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NEO-URIZIDE - HYDROFLUMETHIAZIDE TABLETS 50MG

Active substance(s): HYDROFLUMETHIAZIDE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
NEO-URIZIDE / Hydroflumethiazide Tablets

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Hydroflumethiazide BP 50.00 mg. Also contains lactose.
For excipients see section 6.1

3

PHARMACEUTICAL FORM
Tablet

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
NEO-URIZIDE is a diuretic used to reduce oedema of cardiac, renal or hepatic
origin; also other types of oedema including iatrogenic oedema. It is also used
in pre-menstrual tension.
NEO-URIZIDE is useful in the treatment of hypertension either alone or with
a hypotensive agent.

4.2

Posology and method of administration
Adults:
Oedema: 50 to 200 mg daily, depending upon the severity of the oedema, as a
single dose in the morning. The daily dose should be given early enough to
complete diuresis by bedtime.

Antihypertensive: 25 to 50 mg daily; when given as an adjunct to other
antihypertensive agents the dose of the latter should be halved.
Maintenance: Doses of 25 to 50 mg on alternate days are usually adequate for
maintenance therapy.
Children over 12 years: Daily dosage in children will be at the discretion of
the physician; 1 mg per kg of bodyweight has been suggested as suitable for
most cases.
Elderly: The adult dosage of NEO-URIZIDE may need to be reduced in the
elderly, particularly when renal function is impaired because of the possibility
of electrolyte imbalance.
Route of administration: Oral

4.3

Contraindications
Hypersensitivity, severe renal or hepatic failure, Addisons disease,
hypercalcaemia, symptomatic hyperuricaemia, refractory hypokalaemia,
hyponatraemia and concurrent lithium therapy.

4.4

Special warnings and precautions for use
NEO-URIZIDE may precipitate or aggravate diabetes and may impair control of
diabetes in patients receiving sulphonylureas.
Supplementary potassium is strongly recommended in patients receiving digitalis who
require prolonged diuretic treatment.
May cause hypokalaemia, which may be corrected with potassium or a potassiumsparing drug. Renal function should be monitored.
Increased risk of hypomagnesaemia in alcoholic cirrhosis.
May aggravate gout. Serum uric acid levels may be raised with or without gout in
some patients.
Treat with caution in hepatic or renal impairment (avoid if severe).
May aggravate systemic lupus erythematosus.
Blood dyscrasias and pancreatitis have been reported.
Patients on long-term treatment and elderly patients need blood tests to monitor blood
electrolyte levels and blood dyscrasias.
Expectant mothers who receive thiazide diuretics may be at increased risk from acute
haemorrhagic pancreatitis; thrombocytopenia has been reported in newborn infants
following antepartum use of thiazides.
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
Concurrent therapy with carbenoxolone may necessitate potassium supplements.
Sensitivity to digitalis may increase and signs of overdosage appear.
Potassium supplements should not be given in renal insufficiency complicated by
hyperkalaemia.
Antagonism of diuretic effect may occur when used concurrently with non-steroidal antiinflammatory drugs, (indometacin, ketorolac), corticosteroids and oestrogens &
combined oral contraceptives.

