Enalapril 20mg tablets

Land: Verenigd Koninkrijk

Taal: Engels

Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)

Werkstoffen:

Enalapril maleate

Beschikbaar vanaf:

Waymade Healthcare Plc

ATC-code:

C09AA02

INN (Algemene Internationale Benaming):

Enalapril maleate

Dosering:

20mg

farmaceutische vorm:

Oral tablet

Toedieningsweg:

Oral

klasse:

No Controlled Drug Status

Prescription-type:

Valid as a prescribable product

Product samenvatting:

BNF: 02050501

Bijsluiter

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.
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
These tablets contain enalapril maleate. Enalapril belongs to a group
of medicines known as ‘ACE inhibitors’, which work by widening
your
blood vessels.
They are used to treat:
• High blood pressure.
• Heart failure (symptoms of which include tiredness after light
exercise, breathlessness and swelling of your ankles and legs).
They are also used to prevent heart failure and heart attacks in
people who have heart problems but have no symptoms.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
ENALAPRIL TABLETS
DO NOT TAKE ENALAPRIL TABLETS:
• if you are allergic to enalapril or any of the other ingredients
of this
medicine (listed in section 6)
•
if you have ever had an allergic reaction to a type of medicine
similar to this medicine called an ACE inhibitor
•
if you have ever had swelling of your face, lips, mouth, tongue or
throat which caused difficulty in swallowing or breathing
(angioedema) when the reason why was not known or it was
inherited
• if you are more than 3 months pregnant. (It is also better to
avoid
Enalapril in early pregnancy - see pregnancy section)
• if you have diabetes or impaired kidney function and you are
tre

Productkenmerken

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