BENDROFLUAZIDE 5 Milligram Tablets

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

BENDROFLUMETHIAZIDE

Dostępny od:

Ranbaxy Ireland Limited

INN (International Nazwa):

BENDROFLUMETHIAZIDE

Dawkowanie:

5 Milligram

Forma farmaceutyczna:

Tablets

Status autoryzacji:

Withdrawn

Data autoryzacji:

2007-02-24

Charakterystyka produktu

PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bendroflumethiazide Tablets BP 5mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Bendroflumethiazide 5.0 mg
For excipients, see 6.1
3 PHARMACEUTICAL FORM
White circular biconvex tablet with a breakline on one side and
embossed “RIMA” on the other side.
4 CLINICAL PARTICULARS 
4.1 THERAPEUTIC INDICATIONS
As a diuretic in the management of oedema such
as arise from cardiac, renal or hepatic origin,
toxaemia or pregnancy, 
corticosteroid administration.
4.2 POSOLOGY AND METHOD OF ADMINSTRATION
For oral administration only.
ADULTS:
The usual initial dose is 5-10mg as a single dose, with
a maintenance dosage of 2.5-10mg daily, preferably in the 
morning.
4.3 CONTRAINDICATIONS
Use of this product in the presence of hypokalaemia,
pre-coma associated with
hepatic cirrhosis or Addison’s disease.
4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
Patients who are being treated with this preparation
require regular supervision with monitoring of fluid and
electrolyte 
state to avoid inadequate potassium supplementation
or excessive loss of fluid. The preparation should only
be used 
with particular caution in elderly patients, or those with
potential obstruction of the urinary tract, or with disorders 
rendering
their electrolyte balance precarious. Hyperuricaemia and
gout may be induced by this preparation.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION 
The concomitant administration of this preparation with
cardiac glycosides or hypotensive agents may necessitate 
adjustment of the dosage of these drugs.
The preparation may induce hyperglycaemia particularly in
patients with latent diabetes, and may necessitate 
adjustment of control by hypoglycaemic agents in
cases of diabetes mellitus.
Concurrent use with lithium salts may increase toxicity