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SPC, UK: Androcur (2011)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
Bayer plc
Διεύθυνση :
Bayer House, Strawberry Hill, Newbury, Berkshire, RG14 1JA
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Name of the medicinal product

Androcur 50mg tablets.

Qualitative and quantitative composition

Each tablet contains 50 mg cyproterone acetate. Excipient: lactose 105.5mg. For a full list of excipients, see 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.

Posology and method of administration

Adults Method of admininstration: For oral administration. Dosage regimen: The tablets are to be taken with some liquid after meals. Generally, treatment is started with 1 tablet Androcur 50 mg twice daily, ...

Contraindications

Androcur must not be used in patients with: Hypersensitivity to the active substance or any of the excipients of Androcur Liver diseases (including Dubin-Johnson syndrome and Rotor syndrome) Malignant ...

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

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 ...

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: 56 tablets.

Special precautions for disposal and other handling

No special requirements.

Marketing authorization holder

Bayer plc Bayer House Strawberry Hill Newbury Berkshire RG14 1JA United Kingdom Trading as: Bayer plc, Bayer Schering Pharma

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 January 2011