ALDACTONE 25 MG

Israel - English - Ministry of Health

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Active ingredient:
SPIRONOLACTONE
Available from:
PFIZER PFE PHARMACEUTICALS ISRAEL LTD
ATC code:
C03DA01
Pharmaceutical form:
COATED TABLETS
Composition:
SPIRONOLACTONE 25 MG
Administration route:
PER OS
Prescription type:
Required
Manufactured by:
PIRAMAL HEALTHCARE UK LIMITED
Therapeutic group:
SPIRONOLACTONE
Therapeutic area:
SPIRONOLACTONE
Therapeutic indications:
Congestive heart failure, cirrhotic ascites.
Authorization number:
125 97 24826 00
Authorization date:
2012-07-31

Documents in other languages

Patient Information leaflet Patient Information leaflet - Arabic

26-01-2021

Patient Information leaflet Patient Information leaflet - Hebrew

09-03-2020

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE

PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986

The medicine is dispensed with a doctor’s prescription only

ALDACTONE

®

25 mg

Film-coated tablets

The active ingredient and its quantity:

Each film-coated tablet contains:

Spironolactone 25 mg

The list of inactive and allergenic ingredients in the preparation

is in section 6.

Read this leaflet carefully in its entirety before using the

medicine. This leaflet contains concise information about the

medicine. If you have further questions, refer to the doctor

or pharmacist.

This medicine has been prescribed to treat you. 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?

∙ To treat heart failure.

∙ To treat cirrhosis with edema and ascites.

Therapeutic group:

Spironolactone belongs to a group of medicines called

potassium-sparing diuretics.

2. BEFORE USING THE MEDICINE

Do not use the medicine if:

x you are sensitive (allergic) to the active ingredient or to

any of the other ingredients contained in the medicine (as

detailed in section 6).

x you suffer from urinary retention.

x you suffer from severe kidney disease.

x you suffer from Addison’s disease (a disease characterized

by a feeling of exhaustion, loss of weight and by low blood

pressure).

x you suffer from hyperkalemia (excessive blood

potassium).

x you are breastfeeding.

x you are taking potassium-sparing diuretics or potassium

supplements.

x you are taking a medicine that contains the active ingredient

eplerenone (administered to treat heart failure).

x Do not use the medicine in children suffering from moderate

to severe kidney disease.

Special warnings regarding use of the medicine

Before treatment with Aldactone

®

, tell the doctor if:

∙ you suffer from kidney disease, especially children with

hypertension, or liver disease. The doctor will routinely

assess you, particularly if you are elderly.

∙ you have difficulty passing urine.

∙ you have a disease that can result in electrolyte balance

disturbance in your blood such as potassium or sodium.

∙ you have severe heart failure.

∙ you are pregnant.

! If you experience reduced kidney function or kidney failure,

you may have a severe increase in the levels of potassium

in the blood. This condition may affect the way the heart

functions and in extreme cases may even be fatal.

! Concomitant use of Aldactone

with certain medicines,

potassium supplements and food rich in potassium may

lead to severe hyperkalaemia (increased potassium blood

level). The symptoms of severe hyperkalemia might include

muscle cramps, irregular heart rhythm, diarrhea, nausea,

dizziness or headache.

Drug interactions

If you are taking, or have recently taken, other medicines,

including non-prescription medicines and nutritional

supplements, tell the doctor or pharmacist. Your doctor

may want to adjust the Aldactone

®

dosage. Especially if

you are taking:

∙ digoxin or carbenoxolone

medicines for high blood pressure including preparations from

the angiotensin-converting enzyme (ACE) inhibitor group

∙ diuretics

∙ non-steroidal anti-inflammatory drugs (NSAIDS) (such as

aspirin, indomethacin, mefenamic acid or ibuprofen)

∙ potassium supplements

∙ heparin or low molecular weight heparin (medicines to

prevent blood clots)

∙ antipyrine

∙ medicines known to cause hyperkalemia (raised blood

potassium levels)

∙ trimethoprim and trimethoprim-sulfamethoxazole

Aldactone

reduces your responsiveness to noradrenaline. If

you are going to have an operation where you are expected

to receive anesthetics, tell the doctor that you are taking

Aldactone

Use of the medicine and food

Take the medicine with food.

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant

or are planning to become pregnant, consult the doctor before

taking this medicine.

