SOLVATAN 12.5 Milligram Film Coated Tablet
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
29-05-2024
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Active ingredient:
LOSARTAN POTASSIUM
Available from:
Sinclair IS Pharma Limited
INN (International Name):
LOSARTAN POTASSIUM
Dosage:
12.5 Milligram
Pharmaceutical form:
Film Coated Tablet
Prescription type:
Product subject to prescription which may be renewed (B)
Authorization status:
Withdrawn
Authorization date:
2012-08-01
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Solvatan 12.5 mg Film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 12.5 mg of losartan potassium
For a full list of excipients, see Section 6.1
3 PHARMACEUTICAL FORM
Film coated tablet
White, coated, round biconvex, code: 1L
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Hypertension
Losartan is indicated for the treatment of hypertension.
Reduction in the risk of cardiovascular morbidity in hypertensive patients with left ventricular hypertrophy
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Losartan may be administered with or without food.
Losartan may be administered with other antihypertensive agents.
Hypertension
The starting and maintenance dose is 50 mg once daily for most patients. The maximal antihypertensive effect is
attained 3-6 weeks after initiation of therapy. Some patients may receive an additional benefit by increasing the dose to
100 mg once daily.
For the very small proportion of patients who have intravascular volume depletion (e.g. those treated with high-dose
diuretics), a starting dose of 25 mg once daily should be considered (see 4.4 'Special warnings and special precautions
for use').
No initial dosage adjustment is necessary for elderly patients or for patients with renal impairment, including patients
on dialysis. A lower dose should be considered for patients with a history of hepatic impairment (see 4.4 'Special
warnings and precautions for use').
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 28/02/2012_
_CRN 2094465_
_page number: 1_
4.3 CONTRAINDICATIONS
Losartan is contra-indicated in patients who are hypersensitive to any component of this product.
Second
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