Bendroflumethiazide 5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Bendroflumethiazide

Available from:

Accord-UK 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: 5012617009807

Patient Information leaflet

148x210 Leaflet Reel Fed Profile (BST)
Dimensions:
Component:
Date Sent:
Technologist: TECHNICALLY APPROVED
Pharmacode:
JDE No.:
BENDROFLUMETHIAZIDE ,
TABLETS BP, 2.5 & 5mg, 28 - UK
148x210 (Reel Fed)
51013143
Leaflet for Blisters
1292
RH
24-05-22
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BENDROFLUMETHIAZIDE 2.5MG & 5MG TABLETS PIL - UK
Black
Profile
BBBB4724
NM
31/05/2022
148 x 210
7pts
Accord Barnstaple
n/a
n/a
01
Version 7
12.02.2020
Cartons and label leaflets only
(labels only when specified)
BENDROFLUMETHIAZIDE
2.5MG AND 5MG TABLETS
PACKAGE LEAFLET:
INFORMATION FOR THE PATIENT
_Continued top of next column_
_Continued over page_
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, 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
Bendroflumethiazide tablets belong to

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Bendroflumethiazide Tablets BP 5mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5mg Bendroflumethiazide PhEur.
Excipient with known effect:
Each 5mg tablet contains 65mg Lactose
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
White uncoated tablets.
White Circular, flat bevelled-edge, uncoated tablets impresses “C”
on one face
and the identifying letters “BB” on either side of a central
divion line 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:_
Initially 5-10mg in the morning, daily or on alternate days.
Maintenance dose 5-10mg one to three times weekly.
_ _
_Hypertension:_ The usual dose is 2.5mg taken in the morning. Higher
doses are
rarely necessary. _ _
_Paediatric population _
_Children under 12 years: _Dosage in children may be up to
400micrograms/kg
of body weight initially, reducing to 50-100micrograms/kg of body
weight
daily for maintenance._ _
_ _
_Elderly:_ The dosage of thiazide diuretics may need to be reduced in
the
elderly, particularly when renal function is impaired, because of the
possibility
of electrolyte imbalance.
Method of Adminstration
For oral administration.
4.3
CONTRAINDICATIONS
•
Hypersensitivity to the active substance, to thiazides or to any of
the excipients listed in
section 6.1.
•