Bendroflumethiazide 2.5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Bendroflumethiazide

Available from:

Bristol Laboratories 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; GTIN: 5060013942082

Patient Information leaflet

Same size artwork
400 x 140 mm
Front
PATIENT LEAFLET: INFORMATION FOR THE USER
BENDROFLUMETHIAZIDE 2.5 MG
OR 5 MG TABLETS
BENDROFLUMETHIAZIDE
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 queries, 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 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 2.5 mg tablets or
Bendroflumethiazide
5mg
tablets.
The
active
ingredient
is
Bendroflumethiazide.
Bendroflumethiazide tablets belong to a group of medicines called
thiazide
diuretics (water tablets). They may be used to:
•
reduce fluid retention (oedema) particularly in the heart, kidneys,
liver or that caused by medication, by increasing the flow of urine.
•
reduce high blood pressure alone or with other medication.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
BENDROFLUMETHIAZIDE TABLETS
DO NOT TAKE
Bendroflumethiazide tablets and
TELL
your doctor if
YOU:
•
are allergic to thiazides or any of the other ingredients in
Bendroflumethiazide
tablets (see 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’s disease- syndrome due to
low
level of corticosteroid hormones

Summary of Product characteristics

1
NAME OF THE MEDICINAL PRODUCT
Bendroflumethiazide 2.5mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Bendroflumethiazide 2.5mg
For full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Tablets.
White to off white circular, biconvex, uncoated tablets.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Bendroflumethiazide is indicated for:
1.
Cases where the reduction of fluid retention by diuresis is required;
oedema of
cardiac, renal or hepatic origin and iatrogenic oedema
2.
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
For oral administration
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, 5-10 mg in the morning, daily or on alternate days;
maintenance dose
5-10 mg one to three times weekly
Hypertension
The usual dose is 2.5 mg – 5mg taken in the morning. Higher doses
are rarely
necessary. When Bendroflumethiazide is used concurrently with other
specific
hypotensive agents, the dosage of such agents should be reduced and
then adjusted as
necessary.
Children under 12 years of age: Dosage in children may be up to 400
mcg/kg
bodyweight initially, reducing to 50-100 mcg/kg bodyweight daily for
maintenance. A
more appropriate dosage form may be required.
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
4.3
CONTRAINDICATIONS
•
Sensitivity to bendroflumethiazide or other sulphonamide-derived
drugs. .
•
Severe renal insufficiency or anuria
•
Severe hepatic impairment (risk of precipitation of encephalopathy)
•
Addison's disease.
•
Refractory Hyperkalemi