ANDROCUR 50

Israel - English - Ministry of Health

Buy It Now

Active ingredient:
CYPROTERONE ACETATE
Available from:
BAYER ISRAEL LTD
ATC code:
G03HA01
Pharmaceutical form:
TABLETS
Composition:
CYPROTERONE ACETATE 50 MG
Administration route:
PER OS
Prescription type:
Required
Manufactured by:
BAYER WEIMAR GMBH UND CO.KG, GERMANY
Therapeutic group:
CYPROTERONE
Therapeutic area:
CYPROTERONE
Therapeutic indications:
For antiandrogen therapy in men: sexual disorders, inoperable prostatic carcinoma.
Authorization number:
020 60 21123 01
Authorization date:
2011-10-31

Documents in other languages

Patient Information leaflet Patient Information leaflet - Arabic

17-01-2021

Patient Information leaflet Patient Information leaflet - Hebrew

10-06-2020

Packaging Technology Berlin gf

page 1

Bayer Pharma AG

client: GV04

itemno.: 81203571

PZ: 9307A-4A

code-no.: 131

name: LF-Androcur 50MG TAB H6

country: IL BPH

colors: Black

version: 20.12.2012/02

approval:

replaces: 80816546

Androcur

50

Tablets

81203571_02.indd 1

81203571_02.indd 1

20.12.2012 11:57:48

20.12.2012 11:57:48

1.

Name of the medicinal product

Androcur 50 mg tablets

2.

Qualitative and quantitative composition

Each tablet contains 50 mg cyproterone acetate.

Excipient with known effect: Lactose 108.75 mg

For the full list of excipients, see section 6.1.

3.

Pharmaceutical form

Tablet.

Round tablet. White to faintly yellowish tablets, scored on one side, with an embossed "BV"

in a regular hexagon on the other side.

4.

Clinical particulars

4.1

Therapeutic Indications

For antiandrogen therapy in men: sexual disorders, inoperable prostatic carcinoma.

4.2

Posology and method of administration

Posology

The maximum daily dose is 300 mg.

Adults

Reduction of drive in sexual deviations in men

Generally, treatment is started with 1 tablet Androcur 50 mg twice daily. It may be necessary

to increase the dose to 2 tablets twice daily, or even 2 tablets three times daily for a short

period of time. When a satisfactory result has been achieved, one should try to maintain the

therapeutic effect with the lowest possible dose. Quite often 1/2 tablet twice daily is

sufficient. When establishing the maintenance dose or when discontinuing the preparation,

one should not reduce the dosage abruptly, but gradually.

To this end, the daily dose should be reduced by 1 tablet, or better 1/2 tablet, at intervals of

several weeks.

To stabilize the therapeutic effect it is necessary to take Androcur over a protracted period of

time, if possible with the simultaneous use of psychotherapeutic measures.

Antiandrogen treatment in inoperable carcinoma of the prostate

2 tablets Androcur 50 mg twice to three times daily (= 200 - 300 mg).

Treatment should not be interrupted nor the dosage reduced after improvement or

remissions have occurred.

To reduce the initial increase of male sex hormones in combination therapy with GnRH

agonists.

Initially 2 tablets Androcur 50 mg twice daily (= 200 mg) alone for 5 - 7 days, followed by 2

tablets Androcur 50 mg twice daily (= 200 mg) for 3 - 4 weeks together with a GnRH agonist

in the dosage recommended by the marketing authorization holder (see prescribing

information of GnRH agonist).

To treat hot flushes in patients under combination therapy with GnRH analogs or who

have had orchiectomy.

1-3 tablets Androcur 50 mg per day (50-150 mg) with upward titration up to 2 tablets three

times daily (300 mg) if necessary.

Additional information on special populations

Paediatric population

Androcur is not recommended for use in male children and adolescents below 18 years of

age due to a lack of data on safety and efficacy.

Androcur must not be given before the conclusion of puberty since an unfavourable

influence on longitudinal growth and the still unstabilised axes of endocrine function cannot

be ruled out.

Older people

There are no data suggesting the need for a dosage adjustment in elderly patients.

Patients with hepatic impairment

The use of Androcur is contraindicated in patients with liver diseases (see section 4.4 and

4.8). i.e. as long as liver function values have not returned to normal.

Patients with renal impairment

The use of Androcur in patients with renal impairment has not been investigated. There are

no data suggesting the need for dosage adjustment in patients with renal impairment (see

section 5.2).

Method of administration

The tablets are to be taken with some liquid after meals.

For oral administration.

4.3

Contraindications

Androcur must not be used in patients with:

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1

Liver diseases (including Dubin-Johnson syndrome and Rotor syndrome)

Malignant tumours (except for carcinoma of the prostate)

Previous or existing liver tumours

Wasting diseases (because of transient catabolic action)

A history of or existing thrombosis or embolism

Severe diabetes with vascular changes

Sickle cell anaemia

Severe chronic depression

Meningioma or a history of meningioma

Androcur should not be given to youths under 18 or to those whose bone maturation and

testicular development are incomplete.