Do not use the medicine if you are breastfeeding.

Consult with the doctor regarding use of the medicine. The

doctor will advise you to consider an alternative method of

feeding your baby while you are taking this medicine.

Driving and using machines

Take care when driving a car or operating dangerous

machinery. Use of this medicine may cause drowsiness and

dizziness which may affect your ability to drive a car or operate

dangerous machinery.

3. HOW SHOULD YOU USE THE MEDICINE?

Always use the preparation according to the doctor’s

instructions. Check with the doctor or pharmacist if you

are uncertain about the dosage and treatment regimen of

the preparation. The dosage and treatment regimen will be

determined by the doctor only.

The medicine should be taken once a day with food.

Elderly

The doctor may prescribe a low dosage for you and gradually

increase the dosage as needed, to obtain the desired effect.

Children and adolescents

Dosages for children are calculated according to their weight.

The attending doctor will calculate the dose that the child

should be given.

The treatment in children should be done under the

supervision of a specialist in treating children.

Do not exceed the recommended dose!

Complete the treatment regimen recommended by the

doctor.

Even if there is an improvement in your health, do not stop

treatment with the medicine without consulting the doctor.

There is no information regarding crushing/halving/chewing.

If you took an overdose or if a child has accidentally

swallowed the medicine, immediately refer to a doctor or

proceed to a hospital emergency room and bring the package

of the medicine with you. The symptoms of an overdose may

include feeling drowsy, dizzy, feeling dehydrated and you

may feel confused. You may suffer from nausea or vomiting,

diarrhea and rashes that will appear as flat red areas of skin

with overlapping small raised bumps.

Changes in the blood sodium and potassium levels may cause

a feeling of weakness, tingling, or numbness of the skin and/or

muscle spasms, but these symptoms are unlikely when an

overdose is taken.

If you forget to take this medicine at the required time, take

a dose as soon as you remember unless it is almost time for

the next dose, but never take a double dose to compensate

for a forgotten dose!

If you stop taking the medicine

It is important to keep taking Aldactone

until your doctor tells

you to stop, even if you start to feel better. If you stop taking

the medicine too soon, your condition may get worse.

Do not take medicines in the dark! Check the label and

the dose each time you take medicine. Wear glasses if

you need them.

If you have further questions regarding use of the medicine,

consult the doctor or pharmacist.

4. SIDE EFFECTS

As with any medicine, use of Aldactone

may cause side

effects in some users. Do not be alarmed when reading the

list of side effects. You may not suffer from any of them.

Refer to the doctor immediately if you experience any of the

following symptoms after taking the medicine. Although these

effects are rare, the symptoms may be severe:

∙ Itchiness and blistering of the skin around the lips and the

rest of the body, red or purple rash spreading and forming

blisters (Stevens-Johnson syndrome)

∙ Detachment of the top layer of skin from the lower layers of

the skin, all over the body (toxic epidermal necrolysis)

∙ Skin rash, fever and swelling (which could be symptoms of

something more serious –

Drug Reaction with Eosinophilia

and Systemic Symptoms

∙ Yellow tint to the skin and eyes (jaundice)

∙ The medicine can impair liver function

∙ Irregular heartbeat which can be fatal, tingling sensation,

paralysis (inability to use muscles) or difficulty in breathing,

which may be symptoms of raised potassium levels in

the blood. The doctor will conduct periodic blood tests to

monitor potassium and other electrolyte levels in the blood.

The doctor may stop the treatment.

Additional side effects:

Very common side effects (may affect more than 1 in 10

people):

∙ Raised potassium levels in the blood

Common side effects (may affect up to 1 in 10 people):

∙ Confusion

∙ Dizziness

∙ Vomiting or feeling sick

∙ Itching of the skin

∙ Rash

∙ Muscle or leg cramps

∙ Kidney failure or abnormal kidney function

∙ Breast tissue enlargement in men

∙ Breast pain (in men)

∙ Feeling generally unwell

Uncommon side effects (may affect up to 1 in 100

people):

∙ Changes in the breast such as: breast lumps

∙ Changes in electrolyte levels in the body, such as: high blood

calcium levels

∙ Abnormal functioning of the liver

∙ Allergic reaction in the skin, including itchiness and hives,

nettle like rash (urticaria)

∙ Menstrual changes in women

∙ Breast pain (in women)

