Triapin 5 mg/5 mg prolonged release tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Felodipine; Ramipril

Available from:

IMED Healthcare Ltd.

ATC code:

C09BB; C09BB05

INN (International Name):

Felodipine; Ramipril

Dosage:

5/5 mg/mg

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:

Authorised

Authorization date:

2014-08-15

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
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 is and what it is 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 IS WHAT IT IS USED FOR
Triapin 5 mg / 5 mg prolonged release tablets (called also Triapin
tablets in this leaflet) 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:
•
ramipril or any other ACE inhibitor
•
felodipine or any other calcium antagonists
•
any of the other ingredients of this medicine (listed in section 6)
•
You have ever had a serious

Summary of Product characteristics

Health Products Regulatory Authority
05 May 2022
CRN00CWWV
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Triapin 5 mg/5 mg prolonged release tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg of felodipine and 5 mg of ramipril
Excipient(s)with known effect: Each tablet contains lactose anhydrous
and macrogolglycerol hydroxystearate (castor oil
polyoxyl hydrogenated).
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Prolonged Release Tablet
_Product imported from Italy_
Triapin 5mg/5mg tablets are circular (diameter approx 9 mm),
reddish-brown coloured, biconvex and engraved H/OE on one
side and marked 5 on the other side.
4 CLINICAL PARTICULARS
As per PA0540/082/002
5 PHARMACOLOGICAL PROPERTIES
As per PA0540/082/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Cellulose microcrystalline
Hyprolose
Hypromellose
Iron oxides E172
Lactose anhydrous
Polyethylene Glycol
Macrogolglycerol hydroxystearate (castor oil polyoxyl hydrogenated)
Maize starch
Paraffin
Propyl gallate
Sodium aluminium silicate
Sodium stearyl fumarate
Titanium dioxide E171
Health Products Regulatory Authority
05 May 2022
CRN00CWWV
Page 2 of 2
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the
container and outer carton of the product on the market in
the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25 ºC.
6.5 NATURE AND CONTENTS OF CONTAINER
PVC blisters: 28 tablets.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
IMED Healthcare Ltd.
Unit 625 Kilshane Avenue
Northwest Business Park
Ballycoolin
Dublin 15
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA1463/098/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 15
th
August 2014
10 DATE OF REVISION OF THE TEXT
May 2022