Triapin 2.5mg/2.5mg prolonged release tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Felodipine; Ramipril

Available from:

Sanofi-Aventis Ireland Limited T/A SANOFI

ATC code:

C09BB; C09BB05

INN (International Name):

Felodipine; Ramipril

Dosage:

2.5 mg/2.5 milligram(s)

Pharmaceutical form:

Prolonged-release tablet

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

ACE inhibitors and calcium channel blockers; ramipril and felodipine

Authorization status:

Marketed

Authorization date:

1998-07-13

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
TRIAPIN 2.5 MG / 2.5 MG
TRIAPIN 5 MG / 5 MG
PROLONGED RELEASE TABLETS
ramipril/felodipine
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 or pharmacist; this
includes any possible
side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Triapin are and what they are used for
2.
What you need to know before you take Triapin
3.
How to take Triapin
4.
Possible side effects
5.
How to store Triapin
6.
Contents of the pack and other information
1.
WHAT TRIAPIN ARE AND WHAT THEY ARE USED FOR
Triapin 2.5 mg / 2.5 mg and Triapin 5 mg / 5 mg prolonged release
tablets (called also Triapin
tablets in this leaflet) both contain two medicines called ramipril
and felodipine.

Ramipril belongs to a group of medicines called ‘angiotensin
converting enzyme inhibitors’
(ACE inhibitors). It works by stopping the production of substances
that raise blood
pressure
and makes your blood vessels relax and widen.

Felodipine belongs to a group of medicines called ‘calcium
antagonists’. It makes your
blood
vessels relax and widen. This helps to lower your blood pressure
Triapin tablets are used to treat high blood pressure (hypertension).
High blood pressure can
mean you
are more likely to have problems such as heart disease, kidney disease
and stroke. This
medicine
lowers your blood pressure and lowers the risk of these problems.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRIAPIN
DO NOT TAKE TRIAPIN TABLETS IF:

You are allergic to:
o
ramipril or any other ACE inhibitor
o
felodipine or any other calcium antagonists
o
any of the other ingredients of this med

Summary of Product characteristics

Health Products Regulatory Authority
23 June 2021
CRN00C0F7
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Triapin 2.5mg/2.5mg prolonged release tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.5 mg of felodipine and 2.5 mg of ramipril.
Excipient(s) with known effect:
Each tablet contains 52 mg lactose anhydrous.Each tablet contains 2.50
mg macrogolglycerol hydroxystearate (polyoxyl
hydrogenated castor oil).
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Triapin 2.5mg/2.5mg tablets are circular (diameter approx 9 mm),
apricot coloured, biconvex and engraved H/OD on one side
and marked 2.5 on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of essential hypertension. Triapin fixed dose combination is
indicated in patients whose blood pressure is not
adequately controlled on felodipine or ramipril alone.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Use in adults, including older people:_
One tablet Triapin 2.5mg/2.5mg once daily. The maximum dose is two
tablets Triapin 2.5mg/2.5mg once daily.
Special populations
_Use in patients with impaired liver function:_
See sections 4.3 and 4.4.
_Use in patients with impaired renal function or patients already on
diuretic treatment:_
See sections 4.3 and 4.4.
Individual dose titration with the components can be recommended and
when clinically appropriate, direct change from
monotherapy to the fixed combination may be considered.
_Paediatric population_
Triapin is not recommended for use in children due to a lack of data.
Method of administration
Triapin tablets should be swallowed whole with a sufficient amount of
liquid. The tablets must not be divided, crushed or
chewed. The tablet can be administered without food or following a
light meal not rich in fat or carbohydrate.
4.3 CONTRAINDICATIONS
Health Products Regulatory Authority
23 June 2021
CRN00C0F7
Page 2 of 13
• hypersensitivity to felodipine (or other dihydropyridines)
ramipril, other angiotensin conve