Enalapril 10mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Enalapril maleate

Available from:

Almus Pharmaceuticals Ltd

ATC code:

C09AA02

INN (International Name):

Enalapril maleate

Dosage:

10mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02050501; GTIN: 05060057400999

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 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
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