4.4

Special warnings and precautions for use

Liver: Direct hepatic toxicity, including jaundice, hepatitis and hepatic failure , has been

observed in patients treated with Androcur. At dosages of 100 mg and above, cases with

fatal outcome have also been reported. Most reported fatal cases were in men with

advanced prostatic cancer. Toxicity is dose-related and develops, usually, several months

after treatment has begun. Liver function tests should be performed pre-treatment, regularly

during treatment and whenever any symptoms or signs suggestive of hepatotoxicity occur. If

hepatotoxicity is confirmed, Androcur should be withdrawn, unless the hepatotoxicity can be

explained by another cause, e.g. metastatic disease, in which case Androcur should be

continued only if the perceived benefit outweighs the risk.

In very rare cases benign and malignant liver tumours, which may lead to life-threatening

intra-abdominal haemorrhage have been observed after the use of Androcur. If severe upper

abdominal complaints, liver enlargement or signs of intra-abdominal haemorrhage occur, a

liver tumour should be considered in the differential diagnosis.

Thromboembolic events: The occurrence of thromboembolic events has been reported in

patients using Androcur, although a causal relationship has not been established. Patients

with previous arterial or venous thrombotic / thromboembolic events (e.g. deep vein

thrombosis, pulmonary embolism, myocardial infarction), with a history of cerebrovascular

accidents or with advanced malignancies are at increased risk of further thromboembolic

events, and may be at risk of recurrence of the disease during Androcur therapy. See also

section 4.3.

Meningiomas:

The occurrence of meningiomas (single and multiple) has been reported in association with

use of cyproterone acetate primarily at doses of 25 mg and above. The risk of meningioma

increases with increasing cumulative doses of cyproterone acetate (see section 5.1). High

cumulative doses can be reached with prolonged use (several years) or shorter duration with

high daily doses. Patients should be monitored for meningiomas in accordance with clinical

practice. If a patient treated with Androcur is diagnosed with meningioma, treatment with

Androcur and other cyproterone containing products must be permanently stopped (see

section ‘Contraindications’). There is some evidence that the meningioma risk may decrease

after treatment discontinuation of cyproterone.

Shortness of breaths: Shortness of breath may occur under high-dosed treatment with

Androcur. This may be due to the stimulatory effect of progesterone and synthetic

progestogens on breathing, which is accompanied by hypocapnia and compensatory

alkalosis, and which is not considered to require treatment.

Adrenocortical function: During treatment adrenocortical function should be checked

regularly, as preclinical data suggest a possible suppression due to the corticoid-like effect of

Androcur with high doses (see section 5.3).

Diabetes mellitus: Strict medical supervision is necessary if the patient suffers from diabetes

as Androcur can influence carbohydrate metabolism. Parameters of carbohydrate

metabolism should be examined carefully in all diabetics before and regularly during

treatment because the requirement for oral antidiabetics or insulin can change. See also

section 4.5.

Anaemia: Anaemia has been reported during long- term treatment. Therefore, the red blood

count should be checked regularly during treatment.

Lactose: Androcur contains 108.75 mg lactose per tablet. Patients with rare hereditary

problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose

malabsorption should not take this medicine. Patients who are on a lactose-free diet should

take this amount into consideration.

Spermatogenesis: A spermatogram should be recorded before starting treatment in patients

of procreative age, as a guard against attribution of pre-existing infertility to Androcur at a

later stage. It should be noted that the decline in spermatogenesis is slow, and Androcur

should, therefore, not be regarded as a male contraceptive.

Medico-legal considerations: Doctors are advised to ensure that the fully informed consent of

the patient to Androcur treatment is witnessed and can be verified.

4.5

Interaction with other medicinal products and other forms of interaction

Diabetes: At high therapeutic cyproterone acetate doses of three times 100 mg per day,

cyproterone acetate may inhibit CYP2C8 (see below). Thiazolidinediones (i.e. the anti-

diabetics pioglitazone and rosiglitazone) are substrates of CYP2C8 (increased blood levels

of these anti-diabetics may require dose adjustment).

Chronic alcoholism: Alcohol appears to reduce the effect of Androcur which is of no value in

chronic alcoholics.

Other interactions: Clinical interaction studies have not been performed. However, since

cyproterone acetate is metabolised by CYP3A4, it is expected that ketoconazole,

itraconazole, clotrimazole, ritonavir and other strong inhibitors of CYP3A4 inhibit the

metabolism of cyproterone acetate. On the other hand, inducers of CYP3A4 such as

rifampicin, phenytoin and products containing St. John's Wort may reduce the levels of

cyproterone acetate.

Based on in vitro inhibition studies, an inhibition of the cytochrome P450 enzymes CYP2C8,

2C9, 2C19, 3A4 and 2D6 is possible at high cyproterone acetate doses of 100 mg three

times per day. (This is three times the maximum total daily dose).

