Bendroflumethiazide 2.5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Bendroflumethiazide

Available from:

Dr Reddy's Laboratories (UK) Ltd

ATC code:

C03AA01

INN (International Name):

Bendroflumethiazide

Dosage:

2.5mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02020100

Patient Information leaflet

CHANGE CONTROL : Version changes due to change in:
Size/Layout Regulatory Non-Regulatory
Changes in detail:
• New regulatory text
• Removed pre-printed L.I.No. from front page 1/2
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READ ALL OF THIS LEAFLET CAREFULLY BEFORE
YOU START TAKING THIS MEDICINE
BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
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 only. Do not pass it on to others. It
may harm them, even if their signs of
illness are the same as yours.
-
If you get any side effects, talk to your
doctor or pharmacist. This includes
any possible side effects not listed in
this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Bendroflumethiazide Tablets are
and what they are used for
2. What you need to know before you
take Bendroflumethiazide Tablets
3. How to take Bendroflumethiazide
Tablets
4. Possible side effects
5. How to store Bendroflumethiazide
Tablets
6. Contents of the pack and other
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. WHAT YOU NEED TO KNOW BEFORE YOU
TAKE BENDROFLUMETHIAZIDE TABLETS
DO NOT TAKE BENDROFLUMETHIAZIDE
TABL

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Bendroflumethiazide 2.5mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Bendroflumethiazide 2.5mg
For the full list of excipients, see section 6.1
Each tablet contains 49.85mg of lactose.
3
PHARMACEUTICAL FORM
White, circular flat tablets with bevelled edges, having a CP logo on
one side and B
2.5 separated by a breakline on the reverse
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Bendroflumethiazide is indicated for:
Cases where the reduction of fluid retention by diuresis is required;
oedema of cardiac, renal or hepatic origin and iatrogenic oedema.
Bendroflumethiazide produces a moderate but usefully prolonged fall of
blood pressure in hypertensive patients. It may be used as the sole
antihypertensive agent or as an adjunct to other drugs whose action it
potentiates. In non-oedematous patients, there may be little
noticeable
diuretic effect.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
It is recommended that the tablets should be taken in the morning to
avoid nocturia.
_ Adults and children aged 12 years and over:_
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.
Bendroflumethiazide is used concurrently with other specific
hypotensive agents,
the dosage of such agents should be reduced and then adjusted as
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.
_ Children under 12 years: _
_ _
_ _
Oedema: Up to 400µg per kg body weight daily initially, reducing to
50-100µg per kg
for maintenance. A more appropriate dosage form may be required. METHOD OF ADMINISTRATION: Oral.
4.3
CONTRAI