other information
1. WHAT ENALAPRIL IS AND
WHAT IT IS USED FOR
Enalapril belongs to a group of medicines known as
angiotensin-converting enzyme inhibitors ('ACE
inhibitors'). It works by causing your blood vessels to
relax, making it easier for your heart to pump blood
around your body.
Enalapril can be used to treat:
●
high blood pressure (hypertension)
●
heart failure, where the heart has difficulty pumping
blood around the body
Enalapril can also:
●
slow down the development of the symptoms of
heart failure, which include shortness of breath,
swelling of the ankles and feet, and tiredness after
only light activity
●
slow down the progress of heart failure
●
reduce the need for hospitalisation in patients with
heart failure or unstable angina
●
reduce the risk of heart attacks occurring in patients
with unstable angina
If you are not sure why you have been prescribed
Enalapril, please ask your doctor.
2. WHAT YOU NEED TO KNOW
BEFORE YOU TAKE ENALAPRIL
DO NOT TAKE ENALAPRIL:
●
If you are allergic (hypersensitive) to enalapril, other
ACE inhibitors (such as captopril, lisinopril or
ramapril), or any of the other ingredients of Enalapril
Tablets (see section 6). The symptoms of an allergic
reaction may include itching, rash, swel

제품 특성 요약

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Enalapril 20mg Tablets.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 20 mg enalapril (as maleate).
Also contains 111.0 mg of lactose per tablet, for a full list of
excipients, see
section 6.1
3
PHARMACEUTICAL FORM
Tablet.
White circular biplanar uncoated tablets with 20 embossed on one face
and
score line on the other.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of hypertension:
All grades of essential hypertension and renovascular hypertension.
Treatment of heart failure:
In heart failure, Enalapril 20 mg, tablets should be used as an
adjunctive
therapy with non-potassium-sparing diuretics and, where appropriate,
digitalis.
Enalapril 20 mg, tablets have been shown to improve symptoms, retard
the
progression of the disease, and reduce mortality and hospitalisation.
Prevention of symptomatic heart failure:
When
used
in
asymptomatic
patients
with
left
ventricular
dysfunction,
Enalapril 20 mg, tablets retard the development of symptomatic heart
failure,
and reduce hospitalisation for heart failure.
Prevention of coronary ischaemic events in patients with left
ventricular
dysfunction:
Enalapril 20 mg, tablets reduce both the incidence of myocardial
infarction
and hospitalisation for unstable angina pectoris.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The absorption of enalapril is not affected by food intake.
The dose should be individualised according to the 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
is given
once daily. In mild hypertension, the recommended 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 sta