Innozide 20 mg/12.5 mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Enalapril maleate; Hydrochlorothiazide

Available from:

Merck Sharp & Dohme Ireland (Human Health) Limited

ATC code:

C09BA; C09BA02

INN (International Name):

Enalapril maleate; Hydrochlorothiazide

Dosage:

20 mg/12.5 milligram(s)

Pharmaceutical form:

Tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

ACE inhibitors and diuretics; enalapril and diuretics

Authorization status:

Not marketed

Authorization date:

1991-12-16

Patient Information leaflet

WS153
PACKAGE LEAFLET: INFORMATION FOR THE USER
INNOZIDE
® 20 MG/12.5 MG TABLETS
enalapril maleate/hydrochlorothiazide
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
Keep this leaflet. You may want 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 symptoms 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 Innozide is and what it is used for
2.
What you need to know before you take Innozide
3.
How to take Innozide
4.
Possible side effects
5.
How to store Innozide
6.
Contents of the pack and other information
1.
WHAT INNOZIDE
IS AND WHAT IT IS USED FOR
Innozide contains enalapril maleate and hydrochlorothiazide:

enalapril belongs to a group of medicines known as ACE inhibitors
which work by
widening your blood vessels

hydrochlorothiazide belongs to a group of medicines known as
water tablets
(diuretics), which increase the volume of urine you produce.
The effect of these medicines is to lower your blood pressure.
Innozide is used to treat
high blood pressure (hypertension). Taking both medicines that
Innozide contains can
increase their effect compared to taking just one.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE INNOZIDE
DO NOT TAKE INNOZIDE
IF:

you have ever had an allergic reaction to Innozide, a similar medicine
or to any of
the ingredients (listed in Section 6). The signs may have been
itching, nettle rash,
wheezing or swelling of your hands, throat, mouth or eyelids

you are allergic to a type of medicine called ‘sulphonamides’

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 inher

Summary of Product characteristics

Health Products Regulatory Authority
16 June 2021
CRN00CFJ4
Page 1 of 15
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Innozide 20 mg/12.5 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 20 mg enalapril maleate and 12.5 mg
hydrochlorothiazide.
Excipients: Contains 141.00 mg lactose monohydrate.
_For a full list of excipients, see section 6.1. _
3 PHARMACEUTICAL FORM
Tablet.
Round, fluted, yellow tablets with MSD 718 on one side and scored on
the other
The scoreline allows breaking for ease of swallowing only.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Management of hypertension where a further reduction in blood pressure
is required following the use of 20 mg enalapril.
Management of hypertension in patients who have been stabilised on the
individual components.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration.
The dosage of ‘Innozide’ should be determined primarily by the
experience with the enalapril maleate component.
The maximum recommended daily dose is two tablets.
_Adults_
_Essential hypertension_
The dosage is one tablet, taken once daily. If necessary, the dosage
may be increased by a small increment of either
constituent.
_Dosage in renal insufficiency_
Thiazides may not be appropriate diuretics for use in patients with
renal impairment and are ineffective at creatinine clearance
values of 30 ml/min or below (i.e. moderate or severe renal
insufficiency).
In patients with creatinine clearance of >30 and <80 ml/min,
‘Innozide’ should be used only after titration of the individual
components.
_Use in the elderly_
In clinical studies the efficacy and tolerability of enalapril maleate
and hydrochlorothiazide, administered concomitantly, were
similar in both elderly and younger hypertensive patients.
_Paediatric use_
Safety and effectiveness in children have not been established.
Health Products Regulatory Authority
16 June 2021
CRN00CFJ4
Page 2 of 15
_Prior diuretic therapy_
Symptomatic hypotension may occur following the initia