Active ingredients: Cyproterone (cyproterone acetate)
ANDROCUR 50 mg tablets
Androcur package inserts are available for pack sizes:- ANDROCUR 50 mg tablets
- ANDROCUR 100 mg tablets
- ANDROCUR 300 mg prolonged-release solution for injection for intramuscular use
Why is Androcur used? What is it for?
Pharmacotherapeutic group
Antiandrogen hormone.
Therapeutic indications
Reduction of the deviations of the sexual instinct in men.
Antiandrogen treatment in inoperable prostate cancer.
NB: the use of ANDROCUR is not indicated in women.
Contraindications When Androcur should not be used
- Hypersensitivity to the active substance or to any of the excipients
- Liver disease
- Dubin-Johnson syndrome, Rotor syndrome
- Current or previous liver tumors (except those from prostate cancer metastases)
- Debilitating diseases (excluding inoperable prostate cancer)
- Severe chronic depression
- Current or previous thromboembolic processes
- Severe forms of diabetes with vasculopathy
- Sickle cell anemia
Androcur should not be used in patients with meningioma or a history of meningioma.
Precautions for use What you need to know before taking Androcur
Androcur is not recommended for male children and adolescents below 18 years of age due to insufficient data on safety and efficacy.
Androcur should not be administered before the end of the pubertal period, due to the possible negative influence on the growth and on the still immature endocrine function.
Liver
Manifestations of direct liver toxicity such as jaundice, hepatitis and hepatic failure have been observed in patients treated with Androcur. Cases with fatal outcome have also been reported at doses of 100 mg or greater. Most of the fatal cases involved male patients with advanced prostate cancer.
Hepatotoxicity is dose-related and typically occurs several months after initiation of treatment.
It is therefore recommended to perform liver function tests before the start of treatment, at regular intervals during treatment and whenever symptoms related to hepatotoxicity occur.
If this is confirmed, the administration of Androcur should be suspended, unless the hepatotoxicity can be traced to a different cause such as, for example, the presence of metastases; in this case it is recommended to continue treatment with Androcur only if the perceived benefit outweighs the associated risk.
Interactions Which drugs or foods can modify the effect of Androcur
Tell your doctor or pharmacist if you have recently taken any other medicines, even those without a prescription.
Although no clinical interaction studies have been performed, as this medicinal product is metabolised by CYP3A4, it is believed that ketoconazole, itraconazole, clotrimazole, ritonavir and other potent inhibitors of CYP3A4 may inhibit the metabolism of cyproterone acetate. , inducers of CYP3A4, such as eg. rifampicin, phenytoin and products containing Hypericum perforatum (St. John's wort), can reduce the levels of cyproterone acetate.
Based on in vitro inhibition studies, inhibition of cytochrome P450 enzymes CYP2C8, 2C9, 2C19, 3A4 and 2D6 is possible at high therapeutic doses of cyproterone acetate of 100 mg three times daily.
The risk of statin-associated rhabdomyolysis or myopathies may be increased when HMGCoA inhibitors (statins), which are primarily metabolised by CYP3A4, are administered concomitantly with high therapeutic doses of cyproterone acetate, as they share the same metabolic pathway.
Warnings It is important to know that:
Liver
Following the use of Androcur, benign and malignant liver tumors have been observed very rarely which can cause life-threatening intra-abdominal haemorrhage. should consider the possibility of liver cancer in the differential diagnosis.
Meningioma
Meningiomas (single and multiple) have been reported in association with prolonged use (years) of cyproterone acetate doses of 25 mg / day or more. If meningioma is diagnosed in a patient treated with Androcur, treatment must be discontinued (see "Contraindications").
Anemia
Cases of anemia have been reported during treatment with Androcur. Therefore, periodic blood count checks are recommended during treatment.
Diabetes mellitus
Close medical supervision is required in diabetic subjects as the need for insulin or oral antidiabetic drugs may change during treatment with Androcur (see also "Contraindications").
Adrenocortical function
During treatment, adrenocortical function should be monitored regularly, since preclinical data indicate a possible suppression, due to the corticoid-like effect of Androcur administered at high doses.
