Bendroflumethiazide 5 mg Tablets

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Bendroflumethiazide

Διαθέσιμο από:

Bristol Laboratories Limited

Φαρμακολογική κατηγορία (ATC):

C03AA01

INN (Διεθνής Όνομα):

Bendroflumethiazide

Δοσολογία:

5 milligram(s)

Φαρμακοτεχνική μορφή:

Tablet

Τρόπος διάθεσης:

Product subject to prescription which may be renewed (B)

Θεραπευτική περιοχή:

bendroflumethiazide

Ημερομηνία της άδειας:

2018-11-23

Φύλλο οδηγιών χρήσης

Same size artwork
400 x150 mm
Front
PATIENT LEAFLET: INFORMATION FOR THE USER
BENDROFLUMETHIAZIDE 2.5 MG TABLETS
BENDROFLUMETHIAZIDE 5 MGTABLETS
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 queries, 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 you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
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
The name of your medicine is Bendroflumethiazide 2.5 mg tablets or
Bendroflumethiazide 5 mg tablets. The active ingredient is
bendroflumethiazide.
Bendroflumethiazide tablets belong to a group of medicines called
thiazide diuretics (water tablets).
Diuretic medicines are those that promote the excretion of urine.
Bendroflumethiazide Tablets are used to treat hypertension (high blood
pressure) and oedema (fluid retention). They are also used to stop the
production of breast milk.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
BENDROFLUMETHIAZIDE TABLETS
DO NOT TAKE
Bendroflumethiazide tablets and
TELL
your doctor if
:
•
you ever had an allergic reaction to bendroflumethiazide or any other
ingredients of this medicine (allergic reactions include mild symptoms
such as itching and/or rash. More severe symptoms include swelling
of the face, lips, tongue and/or throat with difficulty in swallowing
or
breathing);
•
you suffer from an imbalance of water and

Αρχείο Π.Χ.Π.

Health Products Regulatory Authority
27 November 2018
CRN008KLM
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bendroflumethiazide 5 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Bendroflumethiazide 5 mg.
Excipient with known effect: Also contains 120 mg of lactose.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablet
White to almost white, circular, flat, beveled edged, uncoated tablets
with ‘5’
embossing on one side and plain on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of oedema and hypertension. Bendroflumethiazide may
also be
used to suppress lactation.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Adults:
Oedema:
Initially, 5-10 mg in the morning, daily or on alternate days;
maintenance dose 5-10
mg one to three times weekly.
Hypertension:
The usual dose is 2.5 mg taken in the morning. Higher doses are rarely
necessary.
Suppression of lactation:
5 mg in the morning and 5 mg at midday for about five days.
Health Products Regulatory Authority
27 November 2018
CRN008KLM
Page 2 of 8
Children:
Dosage in children may be up to 400 mcg/kg bodyweight initially,
reducing to
50-100 mcg/kg bodyweight daily for maintenance.
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.
Method of administration
For oral administration
4.3 CONTRAINDICATIONS

Hypersensitivity to the active substance, other thiazides, or to any
of the
excipients listed in section 6.1

Refractory hypokalaemia, hyponatraemia, or hypercalcaemia

Severe renal and hepatic insufficiency

Symptomatic hyperuricaemia

Addison's disease
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Bendroflumethiazide may raise serum uric acid levels with consequent
exacerbation
of gout insusceptible patients.
Bendroflumethiazide should be used with caution in patients with mild
to moderate
hepatic or r