Spironolactone 100 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Spironolactone

Available from:

Accord Healthcare Ireland Ltd.

ATC code:

C03DA; C03DA01

INN (International Name):

Spironolactone

Dosage:

100 milligram(s)

Pharmaceutical form:

Film-coated tablet

Therapeutic area:

Aldosterone antagonists; spironolactone

Authorization status:

Marketed

Authorization date:

2016-01-29

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
SPIRONOLACTONE 25 MG FILM-COATED TABLETS
SPIRONOLACTONE 50 MG FILM-COATED TABLETS
SPIRONOLACTONE 100 MG FILM-COATED TABLETS
spironolactone
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, 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
iftheir signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist or
nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Spironolactone film-coated tablet is and what it is used for
2.
What you need to know before you take Spironolactone film-coated
tablets
3.
How to take Spironolactone film-coated tablets
4.
Possible side effects
5.
How to store Spironolactone film-coated tablets
6.
Contents of the pack and other information
1.
WHAT SPIRONOLACTONE FILM-COATED TABLET IS AND WHAT IT IS USED FOR
The active ingredient of the tablets is Spironolactone. Spironolactone
belongs to a particular group of
medicines, known as aldosterone antagonists, which inhibit the action
of the hormone aldosterone. One of
the functions of aldosterone is to ensure that the body retains
sodium. It forms part of a system that
regulates the balance of fluids and salts in the body (‘RAAS’,
renin angiotensin aldosterone system).
Spironolactone promotes the excretion of urine in patients in whom
there is an accumulation of fluid in
the tissues (oedema) or in the abdominal cavity (ascites) by
increasing the amount of sodium (salt)
excreted in the urine. Potassium loss as a possible consequence of
using certain diuretics is reduced. The
antihypertensive effect relies on the excretion of water and salt.
Spironolactone film-coated tablets may be prescribed by your doctor
for the treatment of:
•
accumu

Summary of Product characteristics

Health Products Regulatory Authority
30 May 2022
CRN00CYCX
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Spironolactone 100 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Spironolactone 100 mg film-coated tablets contain 100 mg
spironolactone
Excipients with known effect: Lactose
Each tablet contains 300 mg lactose monohydrate.
3 PHARMACEUTICAL FORM
Spironolactone 100 mg film-coated tablets are white to pale white,
round, biconvex tablets printed with "AF" on one side and
no imprint on the other side.
100mg tablet diameter is approximately 11.2 mm.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
- Oedema associated with congestive heart failure
- Severe heart failure, (NYHA III-IV)
- As an adjuvant in treatment of resistant hypertension
- Nephrotic syndrome
- Liver cirrhosis with ascites and oedema
- Diagnosis and treatment of primary hyperaldosteronism (Conn's
syndrome)
Children should only be treated under guidance of a paediatric
specialist.There is limited paediatric data available (see sections
5.1 and 5.2)
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Posology_
Adults
The dosage should be determined individually depending on the
condition and the degree of diuresis required. Dosage up
to100 mg daily may be administered as a single dose or in divided
doses.
_ _
_Oedema associated with congestive heart failure _
For management of oedema an initial daily dose of 100 mg of
spironolactone administered in either single or divided doses is
recommended, but may range from 25 to 200 mg daily. Maintenance dose
should be individually determined.
_Severe heart failure (NYHA Class III-IV)_
Treatment in conjunction with standard therapy should be initiated at
a dose of spironolactone 25 mg once daily if serum
potassium is ≤ 5.0 mEq/L and serum creatinine is ≤ 2.5 mg/dL (221
µmol/L). Patients who tolerate 25 mg once daily may have
their dose increased to 50 mg once daily as clinically indicated.
Patients who do not tolerate 25 mg once daily may have their
dose reduc