Side effects of unknown frequency (effects whose frequency

cannot be determined from the available data):

∙ Lowered white blood cell count in blood

∙ Reduced number of cells in the blood that fight infections,

white blood cells, which makes infection more likely

∙ Reduced number of cells that help with blood clotting, which

increases the risk of bleeding or bruising

∙ Changes in sex drive (in both men and women)

∙ Digestive problems, abdominal discomfort

∙ Skin problem presenting with fluid-filled blisters

(pemphigoid)

∙ Hair loss

∙ Excessive hair growth

If a side effects occurs, if one of the side effects worsens,

or if you suffer from a side effect not mentioned in the

leaflet, consult with the doctor.

Side effects can be reported to the Ministry of Health by

clicking on the link “Report Side Effects of Drug Treatment”

found on the Ministry of Health homepage (www.health.gov.il)

that directs you to the online form for reporting side effects, or

by entering the link: https://sideeffects.health.gov.il

5. HOW SHOULD THE MEDICINE BE STORED?

Avoid poisoning! This medicine and any other medicine

should be kept in a safe place out of the reach of children

and/or infants in order to avoid poisoning. Do not induce

vomiting unless explicitly instructed to do so by the doctor.

∙ Do not use the medicine after the expiry date (exp. date) that

appears on the package. The expiry date refers to the last

day of that month.

∙ Store the medicine at a temperature below 30°C.

6. FURTHER INFORMATION

In addition to the active ingredient, the medicine also

contains:

Calcium sulphate dihydrate, Corn starch, Povidone K-30,

Peppermint flavor, Hypromellose 5cps, Hypromellose

15cps, Opaspray M-1-6032B yellow, Magnesium stearate,

Polyethylene glycol 400.

What the medicine looks like and the contents of the

package:

A carton package that contains two trays (blisters).

Each tray contains 10 round tablets.

License holder: Pfizer PFE Pharmaceuticals Israel Ltd.,

9 Shenkar St., Herzliya Pituach 46725.

Manufacturer: Piramal Healthcare Limited, Northumberland,

This leaflet was checked and approved by the Ministry of

Health in December 2016 and was updated in accordance

with the Ministry of Health guidelines in August 2019

Registration number of the medicine in the National Drug

Registry of the Ministry of Health: 125.97.24826

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Summary of Product Characteristics

1.

NAME OF THE MEDICINAL PRODUCT

Aldactone

25mg

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each coated tablet contains 25mg spironolactone

For the full list of excipients, see section 6.1.

3.

PHARMACEUTICAL FORM

Aldactone 25mg tablets are round buff, film coated tablets.

4.

CLINICAL PARTICULARS

4.1

Therapeutic indications

Congestive heart failure

Cirrhotic ascites

4.2

Posology and method of administration

Administration of Aldactone 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 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

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If urinary Na+/K+ ratio is greater than 1.0, 100 mg/day. If the ratio is less than 1.0, 200 mg/day to

400 mg/day. Maintenance dosage should be individually determined.

Elderly

It is recommended that treatment is started with the lowest dose and titrated upwards as required

to achieve maximum benefit. Care should be taken with severe hepatic and renal impairment

which may alter drug metabolism and excretion.

Paediatric population

Initial daily dosage should provide 3 mg of spironolactone per kilogram body weight given in

divided doses. Dosage should be adjusted on the basis of response and tolerance (see sections 4.3

and 4.4).

Children should only be treated under guidance of a paediatric specialist. There is limited

paediatric data available (see sections 5.1 and 5.2).

4.3

Contraindications

Spironolactone is contraindicated in adult and paediatric patients with the following:

acute renal insufficiency, significant renal compromise, anuria

Addison’s disease

hyperkalaemia

hypersensitivity to spironolactone or to any of the excipients listed in section 6.1

concomitant use of eplerenone or other potassium sparing diuretics

Spironolactone is contraindicated in paediatric patients with moderate to severe renal

impairment

Aldactone should not be administered concurrently with other potassium conserving diuretics and

potassium supplements should not be given routinely with Aldactone as hyperkalaemia may be

induced.

4.4

Special warnings and precautions for use

Fluid and electrolyte balance

Fluid and electrolyte status should be regularly monitored particularly in the elderly, in those with

significant renal and hepatic impairment.