Enhanced hypotensive effect when given with adrenergic neurone blockers,
general anaesthetics, ACE inhibitors, angiotensin II antagonists, anxiolytics and
hypnotics, calcium-channel blockers, beta-blockers, MAOIs, nitrates,
phenothiazines, several antihypertensive drugs, alprostadil, aldesleukin,
levodopa, baclofen, moxisylyte, tizanidine and alpha-blockers such as prazosin.
Increased risk of nephrotoxicity with NSAIDs, and of nephrotoxicity and
ototoxicity with cisplatin.
Increased risk of nephrotoxicity and possibly hypermagnesaemia are also reported
when thiazides and related diuretics are given with ciclosporin.
Corticosteroids, acetazolamide, amphotericin, reboxetine, beta2 sympathomimetics,
theophylline, loop diuretics may exacerbate hypokalaemia.
Hypokalaemia caused by thiazides and related diuretics:
Increases cardiac toxicity with cardiac glycosides, disopyramide, flecainide,
amiodarone and quinidine
Antagonises action of lidocaine and mexiletine
Increases risk of ventricular arrhythmias with sotalol, amisulpride, atomoxetine,
sertindole and terfenadine. Avoid concomitant use with pimozide.
There is an increased risk of postural hypotension with alcohol and tricyclic
antidepressants.
Antagonism of hypoglycaemic effect of antidiabetic agents.
There is an increased risk of hypersensitivity when thiazides and related diuretics are
given with allopurinol especially in renal impairment.
Increased risk of hyponatraemia if given with carbamazepine, chlorpropamide and
aminoglutethimide.
Increased risk of hypercalcaemia with calcium salts, toremifene and vitamin D.
Increased risk of lithium toxicity with lithium salts when given concurrently with
thiazide diuretics.
Colestipol and colestyramine may reduce the absorption of thiazides and related
diuretics.

4.6

Pregnancy and lactation
i)
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.
ii)
There is inadequate evidence of safety in human pregnancy. Foetal
bone marrow depression and thrombocytopaenia as well as foetal and neonatal
jaundice have also been described.
iii)
As diuretics pass into breast milk they should be avoided in mothers
who wish to breast feed.

4.7

Effects on ability to drive and use machines
Not known

4.8

Undesirable effects
Impotence. Mild anorexia or indigestion may be avoided by taking dose after meals.
The following have also been reported as undesirable effects of thiazide diuretics:
postural
hypotension,
hypokalaemia,
hyponatraemia,
hypomagnesaemia,
hypercalcaemia, hypochloraemic alkalosis, gout, hyperuricaemia, hyperglycaemia,
altered plasma lipid concentrations, skin rashes, photosensitivity, blood disorders
(including neutropenia and thrombocytopenia), hypersensitivity reactions, pancreatitis,
intrahepatic cholestasis, bone marrow depression.

4.9

Overdose
Treatment should be symptomatic and directed at monitoring blood pressure,
fluid and electrolyte balance. In the case of recent ingestion, gastric lavage
should be performed.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

The principal site of action of Hydroflumethiazide is on the distal convoluted
tubule distal to the thick segment of the end limb of the loop of Henle.
Hydroflumethiazide inhibits the distal tubular re-absorption of sodium and
chloride ions. Increased delivery of sodium to ion exchange sites in the
collecting duct results in increased urinary loss of potassium and also of
magnesium. Hydroflumethiazide also enhances the renal tubular re-absorption
of calcium. The antihypertensive effect is mainly due to sodium loss.

5.2

Pharmacokinetic properties
Hydroflumethiazide is incompletely but rapidly absorbed after oral administration.
Plasma concentration peaks between 1 and 4 hours. Significant pre-systemic
metabolism has been reported. Plasma elimination half-life varies from 12.4 to 26.9
hours after single doses. Between 40% and 80% of the drug is excreted unchanged in
the urine. The remainder is metabolised. Plasma protein binding is approximately
75%. Volume of distribution averages 6.4 l/kg in normal subjects.

5.3

Preclinical safety data
Not applicable.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Lactose
Maize starch
Pre-gelatinised maize starch
Sodium starch glycollate
Magnesium stearate

6.2

Incompatibilities
None known.

6.3

Shelf life
3 years.

6.4

Special precautions for storage
Store below 25ÂșC in a dry place in well closed containers.

6.5

Nature and contents of container
High density polystyrene with polythene lids and/or polypropylene containers
with polypropylene or polyurethane lids and polyurethane/polythene inserts.
Packs of 100, 500 and 1000 tablets.

6.6

Special precautions for disposal
No special instructions

7

MARKETING AUTHORISATION HOLDER
Chelonia Healthcare Limited
11 Boumpoulinas Street,
3rd floor, 1060 Nicosia
Cyprus

8

MARKETING AUTHORISATION NUMBER(S)
PL 33414/0048

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
18/02/2009

10

DATE OF REVISION OF THE TEXT
18/02/2009

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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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