Bendroflumethiazide 2.5mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Bendroflumethiazide

Available from:

Crescent Pharma 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: 5017123268021 5017123268106

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

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Bendroflumethiazide Tablets 2.5mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Bendroflumethiazide 2.5 mg per tablet.
For excipients, see 6.1.
3
PHARMACEUTICAL FORM
Tablet.
White flat bevelled edge tablets engraved with the company logo on one
side
and A268 on the other.
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:
Initially: 5 - 10mg in the morning, once daily or on alternative days.
Maintenance: 2.5 - 5mg 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.
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
Hypersensitivity to Bendroflumethiazide or any of the excipients.
Bendroflumethiazide is contra-indicated in patients with:
•
severe renal insufficiency
•
Addison's disease
•
refractory hypokalaemia
•
hyponatraemia
•
hypercalcaemia
•
serious hepatic disorders
•
symptomatic hyperuricaemia.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Bendroflumethiazide should be used with caution in patients with m