Source: Health Products Regulatory Authority (IE) Revision Year: 2021 Publisher: Sanofi-Aventis Ireland Limited T/A SANOFI, Citywest Business Campus, Dublin 24, Ireland
Treatment of essential hypertension. Triapin fixed dose combination is indicated in patients whose blood pressure is not adequately controlled on felodipine or ramipril alone.
One tablet Triapin 2.5mg/2.5mg once daily. The maximum dose is two tablets Triapin 2.5mg/2.5mg once daily.
Use in patients with impaired liver function: See sections 4.3 and 4.4.
Use in patients with impaired renal function or patients already on diuretic treatment: See sections 4.3 and 4.4.
Individual dose titration with the components can be recommended and when clinically appropriate, direct change from monotherapy to the fixed combination may be considered.
Triapin is not recommended for use in children due to a lack of data.
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 carbohydrate.
Overdose may cause excessive peripheral vasodilatation with marked hypotension, bradycardia, shock, electrolyte disturbances and renal failure.
Primary detoxification by, for example, gastric lavage, administration of adsorbents and/or sodium sulphate (if possible during the first 30 minutes). In case of hypotension, administration of ฮฑ1โadrenergic sympathomimetics and angiotensin II must be considered in addition to volume and salt substitution. Bradycardia or extensive vagal reactions should be treated by administering atropine.
No experience is available concerning the efficacy of forced diuresis, alteration in urine pH, haemofiltration, or dialysis in speeding up the elimination of ramipril or ramiprilat. If dialysis or haemofiltration is nevertheless considered, see also under section 4.4.
3 years.
Do not store above 25ยฐC.
PVC/PVDC blisters: 10, 14, 15, 21, 28, 30, 50, 98 and 100 tablets.
Not all pack sizes may be marketed.
No special requirements.
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