Shortness of breath
A feeling of shortness of breath may occur in patients treated with high doses of Androcur. The differential diagnosis in such cases should include the known stimulatory effect of progesterone and synthetic progestogens on the breath, which is accompanied by hypocapnia and compensated respiratory alkalosis and is not considered to require treatment.
Thromboembolic events
Thromboembolic events have been reported in patients treated with Androcur, although a causal relationship with the medicinal product has not been established. Patients with previous arterial or venous thrombotic / thromboembolic events (eg.deep vein thrombosis, pulmonary embolism, myocardial infarction), or a history of stroke or advanced cancer, are subject to an increased risk of further thromboembolic events.
Other conditions
In the "indication" reduction of deviations of the "sexual instinct", the therapeutic efficacy of Androcur may decrease under the effect of alcohol.
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before taking any medicine. Treatment with Androcur is not indicated for women.
Effects on ability to drive and use machines
Patients whose activity requires a high degree of attention (e.g. drivers, machine users) should be aware that Androcur can cause asthenia (fatigue) and reduced vitality and impair the ability to concentrate.
Important information about some of the ingredients of ANDROCUR
Androcur contains 105.5 mg of lactose per tablet: patients suffering from intolerance to some sugars should consult their doctor before taking this medicine.
Dosage and method of use How to use Androcur: Dosage
Route of administration
Oral use
Dosage
The tablets should be taken with a little liquid after meals.
The maximum daily dose is 300 mg.
Reduction of the deviations of the sexual instinct in men
Treatment usually starts with 1 Androcur 50 mg tablet twice a day. The dose may need to be increased to 2 tablets twice a day, or up to 2 tablets three times a day for a short period of time. Once a satisfactory result has been achieved, an attempt will be made to maintain the therapeutic effect with the lowest possible dosage. Often ½ tablet twice a day is sufficient. When reaching the maintenance dose or in the event of discontinuation of therapy, a reduction must be made. To this end it is recommended to reduce the daily dose by 1 or better ½ tablet at intervals of several weeks. To stabilize the therapeutic effect it is necessary to take Androcur for a prolonged period of time, if possible by simultaneously adopting appropriate psychotherapeutic measures .
Antiandrogenic treatment of inoperable prostate cancer
2 tablets of Androcur 50 mg two or three times a day (= 200 - 300 mg), according to the doctor's instructions. The tablets should be taken with a little liquid after meals. It is recommended not to interrupt the treatment, nor to reduce the dosage following improvement or remission.
- Reduction of the initial increase of male sex hormones in combination treatment with GnRH agonists
To eliminate the exacerbation of the disease in the initial period of treatment with GnRH agonists, start with 2 tablets of Androcur 50 mg twice daily (= 200 mg) for 5 - 7 days, followed by 2 tablets of Androcur 50 mg twice a day. per day (= 200 mg) for 3 - 4 weeks together with a GnRH agonist in the dosage recommended by the marketing authorization holder.
- For the treatment of hot flashes in patients being treated in combination with GnRH analogues or after orchiectomy:
1 - 3 tablets of Androcur 50 mg per day (= 50 - 150 mg) with increasing titration up to 2 tablets three times per day (= 300 mg) as needed.
Further information for special categories of patients
Children and adolescents
The use of Androcur is not recommended in children and adolescents under 18 years of age due to insufficient data on safety and efficacy.
Androcur should not be administered before the end of the pubertal period, due to the possible negative influence on the growth and on the still immature endocrine function.
Elderly patients
There are no data indicating the need for dosage adjustment in elderly patients.
Patients with impaired hepatic function
The use of Androcur is contraindicated in patients with liver disease (up to normalization of liver function indices).
Patients with impaired renal function
There are no data indicating the need for dosage adjustment in patients with impaired renal function.
Overdose What to do if you have taken too much Androcur
Harmful effects from excessive doses of the medicinal product have never been reported or are expected. In case of accidental intake of an excessive dose of Androcur, notify your doctor immediately or go to the nearest hospital.
If you have any questions about the use of Androcur, ask your doctor or pharmacist.
Side Effects What are the side effects of Androcur
Like all medicines, Androcur can cause side effects, although not everybody gets them.
The most frequent side effects associated with the use of Androcur are decreased libido, erectile dysfunction and reversible inhibition of spermatogenesis.
