Bendroflumethiazide 2.5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Bendroflumethiazide

Available from:

Mawdsley-Brooks & Company 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

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
BENDROFLUMETHIAZIDE 2.5 MG TABLETS BP
BENDROFLUMETHIAZIDE 5 MG TABLETS BP
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 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 any of the 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 contain bendroflumethiazide as the
active
ingredient. They 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.
•
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, thiazides or any of the other
ingredients of
this
medicine (listed in section 6)
•
have severely impaired kidney or liver function
•
have high level of calcium in your blood (hypercalcaemia)
•
have low levels of sodium in your blood (hyponatraemia)
•
have low levels of potassium in your blood which has not responded to
treatment (refractory hypokalaemia)
•
have had

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Bendroflumethiazide 2.5mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Bendroflumethiazide 2.5 mg per tablet.
For excipients, see 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
Bendroflumethiazide 2.5 mg tablets are presented as white flat
bevelled edge
tablets engraved with the company logo on one side and A268 on the
other
side.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Oedema:
Bendroflumethiazide is indicated in the treatment of oedema associated
with
conditions such as congestive heart failure, nephrotic syndrome,
cirrhosis of
the liver.
Essential hypertension:
Bendroflumethiazide may be used as the sole antihypertensive agent or
used
concurrently with other specific hypotensive agents whose action it
potentiates.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration: Oral
ADULTS:
Oedema:
5.0 - 10.0 mg once daily or on alternate days
Maintenance:
2.5 - 5.0 mg two or three times a week
Essential hypertension:
2.5 mg in the morning, alone or in conjunction with other
antihypertensive
agents in more severe hypertension.
The dosage should be reduced in the elderly with impaired renal
function.
CHILDREN:
Diuretic - Initial: 0.4 mg per kg of body-weight per day.
Maintenance: 0.05 to 0.1 mg per kg of body-weight per day.
Antihypertensive: 0.05 to 0.4 mg/kg body-weight per day as a single
dose or in
two divided daily doses, adjusted according to response.
4.3.
CONTRAINDICATIONS
Bendroflumethiazide is contra-indicated in patients hypersensitive to
this drug
or any of the excipients and in patients with severe renal
insufficiency,
Addison’s disease, refractory hypokalaemia, hyponatraemia,
hypercalcaemia,
serious hepatic disorders, symptomatic hyperuricaemia and acute
porphyria.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
When doses higher than those stated in Section 4.2 Posology and method
of
administration are given to patients being treated for hypertension,
more
marked changes in plasma potassium, uric acid, glucose and lipids