Enalapril 10mg tablets

Land: Verenigd Koninkrijk

Taal: Engels

Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)

Werkstoffen:

Enalapril maleate

Beschikbaar vanaf:

Phoenix Healthcare Distribution Ltd

ATC-code:

C09AA02

INN (Algemene Internationale Benaming):

Enalapril maleate

Dosering:

10mg

farmaceutische vorm:

Oral tablet

Toedieningsweg:

Oral

klasse:

No Controlled Drug Status

Prescription-type:

Valid as a prescribable product

Product samenvatting:

BNF: 02050501

Bijsluiter

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

Productkenmerken

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.