The most serious side effects associated with the use of Androcur are liver toxicity, benign and malignant liver tumors which can cause intra-abdominal haemorrhage and thromboembolic events.
The frequency of undesirable effects is shown in the table below.
Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 and
§ See paragraph 4.3
* For further information see section 4.4
** A causal relationship with Androcur has not been established.
During treatment with Androcur, sexual desire and potency are reduced and the function of the gonads is inhibited. These changes are reversible after discontinuation of therapy. When taken for several weeks, Androcur inhibits spermatogenesis due to its antiandrogenic and antigonadotropic action. Recovery of spermatogenesis occurs gradually within a few months of stopping therapy. Androcur can cause gynecomastia (sometimes associated with nipple sensitivity to touch), which normally regresses upon discontinuation of treatment.
As with other antiandrogen treatments, Androcur-induced long-term androgen deprivation can cause osteoporosis.
The occurrence of (multiple) meningiomas has been reported in association with the prolonged use (years) of cyproterone acetate doses of 25 mg / day or more (see "Contraindications" and "Special warnings").
Compliance with the instructions contained in the package leaflet reduces the risk of undesirable effects. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please inform your doctor or pharmacist.
Expiry and Retention
Expiry: see the expiry date printed on the package.
The expiry date refers to the product in intact packaging, correctly stored.
Warning: do not use the medicine after the expiry date shown on the package.
The medicinal product does not require any special storage conditions.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
KEEP THE MEDICINAL PRODUCT OUT OF THE REACH AND SIGHT OF CHILDREN
Composition and pharmaceutical form
Composition
Each tablet contains:
Active ingredient: cyproterone acetate 50 mg.
Excipients: lactose monohydrate, corn starch, povidone 25, colloidal silica, magnesium stearate.
Pharmaceutical form and content
Tablet for oral use.White to slightly yellowish tablets, scored on one side and with the letters "BV" debossed in a regular hexagon on the other.
The tablet can be divided into equal halves. 15 and 25 tablets of 50 mg.
Not all pack sizes may be marketed.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
ANDROCUR 50 MG TABLETS
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
Active ingredient: cyproterone acetate 50 mg.
Excipient: lactose, 105.5 mg per tablet (see section 4.4)
For the full list of excipients, see section 6.1
03.0 PHARMACEUTICAL FORM
Tablet.
White to slightly yellowish tablets, scored on one side and with the letters "BV" debossed in a regular hexagon on the other.
The tablet can be divided into equal halves.
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Reduction of the deviations of the sexual instinct in men.
Antiandrogen treatment in inoperable prostate cancer.
NB: the use of ANDROCUR is not indicated in women.
04.2 Posology and method of administration
Route of administration
Oral use.
Dosage
The tablets should be taken with a little liquid after meals.
The maximum daily dose is 300 mg.
Reduction of the deviations of the sexual instinct in men
Treatment usually starts with 1 Androcur 50 mg tablet twice a day. The dose may need to be increased to 2 tablets twice a day, or up to 2 tablets three times a day for a short period of time.
Once a satisfactory result has been achieved, an attempt will be made to maintain the therapeutic effect with the lowest possible dosage. Often ½ tablet twice a day is sufficient. gradual reduction of the dosage To this end it is recommended to reduce the daily dose by 1 or better ½ tablet at intervals of several weeks.
To stabilize the therapeutic effect it is necessary to take Androcur for a prolonged period of time, if possible while taking appropriate psychotherapeutic measures.
Antiandrogenic treatment of inoperable prostate cancer
2 tablets of Androcur 50 mg two or three times a day (= 200 - 300 mg), according to the doctor's instructions.
The tablets should be taken with a little liquid after meals
It is recommended not to interrupt the treatment, nor to reduce the dosage following improvement or remission.
Reduction of the initial increase of male sex hormones in combination treatment with GnRH agonists
To eliminate the exacerbation of the disease in the initial period of treatment with GnRH agonists, start with 2 tablets of Androcur 50 mg only twice a day (= 200 mg) for 5 - 7 days, followed by 2 tablets of Androcur 50 mg twice a day. per day (= 200 mg) for 3 - 4 weeks together with a GnRH agonist in the dosage recommended by the marketing authorization holder (consult the GnRH agonist SmPC).
