SPIRONOLACTONE TEVA 100 MG

Nchi: Israeli

Lugha: Kiingereza

Chanzo: Ministry of Health

Viambatanisho vya kazi:

SPIRONOLACTONE

Inapatikana kutoka:

TEVA ISRAEL LTD

ATC kanuni:

C03DA01

Dawa fomu:

TABLETS

Tungo:

SPIRONOLACTONE 100 MG

Njia ya uendeshaji:

PER OS

Dawa ya aina:

Required

Viwandani na:

TEVA ISRAEL LTD, ISRAEL

Kundi la matibabu:

SPIRONOLACTONE

Eneo la matibabu:

SPIRONOLACTONE

Matibabu dalili:

Edematous conditions: congestive heart failure; cirrosis of the liver accompanied by edema and/or ascites nephrotic syndrome. Essential hypertention. Primary hyperaldostronism. Hypokalemia.

Idhini ya tarehe:

2021-11-30

Taarifa za kipeperushi

PATIENT LEAFLET IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed with a doctor's prescription only
SPIRONOLACTONE TEVA
25 MG
SPIRONOLACTONE TEVA
100 MG
TABLETS
TABLETS
COMPOSITION:
COMPOSITION:
Each tablet contains:
Each tablet contains:
Spironolactone 25 mg
Spironolactone 100 mg
For information about inactive ingredients see section 6 -
“Additional information”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE.
This leaflet contains concise information about the medicine.
If you have additional questions, refer to the doctor or the
pharmacist.
This medicine has been prescribed for your treatment. Do
not pass it on to others. It may harm them even if it seems to
you that their medical condition is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
Treatment
of
congestive
heart
failure,
cirrhosis
of
the
liver accompanied by edema and ascites, lowering blood
pressure, adrenal gland overactivity (hyperaldosteronism),
hypokalemia (low levels of potassium in the blood).
THERAPEUTIC CLASS:
Spironolactone belongs to a group of medicines called
potassium-sparing diuretics.
2. BEFORE USING THE MEDICINE
Do not use this medicine if:
•
You are sensitive (allergic) to the active ingredient or to
any of the other ingredients this medicine contains (see
section 6 – “additional information”).
•
You suffer from urinary retention.
•
You suffer from a severe kidney disease.
•
You
suffer
from
Addison’s
disease
(a
disease
characterized by a feeling of exhaustion, loss of weight
and low blood pressure).
•
You suffer from hyperkalemia (excess potassium in the
blood).
•
You are breastfeeding.
•
You are taking potassium-sparing diuretics or potassium
supplements.
•
You are taking a medicine that contains the active
ingredient
eplerenone
(administered
to
treat
heart
failure).
•
Do not use the medicine in children suffering from
moderate to severe kidney disease.
SPECIAL WARNINGS REGARDING THE USE OF THE MEDICINE
BEFORE TREATMENT WITH SPIRONOLACTONE TEV

Tabia za bidhaa

Spironolactone Teva 100mg MF Notification 10/2022 CLEAN
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Spironolactone Teva 100mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 100mg spironolactone.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Spironolactone Teva 100mg tablets are white, round flat tablets with
beveled edges, engraved
"TEVA" on one side, scored in half on the other, with peppermint odor.
The tablet can be
divided into equal halves.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Edematous conditions:

Congestive heart failure

Cirrhosis of the liver accompanied by edema and/or ascites

Nephrotic syndrome

Essential hypertension

Primary hyperaldosteronism

Hypokalemia
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Administration of Spironolactone Teva once daily with a meal is
recommended.
Children should only be treated under guidance of a paediatric
specialist. There is limited
paediatric data available (see sections 5.1 and 5.2).
POSOLOGY
ADULTS
CONGESTIVE CARDIAC FAILURE WITH OEDEMA
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
mg to 200 mg daily.
Maintenance dose should be individually determined.
SEVERE HEART FAILURE (NEW YORK HEART ASSOCIATION CLASS III-IV)
Based on the Randomized Aldactone (spironolactone) Evaluation Study
(RALES: see also
section 5.1), 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. 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 reduced to 25 mg every other day. See section 4.4 for advice on
monitoring serum
potassium and serum creatinine.
HEPATIC CIRRHOSIS WITH ASCITES AND OEDEMA
If urinary Na+/K+ ratio is gre