CYPROTERONE ACETATE 50 MG TABLETS
Active substance(s): CYPROTERONE ACETATE
Neutral code not required on the leaflet artworks.
Package Leaflet: Information for the user
Cyproterone Acetate 50mg Tablets
Cyproterone Acetate 100mg Tablets
Read all of this leaflet
carefully before you
start taking this
medicine because it
information for you.
- Keep this leaflet. You
may need to read it
- If you have further
questions, please ask
your doctor or your
- This medicine has been prescribed for you personally
and you should 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.
In this leaflet:
1. What Cyproterone Tablets are and what they are used for
2. What you need to know before you take Cyproterone
3. How to take Cyproterone Tablets
4. Possible side effects
5. How to store Cyproterone Tablets
6. Contents of the pack and other information
1. What Cyproterone Tablets are and
what they are used for
Cyproterone acetate belongs to a group of medicines
called anti-androgens. These medicines work by blocking
the actions of male sex hormones (androgens) and reducing
the amount of male sex hormones produced by the body.
Cyproterone Tablets are used either on their own or in
conjunction with other hormone treatments to treat
patients with certain prostate gland problems.
2. What you need to know before you
take Cyproterone Tablets
Do not take Cyproterone Tablets:
• if you have ever been diagnosed with meningioma (a
generally benign tumour of the tissue layer between
the brain and the skull). You should ask your physician if
you are in doubt.
• if you are allergic to cyproterone acetate or any of the
other ingredients of this medicines (listed in section 6)
• suffer from liver disease
• suffer from liver tumours (now or in the past) that are
not due to prostate cancer
• have cancer (other than prostate cancer)
• suffer from a wasting disease (one which has caused
you to lose muscle mass)
• have a tendency for your blood to clot too easily, are
suffering from thrombosis (a clot in a blood vessel) or
have had a thrombosis in the past.
• are a woman
• are a young male who is not fully developed as an adult,
usually under 18 years of age
• drink large amounts of alcohol
Warnings and precautions:
Talk to your doctor or pharmacist before taking
Cyproterone Tablets if you:
• are suffering from diabetes mellitus (blood sugar levels
should be monitored initially and at regular intervals)
• are severely depressed
• suffer from sickle cell anaemia (a disease of the blood)
• shortness of breath has been reported in patients
taking this medicine at high doses (300mg daily)
• Your doctor will check the function of your adrenal
glands, as they may become suppressed during
treatment with Cyproterone Tablets.
Prior to taking these tablets you must have blood tests to
check that your blood count and liver function are healthy.
You may need to have periodic blood tests to check your
blood count and the function of your liver and adrenal glands.
Other medicines and Cyproterone Tablets
Taking another medicine while you are taking Cyproterone
Tablets can affect how it or the other medicine works.
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medications. Please
check with your doctor if you are taking any of the following:
• Ketroconazole, intraconazole, clotimazole, or other
medicines for the treatment of fungal conditions
• Ritonavir or other medicines used to treat HIV infections
• Rifampicin, or any other medicines used for the
treatment of tuberculosis
• Phenytoin, or any other medicine used to treat epilepsy
or other illness
• St. John's wort
• other sex hormones
• oral antidiabetic medicines such as thiazolidinediones
If you have any doubts about whether you should take this
medicine then discuss matters with your doctor before
Cyproterone Tablets with food and drink
You should avoid drinking alcohol because it reduces the
effect of Cyproterone Tablets
Cyproterone Tablets should be taken with water unless
Driving and using machines
Cyproterone Tablets may cause fatigue or weakness
especially when treatment is first started. If affected, you
should not drive or operate machinery.
Cyproterone Tablets contains lactose
If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before
taking this medicinal product.
3. How to take Cyproterone Tablets
Always take Cyproterone Tablets exactly as your doctor
has told you. You should check with your doctor or
pharmacist if you are not sure.
For adults, including older people, the dose for
Cyproterone Tablets is dependent upon the condition for
which your doctor has prescribed them.
Treatment in conjunction with other hormone treatment
When treatment in conjunction with other hormone
treatment is first started, the recommended dose is 300mg
daily (may be reduced to 200mg).
Long term treatment
For long term treatment with Cyproterone Tablets alone,
the recommended dose is 200 – 300mg daily.
Treatment of hot flushes in patients who have had
orchidectomy (removal of the testes)
For the treatment of hot flushes which may arise in
patients who are being treated with other hormones or
those who have had orchidectomy (removal of the testes),
the recommended starting dose is 50mg daily, increasing
if necessary up to 150mg daily.
