Androcur 100 mg Tablets
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
08-11-2022
Summary of Product characteristics
(SPC)
21-11-2022
Active ingredient:
Cyproterone acetate
Available from:
Bayer Limited
ATC code:
G03HA01
INN (International Name):
Cyproterone acetate
Dosage:
100 milligram(s)
Pharmaceutical form:
Tablet
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
cyproterone
Authorization status:
Marketed
Authorization date:
1997-01-24
Patient Information leaflet
BP22036_REC30610
PACKAGE LEAFLET: INFORMATION FOR THE USER
ANDROCUR
® 100 MG TABLETS
cyproterone acetate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START
TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
➢
Keep this leaflet. You may need to read it again.
➢
If you have any further questions, ask your doctor or
pharmacist.
➢
This medicine has been prescribed for you only. Do
not pass it on to others. It may harm them, even if
their signs of illness are the same as yours.
➢
If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Androcur is and what it is used for
2. What you need to know before you take Androcur
3. How to take Androcur
4. Possible side effects
5. How to store Androcur
6. Contents of the pack and other information
1. WHAT ANDROCUR IS AND WHAT IT IS USED FOR
Androcur is a medicine containing cyproterone
acetate. It is an anti-androgen therapy. It blocks the
actions of male sex hormones (androgens) and
reduces the amount of male sex hormones produced
by the body.
Androcur is used in men to treat prostate cancer where
surgery is not an option.
Androcur is also used to control sexual desire in men
who have a sexual deviation.
You should only take
Androcur, if your doctor considers that other
interventions are inappropriate.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE
ANDROCUR
DO NOT TAKE ANDROCUR
_FOR CONTROL OF SEXUAL DRIVE _
If you have:
➢
liver diseases (including previous or existing liver
tumours), Dubin-Johnson or Rotor syndromes
➢
ever been diagnosed with a meningioma (a
generally benign tumour of the tissue layer between
the brain and the skull). You should ask your doctor
if you are in doubt
➢
wasting diseases (diseases involving an
unintended loss of weight or muscle)
➢
severe depression which you have had for many
months
➢
blood clots (thrombosis or embolism) or have ever
had these
➢
severe diabetes that affects your blood circu
Read the complete document
Summary of Product characteristics
Health Products Regulatory Authority
21 November 2022
CRN00D8K3
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Androcur 100 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 100 mg cyproterone acetate.
Excipient with known effect
Each tablet contains 184 mg lactose (as monohydrate), please see
section 4.4 for further information.
For the full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Tablets.
White to faintly yellowish capsule-shaped tablet imprinted on the
upper surface with ‘LA’ on both sides of a score and with an
equilateral hexagon on the lower surface. The tablet can be divided
into equal halves.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Antiandrogen treatment in inoperable carcinoma of the prostate
Reduction of drive in sexual deviations in men, cyproterone acetate
100 mg can be used when other interventions
are considered inappropriate
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
1 tablet twice to three times daily (= 200 – 300 mg). The maximum
daily dose is 300mg.
The tablets are to be taken with some liquid after meals.
The therapy should not be discontinued nor the dose reduced once
improvement or remission occurs.
_To reduce the initial increase of androgens in combination therapy
with GnRH agonists:_
Initially 1 tablet Androcur 100 twice daily (= 200 mg) alone for 5 –
7 days, followed by 1 tablet Androcur 100 twice daily (= 200
mg) for 3 – 4 weeks together with a GnRH agonist in the dosage
recommended by the marketing authorisation holder (see
prescribing information of GnRH agonist).
_To treat hot flushes in patients under combination therapy with GnRH
analogues or who have had orchiectomy:_ ½ - 1½ tablets
per day (50 – 150 mg) with upward titration up to 1 tablet three
times daily (300 mg) if necessary.
_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
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