Enalapril 10mg tablets

देश: यूनाइटेड किंगडम

भाषा: अंग्रेज़ी

स्रोत: MHRA (Medicines & Healthcare Products Regulatory Agency)

सक्रिय संघटक:

Enalapril maleate

थमां उपलब्ध:

Actavis UK Ltd

ए.टी.सी कोड:

C09AA02

INN (इंटरनेशनल नाम):

Enalapril maleate

डोज़:

10mg

फार्मास्यूटिकल फॉर्म:

Oral tablet

प्रशासन का मार्ग:

Oral

वर्ग:

No Controlled Drug Status

प्रिस्क्रिप्शन प्रकार:

Valid as a prescribable product

उत्पाद समीक्षा:

BNF: 02050501

सूचना पत्रक

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).
THIS LEAFLET CONTAINS
1. What Enalapril is and what it is used for
2. What you need to know before you take Enalapril
3. How to take Enalapril
4. Possible side effects
5. How to store Enalapril
6. Contents of the pack and other information
1. WHAT ENALAPRIL IS AND
WHAT IT IS USED FOR
Enalapril belongs to a group of medicines known as
angiotensin-converting enzyme inhibitors ('ACE
inhibitors'). It works by causing your blood vessels to
relax, making it easier for your heart to pump blood
around your body.
Enalapril can be used to treat:
●
high blood pressure (hypertension)
●
heart failure, where the heart has difficulty pumping
blood around the body
Enalapril can also:
●
slow down the development of the symptoms of
heart failure, which include shortness of breath,
swelling of the ankles and feet, and tiredness after
only light activity
●
slow down the progress of heart failure
●
reduce the need for hospitalisation in patients with
heart failure or unstable angina
●
reduce the risk of heart attacks occurring in patients
with unstable angina
If you are not sure why you have been prescribed
Enalapril, please ask your doctor.
2. WHAT YOU NEED TO KNOW
BEFORE YOU TAKE ENALAPRIL
DO NOT TAKE ENALAPRIL:
●
If you are allergic (hypersensitive) to enalapril, other
ACE inhibitors (such as captopril, lisinopril or
ramapril), or any of the other ingredients of Enalapril
Tablets (see section 6). The symptoms of an allergic
reaction may include itching, rash, swel

उत्पाद विशेषताएं

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Enalapril maleate10 mg Tablets.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Enalapril 10mg: Each tablet contains 10mg of Enalapril maleate
Excipient with known effect: Each tablet contains 98.30mg of lactose
monohydrate
(see section 4.4).
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
Enalapril 10mg: White, circular, biplanar, uncoated tablets with
“10” embossed on
one face and score line on the other. The score line is only to
facilitate breaking for
ease of swallowing and not to divide into equal doses.
The diameter of the tablet is 7.0 mm
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
The absorption of Enalapril tablets is not affected by food.
The dose should be individualised 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 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
fo