LOSARTAN POTASSIUM/HYDROCHLOROTHIAZIDE LICONSA 100
País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
Características técnicas
(SPC)
26-05-2024
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Ingredientes ativos:
LOSARTAN POTASSIUM HYDROCHLOROTHIAZIDE
Disponível em:
Laboratorios LICONSA, S.A.
Dosagem:
100/25 Milligram
Forma farmacêutica:
Film Coated Tablet
Data de autorização:
2008-05-02
Características técnicas
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Losartan Potassium/Hydrochlorothiazide Liconsa 100 mg/25 mg film-coated tablets.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 100 mg of losartan potassium, equivalent to 91.52 mg of losartan, and 25 mg of
hydrochlorothiazide.
Excipient: 140.61 mg of lactose monohydrate/film-coated tablet
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Round, yellow, film-coated tablet.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of essential hypertension in patients whose blood pressure is not adequately controlled by losartan 50
mg/ hydrochlorothiazide 12.5 mg once daily.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Method of administration_
The tablet should be swallowed with a sufficient amount of fluid (e.g. one glass of water). Losartan
potassium/Hydrochlorothiazide may be administered with or without food.
The combination of 100 mg losartan potassium / 25 mg hydrochlorothiazide is not recommended as initial therapy.
One losartan potassium / hydrochlorothiazide tablet once daily is recommended for those patients who do not respond
adequately to a combination of 50 mg losartan potassium / 12.5 mg hydrochlorothiazide given once daily. In general,
the antihypertensive effect is attained within three to four weeks after initiation of therapy.
_Use in the elderly: _No initial dose adjustment is necessary. Experience is limited in this population.
_Use in renal impairment_: No initial dosage adjustment is necessary in patients with mild to moderate renal impairment
(i.e. creatinine clearance 30-50 ml/min). Losartan potassium/Hydrochlorothiazide is not recommended for patients on
dialysis. It is contraindicated in patients with severe renal impairment (i.e. c
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