Hyperkalaemia may occur in patients with impaired renal function or excessive potassium intake

and can cause cardiac irregularities which may be fatal. Should hyperkalaemia develop

Aldactone should be discontinued, and if necessary, active measures taken to reduce the serum

potassium to normal (see section 4.3).

Reversible hyperchloraemic metabolic acidosis, usually in association with hyperkalaemia has

been reported to occur in some patients with decompensated hepatic cirrhosis, even in the

presence of normal renal function.

Concomitant use of Aldactone with other potassium-sparing diuretics, angiotensin-converting

enzyme (ACE) inhibitors, nonsteroidal anti-inflammatory drugs, angiotensin II antagonists,

aldosterone blockers, heparin, low molecular weight heparin or other drugs or conditions known

to cause hyperkalaemia, potassium supplements, a diet rich in potassium or salt substitutes

containing potassium, may lead to severe hyperkalaemia.

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Urea

Reversible increases in blood urea have been reported in association with Aldactone therapy,

particularly in the presence of impaired renal function.

Hyperkalaemia in Patients with Severe Heart Failure

Hyperkalaemia may be fatal. It is critical to monitor and manage serum potassium in patients

with severe heart failure receiving spironolactone. Avoid using other potassium-sparing

diuretics. Avoid using oral potassium supplements in patients with serum potassium >3.5

mEq/L. The recommended monitoring for potassium and creatinine is 1week after initiation or

increase in dose of spironolactone, monthly for the first 3 months, then quarterly for a year,

and then every 6 months. Discontinue or interrupt treatment for serum potassium >5 mEq/L

or for serum creatinine >4 mg/dL (see section 4.2).

Paediatric population

Potassium-sparing diuretics should be used with caution in hypertensive paediatric patients

with mild renal insufficiency because of the risk of hyperkalaemia. (Spironolactone is

contraindicated for use in paediatric patients with moderate or severe renal impairment; see

section 4.3).

4.5

Interactions with other medicinal products and other forms of interaction

Concomitant use of drugs known to cause hyperkalaemia with spironolactone may result in

severe hyperkalaemia.

In addition, concomitant use of trimethoprim/sulfamethoxazole (co-

trimoxazole) with spironolactone may result in clinically relevant hyperkalaemia.

Spironolactone has been reported to increase serum digoxin concentration and to interfere with

certain serum digoxin assays. In patients receiving digoxin and spironolactone the digoxin

response should be monitored by means other than serum digoxin concentrations, unless the

digoxin assay used has been proven not to be affected by spironolactone therapy. If it proves

necessary to adjust the dose of digoxin patients should be carefully monitored for evidence of

enhanced or reduced digoxin effect.

Potentiation of the effect of antihypertensive drugs occurs and their dosage may need to be

reduced when Aldactone is added to the treatment regime and then adjusted as necessary. Since

ACE inhibitors decrease aldosterone production they should not routinely be used with

Aldactone, particularly in patients with marked renal impairment.

As carbenoxolone may cause sodium retention and thus decrease the effectiveness of Aldactone

concurrent use should be avoided.

Non-steroidal anti-inflammatory drugs such as aspirin, indomethacin, and mefenamic acid may

attenuate the natriuretic efficacy of diuretics due to inhibition of intrarenal synthesis of

prostaglandins and. have been shown to attenuate the diuretic effect of spironolactone.

Spironolactone reduces vascular responsiveness to noradrenaline. Caution should be exercised in

the management of patients subjected to regional or general anaesthesia while they are being

treated with Aldactone.

In fluorimetric assays, spironolactone may interfere with the estimation of compounds with

similar fluorescence characteristics.

Spironolactone has been shown to increase the half-life of digoxin.

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Spironolactone enhances the metabolism of antipyrine.

Spironolactone can interfere with assays for plasma digoxin concentrations

4.6

Fertility, pregnancy and lactation

Pregnancy

Spironolactone or its metabolites may cross the placental barrier. With spironolactone,

feminisation has been observed in male rat foetuses. The use of Aldactone in pregnant women

requires that the anticipated benefit be weighed against the possible hazards to the mother and

foetus.

Breast-feeding

Metabolites of spironolactone have been detected in breast milk. If use of Aldactone is

considered essential, an alternative method of infant feeding should be instituted.

4.7

Effects on ability to drive and use machines

Somnolence and dizziness have been reported to occur in some patients. Caution is advised

when driving or operating machinery until the response to initial treatment has been

determined.