If you take more Cyproterone Tablets than you should
If you or anybody else takes too many tablets, you should
ART WORK CHECK BOX
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Cyproterone Acetate 50 & 100mg - 56, 84 & 168 Tabs
FP2199; FP2200; FP2201
(w)148mm x (h)210mm
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13th & 17th June, 2014
1st PDF sent on - 18TH JUNE 2014
2nd PDF sent on - 20TH JUNE 2014
CHANGE CONTROL : Version changes due to change in:
Changes in detail: • New regulatory text (as requested by WUK)
• Pharmacode placed on 8mm from the cutting edge
What Cyproterone Tablets contain
The active substance in the Cyproterone Tablets is
The other ingredients are lactose, maize starch, povidone,
colloidal silicon dioxide and magnesium stearate.
What Cyproterone Tablets look like and contents of
Cyproterone acetate 50mg tablets are round white tablets
marked CPA, breakline and 50 on one face and CP on the
Cyproterone acetate 100mg tablets are round white
tablets marked CPA, breakline and 100 on one face and CP
on the reverse.
Cyproterone acetate 50mg tablets are available in blister packs
of PVC film and aluminium foil containing 56 or 168 tablets.
Cyproterone acetate 100mg tablets are available in blister
packs of PVC film and aluminium foil containing 84 tablets.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Wockhardt UK Limited,
Ash Road North, Wrexham, LL13 9UF, UK.
Manufacturer: CP Pharmaceuticals Limited,
Ash Road North, Wrexham, LL13 9UF, UK.
To listen to or request a copy of this leaflet in Braille, large
print or audio please call, free of charge:
0800 198 5000 (UK Only)
Please be ready to give the following information:
Cyproterone acetate 50mg tablets
Cyproterone acetate 100mg tablets
This is a service provided by the Royal National Institute of
Date of leaflet preparation: June 2014
6. Further Information
Keep out of the sight
and reach of children.
Do not store above 25°C. Store in the original package or
Do not use this medicine after the expiry date which is
stated on the carton. The expiry date refers to the last day
of that month.
Do not use this medicine if you notice they are
discoloured (they should be white).
Do not throw away any medicines via wastewater or
household waste. Ask your pharmacist how to throw
away medicines you no longer use. These measures will
help protect the environment.
Like all medicines, this medicine can cause side effects,
although not everybody gets them.
If you have trouble breathing or swallowing, this may
be a sign of a rare allergic reaction – contact your doctor
or go to a hospital straight away.
The occurrence of meningiomas has been reported in
association with longer term use (years) of cyproterone at
doses of 25mg/day and above.
Common (may affect up to 1 in every 10 people)
The most common side effects are impotence (erectile
dysfunction) and a reduction in sexual desire (libido),
sperm production, resulting in infertility (this is reversible,
but should NOT be used as a male contraceptive). You
may still produce some sperm but more of them than
usual will be abnormal, with a possible increased risk of
abnormal babies. Your doctor will advise you further if you
are thinking of having children.
Other side effects
Side effects that some other patients have had with
Cyproterone Tablets include:
• heart attack
• raised blood pressure
• hot flushes
• swelling of the ankles
• thrombosis (a clot in a blood vessel)
• suppression of adrenal gland function
• temporary restless ness
• development of breasts (which usually lessen as
treatment continues however, this enlargement may
also remain permanent), sometimes combined with
• discharge from the nipples
• breast lumps
• fatigue or sleepiness (usually lessening as treatment
• headache (also lessening as treatment continues)
• feeling sick
• jaundice (yellowing of the skin) and liver problems
including tumours (benign and malignant)
• bleeding inside the abdomen causing pain and loss of
blood pressure with possible fainting or collapse.
• tumours of the lining of the brain (meningiomas)
• rash, sweating
• breathing problems
• loss of hair or an increase in body hair and scalp hair
• lightening of hair colour
• Change in shape of pubic hair
• dry skin
• possible improvement of acne
• weight changes (chiefly weight gain due to fluid retention)
• thinning of the bones (osteoporosis)
5. How to store
4. Possible side effects
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist
or nurse. This includes any possible side effects not listed
in this leaflet. You can also report side effects directly via
the Yellow Card Scheme.
By reporting side eﬀects
you can help provide
more information on
the safety of this
contact your doctor, pharmacist or nearest hospital
casualty department immediately. Take this leaflet and
any tablets you have left to show the doctor or pharmacist.
If you forget to take Cyproterone Tablets:
If you forget to take a dose do not worry, just take the next
dose when it is due. Do not take a double dose to make up
for a forgotten tablet.
If you stop taking Cyproterone Tablets
Do not stop taking the medicine without talking to your
doctor first. When it is time to stop taking Cyproterone
Tablets the dose should be reduced gradually.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.