Arrow - Bendrofluazide 2.5
Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Patient Information leaflet
(PIL)
19-04-2020
Summary of Product characteristics
(SPC)
05-01-2022
Active ingredient:
Bendroflumethiazide 2.5mg; ;
Available from:
Teva Pharma (New Zealand) Limited
INN (International Name):
Bendroflumethiazide 2.5 mg
Dosage:
2.5 mg
Pharmaceutical form:
Tablet
Composition:
Active: Bendroflumethiazide 2.5mg Excipient: Lactose Purified talc Starch Stearic acid
Units in package:
Blister pack, PVD/PVDC,, 14 tablets
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
Ipca Laboratories Limited
Therapeutic indications:
Bendrofluazide is indicated in the treatment of oedema associated with conditions such as: congestive heart failure, nephrotic syndrome and cirrhosis of the liver.
Product summary:
Package - Contents - Shelf Life: Blister pack, PVD/PVDC, - 14 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, PVD/PVDC, - 28 tablets - 24 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE, - 500 tablets - 24 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE, - 1000 tablets - 24 months from date of manufacture stored at or below 25°C
Authorization date:
2009-06-03
Patient Information leaflet
CONSUMER MEDICINE INFORMATION
ARROW - BENDROFLUAZIDE
BENDROFLUMETHIAZIDE 2.5 MG AND 5 MG TABLETS
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you start taking
ARROW-BENDROFLUAZIDE.
This leaflet answers some common questions about ARROW-BENDROFLUAZIDE.
It does
not contain all the available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of you taking
ARROW-BENDROFLUAZIDE against the benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again.
WHAT ARROW - BENDROFLUAZIDE IS USED FOR
ARROW-BENDROFLUAZIDE contains the active ingredient
bendroflumethiazide, also known
as bendrofluazide.
ARROW-BENDROFLUAZIDE is a fluid tablet or diuretic. It helps reduce
the amount of
excess fluid in the body by increasing the amount of urine produced.
It is used to treat
swelling of the ankles, feet or legs, which is called oedema. This can
occur in some heart,
liver or kidney conditions.
ARROW-BENDROFLUAZIDE is also used to treat high blood pressure either
alone or in
combination with other medicines.
Your doctor may have prescribed ARROW-BENDROFLUAZIDE for another
reason.
Ask your doctor if you have any questions about why
ARROW-BENDROFLUAZIDE has been
prescribed for you.
ARROW-BENDROFLUAZIDE is available only with a doctor’s prescription.
BEFORE YOU TAKE ARROW-BENDROFLUAZIDE
_WHEN YOU MUST NOT TAKE IT _
Do not take ARROW-BENDROFLUAZIDE if you have had an allergic reaction
to
bendroflumethiazide or any of the ingredients in ARROW-BENDROFLUAZIDE
listed at the
end of this leaflet.
Some of the symptoms of an allergic reaction may include:
•
shortness of breath, wheezing or difficulty breathing
•
swelling of the face, lips, tongue or other parts of the body
•
lumpy skin rash ("hives"), hayfever or fainting.
Do not take ARROW-BENDROFLUAZIDE if you have an allergy or have ev
Read the complete document
Summary of Product characteristics
Version 1.3
Page
1
of
7
NEW ZEALAND DATA SHEET
1 NAME OF THE MEDICINE
Arrow-Bendrofluazide 2.5, 2.5 mg, tablets
Arrow-Bendrofluazide 5, 5 mg, tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 2.5 mg or 5 mg of bendroflumethiazide (also known
as bendrofluazide).
Excipient with known effect:
lactose
For the full list of excipients, see section 6.1 List of excipients.
3 PHARMACEUTICAL FORM
Tablets 2.5 mg: White to almost white, circular, biconvex, uncoated
tablets.
Tablets 5 mg: White to almost white, circular, flat, bevelled edged
uncoated tablets with ‘5’ embossed
on one side.
Do not halve the tablets. Dose equivalence when the tablet is divided
has not been established.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Bendroflumethiazide is indicated in the treatment of oedema associated
with conditions such as:
congestive heart failure, nephrotic syndrome and cirrhosis of the
liver.
Bendroflumethiazide is indicated in the treatment of essential
hypertension where it may be used as the
sole antihypertensive agent, or as an adjunct to other medicines whose
action it potentiates.
4.2
DOSE AND METHOD OF ADMINISTRATION
ADULTS
When bendroflumethiazide is added to other antihypertensive agents,
the dosage of the latter can usually
be reduced gradually as bendroflumethiazide takes effect.
OEDEMA
Initially 5 to 10 mg once daily or on alternate days.
Maintenance: 2.5 to 10 mg two or three times weekly.
5 mg given orally once daily in the morning usually produces the
desired effect without diuresis
interfering with sleep, but this dose can be increased to 10 mg if
required. During the first few days of
treatment there is usually a large increase in urinary volume, which
diminishes as treatment continues.
ESSENTIAL HYPERTENSION
2.5 mg to 10 mg once daily, alone or in conjunction with other
antihypertensive agents.
Doses higher than 2.5 mg per day (for hypertension) are rarely
necessary.
ELDERLY
The dosage of thiazide diuretics may need to be reduced in the
elderly, particularly when renal functio
Read the complete document
