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BENDROFLUMETHIAZIDE TABLETS 5.0MG

Active substance(s): BENDROFLUMETHIAZIDE / BENDROFLUMETHIAZIDE / BENDROFLUMETHIAZIDE

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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 A269 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.
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:







4.4

severe renal insufficiency
Addison's disease
refractory hypokalaemia
hyponatraemia
hypercalcaemia
serious hepatic disorders
symptomatic hyperuricaemia.

Special warnings and precautions for use
Bendroflumethiazide should be used with caution in patients with mild to
moderate hepatic or renal impairment (avoid if severe). Renal function should
be continuously monitored during thiazide therapy. Thiazide diuretics may
exacerbate or activate systemic lupus erythematosus in susceptible patients.
All thiazide diuretics can produce a degree of electrolyte imbalance, especially
in patients with renal or hepatic impairment or when dosage is high or
prolonged. Serum electrolytes should be checked for abnormalities,
particularly hypokalaemia, and the latter corrected by the addition of a
potassium supplement to the regimen. Aggravates diabetes and gout; increased

risk of hypomagnesaemia in alcoholic cirrhosis.
Regular ongoing monitoring and blood tests are to be performed in elderly
patients and patients who are on long term treatment with
bendroflumethiazide.
This product contains lactose. Patients with rare hereditary problems of
galactose intolerance, the Lapp lactase deficiency or glucose-galactose
malabsorption should not take this medicine.
4.5

Interaction with other medicinal products and other forms of interaction
Analgesics: Diuretics such as bendroflumethiazide increase the risk of
nephrotoxicity associated with non-steroidal anti-inflammatory analgesics
(NSAIDs). NSAIDs, particularly indometacin and ketorolac may antagonise
the natriuresis and increase in plasma renin activity caused by thiazide
diuretics. It may also reduce the antihypertensive effect and increase in urine
volume caused by thiazide diuretics, possibly by inhibiting renal prostaglandin
synthesis and/or by causing sodium and fluid retention. Concomitant use with
opiates leads to an increased risk of postural hypotension.
Anion-exchange resins: colestyramine and colestipol lead to decreased
absorption of thiazides. It has been recommended that administration is at least
2 hours prior to, or after the ingestion of bendroflumethiazide.
Antidiabetics: Concurrent administration of bendroflumethiazide in patients
receiving sulphonylureas may impair control of diabetes by antagonising the
hypoglycaemic effect.
Chlorpropamide increases the risk of hyponatraemia associated with taking
thiazides such as bendroflumethiazide in combination with potassium-sparing
diuretics.

Antiepileptics: There is an increased risk of hyponatraemia with
carbamazepine.
Antifungals: There is an increased risk of hypokalaemia if thiazides are given
with amphotericin.
Antihistamines: Patients with hypokalaemia or other electrolyte imbalance
have an increased risk of ventricular arrhythmias with terfenadine.
Antihypertensives: Concurrent use of bendroflumethiazide with
antihypertensives enhances the hypotensive effect. There is an increased risk
of first-dose hypotensive effect of postsynaptic alpha-blockers such as
prazosin.
Antipsychotics: Patients with hypokalaemia have an increased risk of
ventricular
arrhythmias with pimozide. Concomitant use should be avoided.
Alprostadil: Concomitant use with alprostadil enhances the hypotensive effect.
Anti-arrhythmics: The cardiac toxicity associated with amiodarone,
disopyramide, flecainide, and quinidine is increased if hypokalaemia occurs.
The action of lidocaine and mexiletine is antagonised by hypokalaemia.

