Spironolactone 50mg tablets

国: イギリス

言語: 英語

ソース: MHRA (Medicines & Healthcare Products Regulatory Agency)

有効成分:

Spironolactone

から入手可能:

Teva UK Ltd

ATCコード:

C03DA01

INN（国際名）:

Spironolactone

投薬量:

50mg

医薬品形態:

Oral tablet

投与経路:

Oral

クラス:

No Controlled Drug Status

処方タイプ:

Valid as a prescribable product

製品概要:

BNF: 02020300; GTIN: 5017007070788

情報リーフレット

SPIRONOLACTONE 25 MG, 50 MG AND
100 MG TABLETS
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
TAKING THIS MEDICINE.
•
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. Do not
pass it on to others. It may harm them, even if their
symptoms are the same as yours.
•
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
1. WHAT SPIRONOLACTONE IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
SPIRONOLACTONE
3. HOW TO TAKE SPIRONOLACTONE
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE SPIRONOLACTONE
6. CONTENTS OF THE PACK AND OTHER INFORMATION
WHAT SPIRONOLACTONE IS AND WHAT
IT IS USED FOR
Spironolactone is a type of medicine called a diuretic,
which increases the amount of water (urine) passed.
Spironolactone is used to stimulate your kidneys to
pass more urine, to get rid of excess water and salt
which may be causing problems.
Spironolactone Tablets are used for:
•
treating build-up of fluid in the body (oedema)
which may be caused by congestive heart
failure, liver cirrhosis, the kidney condition
nephrotic syndrome (kidney damage which
results in large amounts of protein in the urine)
or ascites, a condition in which fluid collects in
the abdomen
•
diagnosis and treatment of hyperaldosteronism
(overproduction of the hormone aldosterone).
WHAT YOU NEED TO KNOW BEFORE YOU
TAKE SPIRONOLACTONE
DO NOT TAKE SPIRONOLACTONE AND TALK TO YOUR DOCTOR IF
YOU:
•
are allergic (hypersensitive) to spironolactone or
any of the other ingredients of this medicine
•
suffer from kidney failure, or significant
deterioration of kidney function
•
have a high level of potassium in your blood
(hyperkalaemia)
•
suffer from Addison's disease (an underactive
adrenal gland)
•
are sometimes completely unable to pass urine
•
are pregnant or breast-feeding.
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTO

製品の特徴

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