Triapin 5mg/5mg prolonged release tablet

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Ramipril; Felodipine

Available from:

PCO Manufacturing Ltd.

ATC code:

C09BA; C09BA05

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 diuretics; ramipril and diuretics

Authorization status:

Authorised

Authorization date:

2014-02-14

Patient Information leaflet

_ _
_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
TRIAPIN
® 2.5 MG / 2.5 MG AND
TRIAPIN
® 5 MG / 5 MG
PROLONGED RELEASE TABLETS
ramipril/felodipine
Is this leaflet hard to see or read?
Phone [phone] for help
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 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:
•
ramipril or any other ACE inhibitor
•
felodi

Summary of Product characteristics

Health Products Regulatory Authority
04 October 2018
CRN008K9W
Page 1 of 3
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 lactose anhydrous. Also contains polyoxyl 40
hydrogenated
castor oil.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Prolonged release tablets.
_Product imported from Italy_:
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
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
_Lactose_
This product contains lactose. Patients with rare hereditary problems
of galactose
intolerance, the Lapp lactase deficiency or glucose-galactose
malabsorption should
not take this medicine.
_Polyoxyl 40 hydrogenated castor oil_
This product contains polyoxyl 40 hydrogenated castor oil. It may
cause stomach
upset or diarrhoea.
5 PHARMACOLOGICAL PROPERTIES
As per PA0540/082/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Health Products Regulatory Authority
04 October 2018
CRN008K9W
Page 2 of 3
Cellulose microcrystalline
Hyprolose
Hypromellose
Iron oxides E172
Lactose anhydrous
Polethylene glycol
Polyoxyl 40 hydrogenated castor oil
Maize starch
Paraffin
Propyl gallate
Sodium aluminium silicate
Sodium stearyl fumarate
Titanium dioxide E171
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product shall be the date shown on
the bottle 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 in an outer cardboard carton
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
No special requirements.
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing
Unit 10, Ashbourne Business Park
Rath, Ashbourne
Co