We use cookies to ensure that we give you the best experience on our website. If you continue without changing your settings, we'll assume that you are happy to receive all cookies on the medicines.ie website. Find out more

Bayer Limited

The Atrium, Blackthorn Road, Dublin 18,
Telephone: +353 1 2999 313
Fax: +353 1 2061 456
Summary of Product Characteristics last updated on medicines.ie: 22/01/2015
SPC Androcur 100

When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 22/01/2015 and displayed until Current
Reasons for adding or updating:
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   19-Dec-2014
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

Section 4.8 was updated to include HPRA adverse effect reporting text
Updated on 18/10/2011 and displayed until 22/01/2015
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   03-Oct-2011
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



4.3 Contraindications

 

·         Androcur 100 must not be used in patients with meningioma or a history of meningioma.

 

Was replaced with the bullet point in the body of the texts:

 

·         Presence or history of meningioma

 

4.4 Special Warnings and Precautions for Use

 

“Initiation of anti-androgen therapy and its overall direction should only be carried out by specialists.” was added to the beginning of the section instead of further down.

 

Meningioma was included as a heading.

 

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. If a patient treated with Androcur 100 is diagnosed with meningioma, treatment with Androcur 100 must be stopped (see section 4.3).

 

Was replaced with

 

The occurrence of (single and multiple) meningiomas has been reported in association with longer term use (years) of cyproterone acetate at doses of 25 mg/day and above. If a patient treated with Androcur 100 is diagnosed with meningioma, treatment with Androcur 100 must be stopped (see section 4.3 Contra-indications).

 

 

Liver

 

Direct hepatic toxicity including jaundice, hepatitis and hepatic failure, which has been fatal in some cases, has been reported in patients treated with 200 - 300 mg Androcur. Most reported cases are in men with carcinoma of the prostate. Toxicity is dose-related and develops, usually, several months after treatment has begun. Liver function tests should be performed pre-treatment, at regular intervals during treatment and whenever symptoms or signs suggestive of hepatotoxicity occur. If hepatotoxicity is confirmed, Androcur should normally 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.

 

Was replaced with

 

Liver

 

Direct hepatic toxicity including jaundice, hepatitis and hepatic failure has been observed in patients treated with Androcur. At dosages of 100mg 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. Liver function tests should be performed pre-treatment, at regular intervals during treatment and whenever 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.

 

4.8 Undesirable Effects

 

“Meningioma§)*)” in the table replaced “benign cerebral meningiomas”

 

“§) See section 4.3 Contra-indications” was included after the table.

 

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.

 

Was replaced with:

 

                               Meningiomas have been reported in association with longer term use (several years) of cyproterone acetate at doses of 25 mg/day and above (see sections 4.3 Contra-indications and 4.4 Special warnings and precautions for use).

 

10. Date of Revision of the Text

September 2011 (dated of automated email approval of variation)

Updated on 22/02/2010 and displayed until 18/10/2011
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Date of revision of text on the SPC:   12-Feb-2010
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



In section 2. Qualitative and Quantitative Composition, two sentences were expanded upon adding: “see section 4.4 ‘Special warnings and precautions for use’” and “ ‘List of excipients’”

 

In section 3. Pharmaceutical Form the reason for a score line has been added “The tablet can be divided into equal halves.”

In section 4.1 Therapeutic Indications, the indication was changed to “Antiandrogen treatment in inoperable carcinoma of the prostate”

Scetion 4.2 Posology and Method of Administration has largely changed to add information on special populations

 

The following sencence was added to section 4.3:
   " •Androcur 100 must not be used in patients with meningioma or a history of meningioma."

In section 4.4 the following paragraph was added:
" 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. If a patient treated with Androcur 100 is diagnosed with meningioma, treatment with Androcur 100 must be stopped (see section 4.3)" as well as information on anemia, diabetes mellitus, shortness of breath, adrenocortical function and lactose.

 

In section 4.5 Interaction with other Medicinal products and other forms of Interaction the following paragraphs were added:

“Although clinical interaction studies have not been performed, since this drug is metabolized 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 e.g. rifampicin, phenytoin and products containing St. John’s wort may reduce the levels of cyproterone acetate.” And

“In the indication “reduction of drive in sexual deviations”, the drive-reducing effect of Androcur can be diminished under the disinhibitory influence of alcohol.”

 

Section 4.6 Pregnancy and Lactation has changed to “Treatment with Androcur 100 (for use in men) is not indicated in women”

 

Section 4.7 Effects on Ability to Drive and Use Machines has been updated to say “Androcur 100 mg can lead to tiredness and diminished vitality and can impair the ability to concentrate. Patients receiving the drug should not drive or operate machinery unless it has been shown not to effect physical or mental ability.”

 

Section 4.8 Undesirable Effects has been updated to read:

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 adverse drug reactions (ADRs) in patients receiving Androcur are hepatic toxicity, benign and malignant liver tumors which may lead to intra-abdominal hemorrhage, and thromboembolic events.

The frequencies of ADRs reported with Androcur are summarized in the table below. Frequencies are defined as very common (³ 1/10), common (³ 1/100 and < 1/10), uncommon (³ 1/1,000 and < 1/100), rare (³ 1/10,000 and < 1/1,000) and very rare (< 1/10,000). The ADRs identified only during postmarketing surveillance, and for which a frequency could not be estimated are listed under “not known”.

