Bendroflumethiazide Tablets 5mg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

BENDROFLUMETHIAZIDE

Available from:

Wockhardt UK Limited Ash Road North, Wrexham, LL13 9UF, United Kingdom

ATC code:

C03AA01

INN (International Name):

BENDROFLUMETHIAZIDE 5 mg

Pharmaceutical form:

TABLET

Composition:

BENDROFLUMETHIAZIDE 5 mg

Prescription type:

POM

Therapeutic area:

DIURETICS

Authorization status:

Withdrawn

Authorization date:

2006-08-18

Patient Information leaflet

CHANGE CONTROL :  
Version changes due to change in:

   Size/Layout            Regulatory          
 Non-Regulatory
Changes in detail:  • Regulatory text amends

• Pharmacode placed on 8mm from the cutting edge
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READ ALL OF THIS LEAFLET CAREFULLY BEFORE 
YOU START TO TAKE THIS MEDICINE. 
-  Keep this leaflet. You may need to 
read it again. 
-  If you have any further questions, 
please ask your doctor or pharmacist.
-  This medicine has been prescribed for 
you. Do not pass it on to others. It may 
harm them, even if their symptoms are 
the same as yours.
-  If any of the side effects get serious, or 
if you notice any side effects not listed 
in this leaflet, please tell your doctor or 
pharmacist. 
IN THIS LEAFLET: 
1. What Bendroflumethiazide Tablets are 
and what they are used for
2. Before you take Bendroflumethiazide 
Tablets
3. How to take Bendroflumethiazide 
Tablets
4. Possible side effects 
5. How to store Bendroflumethiazide 
Tablets
6. Further information 
1. WHAT BENDROFLUMETHIAZIDE TABLETS 
ARE AND WHAT THEY ARE USED FOR
The name of your medicine is 
Bendroflumethiazide Tablets. The active 
ingredient in your medicine is 
bendroflumethiazide. 
Bendroflumethiazide Tablets belong to a 
group of medicines called diuretics 
(water tablets) which increase the 
amount of urine you produce.
Bendroflumethiazide Tablets are used to 
treat high blood pressure (hypertension) 
and fluid retention (oedema) associated 
with kidney, liver or heart problems, and 
pre-menstrual syndrome.
2. BEFORE YOU T

Summary of Product characteristics

Page 1 of 9
_ _
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Bendroflumethiazide 5mg_ _Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Bendroflumethiazide 5mg
For excipients, see 6.1
3 PHARMACEUTICAL FORM White, circular flat faced tablets with bevelled edges having a CP
logo on one
face and B 5 separated by a breakline on the reverse.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Bendroflumethiazide is a diuretic. The tablets are indicated in the
treatment of
essential hypertension and oedema associated with such conditions as
nephrotic
syndrome,
cirrhosis
of the
liver,
congestive
heart
failure
and
pre-menstrual
syndrome.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ _
_Adults_
Oedema:
5-10mg
daily
in
the
morning
initially.
Maintenance: usually 2.5mg-5mg on only
two or three days in the week. A single
dose may be sufficient.
Essential Hypertension:
2.5mg in the morning. Doses above 2.5mg
are rarely necessary.
Pre-menstrual syndrome:
2.5mg each morning for seven days before
the period is due.
_Elderly _
Particular caution is needed in the elderly because of their
susceptibility to
electrolyte imbalance. Lower initial doses should be used and
electrolyte
balance and renal function should be carefully monitored.
Page 2 of 9
_ _
_ _
_Children _
_ _
_ _
Oedema:
Up to 400µg per kg body weight daily
initially, reducing to 50-100µg per kg for
maintenance.
4.3
CONTRAINDICATIONS
Sensitivity to bendroflumethiazide or other sulphonamide-derived
drugs.
Hypercalcaemia. Severe renal insufficiency or anuria, severe hepatic
impairment
(risk of precipitation of encephalopathy), Addison’s disease.
Bendroflumethiazide tablets should not be administered with lithium
carbonate.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Continued or intensive use of bendroflumethiazide may produce
potassium
depletion. A potassium chloride supplement is recommended in these
circumstances. Potassium replacement or conservation is also likely to
be
necessary in patients at risk from the cardiac effects of
hypokalaemia,