Bendroflumethiazide 5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Bendroflumethiazide

Available from:

Dowelhurst 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

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
BENDROFLUMETHIAZIDE 2.5MG & 5MG TABLETS
BENDROFLUMETHIAZIDE is the new name for Bendrofluazide.
If you have been taking Bendrofluazide tablets, do not worry, as this
is the same medicine
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
The active ingredient in this medicine is Bendroflumethiazide.
Bendroflumethiazide belongs to a group of medicines called thiazide
diuretics
(‘water tablets’). They are used to increase the flow of urine to
help reduce high blood pressure and reduce the build-up of fluid in
tissue below
the skin (oedema). They are also used to stop the production of breast
milk.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE BENDROFLUMETHIAZIDE TABLETS
DO NOT TAKE BENDROFLUMETHIAZIDE TABLETS IF YOU:
•
are ALLERGIC to Bendroflumethiazide, other thiazide diuretics or any
of the other ingredients of this medicine (listed in Section 6);
•
have SEVERE LIVER OR KIDNEY DISEASE;
•
have GOUT or an increase in uric acid in the blood
•
are TAKING LITHIUM (for some mental disorders);
•
are PREGNANT, PLANNING TO BECOME PREGNANT or are
BREAST-FEEDING;
WARNINGS AND PRECAUTIONS
Talk to your doctor or ph

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