Innozide 20mg/12.5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Enalapril maleate; Hydrochlorothiazide

Available from:

Organon Pharma (UK) Ltd

ATC code:

C09BA02

INN (International Name):

Enalapril maleate; Hydrochlorothiazide

Dosage:

20mg ; 12.5mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02050501; GTIN: 5013945093506

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
INNOZIDE
® 20/12.5MG 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 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 of 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 called angiotensin
converting enzyme
inhibitors (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 are allergic to enalapril maleate, hydrochlorothiazide, or any
of the other
ingredients of this medicine (listed in section 6).
•
if you have previously been treated with a medication in the same
group of drugs
as this medicine (ACE inhibitors) and have had allergic reactions with
swelling of
the face, lips, tongue and/or throat with difficulty in swallowing or
breathing. You
should not take this medicine if you have had these types of

Summary of Product characteristics

OBJECT 1
INNOZIDE TABLETS
Summary of Product Characteristics Updated 10-Feb-2016 | Merck Sharp &
Dohme Limited
1. Name of the medicinal product
Innozide® 20/12.5 mg tablets
2. Qualitative and quantitative composition
Each tablet of Innozide contains 20 mg enalapril maleate and 12.5 mg
hydrochlorothiazide.
Excipient(s) with known effect:
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Innozide is supplied as round, fluted, yellow tablets with 'MSD 718'
on one side and scored on the other.
4. Clinical particulars
4.1 Therapeutic indications
Innozide is indicated for the treatment of mild to moderate
hypertension in patients who have been
stabilised on the individual components given in the same proportions.
(See sections 4.3, 4.4, 4.5 and 5.1.)
4.2 Posology and method of administration
Posology
The dosage of Innozide should be determined primarily by the
experience with the enalapril maleate
component.
Adults
_Essential hypertension_
The usual dosage is one tablet, taken once daily. If necessary, the
dosage may be increased to two tablets,
taken once daily.
_Prior diuretic therapy_: symptomatic hypotension may occur following
the initial dose of Innozide; this is
more likely in patients who are volume and/or salt depleted as a
result of prior diuretic therapy. The
diuretic therapy should be discontinued for 2-3 days prior to
initiation of therapy with Innozide.
_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 population_
Safety and effectiveness in childr