CYPROSTAT Tablet (2020)
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Περιεχόμενα
1. Name of the medicinal product
Cyprostat 50 mg.
2. Qualitative and quantitative composition
Each white, scored tablet contains 50 mg cyproterone acetate. <u>Excipient with known effect:</u> lactose 108.75 mg. For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Tablet. White, round tablet, scored on one side and embossed with the letters BV in a regular hexagon on the other side.
4.1. Therapeutic indications
Management of patients with prostatic cancer (1) to suppress flare with initial LHRH analogue therapy,(2) in long-term palliative treatment where LHRH analogues or surgery are contraindicated, not tolerated, ...
4.2. Posology and method of administration
Posology Adults The maximum daily dose is 300 mg. For long-term palliative treatment where LHRH analogues or surgery are contraindicated, not tolerated, or where oral therapy is preferred the dosage is ...
4.3. Contraindications
Cyprostat must not be used in patients with: Meningioma or a history of meningioma. Liver diseases (including Dubin-Johnson syndrome and Rotor syndrome). Malignant tumours (except for carcinoma of the ...
4.4. Special warnings and precautions for use
Liver Direct hepatic toxicity, including jaundice, hepatitis and hepatic failure, has been observed in patients treated with Cyprostat. At dosages of 100 mg and above cases with fatal outcome have also ...
4.5. 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) ...
4.6. Pregnancy and lactation
Not applicable.
4.7. 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.
4.8. Undesirable effects
The most frequently observed adverse drug reactions (ADRs) in patients receiving Cyprostat are decreased libido, erectile dysfunction and reversible inhibition of spermatogenesis. The most serious ADRs ...
4.9. Overdose
There have been no reports of ill-effects of overdosage, which it is, therefore, generally unnecessary to treat. There are no specific antidotes and if treatment is required it should be symptomatic. ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> sex hormones and modulators of the genital system, antiandrogens, plain <b>ATC code:</b> G03HA01 Prostatic carcinoma and its metastases are in general androgen-dependent. ...
5.2. 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 ...
5.3. 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 ...
6.1. List of excipients
Maize starch Povidone 25 000 Magnesium stearate (E572) Lactose Colloidal anhydrous silica
6.2. Incompatibilities
None known.
6.3. Shelf life
5 years.
6.4. Special precautions for storage
None.
6.5. Nature and contents of container
Original packs containing 160 tablets (16 blister strips of 10 tablets), 80 tablets (8 blister strips of 10 tablets) or 60 tablets (6 blister strips of 10 tablets).
6.6. Special precautions for disposal and other handling
No special requirements.
7. Marketing authorization holder
Bayer plc, 400 South Oak Way, Reading, RG2 6AD
8. Marketing authorization number(s)
PL 00010/0525
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 01 May 2008 Date of Renewal of the Authorisation: 08 August 2003
10. Date of revision of the text
26 May 2020
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