Triapin 5 mg/5 mg prolonged release tablets

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

Ramipril; Felodipine

Disponible desde:

Imbat Limited

Código ATC:

C09BB; C09BB05

Designación común internacional (DCI):

Ramipril; Felodipine

Dosis:

5/5 mg/mg

formulario farmacéutico:

Prolonged-release tablet

tipo de receta:

Product subject to prescription which may be renewed (B)

Área terapéutica:

ACE inhibitors and calcium channel blockers; ramipril and felodipine

Estado de Autorización:

Authorised

Fecha de autorización:

2016-02-19

Información para el usuario

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
TRIAPIN
® 5 MG/5 MG PROLONGED RELEASE TABLETS
(ramipril / felodipine)
Blind or partially sighted?
Is this leaflet hard to see or
read?
Call [phone]
(Regulatory)
Your medicine is available using the above name but will be
referred to as Triapin throughout this leaflet.
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 AND WHAT IT IS USED FOR
Triapin contains 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 is 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 IF:

You are allergic to:

ramipril or any other ACE inhibitor

felodipine or a

Ficha técnica

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 ramipril and 5 mg of felodipine.
Excipient(s) with known effect
Each tablet contains lactose anhydrous and polyoxyl 40 hydrogenated
castor oil.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Prolonged Release Tablet
_Product imported from Italy_
Circular, 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
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
_Polyoxyl 40 hydrogenated castor oil_
This product contains polyoxyl 40 hydrogenated castor oil. May cause
stomach upset and diarrhoea.
5 PHARMACOLOGICAL PROPERTIES
As per PA0540/082/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Microcrystalline cellulose
Hyprolose
Hypromellose
Iron oxide E172
Lactose anhydrous
Macrogol
Polyoxyl 40 hydrogenated castor oil
Maize starch
Paraffin
Propyl gallate
Sodium silicate of aluminium
Sodium stearyl fumarate
Titanium dioxide E171
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6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the
blister and outer carton of the product as marketed in
the country of