Enalapril 20mg tablets

Riik: Suurbritannia

keel: inglise

Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Toimeaine:

Enalapril maleate

Saadav alates:

Viatris UK Healthcare Ltd

ATC kood:

C09AA02

INN (Rahvusvaheline Nimetus):

Enalapril maleate

Annus:

20mg

Ravimvorm:

Oral tablet

Manustamisviis:

Oral

Klass:

No Controlled Drug Status

Retsepti tüüp:

Valid as a prescribable product

Toote kokkuvõte:

BNF: 02050501; GTIN: 5016695310060

Infovoldik

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

Toote omadused

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Enalapril Maleate 20mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 20 mg Enalapril maleate.
Excipient: each tablet contains 110.933 mg of lactose monohydrate.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablets
White to off-white round flat bevelled edged tablets marked with
“20” on one side
and break line on the other.
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
Food does not interfere with the absorption of enalapril.
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 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, 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.
Heart