TRIAPIN 5MG/5MG PROLONGED RELEASE TABLET 5mg/5mg Milligram Tablet Prolonged Release
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
18-04-2024
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Active ingredient:
FELODIPINE RAMIPRIL
Available from:
PCO Manufacturing
INN (International Name):
FELODIPINE RAMIPRIL
Dosage:
5mg/5mg Milligram
Pharmaceutical form:
Tablet Prolonged Release
Prescription type:
Product subject to prescription which may be renewed (B)
Authorization status:
Withdrawn
Authorization date:
0000-00-00
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 5mg of felodipine and 5mg of ramipril.
Excipients: contains lactose anhydrous and polyoxyl hydrogenated castor oil.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Prolonged release tablet
_Product imported from the UK:_
Triapin 5mg/5mg tablets are circular (diameter approx 9mm), reddish-brown coloured, biconvex, and engraved 'H/OE'
on one side, and marked '5' on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of essential hypertension. Triapin fixed dose combination is indicated in patients whose blood pressure is not
adequately controlled on felodipine or ramipril alone.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Use in adults, including elderly:_
One tablet Triapin once daily, which is also the maximum dose.
_Use in patients with impaired liver function:_
See sections (_See section 4.3, Contraindications _and _see section 4.4, Special warnings and precautions for use_).
_Use in patients with impaired renal function or patients already on diuretic treatment:_
(_See section 4.3, Contraindications _and _see section 4.4, Special warnings and precautions for use_)1.
Individual dose titration with the components can be recommended and when clinically appropriate, direct change from
monotherapy to the fixed combination may be considered.
_Use in children:_
Triapin is not recommended for use in children due to a lack of data.
_Administration:_
Triapin tablets should be swallowed whole with a sufficient amount of liquid. The tablets must not be divided, crushed
or chewed. The tablet can be administered without food or following a light meal not rich in fat or carbohydr
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