Enalapril 5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Enalapril maleate

Available from:

Kent Pharma (UK) Ltd

ATC code:

C09AA02

INN (International Name):

Enalapril maleate

Dosage:

5mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02050501

Patient Information leaflet

Patient Information Leaflet
ENALAPRIL MALEATE TABLETS 2.5
MG
ENALAPRIL MALEATE TABLETS 5
MG
ENALAPRIL MALEATE TABLETS 10
MG
ENALAPRIL MALEATE TABLETS 20
MG
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 further questions, please ask your doctor or
your 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 MALEATE TABLETS are and what
they are used for
2. What you need to know before you take ENALAPRIL
MALEATE TABLETS
3. How to take ENALAPRIL MALEATE TABLETS
4. Possible side effects
5. How to store ENALAPRIL MALEATE TABLETS
6. Contents of the pack and other information
1. WHAT ENALAPRIL MALEATE TABLETS ARE
AND WHAT THEY ARE USED FOR
ENALAPRIL
MALEATE
TABLETS
(referred
to
as
‘ENALAPRIL’
throughout
this
leaflet)
contains
the
active substance enalapril maleate.
‘ENALAPRIL’ belongs to a group of medicines known
as ACE inhibitors (Angiotensin Converting Enzyme
Inhibitors). ‘ENALAPRIL’ works by causing your blood
vessels to widen. This helps your blood pressure to
fall. It also makes it easier for your heart to pump blood
around your body.
The medicine usually starts to work within an hour, and
the effect lasts for at least 24 hours. Some people will
require several weeks of treatment until the best effect
on their blood pressure is seen.
‘ENALAPRIL’ IS USED:
• To treat high blood pressure – also called hypertension
• To treat heart failure (weakening of heart function). It
can lower the need to go to hospital and can help some
patients live longer.
• To prevent the signs of heart failure. The signs include:
shortness of breath, tiredness after light ph

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Enalapril 5mg Tablets.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg enalapril (as maleate).
Also contains 79.7 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 5 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 5 mg, tablets should be used as an
adjunctive therapy
with
non-potassium-sparing
diuretics
and,
where
appropriate,
digitalis.
Enalapril 5 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 5 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 5 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 starting do