4.8

Undesirable effects

Gynaecomastia may develop in association with the use of spironolactone. Development appears

to be related to both dosage level and duration of therapy and is normally reversible when the

drug is discontinued. In rare instances some breast enlargement may persist.

The following adverse events have been reported in association with spironolactone therapy:

System

Organ Class

Very

Common

≥ 1/10

Common

≥ 1/100 to

< 1/10

Uncommo

n

≥ 1/1,000

to < 1/100

Rare

≥ 1/10,000

to

< 1/1,000

Very Rare

< 1/10,000

Frequency

Not Known

(cannot be

estimated

from the

available

data)

Neoplasms

benign,

malignant

unspecified

(including

cysts and

polyps)

Benign

breast

neoplasm

(male)

Blood and

lymphatic

system

disorders

Agranulocytos

Leukopenia,

Thrombocytop

enia

Metabolism

and nutrition

disorders

Hyperkala

emia

Electrolyte

imbalance

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System

Organ Class

Very

Common

≥ 1/10

Common

≥ 1/100 to

< 1/10

Uncommo

n

≥ 1/1,000

to < 1/100

Rare

≥ 1/10,000

to

< 1/1,000

Very Rare

< 1/10,000

Frequency

Not Known

(cannot be

estimated

from the

available

data)

Psychiatric

disorders

Confusion

al state

Libido

disorder

Nervous

system

disorders

Dizziness

Gastrointesti

nal disorders

Nausea

Gastrointestina

l disorder

Hepatobiliar

y disorders

Hepatic

function

abnormal

Skin and

subcutaneous

tissue

disorders

Pruritus,

Rash

Urticaria

Toxic

epidermal

necrolysis

(TEN),

Stevens-

Johnson

syndrome,

Drug reaction

with

eosinophilia

and systemic

symptoms

(DRESS),

Alopecia,

Hypertrichosis

, Pemphigoid

Musculoskel

etal and

connective

tissue

disorders

Muscle

spasms

Renal and

urinary

disorders

Acute

kidney

injury

Reproductive

system and

breast

disorders

Gynaecom

astia,

Breast

pain

(male)

Menstrual

disorder,

Breast

pain

(female)

General

disorders and

administratio

n site

conditions

Malaise

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System

Organ Class

Very

Common

≥ 1/10

Common

≥ 1/100 to

< 1/10

Uncommo

n

≥ 1/1,000

to < 1/100

Rare

≥ 1/10,000

to

< 1/1,000

Very Rare

< 1/10,000

Frequency

Not Known

(cannot be

estimated

from the

available

data)

Abbreviations: CDS = Core Data Sheet; F = female; LLT = lower level term; M = male; PT =

preferred term; WHO-ART = World Health Organization Adverse Drug Reaction Terminology.

The term Breast pain is mapped from CDS and the frequency is derived from WHO-ART term

Breast pain (M); however, Breast pain male is the LLT.

Breast pain is the PT from CDS, and the frequency is derived from WHO-ART term Breast

pain (F).

Reporting of suspected adverse reactions

Reporting

suspected

adverse

reactions

after

authorisation

medicinal

product

important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

Any suspected adverse events should be reported to the Ministry of Health according to the

National Regulation by using an online form

https://sideeffects.health.gov.il/

4.9

Overdose

Acute overdosage may be manifested by drowsiness, mental confusion, nausea, vomiting,

dizziness or diarrhoea. Hyponatraemia, or hyperkalaemia may be induced, but these effects are

unlikely to be associated with acute overdosage. Symptoms of hyperkalaemia may manifest as

paraesthesia, weakness, flaccid paralysis or muscle spasm and may be difficult to distinguish

clinically from hypokalaemia. Electrocardiographic changes are the earliest specific signs of

potassium disturbances. No specific antidote has been identified. Improvement may be expected

after withdrawal of the drug. General supportive measures including replacement of fluids and

electrolytes may be indicated. For hyperkalaemia, reduce potassium intake, administer potassium-

excreting diuretics, intravenous glucose with regular insulin or oral ion-exchange resins.

5.

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

Pharmacotherapeutic group: potassium-sparing agents, ATC code C03DA01

Mechanism of action

Spironolactone, as a competitive aldosterone antagonist, increases sodium excretion whilst

reducing potassium loss at the distal renal tubule. It has a gradual and prolonged action.