The risk of statin-associated myopathy or rhabdomyolysis may be increased when those

HMG-CoA inhibitors (statins) which are primarily metabolised by CYP3A4 are co-

administered with high cyproterone acetate doses, since they share the same metabolic

pathway.

4.6

Fertility, pregnancy and lactation

Not applicable.

4.7

Effects on ability to drive and use machines

Fatigue and lassitude are common - patients should be warned about this and if affected

should not drive or operate machinery.

4.8

Undesirable effects

The most frequently observed adverse drug reactions (ADRs) in patients receiving Androcur

are decreased libido, erectile dysfunction and reversible inhibition of spermatogenesis.

The most serious ADRs in patients receiving Androcur are hepatic toxicity, benign and

malignant liver tumours which may lead to intra-abdominal haemorrhage and

thromboembolic events.

The following approximate incidences were estimated from published reports of a number of

small clinical trials and spontaneous ADR reports:

very common: incidence ≥ 1:10

common: incidence < 1:10 but ≥ 1:100

uncommon: incidence < 1:100 but ≥ 1:1,000

rare: incidence < 1:1,000 but ≥ 1:10,000

very rare: incidence < 1:10,000

not known (cannot be estimated from available data)

Neoplasms benign, malignant and unspecified (incl. cysts and polyps)

Rare:

Meningioma. The occurrence of meningiomas (single and multiple)

has been reported in association with use of cyproterone acetate (see

section 4.4).

Very rare:

Benign and malignant liver tumours which may lead to life-threatening

intra-abdominal haemorrhage (see section 4.4).

Blood and the lymphatic system disorders

Not known:

Anaemia during long-term treatment (see section 4.4).

Immune system disorders

Rare:

Hypersensitivity reactions may occur.

Endocrine disorders

Not known:

Suppression of adrenocorticol function.

Metabolism and nutrition disorders

Common:

Changes in bodyweight during long term treatment (chiefly weight

gains in association with fluid retention)

Psychiatric disorders

Common:

Depressive moods and restlessness (temporary).

Vascular disorders

Not known:

Thromboembolic events, although a causal relationship has not been

established (see section 4.4).

Respiratory, thoracic and mediastinal disorders

Common:

Dyspnoea (see section 4.4).

Hepato-biliary disorders

Common:

Direct hepatic toxicity, including jaundice, hepatitis and hepatic failure

has been observed in patients treated with Androcur. At dosages of

100 mg and above, cases with fatal outcome have also been reported.

Most reported fatal cases were in men with advanced carcinoma of

the prostate. Toxicity is dose related and develops,

usually several months after treatment has begun.

Skin and subcutaneous tissue disorders

Uncommon:

Rash

Not known:

Reduction of sebum production leading to dryness of the skin and

improvement of existing acne vulgaris has been reported as well as;

transient patchy loss and reduced growth of body hair, increased

growth of scalp hair, lightening of hair colour and female type of pubic

hair growth.

Musculoskeletal and connective tissue disorders

Not known: Osteoporosis (due to long-term androgen deprivation).

Reproductive system disorders

Inhibition of spermatogenesis:

Very common: Sperm count and the volume of ejaculate are reduced.

Infertility is usual, and there may be azoospermia after 8 weeks. There is usually slight

atrophy of the seminiferous tubules. Follow-up examinations have shown these changes to

be reversible, spermatogenesis usually reverting to its previous state about 3-5 months after

stopping Androcur, or in some users, up to 20 months. That spermatogenesis can recover

even after very long treatment is not yet known. There is evidence that abnormal sperms

which might give rise to malformed embryos are produced during treatment with Androcur.

Gynaecomastia:

Common:

Gynaecomastia (sometimes combined with tenderness to touch of the

mamillae) which usually regresses after withdrawal of the preparation.

Rare:

Galactorrhoea and tender benign nodules have been reported.

Symptoms mostly subside after discontinuation of treatment or reduction of dosage.

General disorders and administration site conditions

Common:

Hot flushes, sweating, fatigue and lassitude.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is

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

There have been no reports of ill-effects from overdosage, which it is, therefore, generally

unnecessary to treat. There are no specific antidotes and if treatment is required it should be

symptomatic.

5.

Pharmacological properties

5.1

Pharmacodynamic properties

Pharmacotherapeutic group: sex hormones and modulators of the genital system,

antiandrogens, plain, ATC code: G03HA01

Cyproterone acetate acts as an antiandrogen by blocking androgen receptors. It also has

progestogenic activity, which exerts a negative feedback effect on hypothalamic receptors,

so leading to a reduction in gonadotrophin release, and hence to diminished production of

testicular androgens. Sexual drive and potency are reduced and gonadal function is

inhibited.

An occasional tendency for the prolactin levels to increase slightly has been observed under

higher doses of cyproterone acetate.

