Bendroflumethiazide 2.5mg tablets
Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Patient Information leaflet
(PIL)
03-05-2019
Summary of Product characteristics
(SPC)
19-11-2019
Public Assessment Report
(PAR)
15-06-2006
Active ingredient:
Bendroflumethiazide
Available from:
The Boots Company Plc
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
PATIENT INFORMATION LEAFLET
BENDROFLUMETHIAZIDE 2.5MG & 5MG TABLETS
Please read this leaflet carefully before you start taking your
tablets. If you have any
questions or are not sure about anything, ask your doctor or
pharmacist.
WHAT YOU SHOULD KNOW ABOUT THIS MEDICINE
Bendroflumethiazide Tablets are available in 2 strengths and contain
Bendroflumethiazide 2.5mg or
5mg as the active ingredient. They also contain the following other
ingredients: lactose, maize starch and magnesium
stearate.
This medicine is available in pack sizes of 28, 56, 84 or 112 tablets.
The product licence holder of this medicine is:
Sandoz Ltd, Woolmer Way, Bordon, Hampshire GU35 9QE.
The manufacturer of this medicine is:
Crescent Pharma Ltd, Units 3 & 4 Quidhampton Buisness Units,
Polhampton
Lane, Overton, Hampshire, RG25 3ED
This medicine belongs to a group of drugs known as thiazide diuretics.
These are used for
increasing water loss through the kidneys; this makes you pass more
water.
This medicine is used for reducing swelling of any part of the body
caused by heart, liver or
kidney conditions and is frequently used to treat high blood pressure,
either alone or in
combination with other drugs which lower blood pressure.
WHAT YOU SHOULD CHECK BEFORE TAKING THIS MEDICINE
Do not take this medicine if you are allergic to Bendroflumethiazide
or any of the ingredients listed above.
Do not take this medicine if you have Addison’s disease (underactive
adrenal gland), hyponatraemia (low
levels of sodium in the blood), refractory hypokalaemia (long-term
problems with low levels of potassium in
the blood), hypercalcaemia (high levels of calcium in the blood),
symptomatic hyperuricaemia (high levels of
uric acid in the blood), acute porphyria (blood metabolism disorder)
or if you have long-term kidney or liver
problems.
This medicine contains lactose. If you have been told by your doctor
that you have an intolerance to some
sugars, contact your doctor before taking this medicine.
Tell your doctor or pharmacist if you are taking
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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
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