For the treatment of hot flashes in patients being treated in combination with GnRH analogues or after orchiectomy
1 - 3 tablets of Androcur 50 mg per day (= 50 - 150 mg) with increasing titration up to 2 tablets three times per day (= 300 mg) as needed.
Further information for special categories of patients
Children and adolescents
The use of Androcur is not recommended in male children and adolescents below 18 years due to insufficient data on safety and efficacy.
Androcur should not be administered before the end of the pubertal period, due to the possible negative influence on the growth and on the still immature endocrine function.
Elderly patients
There are no data indicating the need for dosage adjustment in elderly patients.
Patients with impaired hepatic function
The use of Androcur is contraindicated in patients with liver disease (up to normalization of liver function indices).
Patients with impaired renal function
There are no data indicating the need for dosage adjustment in patients with impaired renal function.
04.3 Contraindications
• Hypersensitivity to the active substance or to any of the excipients
• Liver disease
• Dubin-Johnson syndrome, Rotor syndrome
• Current or previous liver tumors
• Debilitating diseases (excluding inoperable prostate cancer)
• Severe chronic depression
• Current or previous thromboembolic processes
• Severe forms of diabetes with vascular disease
• Sickle cell anemia
Androcur should not be used in patients with meningioma or a history of meningioma.
04.4 Special warnings and appropriate precautions for use
Liver
Manifestations of direct liver toxicity such as jaundice, hepatitis and hepatic failure have been observed in patients treated with Androcur. Cases with fatal outcome have also been reported at doses of 100 mg or greater. Most of the fatal cases involved male patients with advanced prostate cancer.
Hepatotoxicity is dose-related and typically occurs several months after initiation of treatment.
It is therefore recommended to perform liver function tests before the start of treatment, at regular intervals during treatment and whenever symptoms related to hepatotoxicity occur.
If this is confirmed, the administration of Androcur should be suspended, unless the hepatotoxicity can be traced to a different cause such as, for example, the presence of metastases; in this case it is recommended to continue treatment with Androcur only if the perceived benefit outweighs the associated risk.
Following the use of Androcur, benign and malignant liver tumors have been observed very rarely, which can cause life-threatening intra-abdominal haemorrhage.
If severe upper abdominal discomfort, liver enlargement or signs of intra-abdominal haemorrhage occur, the possibility of liver cancer should be considered in the differential diagnosis.
Meningioma
Meningiomas (single and multiple) have been reported in association with prolonged use (years) of cyproterone acetate doses of 25 mg / day or more. must be discontinued (see section 4.3).
Thromboembolic events
Thromboembolic events have been reported in patients treated with Androcur, although a causal relationship with the drug has not been established.
Patients with a history of arterial or venous thrombotic / thromboembolic events (e.g. deep vein thrombosis, pulmonary embolism, myocardial infarction), or a history of stroke or advanced cancers, are at an increased risk of further thromboembolic events.
Anemia
Cases of anemia have been reported during treatment with Androcur. Therefore, periodic blood count checks are recommended during treatment.
Diabetes mellitus
Close medical surveillance is required in diabetic subjects as the need for insulin or oral antidiabetic drugs may change during treatment with Androcur (see also section 4.3).
Shortness of breath
A feeling of shortness of breath may occur in patients treated with high doses of Androcur.
The differential diagnosis in such cases should include the known stimulatory effect of progesterone and synthetic progestogens on the breath, which is accompanied by hypocapnia and compensated respiratory alkalosis and is not considered to require treatment.
Adrenocortical function
Adrenocortical function should be monitored regularly during treatment, as preclinical data indicate its possible suppression due to the corticoid-like effect of Androcur administered at high doses (see section 5.3).
Other conditions
In the "indication" reduction of deviations of the "sexual instinct", the therapeutic efficacy of Androcur may decrease under the effect of alcohol.
The occurrence of (multiple) meningiomas has been reported in association with the prolonged use (years) of cyproterone acetate doses of 25 mg / day or more. If meningioma is diagnosed in a patient treated with Androcur, treatment should be interrupted (see section 4.3).
Attention: Androcur 50 mg contains 105.5 mg of lactose per tablet: patients with rare hereditary problems of galactose intolerance, lactase deficiency or glucose-galactose malabsorption should not take this medicine.