 

System organ class

MedDRA v. 8.0

Very common

 

Common

 

Uncommon

 

Rare

 

Very rare

 

Not known

Neoplasms benign, malignant and unspecified

 

 

 

 

Benign and malignant liver tumors*)

Benign cerebral mening-iomas

Blood and lymphatic system disorders

 

 

 

 

 

Anemia*)

Immune system disorders

 

 

 

Hyper-sensitivity reaction

 

 

Metabolism and nutrition disorders

 

Weight increased or weight decreased

 

 

 

 

Psychiatric disorders

Libido decreased, erectile dysfunction

Depressed mood, Restlessness (temporary)

 

 

Vascular disorders

 

 

 

Thrombo-embolic event*)**)

Respiratory, thoracis and mediastinal disorders

 

Shortness of breath*)

 

 

Gastro-intestinal disorders

 

 

 

Intra-abdominal hemorrr-hage *)

Hepato-biliary disorders

 

Hepatic toxicity, including jaundice, hepatitis, hepatic failure*)

 

 

Skin and subcutaneous tissue disorders

 

 

Rash

 

 

 

Musculoskeletal and connective tissue disorders

 

 

 

 

 

Osteo-porosis

Reproductive system and breast disorders

Reversible inhibition of spermatogenesis

Gynaeco-mastia

 

 

 

 

General disorders and administration site conditions

 

Fatigue, Hot flushes, Sweating

 

 

 

 

*) For further information see section ‘Special warnings and precautions for use’.

**) A causal relationship with Androcur has not been established.

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.

 

Under treatment with Androcur, sexual drive and potency are reduced and gonadal function is inhibited. These changes are reversible after discontinuation of therapy.

 

Over the course of several weeks, Androcur inhibits spermatogenesis as a result of the antiandrogenic and antigonadotropic actions. Spermatogenesis recovers gradually within a few months of discontinuing the therapy.

 

Androcur may lead to gynaecomastia (sometimes combined with tenderness to touch of the mammillae) which usually regresses after withdrawal of the preparation.

 

As with other antiandrogenic treatments, long-term androgen deprivation with Androcur may lead to osteoporosis.

 

The most appropriate MedDRA term (version 8.0) to describe a certain adverse reaction is listed. Synonyms or related conditions are not listed, but should be taken into account as well.

 

In section 5.1 Pharmacodynamic Properties “Pharmacotherapeutic group: Antiandrogens, plain” and “ATC code: G03HA01” were added

 

Section 5.2 Pharmacokinetic Properties was updated to include:

“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.

According to the long half-life of the terminal disposition phase from plasma (serum) and the daily intake, an accumulation of cyproterone acetate by a factor of about 3 can be expected in the serum during repeated daily administration. 2

In section 5.3 Preclinical Safety Data there was a deletion of text.

 

Section 10 Date of Revision of the Text was updated to February 2010

 

Updated on 06/12/2007 and displayed until 22/02/2010
Reasons for adding or updating:
  • Change to section 8 - MA number
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   11/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Section 7: New MA holder is Bayer Ltd
 
Section 8: New MA number is 1410/1/1
Updated on 13/02/2007 and displayed until 06/12/2007
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
Date of revision of text on the SPC:   01/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Main Changes to the SPC

 

Section 2 Qualitative and Quantitative Composition

Addition of information regarding lactose content of the tablets.

 

Section 4.4 Special Warnings and Precautions for Use

Addition of the following:

This medicinal product contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medication.”

 

Section 6.4 Special Precautions for Storage

Inclusion of the standard statement:

This medicinal product does not require any special storage conditions.

 

Section 6.6 Instructions for Use and Handling

Inclusion of the standard statement:

No special requirements.

Updated on 18/07/2006 and displayed until 13/02/2007
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
Date of revision of text on the SPC:   06/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Main changes to the SPC include:

 

SECTION 4.3 CONTRAINDICATIONS

Reformatting of section. Contraindications when used in reduction of drive in sexual deviation and when used in treatment of inoperable carcinoma of the prostate are now listed separately.

 

SECTION 4.4 SPECIAL PRECAUTIONS AND WARNINGS FOR USE

The following precautions / warnings have been added:

  • should not be given before the conclusion of puberty
  • warning regarding use in patients at risk of thromboembolic events

·         effect of alcohol on the drive-reducing action of Androcur

The following precautions / warnings have been removed:

  • use in patients with epilepsy, history of migraine, asthma, hypertension or cardiac dysfunction
  • discontinue use before elective surgery

 

SECTION 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION

Addition of information regarding possible interactions with:

  • inhibitors of CYP3A4 e.g. ketoconazole, itraconazole, clotrimazole, ritonavir
  • inducers of CY3A4 e.g. rifampicin, phenytoin, St John’s wort

·         HMGCoA inhibitors (statins) which are primarily metabolised by CYP3A4 (increased risk of statin-associated myopathy or rhabdomyolysis)

Inhibition of the cytochrome P450 enzymes, CYP2C8, 2C9, 2C19 and 2D6 is possible at high therapeutic doses of cyproterone acetate.

 

SECTION 4.8 UNDESIRABLE EFFECTS

Reformatting of this section; post marketing data is tabulated.

Additional adverse effects listed include fatigue, hot flushes and sweating.

 

SECTION 5.2 PHARMACOKINETIC PROPERTIES

Additional / updated information includes:

  • Maximum serum cyproterone acetate levels
  • Phase I metabolism mainly catalysed via CYP3A4
Updated on 15/06/2006 and displayed until 18/07/2006
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
Updated on 11/05/2004 and displayed until 15/06/2006
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
Updated on 22/10/2003 and displayed until 11/05/2004
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.3 - Preclinical safety data
Updated on 02/07/2003 and displayed until 22/10/2003
Reasons for adding or updating:
  • Improved electronic presentation
Updated on 10/06/2003 and displayed until 02/07/2003
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product

Document Links

 
  View all medicines
from this company
View Document
Bookmark and Share

Active Ingredients

 
   Cyproterone Acetate