Bendroflumethiazide 5mg Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

BENDROFLUMETHIAZIDE

Available from:

Crescent Pharma International Limited 260, Triq San Albert, Gzira GZR 1150, Malta

ATC code:

C03AA01

INN (International Name):

BENDROFLUMETHIAZIDE 5 mg

Pharmaceutical form:

TABLET

Composition:

BENDROFLUMETHIAZIDE 5 mg

Prescription type:

POM

Therapeutic area:

DIURETICS

Authorization status:

Authorised

Authorization date:

2019-06-17

Patient Information leaflet

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PATIENT INFORMATION LEAFLET
BENDROFLUMETHIAZIDE TABLETS 2.5MG & 5MG
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, pharmacist or nurse.
• 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, pharmacist or nurse. 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
This medicine belongs to a group of drugs known as diuretics (water
tablets). This medicine is used to
reduce fluid retention (oedema) caused by heart, liver or kidney
conditions by increasing the flow of
urine. It is also used to treat high blood pressure, either alone or
in combination with other drugs which
lower blood pressure.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
BENDROFLUMETHIAZIDE TABLETS
DO NOT TAKE
BENDROFLUMETHIAZIDE TABLETS IF YOU
HAVE:
•
an allergy to bendroflumethiazide or to any of the other ingredients
(see section 6) Addison's
disease (a disorder where the adrenal glands do not produce enough
steroid hormones)
•
low blood levels of sodium (hyponatraemia) or of potassium
(hypokalaemia)
•
high levels of calcium in the blood (hypercalcaemia)
•
high levels of uric acid in the blood (hyperuricaemia) causing
symptoms of gout ie. pain in the
joints severe kidney or liver function problems.
WARNINGS
AND
PRECAUTIONS
TALK TO YOUR DOCTOR BEFORE TAKING
BENDROFLUMET

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Bendroflumethiazide Tablets 5.0 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Bendroflumethiazide 5.0 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 C218 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.
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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