04.5 Interactions with other medicinal products and other forms of interaction
Although no clinical interaction studies have been performed, as this drug is metabolised by CYP3A4, it is believed that ketoconazole, itraconazole, clotrimazole, ritonavir and other potent inhibitors of CYP3A4 may inhibit the metabolism of cyproterone acetate. , inducers of CYP3A4, such as eg. rifampicin, phenytoin and products containing Hypericum perforatum (St. John's wort), can reduce the levels of cyproterone acetate.
Based on in vitro inhibition studies, an inhibition of cytochrome P450 enzymes CYP2C8, 2C9, 2C19, 3A4 and 2D6 is possible at high therapeutic doses of cyproterone acetate of 300 mg per day.
The risk of statin-associated rhabdomyolysis or myopathies may be increased when HMGCoA inhibitors (statins), which are primarily metabolised by CYP3A4, are administered concomitantly with high therapeutic doses of cyproterone acetate, as they share the same metabolic pathway.
04.6 Pregnancy and lactation
If taken for several weeks, Androcur inhibits spermatogenesis due to its antiandrogenic and antigonadotropic action. The recovery of spermatogenesis occurs gradually within a few months of stopping the therapy.
Treatment with Androcur 50 mg is not indicated for women.
04.7 Effects on ability to drive and use machines
Patients whose activity requires a high degree of attention (eg drivers, machine users) should be aware that Androcur can cause asthenia and decreased vitality and impair the ability to concentrate.
04.8 Undesirable effects
The most frequent side effects associated with the use of Androcur are decreased libido, erectile dysfunction and reversible inhibition of spermatogenesis.
The most serious side effects associated with the use of Androcur are liver toxicity, benign and malignant liver tumors which can cause intra-abdominal haemorrhage and thromboembolic events.
The frequency of undesirable effects is shown in the table below.
Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 and
Undesirable effects identified only in the post-marketing phase, and for which the frequency cannot be calculated, are listed under the frequency "not known".
§ See paragraph 4.3
* For further information see section 4.4
** A causal relationship with Androcur has not been established.
During treatment with Androcur, sexual desire and potency are reduced and the function of the gonads is inhibited. These changes are reversible after discontinuation of therapy.
If taken for several weeks, Androcur inhibits spermatogenesis due to its antiandrogenic and antigonadotropic action. The recovery of spermatogenesis occurs gradually within a few months of stopping the therapy.
Androcur can cause gynaecomastia (sometimes associated with nipple sensitivity to touch), which usually subsides upon discontinuation of treatment.
As with other antiandrogen treatments, Androcur-induced long-term androgen deprivation can cause osteoporosis.
(Multiple) meningiomas have been reported in association with prolonged use (years) of cyproterone acetate doses of 25 mg / day or more (see sections 4.3 and 4.4).
The list contains the MedDRA term that best describes a given adverse reaction. Related symptoms or conditions are not listed, but should be considered.
04.9 Overdose
Acute toxicity studies following single administration have shown that cyproterone acetate, the active substance in Androcur, can be classified as practically non-toxic. There is therefore no risk of acute intoxication in the event of accidental intake of a dose even several times higher than the therapeutic one.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: unassociated antiandrogens - ATC code: G03HA01, cyproterone acetate.
Androcur is a hormonal preparation with antiandrogenic action.
During treatment with Androcur, libido and sexual potency are reduced and gonadal function is inhibited. These effects are reversible upon discontinuation of treatment.
Cyproterone acetate, with a competitive mechanism, prevents androgens from binding to cell receptors at target organ level, for example by counteracting the stimulation of prostatic tissue growth due to the action of androgens produced by the gonads and / or adrenal cortical.
Cyproterone acetate also exerts an inhibitory effect at the central hypothalamic-pituitary level. The antigonadotropic effect leads to a reduction in the synthesis of testosterone in the testes and, therefore, in its plasma concentration.
The antigonadotropic effect of cyproterone acetate also occurs when it is administered in combination with GnRH agonists. The initial increase in testosterone caused by these drugs is reduced by cyproterone acetate.
With higher doses of cyproterone acetate, a tendency to a slight increase in prolactinaemia has occasionally been observed.
