Triapin 5mg/5mg prolonged release tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ramipril; Felodipine

Available from:

LTT Pharma Limited

ATC code:

C09BB; C09BB05

INN (International Name):

Ramipril; Felodipine

Dosage:

5/5 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:

Authorised

Authorization date:

2014-10-17

Patient Information leaflet

TRIAPIN 5MG/5MG PROLONGED-RELEASE TABLETS
(ramipril/felodipine)
PATIENT INFORMATION 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
What Triapin is and what it is used for
What you need to know before you take Triapin
How to take Triapin
Possible side effects
How to store Triapin
Contents of the pack and other information
WHAT TRIAPIN IS AND WHAT IT IS USED FOR
Triapin 5 mg / 5 mg prolonged release tablets (called also Triapin
tablets in
this leaflet) 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 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.
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 allergic reaction called “angioedema”.
The
signs incl

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Triapin 5mg/5mg prolonged release tablet
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg of felodipine and 5 mg of ramipril.
Each tablet contains 51.5 mg lactose anhydrous.
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), apricot
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
Macrogol 6000
Macrogolglycerol hydroxystearate
Maize starch
Paraffin
Propyl gallate
Sodium aluminium silicate
Sodium stearyl fumarate
Titanium dioxide E 171
6.2 INCOMPATIBILITIES
Not applicable.
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6.3 SHELF LIFE
The shelf life expiry date of this product shall be the date shown on
the container and outer package 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/PVDC blisters: 28 tablets.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED M