Androcur 100

  • Name:

    Androcur 100

  • Company:
    info
  • Active Ingredients:

    Cyproterone Acetate

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 25/06/20

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Summary of Product Characteristics last updated on medicines.ie: 25/6/2020

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Bayer Limited

Bayer Limited

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When a pharmaceutical company changes any document, 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 25 June 2020 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The SmPC has been updated to implement the Art.31 Referral procedure (EMEA/H/A-31/1488) outcome on the risk of meningioma of cyproterone containing medicinal

products. The text update was published by the PRAC and endorsed by the CMDh on 26th March 2020.

 

Change to section 4.1, Therapeutic Indications:

[….]

  • Reduction of drive in sexual deviations in men, cyproterone acetate 100 mg can be used when other interventions are considered inappropriate

[….]

 

Change to section 4.2, Posology and Method of administration:

[….]

Reduction of drive in sexual deviation:

Generally, treatment is started with 50 mg twice daily. It may be necessary to increase the dose to 100 mg twice daily, or even 100 mg three times daily for a short period of time. The duration of cyproterone acetate treatment should be defined on an individual basis. When a satisfactory result has been achieved, the therapeutic effect should be maintained with the lowest possible dose, one should try to maintain the therapeutic effect with the lowest possible dose. Quite often 25 mg twice daily is sufficient. When establishing

the maintenance dose, when changing the dose or when discontinuing cyproterone acetatethe preparation, one should not adjust the dosage abruptly, this should be done but gradually. To this end, the daily dose should be reduced by 50 mg or, better, 25 mg at intervals of several weeks.

To stabilise the therapeutic effect, it is necessary to take Androcur 100 over a protracted period of time, if possible with the simultaneous use of psychotherapeutic measures.

[….]

 

Change to section 4.4, Special Warning and Precautions for Use:

[….]

[….]

Meningioma

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

There is some evidence that the meningioma risk may decrease after treatment discontinuation of cyproterone.

[….]

 

Change to section 4.8, Undesirable effects:

[….]

Undesirable Effects

<Medra category: Neoplasms benign, malignant and unspecified, Meningioma frequency: not known rare>

<Medra category: Respiratory, thoracisc and mediastinal disorders >

[….]

The occurrence of meningiomas (single and multiple) has been reported in association with use of cyproterone acetate (see section 4.4).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).

[….]

 

Change to section 4.8,Reporting of Side effect details:

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. Healthcare professionals are asked to report any suspected adverse reactions via: HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. website: www.hpra.ie.; E-mail: medsafety@hpra.ie.

Ireland

HPRA Pharmacovigilance

Website: www.hpra.ie

Malta

ADR Reporting

Website: www.medicinesauthority.gov.mt/adrportal

 

Change to section 5.1, Pharmacodynamic properties:

[….]

<New statement added>

Meningioma
Based on results from a French epidemiological cohort study, a cumulative dose-dependent association between cyproterone acetate 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 cyproterone tablets. The incidence of meningioma treated with surgery or radiotherapy was compared between women exposed to high-dose cyproterone acetate (cumulative dose ≥3 g) and women who were slightly exposed to cyproterone acetate (cumulative dose <3 g). A cumulative dose-response relationship was demonstrated.

Cumulative dose of cyproterone acetate

Incidence rate (in patient-years)

HRadj (95% CI) a

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]

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

 A cumulative dose of 12g for example can correspond with one year of treatment with 50 mg/day for 20 days each month.

[….]

 

Change to section 10, Date of Revision of the Text:

January 2015 June 2020

Updated on 25 June 2020 PIL

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

The PIL has been updated to implement the Art.31 Referral procedure (EMEA/H/A-31/1488) outcome on the risk of meningioma of cyproterone containing medicinal products. The text update was published by the PRAC and endorsed by the CMDh on 26th March 2020.

 

Change to section 1, What is Androcur 100mg used for:

[….]

  • Androcur 100mg is also used to control sexual desire in men who have a sexual deviation. You should only take Androcur 100 mg, if your doctor considers that other interventions are inappropriate.

[….]

 

Change to section 2, Before you take Androcur:

[….]

Take special care with Androcur:

Several blood tests or checks may be required while you are taking this medicine:

  • meningioma (a generally benign tumour of the tissue layer between the brain and the skull) has been reported with longer term use (years) of Androcur at doses of 25mg or above. Use of Androcur has been linked to the development of meningioma. The risk increases especially when you use it for longer duration (several years) or for a shorter duration with high doses (25 mg per day and above). If you are diagnosed with meningioma, your doctor will stop your treatment with cyproterone acetate (see section ‘Do not take Androcur’). If you notice any symptoms such as changes in vision (e.g. seeing double or blurriness), hearing loss or ringing in the ears, loss of smell, headaches that worsen with time, memory loss, seizures, weakness in your arms or legs, you must tell your doctor straightaway.

[……]

 

Change to section 4, Possible side effects:

[….]

Rare –

up to 1 in every 1000 people may get these

  • meningiomas (a generally benign tumour of the tissue layer between the brain and the skull)
  • allergic reaction

[…..]

 

Other changes that have been reported include (incidence not

known):

  • meningiomas (a generally benign tumour of the tissue layer between the brain and the skull)

[…..]

 

Change to section 4, Reporting of side effect details:

[…..]

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via: HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. website: www.hpra.ie; E-mail: medsafety@hpra.ie.

Ireland

HPRA Pharmacovigilance.

Website: www.hpra.ie

Malta

ADR Reporting

Website: www.medicinesauthority.gov.mt/adrportal

By reporting side effects you can help provide more information on the safety of this medicine.

 […..]

 

Change to section 6, Date of revision:

[…..]

This leaflet was last approved in September 2016 June 2020

[…..]

 

Updated on 7 August 2018 PIL

Reasons for updating

  • Improved presentation of PIL

Updated on 4 October 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 4 October 2016 PIL

Reasons for updating

  • Change to date of revision
  • Addition of manufacturer
  • Change to improve clarity and readability

Updated on 16 December 2015 PIL

Reasons for updating

  • Change to date of revision
  • Change to name of manufacturer

Updated on 22 January 2015 SmPC

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

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 22 January 2015 PIL

Reasons for updating

  • Change to side-effects

Updated on 22 January 2015 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 12 October 2012 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 18 October 2011 SmPC

Reasons for 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

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 14 October 2011 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to date of revision
  • Change to improve clarity and readability
  • Change due to user-testing of patient information

Updated on 15 April 2010 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 22 February 2010 SmPC

Reasons for 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

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 9 February 2010 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision
  • Change of contraindications

Updated on 14 August 2008 PIL

Reasons for updating

  • Change to date of revision

Updated on 12 May 2008 PIL

Reasons for updating

  • Change to marketing authorisation holder
  • Change to date of revision

Updated on 6 December 2007 SmPC

Reasons for updating

  • Change to section 8 - MA number
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

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 February 2007 SmPC

Reasons for 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

Legal category: Product subject to medical prescription which may not be renewed (A)

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 13 February 2007 PIL

Reasons for updating

  • Change of manufacturer
  • Change to warnings or special precautions for use
  • Change to storage instructions

Updated on 1 December 2006 PIL

Reasons for updating

  • Change to name of manufacturer

Updated on 31 July 2006 PIL

Reasons for updating

  • Change of contraindications
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to drug interactions

Updated on 18 July 2006 SmPC

Reasons for 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

Legal category: Product subject to medical prescription which may not be renewed (A)

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 June 2006 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 15 June 2006 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 26 October 2005 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 10 January 2005 PIL

Reasons for updating

  • Change to storage instructions
  • Change to date of revision

Updated on 5 August 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 11 May 2004 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 22 October 2003 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.3 - Preclinical safety data

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 2 July 2003 SmPC

Reasons for updating

  • Improved electronic presentation

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 10 June 2003 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product

Legal category: Product subject to medical prescription which may not be renewed (A)