Meningioma

Based on results from a French epidemiological cohort study, a cumulative dose-dependent

association between cyproterone acetate (CPA) and meningioma has been observed. This

study was based on data from the French Health insurance (CNAM) and included a

population of 253,777 women using 50 - 100 mg CPA tablets. The incidence of meningioma

treated with surgery or radiotherapy was compared between women exposed to high-dose

CPA (cumulative

dose ≥3 g) and women who were slightly exposed to CPA (cumulative

dose <3 g). A cumulative dose-response relationship was demonstrated.

Incidence and risk of meningioma with different cumulative doses of CPA

Cumulative dose of

cyproterone acetate

Incidence rate (in patient

years)

(95% CI)

Slightly exposed (<3 g)

4.5/100,000

Ref.

Exposed to ≥3 g

23.8/100,000

6.6 [4.0-11.1]

12 to 36 g

26/100,000

6.4 [3.6-11.5]

36 to 60g

54.4/100,000

11.3 [5.8-22.2]

more than 60 g

129.1/100,000

21.7 [10.8-43.5]

Adjusted based on age as a time-dependent variable and oestrogen at inclusion

A cumulative dose of 36 g for example can correspond with one year of treatment with 100

mg/day.

5.2

Pharmacokinetic properties

Following oral administration, cyproterone acetate is completely absorbed over a wide dose

range. The ingestion of two cyproterone acetate 50 mg tablets gives maximum serum levels

of about 285 ng/ml at about 3 hours. Thereafter, drug serum levels declined during a time

interval of typically 24 to 120 h, with a terminal half-life of 43.9 ± 12.8 h. The total clearance

of cyproterone acetate from serum is 3.5 ± 1.5 ml/min/kg. Cyproterone acetate is

metabolised by various pathways, including hydroxylations and conjugations. The main

metabolite in human plasma is the 15

-hydroxy derivative.

Some drug is excreted unchanged with bile fluid. Most of the dose is excreted in the form of

metabolites at a urinary to biliary ratio of 3:7. The renal and biliary excretion proceeds with a

half-life of 1.9 days. Metabolites from plasma are eliminated at a similar rate (half-life of 1.7

days).

Cyproterone acetate is almost exclusively bound to plasma albumin. About 3.5 - 4 % of total

drug levels are present unbound. Because protein binding is non-specific, changes in SHBG

(sex hormone binding globulin) levels do not affect the pharmacokinetics of cyproterone

acetate.

The absolute bioavailability of cyproterone acetate is almost complete (88 % of dose).

5.3

Preclinical safety data

Systemic toxicity

Preclinical data reveal no specific risk for humans based on conventional studies of repeated

dose toxicity beyond those discussed in other sections of the SPC.

Experimental investigations produced corticoid-like effects on the adrenal glands in rats and

dogs following higher dosages, which could indicate similar effects in humans at the highest

given dose (300mg/day).

Genotoxicity and carcinogenicity

Recognised first-line tests of genotoxicity gave negative results when conducted with

cyproterone acetate.

However, further tests showed that cyproterone acetate was capable of

producing adducts with DNA (and an increase in DNA repair activity) in liver cells from rats

and monkeys and also in freshly isolated human hepatocytes the DNA-adduct level in the

dog liver cells was extremely low.

This DNA-adduct formation occurred at exposures that might be expected to occur in the

recommended dose regimens for cyproterone acetate. In vivo consequences of cyproterone

acetate treatment were the increased incidence of focal, possibly preneoplastic, liver lesions

in which cellular enzymes were altered in female rats, and an increase of mutation frequency

in transgenic rats carrying a bacterial gene as target for mutation. The clinical relevance of

these findings is presently uncertain.

In long-term carcinogenicity studies in rats cyproterone acetate increased the incidence of

liver tumours including carcinomas at high doses which concomitantly caused liver toxicity

and exceeded the maximum human dose. Further investigations into rodents at lower, non-

hepatotoxic doses revealed benign liver proliferations similar to effects described for other

steroid hormones. However, it must be borne in mind that sex steroids can promote the

growth of certain hormone dependent tissues and tumours.

6.

Pharmaceutical particulars

6.1

List of excipients

Lactose monohydrate

Maize starch

Povidone 25

Magnesium stearate

Colloidal silicon dioxide

6.2

Incompatibilities

None known

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

PVC/Aluminium blister pack.

Pack size: 50 tablets

6.6

Special precautions for disposal and other handling

No special requirements.

7.

Manufacturer:

DELPHARM LILLE S.A.S., FRANCE LYS-LEZ-LANNOY, FRANCE

BAYER WEIMAR GMBH UND CO.KG, GERMANY, WEIMAR, GERMANY

8.

Registration Holder:

Bayer Israel Ltd., 36 Hacharash St., Hod Hasharon 45240

Revised on May 2020

דומע

ךותמ

RESTRICTED

ץרמ

2020

ה/אפור

,ה/דבכנ

,ה/דבכנ ת/חקור

:ןודנה

Androcur 50

Tablets

50mg

CYPROTERONE ACETATE

ונא

םישקבמ םכעידוהל

ל ןולעהש ןכרצל ןולעהו אפור .ונכדוע רישכתה לש

יוותה

רישכתל תרשואמ

For antiandrogen therapy in men: sexual disorders, inoperable prostatic carcinoma.

וז העדוהב םילולכ

ינוכדיע

דבלב םייתוהמה

עיפומ ןלהלש טוריפב

הנושש קרפ לכ ךותמ ,םינולעב

קר .ןכדעתהש עדימה תפסות טסקט

תנמוסמ ןותחת וקב

וכדעה םינ

אפורל ןולעב

4.

CLINICAL PARTICULARS

4.3

Contraindications

Androcur must not be used in patients with:

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1

Liver diseases (including Dubin-Johnson syndrome and Rotor syndrome)

Malignant tumours (except for carcinoma of the prostate)

Previous or existing liver tumours

Wasting diseases (because of transient catabolic action)

A history of or existing thrombosis or embolism

Severe diabetes with vascular changes

Sickle cell anaemia

Severe chronic depression

Meningioma or a history of meningioma

Androcur should not be given to youths under 18 or to those whose bone maturation and testicular

development are incomplete

4.4

Interaction with other medicinal products and other forms of interaction

Diabetes:

At high therapeutic cyproterone acetate doses of three times 100 mg per day, cyproterone

acetate may inhibit CYP2C8 (see below). Thiazolidinediones (i.e. the anti-diabetics pioglitazone and

rosiglitazone) are substrates of CYP2C8 (increased blood levels of these anti-diabetics may require

dose adjustment).

דומע

ךותמ

RESTRICTED

Chronic alcoholism

: Alcohol appears to reduce the effect of Androcur which is of no value in chronic

alcoholics.

Other interactions:

Clinical interaction studies have not been performed. However, since cyproterone

acetate is metabolised by CYP3A4, it is expected that ketoconazole, itraconazole, clotrimazole,

ritonavir and other strong inhibitors of CYP3A4 inhibit the metabolism of cyproterone acetate. On the

other hand, inducers of CYP3A4 such as rifampicin, phenytoin and products containing St. John's

Wort may reduce the levels of cyproterone acetate.

Based on

in vitro

inhibition studies, an inhibition of the cytochrome P450 enzymes CYP2C8, 2C9,

2C19, 3A4 and 2D6 is possible at high cyproterone acetate doses of 100 mg three times per day. (This

is three times the maximum total daily dose).

The risk of statin-associated myopathy or rhabdomyolysis may be increased when those HMG-CoA

inhibitors (statins) which are primarily metabolised by CYP3A4 are co-administered with high

cyproterone acetate doses, since they share the same metabolic pathway.

4.8 Undesirable effects

Neoplasms benign, malignant and unspecified (incl. cysts and polyps)

Very rare:

Benign and malignant liver tumours which may lead to life-threatening

intra-abdominal haemorrhage (see section 4.4).

Not known:

The occurrence of (multiple) meningiomas has been reported in

association with longer term use (years) of cyproterone acetate at

doses of 25 mg/day and above.

Blood and the lymphatic system disorders

Not known:

Anaemia during long-term treatment (see section 4.4).

Immune system disorders

Rare:

Hypersensitivity reactions may occur.

Endocrine disorders

Not known:

Suppression of adrenocorticol function.

Metabolism and nutrition disorders

Common:

Changes in bodyweight during long term treatment (chiefly weight

gains in association with fluid retention)

Psychiatric disorders

דומע

ךותמ

RESTRICTED

Common:

Depressive moods and restlessness (temporary).

Vascular disorders

Not known:

Thromboembolic events, although a causal relationship has not been

established (see section 4.4).

Respiratory, thoracic and mediastinal disorders

Common:

Dyspnoea (see section 4.4).

Hepato-biliary disorders

Common:

Direct hepatic toxicity, including jaundice, hepatitis and hepatic failure

has been observed in patients treated with Androcur. At dosages of

100 mg and above, cases with fatal outcome have also been reported.

Most reported fatal cases were in men with advanced carcinoma of

the prostate. Toxicity is dose related and develops,

usually several months after treatment has begun.

Skin and subcutaneous tissue disorders

Uncommon:

Rash

Not known:

Reduction of sebum production leading to dryness of the skin and

improvement of existing acne vulgaris has been reported as well as;

transient patchy loss and reduced growth of body hair, increased

growth of scalp hair, lightening of hair colour and female type of pubic

hair growth.

Musculoskeletal and connective tissue disorders

Not known: Osteoporosis (due to long-term androgen deprivation).

Reproductive system disorders

Inhibition of spermatogenesis

Very common: Sperm count and the volume of ejaculate are reduced.