05.2 Pharmacokinetic properties
Absorption
After oral administration, cyproterone acetate is completely absorbed regardless of the dose.
The absolute bioavailability of cyproterone acetate is almost complete (88% of the dose).
Distribution
Approximately 3 hours after oral intake of 50 mg of cyproterone acetate, maximum serum concentrations of 140 ng / ml have been reached. Thereafter, the serum concentration of cyproterone acetate decreases over an interval of 24 - 120 hours with a terminal half-life of 43.9 ± 12.8 hours.
Total serum clearance of cyproterone acetate was 3.5 ± 1.5 ml / min / kg.
Cyproterone acetate in plasma binds almost exclusively to albumin. The unbound portion represents approximately 3.5 - 4% of the total. Since the binding to proteins is not specific, changes in the level of SHBG (sex hormone binding globulin) do not influence the pharmacokinetics of cyproterone acetate.
Considering the long half-life of the terminal elimination phase from plasma (serum) and the daily intake, accumulation of cyproterone acetate in serum by a factor of 3 can be expected during repeated administration.
Metabolism / Biotransformation
Cyproterone acetate is metabolised through several mechanisms, including hydroxylations and conjugations. The major metabolite in human plasma is 15 b-hydroxy derivative.
Phase 1 metabolism of cyproterone acetate is mainly catalysed by the cytochrome P450 enzyme CYP3A4.
Elimination
A small part of the administered dose is excreted unchanged with the bile.
Most of it is excreted as metabolites in the urine and faeces at a ratio of 3: 7.
Renal and biliary excretion proceeds with a half-life of 1.9 days. Metabolites are cleared from plasma with a similar half-life (half-life 1.7 days).
05.3 Preclinical safety data
Systemic toxicity
Non-clinical data reveal no special hazard for humans based on conventional studies of repeated dose toxicity.
Reproductive toxicity
The temporary inhibition of fertility in male rats due to daily oral treatment has in no way shown that treatment with Androcur produces damage to the spermatozoa, with possible induction of malformations or impaired fertility of the offspring.
Genotoxicity and carcinogenicity
Genotoxicity studies of recognized validity conducted on cyproterone acetate gave negative results. Further tests on rat and monkey hepatocytes, and also on freshly isolated human hepatocytes, have however shown that cyproterone acetate is able to form adducts with DNA and to increase DNA repair activity, while the level of adducts of DNA in dog liver cells was extremely low.
This formation of DNA adducts occurs following an "exposure that can also be achieved at the usually recommended posologies. The in vivo consequences of treatment with cyproterone acetate have been an" increased incidence of focal hepatic lesions, possibly pre-neoplastic, in cellular enzymes were altered in female rats and an increased mutation rate in transgenic rats bearing a bacterial gene as a target for mutations.
Clinical experience and the results of epidemiological studies to date do not support an "increased incidence of liver tumors in humans." Studies on the carcinogenicity of cyproterone acetate in rodents have not shown any specific carcinogenic potential.
In any case, it must always be kept in mind that sex steroids can promote the growth of certain hormone-dependent tissues and tumors.
Taken together, the available data do not raise objections to the use of cyproterone acetate in humans, provided that the recommended dosages and indications are followed.
Experimental studies conducted in dogs and rats have documented corticoid-like effects on the adrenal glands at higher doses; this could be indicative of similar effects in man, always at the highest doses (300 mg / day). [i1]
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Lactose monohydrate
Cornstarch
Povidone 25
Colloidal silica
Magnesium stearate
06.2 Incompatibility
Not relevant.
06.3 Period of validity
5 years.
06.4 Special precautions for storage
This medicine does not require any special storage conditions.
06.5 Nature of the immediate packaging and contents of the package
PVC / Aluminum blister
15 and 25 tablets of 50 mg
06.6 Instructions for use and handling
No special instructions.
07.0 MARKETING AUTHORIZATION HOLDER
Bayer S.p.A., Viale Certosa 130 - Milan
08.0 MARKETING AUTHORIZATION NUMBER
ANDROCUR 50 mg 15 tablets - AIC 023090018
ANDROCUR 50 mg 25 tablets - AIC 023090020
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
August 1975/01 June 2010
10.0 DATE OF REVISION OF THE TEXT
AIFA Determination of February 2011
