Bendroflumethiazide 2.5mg tablets

国: イギリス

言語: 英語

ソース: MHRA (Medicines & Healthcare Products Regulatory Agency)

有効成分:

Bendroflumethiazide

から入手可能:

Sandoz Ltd

ATCコード:

C03AA01

INN（国際名）:

Bendroflumethiazide

投薬量:

2.5mg

医薬品形態:

Oral tablet

投与経路:

Oral

クラス:

No Controlled Drug Status

処方タイプ:

Valid as a prescribable product

製品概要:

BNF: 02020100

情報リーフレット

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

製品の特徴

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 and symptomatic hyperuricaemia.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
HYPOKALAEMIA
Electrolytes
should
be
monitored
during
treatment
as
continued
or
intensive
use
of
bendroflumethiazide
may
result
in
hypokalaemia.
This
effect
may
be
enhanced
with
concomitant use of medicines that can also cause hypok