Infertility is usual, and there may be azoospermia after 8 weeks. There is usually slight atrophy of the

seminiferous tubules. Follow-up examinations have shown these changes to be reversible,

spermatogenesis usually reverting to its previous state about 3-5 months after stopping Androcur, or in

some users, up to 20 months. That spermatogenesis can recover even after very long treatment is not

yet known. There is evidence that abnormal sperms which might give rise to malformed embryos are

produced during treatment with Androcur.

דומע

ךותמ

RESTRICTED

Gynaecomastia:

Common:

Gynaecomastia (sometimes combined with tenderness to touch of the

mamillae) which usually regresses after withdrawal of the preparation.

Rare:

Galactorrhoea and tender benign nodules have been reported.

Symptoms mostly subside after discontinuation of treatment or reduction of dosage.

General disorders and administration site conditions

Common:

Hot flushes, sweating, fatigue and lassitude.

:ןכרצל ןולעב םינוכדעה

2

)

הפורתב שומישה ינפל

זא

ה

ר

ו

ת

מ

תועגונה תודחוי

ל

שומיש

הפורתב

:

דבכב תויעב ךלש אפורה יכ ןכתי .טאטצא ןורטורפיצ םע לופיטב וחווד , תוינלטק וליפא וא תורומח ןקלח , תא קיספי יכ ןכתי ףאו תאז רטנל תנמ לע וכלהמבו לופיטה ינפל תויתרגש דבכ תוקידב עצבל ךל הרוי ףיעס םג האר .ךרוצה תדימב לופיטה

עפות" ."יאוול תו

רוקורדנאב ולפוט רשא םילוחב ופצנ רשא ידבכ לשכו ,דבכב תקלד ,תבהצ תללוכ תידבכ תוליער

ןונימב לש

םע םירקמ וחווד ןכ ומכ ,הלעמו ג"מ ןטרס םע םירבגב ושחרתה ולא םירקמ ,תוינלטק תואצות ףסונ רבסה ונשי םא אלא לופיטה תא קיספהל שי תנחבואמ תידבכ תוליערו הדימב .הטטסורפב םדקתמ .ןוכיסה לע הלוע תלעותה םא קר רוקורדנאב ךישמהל שי הז הרקמב ,תידבכה תוליערל

רוקורדנא ןוגכ תופורתב שומיש

םיתיעל רשוקמ לש תוחתפתהל דואמ תוקוחר אל( םיריפש דבכ ילודיג )םיריאממ

,ינטב םומידל ליבוהל םילולע דבכ ילודיג .)םיריאממ דבכ ילודיג( דבכ ןטרס לש תורוצ רפסמ לשו .םייח ןכסמ תויהל לולעש רפס ,תוריהמב ףלוח אלש ןטבב באכ וא השדח תוחונ רסוחמ לבוס ךניה םא .דימ ךלש אפורל

םד ישירק ווד לטונ ךניה הניגבש הביסל םג םירושק תויהל םילולעש ,וז הפורת םילטונה םילפוטמב וח רוקורדנא

ךלש אפורל רפס

ןוכיסב אצמנ התאו ןכתיש רחאמ ,ךילע לח םיאבה םיבצמהמ דחא םא :םד שירק חתפל רבגומ

ץבש ,םד ישירק לש הירוטסיה

בל יפקתה וא יחומ

ןטרס

ימנא( םיגירח םימודא םד יאת )תישמרח ה

ךלש םדה רוזחמ לע העיפשמש הרומח תרכוס

)הימנא( םדה לע תועפשה

ףיעס םג האר .וז הפורתב חווט ךורא שומיש ךלהמב תוקוחר םיתיעל וחווד

."יאוול תועפות"

המישנ רצוק

( תוהובג תונמב וז הפורת םילטונה םילפוטמב חווד

.)םויב ג"מ

רוקורדנא

.ךמדב רכוסה תומר תא תונשל הלוכי רכוסה תומר תא קודב ,תרכוסמ לבוס ךניה םא תועיבקב ךמדב .תרכוסב לופיטל ךל הנתינש הפורתה לש הנמה תא הנשי ךלש אפורה יכ ןכתי .

תוטולב דוקפת תא קודבי ךלש אפורה רובעל לולע ןדוקפתש רחאמ ,ךלש )לנרדאה תוטולב( הילכה תרתוי רוקורדנאב לופיטה ךלהמב יוכיד

הדירי ,ןובאית רסוח ,תושישת ,תופייע לולכל םילוכי ךכל םינימסת .

דומע

ךותמ

RESTRICTED

ץחל ,רכוס לש תוכומנ תומר ,לקשמב

םירירש ,ןואכידו טקש רסוח ,שאר באכ ,תושבייתה ,ךומנ םד קשח ,ןטב באכ ,םיבאוכ .לושלשו האקה וא הליחב ,םיחולמ תונוזמ לוכאל

רוקורדנאב )םינש( חווט ךורא שומיש ךלהמב

לש תונמב ,

ג"מ לש תועראיה לע וחווד הלעמו םויל רוקורדנא לטונה לפוטמ .תומויגנינמ

.לופיטה תא קיספהל בייח המויגנינמ םע ןחבואש

ת ללוכ תורחא תופורת תחקל יופצ התא םא וא ,הנורחאל תחקל םא ,חקול התא םא

ר

םשרמ אלל תופו .חקורל וא אפורל ךכ לע רפס ,הנוזת יפסותו

רוקורדנא לש הניקתה תוליעפב עוגפל תולולע תומיוסמ תופורת

50

רוקורדנא ,ףסונב .

