TRI-PLEN TABLET

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Sanofi-Aventis South Africa (Pty) Ltd

Dosage:

See ingredients

Pharmaceutical form:

TABLET

Composition:

EACH TABLET CONTAINS FELODIPINE 2,5 mg RAMIPRIL 2,5 mg

Authorization status:

Registered

Authorization date:

2001-12-01

Patient Information leaflet

sanofi-aventis south africa (pty) ltd
Tri-Plen / Tri-Plen Forte
Film-coated tablets
2,5 or 5 mg felodipine & 2,5 or 5 mg ramipril per tablet
Date of approval: 08 September 2023
Page 1 of 11
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS: S3
TRI-PLEN 2,5 MG/2,5 MG FILM-COATED TABLETS
TRI-PLEN FORTE 5 MG/5 MG FILM-COATED TABLETS
FELODIPINE/RAMIPRIL
CONTAINS SUGAR (52 MG LACTOSE ANHYDROUS).
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING TRI-PLEN OR
TRI-PLEN FORTE.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, please ask your doctor, pharmacist,
nurse or other health care
provider.
•
TRI-PLEN or TRI-PLEN FORTE 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 TRI-PLEN or TRI-PLEN FORTE is and what it is used for
2.
What you need to know before you take TRI-PLEN or TRI-PLEN FORTE
3.
How to take TRI-PLEN or TRI-PLEN FORTE
4.
Possible side effects
5.
How to store TRI-PLEN or TRI-PLEN FORTE
6.
Contents of the pack and other information
1. WHAT TRI-PLEN AND TRI-PLEN FORTE IS AND WHAT IT IS USED FOR
TRI-PLEN and TRI-PLEN FORTE are used to lower high blood pressure.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRI-PLEN OR TRI-PLEN FORTE
sanofi-aventis south africa (pty) ltd
Tri-Plen / Tri-Plen Forte
Film-coated tablets
2,5 or 5 mg felodipine & 2,5 or 5 mg ramipril per tablet
Date of approval: 08 September 2023
Page 2 of 11
DO NOT TAKE TRI-PLEN OR TRI-PLEN FORTE:
•
if you are hypersensitive (allergic) to felodipine, ramipril, any
other ACE inhibitor or any of the
inactive ingredients in TRI-PLEN or TRI-PLEN FORTE, which are listed
above.
•
if you have severe liver problems.
•
if you have or had heart problems such as heart failure, unstable
angina, heart attack, stroke or
atrioventricular block II and III.
•
if you have problems or conditions affecting the flow of blood in and
out of your heart (e.g. aortic or
valvular st

Summary of Product characteristics

sanofi-aventis south africa (pty) ltd
Tri-Plen / Tri-Plen Forte
Film-coated-tablets
2,5 or 5 mg felodipine & 2,5 or 5 mg ramipril per tablet
Date of approval: 08 September 2023
Page 1 of 27
PROFESSIONAL INFORMATION
SCHEDULING STATUS: S3
1.
NAME OF THE MEDICINE
TRI-PLEN 2,5 mg/2,5 mg film-coated tablets
TRI-PLEN FORTE 5 mg/5 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
TRI-PLEN tablets:
Each film-coated tablet contains 2,5 mg of felodipine and 2,5 mg of
ramipril.
Excipient(s) with known effect:
Each tablet contains sugar (52 mg lactose anhydrous).
For the full list of excipients, see section 6.1.
TRI-PLEN FORTE tablets:
Each film-coated tablet contains 5 mg of felodipine and 5 mg of
ramipril.
Excipient(s) with known effect:
Each tablet contains sugar (52 mg lactose anhydrous).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets.
TRI-PLEN: An apricot, circular, biconvex, film-coated tablet engraved
H/OD on one side and 2,5 on
the other side. The core is of double-layer type with white to
off-white and yellow layers.
TRI-PLEN FORTE: A reddish-brown, circular, biconvex, film-coated
tablet engraved H/OE on one side
and 5 on the other side. The core is of double layer type with white
to off-white and yellow layers.
sanofi-aventis south africa (pty) ltd
Tri-Plen / Tri-Plen Forte
Film-coated-tablets
2,5 or 5 mg felodipine & 2,5 or 5 mg ramipril per tablet
Date of approval: 08 September 2023
Page 2 of 27
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of mild to moderate hypertension in patients whose blood
pressure is normalised with
individual components in the same doses as the proposed fixed
combination.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
ADULTS, INCLUDING ELDERLY:
One TRI-PLEN tablet or one TRI-PLEN FORTE tablet once daily.
The maximum dose is one TRI-PLEN FORTE tablet once daily.
SPECIAL POPULATIONS
PATIENTS ON DIURETICS:
Consideration should be given to temporarily discontinuing the
diuretic or at least to reducing the dose