ANDROCUR Tablet (2020)
Βιβλιογραφική αναφορά
Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
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Περιεχόμενα
Name of the medicinal product
Androcur 50 mg tablets.
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.
Pharmaceutical form
Tablet. White, round tablet, scored on one side and embossed with the letters BV in a regular hexagon on the other side.
Therapeutic indications
Control of libido in severe hypersexuality and/or sexual deviation in the adult male. For reduction of drive in sexual deviations in men, cyproterone acetate 50 mg can be used when other interventions ...
Posology and method of administration
Posology Adults Generally, treatment is started with 1 tablet Androcur 50 mg twice daily, after the morning and evening meals. The duration of cyproterone acetate treatment should be defined on an individual ...
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) ...
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 100mg and above, cases with fatal outcome have also ...
Interaction with other medicinal products and other forms of interaction
Diabetes At high therapeutic cyproterone acetate doses of three times 100mg per day, cyproterone acetate may inhibit CYP2C8 (see below). Thiazolidinediones (i.e. the anti-diabetics pioglitazone and rosiglitazone) ...
Pregnancy and lactation
Not applicable.
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.
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 ...
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. ...
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 ...
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 ...
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 ...
List of excipients
Lactose Maize starch Povidone 25 000 Silicon dioxide (aerosil) (E551) Magnesium stearate (E572)
Incompatibilities
None known.
Shelf life
5 years.
Special precautions for storage
No special precautions for storage.
Nature and contents of container
PVC/Aluminium blister pack. Pack size: 60 tablets.
Special precautions for disposal and other handling
No special requirements.
Marketing authorization holder
Bayer plc, 400 South Oak Way, Reading, RG2 6AD
Marketing authorization number(s)
PL00010/0519
Date of first authorization / renewal of the authorization
Date of first authorisation: 01 May 2008
Date of revision of the text
26 May 2020
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