Antidepressants: There is a possible increased risk of postural hypotension
with tricyclic antidepressants and of hypokalaemia if thiazides are given with
reboxetine.
Beta-blockers: Use with bendroflumethiazide enhances the hypotensive effect.
Patients with hypokalaemia have an increased risk of ventricular arrhythmias
with sotalol.
Calcium salts: There is an increased risk of hypercalcaemia with thiazides
such as bendroflumethiazide.
Calcium-channel blockers: Concomitant use with bendroflumethiazide
enhances the hypotensive effect.
Cardiac glycosides: The concurrent use of cardiac glycosides with thiazide
diuretics may enhance the possibility of cardiac toxicity associated with
hypokalaemia, resulting in cardiac arrhythmias.
Corticosteroids: Xanthines, beta-agonists, ACTH There is an increased risk of
hypokalaemia with thiazides such as bendroflumethiazide and the diuretic
effect is antagonised.
Cytotoxics: Concurrent use of diuretics such as bendroflumethiazide with
cisplatin increases the risk of nephrotoxicity and ototoxicity.
Hormone Antagonists: There is an increased risk of hyponatraemia with
aminoglutethimide.
Thiazides such as bendroflumethiazide increase the risk of hypercalcaemia
with toremifene.
Moxisylyte: Concomitant use with bendroflumethiazide enhances the
hypotensive effect.
Muscle relaxants: An enhanced hypotensive effect is associated with
concomitant use with baclofen and tizanidine. Bendroflumethiazide interacts
with nondepolarising neuromuscular blocking drugs leading to prolonged
neuromuscular blockade e.g. tubocurarine.
Oestrogens and Progestogens: The diuretic effect is antagonised with
oestrogens and combined oral contraceptives.
Other diuretics: There is an increased risk of hypokalaemia if thiazides such as
bendroflumethiazide, loop diuretics or acetazolamide are taken together.
Sympathomimetics: There is an increased risk of hypokalaemia if thiazides are
given with high doses of bambuterol, fenoterol, formoterol, reproterol,
ritodrine, salbutamol, salmeterol, terbutaline and tulobuterol. Potentially
serious hypokalaemia may result from beta2 agonist therapy.
as

Theophylline: There is an increased risk of hypokalaemia with thiazides such
bendroflumethiazide.
Ulcer-healing Drugs: There is an increased risk of hypokalaemia if thiazides
are given with carbenoxolone. Carbenoxolone also antagonises the diuretic
effect.

Serum lithium concentrations may be increased by concurrent use of thiazide
diuretics.
Other interactions, vitamin D preparations (leading to increased risk of
hypercalcaemia), alcohol and barbiturates (leading to increased risk of postural
hypotension) have also been reported.

4.6

Fertility, pregnancy and lactation
Diuretics are best avoided for the management of oedema of pregnancy or
hypertension in pregnancy as their use may be associated with hypovolaemia,
increased blood viscosity and reduced placental perfusion.
There is inadequate evidence of safety in human pregnancy and foetal bone
marrow depression and thrombocytopenia have been described. Foetal and
neonatal jaundice have also been described.
As diuretics pass into breast milk and bendroflumethiazide can suppress
lactation, its use should be avoided in mothers who wish to breast-feed.

4.7

Effects on ability to drive and use machines
No adverse effects known.

4.8

Undesirable effects
All thiazide diuretics can produce a degree of electrolyte imbalance, e.g.
hypokalaemia.
Thiazide diuretics may raise the serum uric acid levels with subsequent
exacerbation of gout in susceptible subjects.
Thiazide diuretics sometimes lower carbohydrate tolerance and the insulin
dosage of the diabetic patient may require adjustment. Care is necessary when
bendroflumethiazide is administered to those with a known predisposition to
diabetes.
Postural hypotension, mild gastro-intestinal effects and diarrhoea;
hypokalaemia, hypomagnesaemia, hyponatraemia, hypercalcaemia,
hypochloraemic alkalosis, hyperuricaemia, gout, hyperglycaemia, and altered
plasma lipid concentration.
Less commonly, rashes, photosensitivity; blood disorders (including
neutropenia and thrombocytopenia – when given in late pregnancy neonatal
thrombocytopenia has been reported); pancreatitis, intrahepatic cholestasis,
and hypersensitivity reactions (including pneumonitis, pulmonary oedema,
severe skin reactions) also reported.
Rarely, blood dyscrasias, including agranulocytosis, aplastic anaemia,

thrombocytopenia and leucopenia, and pancreatitis have been reported with
long term therapy. Skin rashes and impotence (reversible on withdrawal of
treatment) have occasionally been reported.
Reporting of suspected adverse reactions:
Reporting suspected adverse reactions after authorisation of the medicinal
product is important. It allows continued monitoring of the benefit/risk
balance of the medicinal product. Healthcare professionals are asked to report
any suspected adverse reactions via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.