50

עיפשהל לולע .ךפוגב תוקרפתמ לטונ התאש תורחא תופורת ובש ןפואה לע

ךלש אפורל רפס

:דחוימב ,עובק ןפואב תופורת חקול התא םא

ופורת תפחשב לופיטל ןיציפמאפיר ןוגכ ת

תורחא תולחמ וא היספליפאב לופיטל ןיאוטינפ ןוגכ תופורת

)םוטרופרפ םוקירפיה( טרוו ןו'ג .טנס יחמצה ביכרמה תא םיליכמה םירישכת

.םייתיירטפ םימוהיזב לופיטל לוזאמירטולק ,לוזאנוקארטיא ,לוזאנוקוטק ןוגכ תופורת

לופיטל ריבאנוטיר ןוגכ תופורת

ימוהיזב ישונאה ינוסיחה לשכה ףיגנ

רוקורדנא .םיניטטס ןוגכ לורטסלוכ תדרוהל תופורת

,םיניטטס לש יאוולה תועפות תא רימחהל לולע .םירירשה קוריפ תא ,לשמל

םיינורכ םיטסילוהוכלא.תרכוסב לופיטל םינוזאטילג ןוגכ תופורת

תא תיחפמ לוהוכלא יכ הארנ רוקורדנא לש העפשהה

,תרכוסמ לבוס ךניה םא האר .תרכוסב לופיטל ךל הנתינש הפורתה לש הנמה תא הנשי ךלש אפורה יכ ןכתי ףיעסב

."הפורתב שומישל תועגונה תודחוימ תורהזא"

4

)

יאוול תועפות

רדנאב שומישה ,הפורת לכב ומכ רוקו

ארקמל להבת לא .םישמתשמהמ קלחב יאוול תועפותל םורגל לולע .ןהמ תחא ףאמ לובסת אלו ןכתי .יאוולה תועפות תמישר

העילב וא המישנ יישק ךל שי םא םילוחה תיבל דימ תונפל וא אפורל דימ תונפל שי ןמיס תויהל לולע הז , .הרידנ תיגרלא הבוגת לש

יבגל עדימ לוהוכלא תכירצ

ףיעסב האר ,הפורתב שומישה ךלהמב

."לוהוכלא תכירצו הפורתב שומיש"

םילבקמה םילוח ברקב רתויב תורומחה יאוולה תועפות רוקורדנא

50

םילודיג ,תידבכ תוליער םניה םיעוריאלו ינטב ךות םומידל ליבוהל םילולעה דבכב םיריאממו םיריפש .םיילובמאובמורת

רוקורדנא ולטנש םילפוטמב ופצנש רתויב תוחיכשה יאוולה תועפות

50

,ינימה קשחב הדירי םניה

.ערז יאת תורצוויהב ךיפה בוכיעו תונוא ןיא

:תופסונ יאוול תועפות

דואמ תוחיכש יאוול תועפות

(

(very common

-

מ רתוי לע עיפשהל תויושעש תועפות

ךותמ

םישמתשמ

ערזה תריפסב הדירי

הכיפשה חפנב הדירי

דומע

ךותמ

RESTRICTED

פות תוחיכש יאוול תוע

(common)

-

דע לע עיפשהל תויושעש תועפות

ךותמ

םישמתשמ

)םילזונ תריגאל הרושק תויהל הלוכי רשא( לקשמב הילע וא הדירי

ינואכד חור בצמ

טקש רסוח

תושיגר םע םיתיעל ,םיידשב תוחיפנ

העזה ,םוח ילג

תופייע תושישתו

המישנ רצוק

תויעב לש תונמב שומישב וחווד ,תוינלטק ףא וא תורומח ןקלח ,דבכב

ג"מ

ןורטורפיצ לש הלעמו ףאו תאז רטנל תנמ לע לופיטה ךלהמב תויתרגש דבכ תוקידב עצבל ךל הרוי ךלש אפורה יכ ןכתי .טאטצא מ ידבכ לשכו ,דבכב תקלד ,תבהצ תללוכ תידבכ תוליער .ךרוצה תדימב לופיטה תא קיספי יכ ןכתי םירק תא קיספהל שי תנחבואמ תידבכ תוליערו הדימב .הטטסורפב םדקתמ ןטרס םע םירבגב ושחרתה ולא תלעותה םא קר רוקורדנאב ךישמהל שי הז הרקמב ,תידבכה תוליערל ףסונ רבסה ונשי םא אלא לופיטה .ןוכיסה לע הלוע

