Patient leaflet - Cyproterone Acetate tablets 50 mg
1. What Cyproterone Acetate is and what it is used for
Cyproterone acetate is a synthetic steroid which blocks the action of hormones called androgens which are released naturally in your body. Cyproterone also reduces the production of these hormones. Increased levels of androgens may cause or worsen several medical conditions.
As Cyproterone Acetate Tablets can reduce the amount of androgens in the body, it can be taken by males to control an overactive sex drive. Depending on the dose prescribed by your doctor, it can also be used to help relieve the symptoms of a tumour in the prostate gland. These symptoms may be as a result of the tumour itself or as a result of other medicines or surgery used to treat the tumour.
For the reduction of drive in sexual deviations, you should only take cyproterone acetate 50 mg, if your doctor considers that other interventions are inappropriate.
This medicine is for adults only.
2. What you need to know before you take Cyproterone
Do NOT take this medicine and tell your doctor if:
- you are younger than 18 years
- you have liver disease
- you know you have tumours or have had tumours, other than in your prostate gland
- you have a wasting disease
- you have or have ever had a blood clot in a blood vessel (heart attack, stroke, deep venous thrombosis, pulmonary embolism), or if anyone in your family has suffered from one of these conditions at an early age
- you suffer from diabetes
- you have or someone in your family has sickle-cell anaemia • you suffer from, or have suffered from depression
- you have taken Cyproterone, a similar medicine or any of the tablet ingredients (listed in section 6) before, and suffered an unusual or allergic reaction to it
- you have an intolerance to some sugars, as this medicine contains lactose Do not use Cyproterone Acetate if you have ever been diagnosed with a meningioma (a generally benign tumor of the tissue layer between the brain and the skull). If you are unsure if any of the above applies to you, please talk to your doctor or pharmacist.
Warnings and precautions
Use of cyproterone acetate has been linked to the development of a generally benign brain tumour (meningioma). The risk increases especially when you use it for longer duration (several years) or for a shorter duration with high doses (25 mg per day and above). If you are diagnosed with meningioma, your doctor will stop your treatment with cyproterone acetate (see section ‘Do not take cyproterone acetate’). If you notice any symptoms such as changes in vision (e.g. seeing double or blurriness), hearing loss or ringing in the ears, loss of smell, headaches that worsen with time, memory loss, seizures, weakness in your arms or legs, you must tell your doctor straightaway.
Talk to your doctor or pharmacist before using Cyproterone Acetate if:
- you are planning a family
- you are an alcoholic
- you suffer from severe pains in the chest or stomach.
Use in children and adolescents (0-17years):
Cyproterone Acetate Tablets are not recommended for children.
Other medicines and Cyproterone Acetate
Tell your doctor or pharmacist if you are taking, have recently taken or might take other medicines.
Cyproterone Acetate with food, drink and alcohol
DO NOT drink alcohol whilst taking Cyproterone Acetate Tablets.
Cyproterone Acetate Tablets should be taken after meals.
Pregnancy, breast-feeding and fertility
Females: Cyproterone acetate is not indicated for use in women.
Males: Your doctor will give you regular blood tests to check your liver function while you are on Cyproterone Acetate Tablets. Cyproterone Acetate Tablets may reduce the production of sperm in males, but should not be used instead of contraception. Your doctor may check your sperm count before and during treatment.
Driving and using machinery:
DO NOT drive or operate machinery if after taking the tablets you feel tired or weak.
3. How to take Cyproterone
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Adults including the Elderly - if you are taking Cyproterone Acetate Tablets for an overactive sex drive, the usual dose is 50 mg (one tablet) twice a day.
If you are taking Cyproterone Acetate tablets to help relieve the symptoms of a prostatic tumour the following doses may be given: To reduce the likelihood of a flare-up of a prostatic tumour which sometimes occurs in the first few weeks of starting LHRH treatment (eg. Buserelin Injection). The usual dose of Cyproterone Acetate is 300 mg (6 tablets) a day, in two or three divided doses. If you suffer from side effects your doctor may reduce this dose to 200 mg (4 tablets) a day.
For patients where LHRH treatment or surgery is unsuitable, the usual total dose of Cyproterone Acetate is 200 mg to 300 mg (4 to 6 tablets) given in two or three divided doses.
To treat the side effects caused by either LHRH therapy or following removal of the testes, the usual starting dose is 50 mg daily. If necessary, your doctor may increase this dose to 150 mg (3 tablets) daily of Cyproterone Acetate.
If you forget to take a dose take it as soon as you remember. If it is almost time for your next dose though, do not double the dose, just carry on as before.
IF YOU TAKE TOO MUCH OF YOUR MEDICATION CONTACT YOUR DOCTOR IMMEDIATELY.
4. Possible side effect
Like all medicines, this medicine can cause side effects, although not everybody gets them. If you get any of the following symptoms after taking these tablets you should contact your doctor or pharmacist immediately:
- any sudden wheeziness, difficulty in breathing or dizziness • yellowing of the whites of the eyes or skin (jaundice)
- inflammation of the liver (hepatitis) with swelling and severe pain in the upper part of the abdomen stomach or chest area (Liver function tests should be performed regularly by your doctor whilst you are taking Cyproterone).
The most common side effects are feeling unusually tired or weak. These side effects may occur in the first few weeks of treatment but usually go away as your body adjusts to your medicine.
Other side effects include:
- worsening of symptoms for patients with existing chronic depression • change in sex drive and reduction in the male sperm count and volume of ejaculate
- infertility
- breast tenderness or swelling of the breasts
- tender harmless growths in the breast tissue
- changes in body weight
- drying of the skin and scalp, improvement of existing acne • lightening of hair colour, increased growth of scalp hair but a loss in body hair. • female type of pubic hair growth
- reoccurrence of obstructed blood vessels in patients with a past history of this condition.
rarely milk secretion from the breasts, brittle bones or benign (non-malignant)
liver tumors
- weakening of the bones (osteoporosis)
- very rarely malignant liver tumors possibly leading to internal bleeding
The occurrence of meningiomas has been reported rarely in association with longer term use (years) of Cyproterone Acetate at doses of 25mg/day and above.
Reporting side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Cyproterone
Store at a temperature not exceeding 25°C and protect from
light.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date, which is stated on the pack or bottle. The expiry date refers to the last day of that month.
If your doctor tells you to stop taking Cyproterone please take any unused medicine back to your pharmacist to be destroyed. 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 protect the environment.
6. Contents of the pack and other information
What Cyproterone contains
The active substance is Cyproterone Acetate 50mg
The other ingredients are lactose BP, maize starch BP, povidone BP, colloidal silicon dioxide BP and magnesium stearate BP.
The tablets are available in blister packs of 56, 84 or 168 tablets or plastic containers of 100, 250 or 500 tablets. Not all pack sizes may be marketed
Marketing authorization holder
Viatris,
Station Close,
Potters Bar,
EN6 1TL,
United Kingdom.
Manufacturer
Generics [UK] Limited
T/A Mylan
Station Close
Potters Bar
Hertfordshire
EN6 1TL