Bendroflumethiazide 2.5 mg Tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Bendroflumethiazide

Available from:

Brillpharma (Ireland) Limited

ATC code:

C03AA01

INN (International Name):

Bendroflumethiazide

Dosage:

2.5 milligram(s)

Pharmaceutical form:

Tablet

Therapeutic area:

bendroflumethiazide

Authorization status:

Marketed

Authorization date:

2018-11-23

Patient Information leaflet

PATIENT LEAFLET: INFORMATION FOR THE USER
BENDROFLUMETHIAZIDE 2.5 MG TABLETS
BENDROFLUMETHIAZIDE 5 MG TABLETS
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 salts in the body;
• you suffer

Summary of Product characteristics

Health Products Regulatory Authority
25 August 2023
CRN00DG50
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bendroflumethiazide 2.5 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Bendroflumethiazide 2.5mg.
Excipient with known effect: Also contains 60 mg of lactose.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablet
White to almost white circular, biconvex, uncoated tablets
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.
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
Health Products Regulatory Authority
25 August 2023
CRN00DG50
Page 2 of 6

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 renal impairment (avoid if
severe). Renal function should be continuously monit