Triapin 5 mg/5 mg, prolonged release tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Felodipine; Ramipril

Available from:

Merit Pharmaceuticals Limited

ATC code:

C09BB; C09BB05

INN (International Name):

Felodipine; Ramipril

Pharmaceutical form:

Prolonged-release tablet

Therapeutic area:

ACE inhibitors and calcium channel blockers; ramipril and felodipine

Authorization date:

2016-03-11

Patient Information leaflet

TRIAPIN
® 5 MG/5 MG PROLONGED RELEASE TABLETS
ramipril/felodipine
PACKAGE LEAFLET: INFORMATION FOR THE USER
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 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
•
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 include itching, hives (urticaria), red marks on the hands,
feet and throat, swelling of the throat and tongue, swelling around
the
eyes and lips, difficulty breathing and swallowing. Taking this
medicine
may increase the risk of having a more serious attack of this
condition
•
You have taken or are currently taking sacubitril/valsartan, a
medicine
used to treat a type of long-term (chronic) heart failure in adults
•
You have heart problems such as heart failure, obstructions in y

Summary of Product characteristics

Health Products Regulatory Authority
27 January 2023
CRN00C2VQ
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.
Each tablet contains 51.5 mg lactose anhydrous.
Each tablet also contains hydrogenated castor oil.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Prolonged release tablet
_Product imported from the Italy._
Triapin 5mg/5mg prolonged release tablets are reddish-brown and have
“H/OE” marked on one side and “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
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 is the date shown on the
blister and outer carton of the product as marketed in the
country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25ºC
Health Products Regulatory Authority
27 January 2023
CRN00C2VQ
Page 2 of 2
6.5 NATURE AND CONTENTS OF CONTAINER
Blisters
28 tablets
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL
No special requirements
7 PARALLEL PRODUCT AUTHORISATION HOLDER
Merit Pharmaceuticals Limited
Unit C4/C3
Metropoint Business Park
Kettles Lane
Swords
Co Dublin
K67 RH92
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA23080/015/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 11
th
March 2016
10 DATE OF REVISION OF THE TEXT
January 2023