Innovace 2.5mg tablets
Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Patient Information leaflet
(PIL)
01-04-2022
Summary of Product characteristics
(SPC)
06-04-2023
Active ingredient:
Enalapril maleate
Available from:
Organon Pharma (UK) Ltd
ATC code:
C09AA02
INN (International Name):
Enalapril maleate
Dosage:
2.5mg
Pharmaceutical form:
Oral tablet
Administration route:
Oral
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 02050501; GTIN: 5013945194005
Patient Information leaflet
PACKAGE LEAFLET: INFORMATION FOR THE USER
INNOVACE
® 2.5 MG, 5 MG, 10 MG OR 20 MG TABLETS
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 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 Innovace is and what it is used for
2.
What you need to know before you take Innovace
3.
How to take Innovace
4.
Possible side effects
5.
How to store Innovace
6.
Contents of the pack and other information
1.
WHAT INNOVACE IS AND WHAT IT IS USED FOR
Innovace contains an active substance called enalapril maleate. This
belongs to the
group of medicines called ACE inhibitors (angiotensin converting
enzyme inhibitors).
Innovace is used:
-
to treat high blood pressure (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 physical activity such as walking, or swelling
of the ankles
and feet.
This medicine works by widening your blood vessels. This lowers your
blood
pressure. 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 your blood pressure is seen.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE INNOVACE
DO NOT TAKE INNOVACE
-
if you are allergic to enalapril maleate 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 AC
Read the complete document
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Innovace 2.5 mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Innovace 2.5 mg
Each tablet contains 2.5 mg of enalapril maleate.
Excipient: each tablet contains 99 mg of lactose monohydrate.
Excipient(s) with known effect:
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet
Strength
Appearance
2.5 mg
White, round shaped tablet, one side
marked MSD 14, the other side plain
*The scoreline is only to facilitate breaking for ease of swallowing
and not to divide into equal
doses.
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 Innovace Tablets is not affected by food.
The dose should be individualised according to patient profile (see
section 4.4)
and blood pressure response.
_Paediatric Population _
There is limited clinical trial experience of the use of Innovace in
hypertensive
paediatric patients (see sections 4.4, 5.1 and 5.2).
_Hypertension _
The
initial
dose
is
5
to
maximally
20 mg,
depending
on
the
degree
of
hypertension and the condition of the patient (see below). Innovace 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 pat
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