ENPRESIL CO TABLET

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Unicorn Pharmaceuticals (Pty) Ltd

Dosage:

20,0 mg & 12,5 mg

Pharmaceutical form:

TABLET

Composition:

EACH TABLET CONTAINS ENALAPRIL MALEATE 20,0 mg HYDROCHLOROTHIAZIDE 12,5 mg

Authorization status:

Registered

Patient Information leaflet

Enpresil Co
Each tablet contains enalapril maleate 20 mg and
Unicorn Pharmaceuticals (Pty) Ltd
hydrochlorothiazide 12,5 mg
May 2023
Page 1 of 15
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS:
ENPRESIL CO 20/12.5MG TABLETS
Enalapril maleate/hydrochlorothiazide
Enpresil Co contains sugar (lactose monohydrate 130,10 mg)
Enpresil Co is sodium-free
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING ENPRESIL CO
•
Keep this leaflet. You may need to read it again.
•
If you have further questions, please ask your doctor, pharmacist,
nurse or other health
care provider.
•
Enpresil Co has been prescribed for you personally and you should not
share your
medicine with other people. It may harm them, even if their symptoms
are the same as
yours.
WHAT IS IN THIS LEAFLET
1. What Enpresil Co is and what it is used for
2. What you need to know before you take Enpresil Co
3. How to take Enpresil Co
4. Possible side effects
5. How to store Enpresil Co
6. Contents of the pack and other information
1.
WHAT ENPRESIL CO IS AND WHAT IT IS USED FOR
Enpresil Co contains enalapril maleate and hydrochlorothiazide:
•
Enalapril belongs to a group of medicines called angiotensin
converting enzyme inhibitors
(ACE inhibitors), and widens your blood vessels. This makes it easier
for your heart to
pump blood to all parts of your body.
•
Hydrochlorothiazide belongs to a group of medicines known as water
tablets (diuretics),
S3
Enpresil Co
Each tablet contains enalapril maleate 20 mg and
Unicorn Pharmaceuticals (Pty) Ltd
hydrochlorothiazide 12,5 mg
May 2023
Page 2 of 15
which make your kidneys pass more water and salt as urin
The effect of both of these medicines is to lower your blood pressure.
Enpresil Co is used to
treat high blood pressure (hypertension).
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE ENPRESIL CO
DO NOT TAKE ENPRESIL CO
•
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 th

Summary of Product characteristics

Enpresil Co
Each tablet contains enalapril maleate 20 mg and
Unicorn Pharmaceuticals (Pty) Ltd
hydrochlorothiazide 12,5 mg
May 2023
Page 1 of 29
PROFESSIONAL INFORMATION
SCHEDULING STATUS:
1.
NAME OF THE MEDICINE
Enpresil Co 20/12,5 mg (tablets)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains enalapril maleate 20 mg and hydrochlorothiazide
12,5 mg.
EXCIPIENTS WITH KNOWN EFFECT
Enpresil Co contains sugar (lactose monohydrate 130,10 mg/tablet)
Enpresil Co contains less than 1 mmol sodium (23 mg) per tablet, that
is to say essentially
‘sodium-free’.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Pale yellow colour, circular, biconvex uncoated tablets with breakline
on one side & plain on
the other side.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Enpresil Co is indicated for the treatment of hypertension in patients
where fixed combination
treatment is considered more appropriate than monotreatment.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_HYPERTENSION _
The usual dosage is 1 tablet, administered once daily. If necessary
the dosage may be
S3
Enpresil Co
Each tablet contains enalapril maleate 20 mg and
Unicorn Pharmaceuticals (Pty) Ltd
hydrochlorothiazide 12,5 mg
May 2023
Page 2 of 29
increased to a maximum of 2 tablets, administered once daily
SPECIAL POPULATIONS
_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).
Enpresil Co is not be used as initial treatment in any patient with
renal insufficiency.
In patients with creatinine clearance of >30 and <80 ml/min, Enpresil
Co may be used but only
after titration of the individual components._ _
METHOD OF ADMINISTRATION
For oral use.
4.3
CONTRAINDICATIONS
•
Hypersensitivity
to
enalapril
maleate
and
hydrochlorothiazide,
or
to
any
of
the
ingredients listed in section 6.1.
•
Severe renal impairment (creatinine clearance ≤ 30 ml/min