תוחיכש ןניאש יאוול תועפות

(uncommon)

-

ע עיפשהל תויושעש תועפות דע ל

ךותמ

םישמתשמ

החירפ

תורידנ יאוול תועפות

(rare)

דע לע עיפשהל תויושעש תועפות

ךותמ

1,000

םישמתשמ

הבוגת ישוק ךל שי םא .המישנ רצוקל רתוי תורידנ םיתיעל וא דרגל ,החירפל םורגל הלולעש( תיגרלא )דימ םילוח תיבל הנפ וא ךלש אפורה םע רשק רוצ ,העילבב וא המישנב

ךרדב ולא תועפות .תומטפהמ בלח ףוטפטו םיידשב םינידע םישוג

םא וא קספומ לופיטה םא תופלוח ללכ רוקורדנא לש ןונימה

תחפומ

דואמ תורידנ יאוול תועפות

(very rare)

דע לע עיפשהל תויושעש תועפות

ךותמ

10,000

םישמתשמ

ףיעסב םג האר .דבכב )םיריאממ אל( םיריפש םילודיג

."הפורתב שומישל תועגונה תודחוימ תורהזא"

)םיריאממ דבכ ילודיג( דבכ ןטרס לש םיגוס רפסמ דל ליבוהל םילולע דבכ ילודיג תויהל לולעש ,ינטב םומי םייח ןכסמ לבוס ךניה םא . באכ וא השדח תוחונ רסוחמ

ךילע ,תוריהמב ףלוח אלש ןטבב ךכ לע רפסל .דימ ךלש אפורל

רוקורדנא לש העפשה

50

ערזה לע

לכות אל יכ חינהל ריבס .ערז ליכת אל ךלש הכיפשה יכ ןכתי ,םישדוח רפסמ הפורתה תא לוטיתש רחאל םישנ סינכהל הז יכ בל םיש ךא ,ןוירהל אל

.תחא תבב הרוק העינמ יעצמאכ וז הפורת לע ךומסת לא

םושב היהת ערז יאת לש ליגרהמ רתוי הלודג תומכ ,תחפי רציימ ךניהש ערז יאת לש ללוכה רפסמהש דועב .בלש .הגירח הרוצ תלעב תוקונית תריציל םורגל םילולע ולא םיגירח ערז יאתש םינימאמש םישנא םנשי םניאש םילמרונ .םלועל םידלי תאבה לע בשוח ךניהו הדימב ךל ץעייל לכוי ךלש אפורה .

:םיללוכ וחוודש םיפסונ םייוניש

םילפוטמב וחווד םד ישירק דח ןפואב ורשקנ אל ולא ךא ,הפורתה תא םילטונה

שומישל יעמשמ רוקורדנאב

ףיעס האר .

"הפורתב שומישל תועגונה תודחוימ תורהזא "

רוקורדנאב )םינש( חווט ךורא שומיש ךלהמב

לש תונמב

תועראיה לע חווד ,הלעמו םויל ג"מ ךרדב( תומויגנינמ לש

המקרה תבכש לש ריפש לודיג ללכ

)תלוגלוגהו חומה ןיבש

הנקא בצמב רופישו שבי רוע

החימצ ,ףוג רעיש תחימצ לש התחפה ,)םיאלט תרוצב( ףוג רעיש לש הדיחא אל תינמז הרישנ הוורעה רעיש לש תישנ החימצ תינבת ,רעישה עבצ לש תורהבתה ,שארה לע רעיש לש תרבגומ

א( םדה לע תועפשה וחווד הפורתב חווט ךורא שומיש ךלהמב ךתוא הנפי ךלש אפורה יכ ןכתי .)הימנ תאז רטנל ידכב לופיטה ךלהמב תויתרגש םד תוקידב עצבל

)סיזורופואיטסוא( תומצע לודלד

דומע

ךותמ

RESTRICTED

רסוח ,תושישת ,תופייע ץחל ,םדב ךומנ רכוס ,לקשמב הדירי ,ןובאת

,שאר באכ ,תושבייתה ,ךומנ םד יא

,םיחולמ תונוזמל קשח ,ןטב באכ ,)םירירש תשלוח תובורק םיתיעל( םירירש יבאכ ,ןואכידו טקש ( לושלשו האקה וא הליחב תשוחת הילכה תרתוי תטולב יוכיד

אפורל ןולעה

תינכרצל ןולעה

חלשנ

םוסרפל

רגאמב

תופורתה

רתאבש

דרשמ

תואירבה

.asp

/units/pharmacy/trufot/index

https://www.old.health.gov.il

ןתינ

לבקל

ספדומ םי

"

הינפ

תרבחל

רייאב

לארשי

חר

חה שר

דוה

ןורשה :ןופלט ,

09-7626700

,הכרבב

לארשי רייאב

Similar products

Search alerts related to this product

View documents history

Share this information