Enalapril 20mg tablets

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)

Δραστική ουσία:

Enalapril maleate

Διαθέσιμο από:

Zanza Specials International Ltd

Φαρμακολογική κατηγορία (ATC):

C09AA02

INN (Διεθνής Όνομα):

Enalapril maleate

Δοσολογία:

20mg

Φαρμακοτεχνική μορφή:

Oral tablet

Οδός χορήγησης:

Oral

Kατηγορία:

No Controlled Drug Status

Τρόπος διάθεσης:

Valid as a prescribable product

Περίληψη προϊόντος:

BNF: 02050501; GTIN: 5060033711057

Φύλλο οδηγιών χρήσης

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

Αρχείο Π.Χ.Π.

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