Enalapril 10mg tablets

מדינה: הממלכה המאוחדת

שפה: אנגלית

מקור: MHRA (Medicines & Healthcare Products Regulatory Agency)

מרכיב פעיל:

Enalapril maleate

זמין מ:

Noumed Life Sciences Ltd

קוד ATC:

C09AA02

INN (שם בינלאומי):

Enalapril maleate

כמות:

10mg

טופס פרצבטיות:

Oral tablet

מסלול נתינה (של תרופות):

Oral

סיווג:

No Controlled Drug Status

סוג מרשם:

Valid as a prescribable product

leaflet_short:

BNF: 02050501; GTIN: 05060453460139

עלון מידע

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ENALAPRIL MALEATE TABLETS 2.5, 5, 10 AND 20MG
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.
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
The name of your medicine is Enalapril Tablets. The active ingredient,
enalapril, belongs to a group
of medicines called angiotensin converting enzyme (ACE) inhibitors,
which work by widening your
blood vessels. This helps reduce blood pressure and also relieves the
workload of the heart in
patients with heart failure and following a heart attack.
Enalapril Tablets are useful in the treatment of:

high blood pressure (hypertension).

heart failure. This means that your heart is not working as well as it
used to in order to pump
blood around your body, leading to tiredness after light exercise,
breathlessness and swelling
of the ankles and legs.

heart muscle damage.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ENALAPRIL TABLETS
DO NOT TAKE ENALAPRIL TABLETS IF

you are allergic to enalapril, a similar medicine or any of the other
ingredients of this
medicine (listed in section 6). Signs of an allergic reaction include:
a rash, swallowing or
breathing problems, swelling of your lips, face, throat or tongue.

you are more than 3 months

מאפייני מוצר

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.