ENALAPRIL HCTZ 20/12,5 AUSTELL Tablets

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Austell Pharmaceuticals (Pty) Ltd

Dosage:

Not Indicated

Pharmaceutical form:

Tablets

Composition:

Each tablet contains ENALAPRIL MALEATE 20,0 mg and HYDROCHLOROTHIAZIDE 12,5 mg

Authorization status:

Registered

Authorization date:

2022-12-07

Patient Information leaflet

Austell Pharmaceuticals (Pty) Ltd, 491089, Enalapril HCTZ Austell,
20/12,5 mg, Tablets
2022.12.23 (v5) Page 1 of 17
APPROVED PATIENT INFORMATION LEAFLET FOR MEDICINES FOR HUMAN USE:
ENALAPRIL HCTZ AUSTELL
SCHEDULING STATUS: S3
ENALAPRIL HCTZ AUSTELL
ENALAPRIL MALEATE 20 MG AND HYDROCHLOROTHIAZIDE 12,5 MG TABLETS
CONTAINS SUGAR.
EACH TABLET CONTAINS LACTOSE MONOHYDRATE 130,10 MG.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING ENALAPRIL
HCTZ AUSTELL._ _
•
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.
•
ENALAPRIL HCTZ AUSTELL 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 ENALAPRIL HCTZ AUSTELL is and what it is used for
2. What you need to know before you take ENALAPRIL HCTZ AUSTELL
3. How to take ENALAPRIL HCTZ AUSTELL
4. Possible side effects
5. How to store ENALAPRIL HCTZ AUSTELL
6. Contents of the pack and other information
1. WHAT ENALAPRIL HCTZ AUSTELL IS AND WHAT IT IS USED FOR:
Austell Pharmaceuticals (Pty) Ltd, 491089, Enalapril HCTZ Austell,
20/12,5 mg, Tablets
2022.12.23 (v5) Page 2 of 17
ENALAPRIL HCTZ AUSTELL contains a combination of 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.
ENALAPRIL HCTZ AUSTELL is
used to treat high blood pressure (hypertension). Taking both
medicines that ENALAPRIL HCTZ
AUSTELL contains can increase their effect compared to taking just
one.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ENALAPRIL HCTZ AUSTELL
Do not take ENALAPRIL HCTZ AUSTELL
• if you are allergic

Summary of Product characteristics

Austell Pharmaceuticals (Pty) Ltd, 491089, Enalapril HCTZ Austell,
20/12,5 mg, Tablets
2022.12.23 (v5) Page 1 of 33
APPROVED PROFESSIONAL INFORMATION FOR MEDICINES FOR HUMAN USE:
ENALAPRIL HCTZ AUSTELL
SCHEDULING STATUS
S3
1. NAME OF THE MEDICINE
ENALAPRIL HCTZ AUSTELL 20/12,5 tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 20 mg of enalapril maleate and 12,5 mg of
hydrochlorothiazide.
Contains sugar.
Each ENALAPRIL HCTZ AUSTELL tablet contains lactose monohydrate 130,10
mg.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablets
ENALAPRIL HCTZ AUSTELL is pale yellow in colour, approximately 8,5 mm,
circular, biconvex
uncoated tablet with a non-functional break line on one side and plain
on the other side. The break
line is not intended for division of the tablet. The tablet should be
swallowed whole.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ENALAPRIL HCTZ AUSTELL is indicated for the treatment of hypertension
in patients where fixed
combination therapy is considered more appropriate than monotherapy.
Austell Pharmaceuticals (Pty) Ltd, 491089, Enalapril HCTZ Austell,
20/12,5 mg, Tablets
2022.12.23 (v5) Page 2 of 33
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_Hypertension _
The usual dosage is one tablet, administered once daily. If necessary,
the dosage may be increased
to a maximum of two tablets, administered once daily.
Special populations
_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).
ENALAPRIL HCTZ AUSTELL is not to be used as initial therapy in any
patient with renal
insufficiency.
In patients with creatinine clearance of greater than 30 and less than
80 mL/min, ENALAPRIL HCTZ
AUSTELL may be used but only after titration of the individual
components.
_ _
_Use in the elderly_
In clinical studies the efficacy and tolerability of enalapril maleate
and hy