4.9

Overdose
Symptoms of overdosage include anorexia, nausea, vomiting, diarrhoea,
diuresis, dehydration, hypotension, dizziness, weakness, muscle cramps,
paraesthesia, tetany, gastrointestinal bleeding, hyponatraemia, hypo- or
hyperglycaemia, hypokalaemia and metabolic alkalosis. Initial treatment
consists of either emesis or gastric lavage, if appropriate. Otherwise treatment
should be symptomatic and supportive including the correction of fluid and
electrolyte imbalance.
Blood pressure should also be monitored. There is no specific antidote.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Pharmacotherapeutic classification: Low-Ceiling Diuretics Thiazides Bendroflumethiazide
ATC code: CO3A A01
Bendroflumethiazide is a thiazide diuretic which reduces the reabsorption of
electrolytes from the renal tubules, thereby increasing the excretion of sodium
and chloride ions, and consequently of water. The excretion of other
electrolytes, notably potassium and magnesium, is also increased. The
excretion of calcium is reduced. Thiazides also reduce the carbonic anhydrase
activity so that bicarbonate excretion is increased but this effect is generally
small and does not appreciably alter the acid base balance or pH of the urine.
Thiazides also have a hypotensive effect, due to a reduction in peripheral
resistance and enhance the effects of other antihypertensive agents.

5.2

Pharmacokinetic properties
Bendroflumethiazide is completely absorbed from the gastrointestinal tract
and it is fairly extensively metabolised. About 30% is excreted unchanged in
the urine. The onset of diuretic action of the thiazides following oral
administration occurs within two hours and the peak effect between three and
six hours after administration. The duration of the diuretic action of

bendroflumethiazide is between 18 and 24 hours. The onset of the hypotensive
action is generally three or four days.
5.3

Preclinical safety data
Not applicable

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Lactose
Maize starch
Pregelatinised starch
Magnesium stearate

6.2

Incompatibilities

Not applicable.
6.3

Shelf life
As packaged for sale:
3 years for opaque plastic containers.
2 years for blister packaging.

6.4

Special precautions for storage
Do not store above 25°C.

6.5

Nature and contents of container
1. Opaque plastic containers composed of polypropylene tubes and polyethylene
tamper-evident closures for pack sizes of 28, 30, 42, 50, 56, 60, 84, 90, 100,
112, 250, 500 and 1000 tablets.
2.

Opaque plastic containers composed of either high density polypropylene or
high density polyethylene with a tamper evident or child resistant tamper
evident closure composed of high density polyethylene with a packing
inclusion of polyether foam or polyethylene or polypropylene filler in pack
sizes of 28, 30, 42, 50, 56, 60, 84, 90, 100, 112, 250, 500 and 1000 tablets.

3.

Blister packs of aluminium/opaque PVC subsequently packed in printed
cartons in pack sizes of 28, 30, 42, 56, 60, 84, 90 and 112 tablets.
Not all pack sizes may be marketed.

6.6

Special precautions for disposal
No special instructions for use/handling.

7

MARKETING AUTHORISATION HOLDER
Crescent Pharma Ltd
Units 3 and 4, Quidhampton Business Units
Polhampton Lane
Overton
Hampshire
RG25 3ED
United Kingdom

8

MARKETING AUTHORISATION NUMBER(S)
PL 20416/0218

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
01/11/2003

10

DATE OF REVISION OF THE TEXT
23/02/2017

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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