Spironolactone 50mg tablets
Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Patient Information leaflet
(PIL)
01-03-2020
Summary of Product characteristics
(SPC)
28-04-2020
Active ingredient:
Spironolactone
Available from:
IVAX Pharmaceuticals UK Ltd
ATC code:
C03DA01
INN (International Name):
Spironolactone
Dosage:
50mg
Pharmaceutical form:
Oral tablet
Administration route:
Oral
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 02020300
Patient Information leaflet
OTHER IMPORTANT INFORMATION YOU SHOULD
REMEMBER WHILE TAKING SPIRONOLACTONE
• If you see another doctor or go into hospital,
let him or the staff know what medicines you
are taking.
• Inform your doctor or dentist if you are taking
Spironolactone before undergoing surgery.
• Spironolactone may also cause problems if
you have a local or a general anaesthetic.
OTHER MEDICINES AND SPIRONOLACTONE
TALK TO YOUR DOCTOR IF YOU ARE TAKING ANY OF THE
FOLLOWING:
• diuretics ('water tablets')
• potassium supplements
• ACE inhibitors (such as captopril or enalapril
maleate)
• antihypertensives (tablets for high blood
pressure)
• carbenoxolone (medicine used for treatment
of mouth and stomach ulcers)
• noradrenaline (medicine used to treat
depression and hyperactivity)
• aspirin, indometacin (non-steroidal
anti-inflammatory drugs)
• digoxin (medicine used to treat various heart
conditions)
• trimethoprim and and
trimethoprim-sulfamethoxazole
Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines.
PREGNANCY AND BREAST-FEEDING
Do not take Spironolactone if you are pregnant,
planning to become pregnant or breast-feeding.
Ask your doctor or pharmacist for advice before
taking any medicine.
DRIVING AND USING MACHINES
Spironolactone may cause drowsiness and
dizziness. If affected do not drive or operate
machinery.
SPIRONOLACTONE CONTAINS LACTOSE AND SODIUM
If you have been told by your doctor that you
have an intolerance to some sugars, contact
your doctor before taking this medicinal
product.
This medicine contains less than 1 mmol
sodium (23 mg) per tablet, that is to say
essentially ‘sodium-free’.
HOW TO TAKE SPIRONOLACTONE
Always take spironolactone exactly as your
doctor has told you. You should check with your
doctor or pharmacist if you are not sure.
The spironolactone tablets should be swallowed
preferably with a glass of water and they
should be taken with food. The usual dose is:
ADULTS
The usual starting dose is 100 mg once daily.
This may then b
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Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Spironolactone 50mg Tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg of spironolactone.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Buff coloured biconvex film coated tablet marked “APS” or plain on
one side
and “50 0707” on the reverse
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Spironolactone tablets are indicated for the treatment of cirrhosis
with ascites
and
oedema,
malignant
ascites,
nephrotic
syndrome,
congestive
cardiac
failure, diagnosis and treatment of primary hyperaldosteronism.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration.
Administration of spironolactone once daily with a meal is
recommended.
ADULTS
An initial dose of 100mg/day increasing if necessary to 200mg or
possibly up
to
400mg
daily.
When
oedema
is
controlled,
the
maintenance
dose
is
determined on an individual basis, usually 75- 200mg/day.
Use of spironolactone in the treatment of nephrotic syndrome is only
advised
when glucocorticoids alone are insufficiently effective.
For treatment of cirrhosis with ascites and oedema the dosage is based
on the
urinary Na
+
/K
+
ratio. If the ratio is greater than 1.0 a dosage of 100mg daily is
recommended and if less than 1.0 a daily dosage of 200 - 400mg.
Diagnosis and treatment of primary hyperaldosteronism
Spironolactone may be used to provide presumptive evidence of primary
aldosteronism while patients are on normal diets.
Long Test: Administer 400mg of spironolactone per day for 3 - 4 weeks.
If
hypokalaemia and hypertension are corrected then consider a
presumptive
diagnosis of primary hyperaldosteronism.
Short Test: Administer 400mg of spironolactone per day for 4 days. If
serum
potassium increases during treatment and drops on cessation of
treatment then
consider a presumptive diagnosis of primary aldosteronism.
On confirmation of hyperaldosteronism, spironolactone may be
administered
in preparation for surgery at a dosage of 100 - 400mg da
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