Clinical efficacy and safety

Severe Heart Failure

RALES was a multinational, double-blind study in 1663 patients with an ejection fraction of

≤35%, a history of NYHA Class IV heart failure within 6 months, and Class III-IV heart

failure at the time of randomization. All patients were taking a loop diuretic, 97% were taking

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an ACE inhibitor and 78% were on digoxin (at the time this trial was conducted, b-blockers

were not widely used to treat heart failure and only 15% were treated with a b-blocker).

Patients with a baseline serum creatinine of >2.5 mg/dL or a recent increase of 25% or with a

baseline serum potassium of >5.0 mEq/L were excluded. Patients were randomized 1:1 to

spironolactone 25 mg orally once daily or matching placebo. Patients who tolerated 25 mg

once daily had their dose increased to 50 mg once daily as clinically indicated. Patients who

did not tolerate 25 mg once daily had their dosage reduced to 25 mg every other day. The

primary endpoint for RALES was time to all-cause mortality. RALES was terminated early,

after a mean follow-up of 24 months, because of significant mortality benefit detected on a

planned interim analysis. Spironolactone reduced the risk of death by 30% compared to

placebo (p<0.001; 95% confidence interval 18% - 40%). Spironolactone also significantly

reduced the risk of cardiac death, primarily sudden death and death from progressive heart

failure as well as the risk of hospitalization for cardiac causes. Changes in NYHA class were

more favourable with spironolactone. Gynaecomastia or breast pain was reported in 10% of

men who were treated with spironolactone, as compared with 1% of men in the placebo group

(p<0.001). The incidence of serious hyperkalaemia was low in both groups of patients.

Paediatric population

There is a lack of substantive information from clinical studies on spironolactone in children.

This is a result of several factors: the few trials that have been performed in the paediatric

population, the use of spironolactone in combination with other agents, the small numbers of

patients evaluated in each trial and the different indications studied. The dosage

recommendations for paediatrics are based upon clinical experience and case studies

documented in the scientific literature.

5.2

Pharmacokinetic properties

Spironolactone is well absorbed orally and is principally metabolised to active metabolites: sulfur

containing metabolites (80%) and partly canrenone (20%). Although the plasma half life of

spironolactone itself is short (1.3 hours) the half lives of the active metabolites are longer (ranging

from 2.8 to 11.2 hours). Elimination of metabolites occurs primarily in the urine and

secondarily through biliary excretion in the faeces.

Following the administration of 100 mg of spironolactone daily for 15 days in non-fasted

healthy volunteers, time to peak plasma concentration (t

), peak plasma concentration (C

and elimination half-life (t

) for spironolactone is 2.6 hr., 80 ng/ml, and approximately 1.4

hr., respectively. For the 7-alpha-(thiomethyl) spironolactone and canrenone metabolites, t

was 3.2 hr. and 4.3 hr., C

was 391 ng/ml and 181 ng/ml, and t

was 13.8 hr. and 16.5 hr.,

respectively.

The renal action of a single dose of spironolactone reaches its peak after 7 hours, and activity

persists for at least 24 hours

Paediatric population

There are no pharmacokinetic data available in respect of use in paediatric population. The

dosage recommendations for paediatrics are based upon clinical experience and case studies

documented in the scientific literature.

5.3

Preclinical safety data

Carcinogenicity: Spironolactone has been shown to produce tumours in rats when administered at

high doses over a long period of time. The significance of these findings with respect to clinical

use is not certain. However the long term use of spironolactone in young patients requires careful

consideration of the benefits and the potential hazard involved. Spironolactone or its metabolites

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may cross the placental barrier. With spironolactone, feminisation has been observed in male rat

foetuses. The use of Aldactone in pregnant women requires that the anticipated benefit be

weighed against the possible hazards to the mother and foetus.

6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Calcium sulphate dihydrate, Corn starch, Povidone K-30, Peppermint flavor, ,

Hypromellose 5cps, Hypromellose 15cps, , Opaspray M-1-6032B yellow, Magnesium stearate,

Polyethylene glycol 400.

6.2

Incompatibilities

None stated.

6.3

Shelf life

The expiry date of the product is indicated on the packaging materials.

6.4

Special precautions for storage

Store below 30

6.5

Nature and contents of container

Aldactone 25mg tablets packaged in PVC/foil blister packs containing 20 tablets.

