RENLIN 20/12,5 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, 491088, Renlin, 20/12,5 mg, Tablets
2022.12.23 (v5) Page 1 of 16
APPROVED PATIENT INFORMATION LEAFLET FOR MEDICINES FOR HUMAN USE:
RENLIN
SCHEDULING STATUS: S3
RENLIN
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 RENLIN._ _
•
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.
•
RENLIN 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 RENLIN is and what it is used for
2. What you need to know before you take RENLIN
3. How to take RENLIN
4. Possible side effects
5. How to store RENLIN
6. Contents of the pack and other information
1. WHAT RENLIN IS AND WHAT IT IS USED FOR:
RENLIN contains a combination of enalapril maleate and
hydrochlorothiazide:
Austell Pharmaceuticals (Pty) Ltd, 491088, Renlin, 20/12,5 mg, Tablets
2022.12.23 (v5) Page 2 of 16
• 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. RENLIN
is used to treat high blood
pressure (hypertension). Taking both medicines that RENLIN contains
can increase their effect
compared to taking just one.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE RENLIN
Do not take RENLIN
• 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 medicines as this
medicine (ACE inhibitors) and have had allerg

Summary of Product characteristics

Austell Pharmaceuticals (Pty) Ltd, 491088, Renlin, 20/12,5 mg, Tablets
2022.12.23 (v5) Page 1 of 32
APPROVED PROFESSIONAL INFORMATION FOR MEDICINES FOR HUMAN USE:
RENLIN
SCHEDULING STATUS
S3
1. NAME OF THE MEDICINE
RENLIN 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 RENLIN tablet contains lactose monohydrate 130,10 mg.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablets
RENLIN 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
RENLIN is indicated for the treatment of hypertension in patients
where fixed combination therapy is
considered more appropriate than monotherapy.
Austell Pharmaceuticals (Pty) Ltd, 491088, Renlin, 20/12,5 mg, Tablets
2022.12.23 (v5) Page 2 of 32
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).
RENLIN 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, RENLIN 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 hydrochlorothiazide,
administered concomitantly, were similar in both elderly and younger
hypertensive patients.
_ _
_Paediatric population _
Safe