Bendroflumethiazide 5mg tablets
Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Patient Information leaflet
(PIL)
20-04-2020
Summary of Product characteristics
(SPC)
19-11-2019
Public Assessment Report
(PAR)
15-06-2006
Active ingredient:
Bendroflumethiazide
Available from:
A A H Pharmaceuticals Ltd
ATC code:
C03AA01
INN (International Name):
Bendroflumethiazide
Dosage:
5mg
Pharmaceutical form:
Oral tablet
Administration route:
Oral
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 02020100; GTIN: 5025903001904
Patient Information leaflet
PACKAGE LEAFLET: INFORMATION FOR THE USER
BENDROFLUMETHIAZIDE 2.5MG TABLETS
BENDROFLUMETHIAZIDE 5MG TABLETS
Bendroflumethiazide (Referred to as Bendroflumethiazide
Tablets in the remainder of the leaflet)
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 TABLETS IF YOU:
• are allergic to bendroflumethiazide, or other sulphonamide-derived
medicine or any of the
other ingredients of this medicine (listed in section 6).
• have high levels of calcium in your blood (hypercalcaemia)
• have severe liver or kidney problems, or you are unable to pass
water (urine)
• have underactive adrenal glands (Addison
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Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Bendroflumethiazide 5mg_ _Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Bendroflumethiazide 5mg
For the full list of excipients, see section 6.1
Each tablet contains 49.92mg of lactose.
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 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
CONTRAIN
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