Not all pack sizes may be marketed.

6.6

Special precautions for disposal and other handling

No special requirements for disposal.

7. MANUFACTURER:

PIRAMAL HEALTHCARE UK LIMITED, NORTHUMBERLAND, UK.

8.LICENSE HOLDER:

Pfizer PFE Pharmaceuticals Israel Ltd.

9 Shenkar St.

Hertzliya Pituach 46725

9. LICENSE NUMBER

125-97-24826

The format of this leaflet was determined by the Ministry of Health and its content was checked and

approved in December 2016 and updated according to the guidelines of the Ministry of Health in

August 2019.

רזייפ יפ

ףא

יא

מ"עב לארשי הקיטבצמרפ

רקנש 'חר

.ד.ת ,

12133

לארשי ,חותיפ הילצרה

46725

:לט

972-9-9700500

:סקפ

972-9-9700501

רבמטפס

2019

,ה/דבכנ ת/חקור ,ה/אפור

ןוכדע לע ךעידוהל וננוצרב ןולעב

אפורל

ןולעב ןכרצל לש

coated tablets

ALDACTONE 25mg

:

ןוטקדלא

25

ג"מ

תופוצמ תוילבט

:ליעפה ביכרמה

SPIRONOLACTONE

25 mg

Indicated for:

Congestive heart failure, cirrhotic ascites.

:אפורל ןולעב םיירקיעה םינוכדעה ןלהל

4.8

U

NDESIRABLE EFFECTS

:

System Organ

Class

Very

Common

≥ 1/10

Common

≥ 1/100 to <

1/10

Uncomm

on

≥ 1/1,000

to

< 1/100

Rare

1/10,000

to

< 1/1,000

Very Rare

< 1/10,000

Frequency Not

Known

(cannot be

estimated from

the available

data)

Neoplasms benign,

malignant and

unspecified

(including cysts

and polyps)

Benign

breast

neoplasm

(male)

Blood and

lymphatic system

disorders

Agranulocytosis

, Leukopenia,

Thrombocytope

Metabolism and

nutrition disorders

Hyperkal

aemia

Electrolyt

imbalanc

Psychiatric

disorders

Confusional

state

Libido disorder

Nervous system

disorders

Dizziness

Gastrointestinal

disorders

Nausea

Gastrointestinal

disorder

Hepatobiliary

disorders

Hepatic

function

abnormal

System Organ

Class

Very

Common

≥ 1/10

Common

≥ 1/100 to <

1/10

Uncomm

on

≥ 1/1,000

to

< 1/100

Rare

1/10,000

to

< 1/1,000

Very Rare

< 1/10,000

Frequency Not

Known

(cannot be

estimated from

the available

data)

Skin and

subcutaneous

tissue disorders

Pruritus,

Rash

Urticaria

Toxic

epidermal

necrolysis

(TEN), Stevens-

Johnson

syndrome, Drug

reaction with

eosinophilia

and systemic

symptoms

(DRESS),

Alopecia,

Hypertrichosis,

Pemphigoid

Musculoskeletal

and connective

tissue disorders

Muscle

spasms

Renal and urinary

disorders

Acute

kidney

injury

Reproductive

system and breast

disorders

Gynaecomas

tia,

Breast pain

(male)

Menstrual

disorder,

Breast

pain

(female)

General disorders

and administration

site conditions

Malaise

Abbreviations: CDS = Core Data Sheet; F = female; LLT = lower level term; M = male; PT = preferred

term; WHO-ART = World Health Organization Adverse Drug Reaction Terminology.

The term Breast pain is mapped from CDS and the frequency is derived from WHO-ART term Breast

pain (M); however, Breast pain male is the LLT.

Breast pain is the PT from CDS, and the frequency is derived from WHO-ART term Breast pain (F).

יעה םינוכדעה ןלהל :ןכרצל ןולעב םיירק

1

.

הפורתב שומישה ינפל

...

:הפורתב שומישל תועגונה תודחוימ תורהזא

...

ןוזמו הפורתב שומיש

.ןוזמ םע הפורתה תא לוטיל שי

...

הקנהו ןוירה

,ןוירהב ךנה םא הקינמ .וז הפורת תליטנ ינפל אפורה םע ץעייתהל שי ןוירה תננכתמ וא ןוירהב תויהל הלולע ךנהש תבשוח ,

...

.העילב / הייצח /השיתכ יבגל עדימ ןיא

...

תויוחיכש ליכהל ןכדוע יאוול תועפות ףיעס

4

.

יאוול תועפות

...

אפורל דימ תונפל שי תואבה יאוולה תועפותמ תחאמ לבוס התא םא ,תורידנ הלא תועפותש תורמל .הפורתה תליטנ רחאל םירומח תויהל םילולע םינימסתה

ףוגה ראשבו םייתפשה ביבס רועב תויחופלש תעפוהו דרג תויחופלש תורצוויהו הלוגס וא המודא תטשפתמ החירפ סנביטס תנומסת) (ןוסנו'ג

,ינלער ילמרדיפא קמנ) ףוגה לכב ,תונותחתה תובכשהמ רועה לש הנוילעה הבכשה לש תודרפה

toxic epidermal necrolysis

תוחיפנו םוח ,רועב החירפ

רתוי רומח בצמ לש םינימסת תויהל םילולעש]

היליפוניזואא םע תיתפורת הבוגת

,םייתכרעמ םינימסתו

nd Systemic Symptoms

Drug Reaction with Eosinophilia a

[

...

:תופסונ יאוול תועפות

תועפות

יאוול

תוחיכש

מ רתוי לע עיפשהל תויושע) דואמ

-

1

ךותמ

10

(םישנא

:

םדב ןגלשא לש תוהובג תומר

תועפות

יאוול

דע לע עיפשהל תויושע) תוחיכש

1

ךותמ

10

(םישנא

:

לובלב

תורוחרחס

האקה

הליחב וא

רועב דרג

החירפ

םילגרב וא םירירשב תויוצווכתה

וא יתיילכ לשכ דוקפתב הערפה הייליכה

םירבגב דשה תמקר תלדגה

(םירבגב) םיידשב באכ

תיללכ ילוח תשוחת

תועפות

יאוול

אל

דע לע עיפשהל תויושע) תוחיכש

1

ךותמ

100

:(םישנא

דשב םייוניש

דשב םישוג :ןוגכ

גב םיטילורטקלאה תומרב םייוניש ףו םדב ההובג ןדיס תמר :ןוגכ

ןיקת אל דבכ דוקפת

הבוגת ,תדפרסו דרג תללוכה רועב תיגרלא תתשורמ החירפ

(הירקיטרוא)

םישנב רוזחמב םייוניש

(םישנב) םיידשב באכ

תועפות

ןתוחיכשש יאוול

הניא

:(םימייקה םינותנהמ ןתוחיכש עובקל ןתינ אלש תועפות) העודי

לש הכומנ הריפס םדב םינבל םד יאת

םימוהיזב םימחלנש םדב םיאתה רפסמב הדירי

תוריבסה תא הלעמש המ םינבל םד יאת םימוהיזל

תורובח וא םימומידל תוריבסה תא הלידגמש , םדהתשירקב םיעייסמה םיאת רפסמב הדירי

ינימה קשחב םייוניש םישנבו םירבגב)

לוכיעב תויעב ןטבב תוחונ יא ,

ה רועב היעב ) לזונב תואלמ תויחופלשב תאטבתמ

pemphigoid

רעיש תרישנ

רתי רועיש

...

ץעייתהל ךילע ,ןולעב הניוצ אלש יאוול תעפותמ לבוס התא רשאכ וא ,הרימחמ יאוולה תועפותמ תחא םא ,יאוול תעפות העיפוה םא .אפורה םע

םייונישה בוהצ עקרב םישגדומה

חסונ ינוכדעו עדימ תטמשה ,עדימ תפסות םיללוכה םיפסונ םייוניש ועצוב ,ןכ ומכ .הרמחה םיווהמ מחה םיווהמ םניאש .תואירבה דרשמ רתאב םינימז םינכדועמה םינולעה .הר

https://www.old.health.gov.il/units/pharmacy/trufot/index.asp?safa=h

תרבחל תונפל ןתינ ספדומ אלמ ןולע תלבקל ,ןיפוליחל רזייפ

מ"עב לארשי הקיטבצמרפ

רקנש

.ד.ת ,

12133

,חותיפ הילצרה

46725

,הכרבב

רדיבא םלש תידיע

הנוממ תחקור

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