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Consumer Medicine Information

Ask your doctor if you have any questions about PROCUR why Procur has been prescribed for you. acetate 50 mg and 100 mg tablets This medicine is available only with a doctor's prescription. What is in this leaflet Before you take Procur Please read this leaflet carefully before you start taking Procur When you must not take it This leaflet answers some common questions about Procur. It does not contain all the available Do not take Procur if you have an allergy to: information. It does not take the place of talking • any medicine containing to your doctor or pharmacist. • any of the ingredients listed at the end of this leaflet All medicines have risks and benefits. Your doctor has weighed the risks of you taking Procur against Some of the symptoms of an allergic reaction may the benefits they expect it will have for you. include: • difficulty in breathing or wheezing If you have any concerns about taking this • shortness of breath medicine, ask your doctor or pharmacist. • swelling of the face, tongue, lips, or other parts

of the body Keep this leaflet with the medicine. You may • on the skin, rash, or itching need to read it again.

Do not take Procur if: What Procur is used for • you are allergic to cyproterone acetate or any other ingredient listed at the end of this leaflet Procur tablets contain the active ingredient • you are pregnant cyproterone acetate. Cyproterone acetate is an • you are breastfeeding . It works by blocking the actions of • you suffer from diseases (including sex hormones () that are produced previous or existing liver tumours, Dubin- mainly in men but also, to a lesser extent in Johnson syndrome or Rotor syndrome) women. • you have a history of (yellowing of skin and/or eyes) or persistent itching during a In men, Procur is used: previous pregnancy • to treat • you have a history of herpes in pregnancy • to control sexual desire in men who have an • you suffer from severe depression which you increased sex drive (hypersexuality) and/or have had for many months sexual abnormalities. • you have previous or existing blood clots (thrombosis or embolism) • In women, Procur is used: you have abnormal red blood cells (sickle-cell anaemia) • to treat severe signs of androgenisation such • You have severe diabetes that affects your as excessive hair growth. blood circulation

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• you have previous or existing benign brain It is known that cyproterone acetate passes tumour (meningioma) into breastmilk). Your doctor can discuss with • you have wasting disease (a disease causing you the risks and benefits involved. muscle loss or loss of strength, with the If you have not told your doctor about any of the exception of prostate cancer) above, tell them before you start taking Procur.

Procur contains lactose monohydrate. If you have Taking other medicines been told by your doctor that you have an

intolerance to some sugars, contact your doctor Tell your doctor if you are taking any other before taking Procur. medicines, including medicines that you buy

without a prescription from your pharmacy, If you are a male your doctor may instruct you to supermarket or health food shop. You should have a sperm count recorded before starting also tell any health professional who is treatment. There may be a reduction in the overall prescribing a new medication for you that you are number of sperm during the treatment but it will taking Procur. gradually recover after you have stopped the

treatment. The long-term effects on female Some medicines may interfere with Procur. These fertility are not known include:

• medicines used to treat diabetes Do not take it after the expiry date (EXP) printed • medicines used to treat fungal , on the back. If you take it after the expiry date has including , itraconzole, passed, it may not work as well.

• , a medicine used in the treatment of Do not take it if the packaging is torn or shows HIV infections signs of tampering. • , a medicine used to treat epilepsy • If you are not sure whether you should start taking Procur, talk to your doctor. • St John’s wort, a herbal remedy • , medicines used to lower levels Before you start to take it

These medicines may be affected by Procur, or Tell your doctor if: may affect how well it works. You may need different amounts of your medicine, or you may 1. you suffer from , previous or need to take different medicines. existing liver tumours, previous or existing benign brain tumours, diabetes, shortness of Your doctor or pharmacist has more information breath, history of blood clotting, sickle cell on medicines to be careful with or avoid while anaemia or anaemia. taking Procur.

2. you have allergies to: • any other medicines How to take Procur • any other substances, such as foods, preservatives or dyes. How much to take 3. you are pregnant or intend to become pregnant. Follow all directions given to you by your doctor or pharmacist carefully. Your doctor may have 4. you are breastfeeding or planning to prescribed a different dose. breastfeed.

Men: Swallow the tablets whole with some liquids Prostate Cancer after meals. The usual total daily dose is 100-300 mg of Procur in divided doses. Your doctor may request you to When to take it take Procur with other medicines and/or change

your dose during treatment. Take your medicine after a meal, at about the same time each day. Control sexual desire Taking your tablets at the same time each day will The usual dose is 50 mg of Procur twice daily and have the best effect. It will also help you may be increased. Once the desired effect is remember when to take the tablets. achieved, your dose may be gradually lowered.

Women: How long to take it Childbearing age Continue taking your medicine for as long as If you are pregnant, do not take Procur. your doctor tells you. Therefore, pregnancy must be excluded before This medicine helps you control your condition but starting treatment. does not cure it. Therefore, you must take it every day. The usual dose is 50 mg of Procur taken once daily for 10 days per month. This dose may be If you forget to take it increased in severe symptoms.

If you are of a childbearing age you should Do not take a double dose to make up for the commence your on the 1st day of the cycle dose that you missed. (= 1st day of bleeding). If you have no menstrual Missed Procur tablets may diminish the periods, your treatment can commence effectiveness of the treatment and may lead to immediately. In this case, the first day of breakthrough bleeding in women. treatment is to be regarded as the 1st day of the cycle. If you are also taking oral contraceptive and more than 12 hours elapsed from the time Procur was Additionally, your doctor will advise the most due to be taken, note that contraceptive appropriate contraceptive for you to take to protection in this cycle may be reduced. If bleeding provide the necessary contraceptive protection fails to occur after this cycle, there is a risk of and to stabilise your cycle. pregnancy. Your doctor may need to check whether you are pregnant before you can The length of use depends on the severity of your continue treatment. symptoms and the extent of response to treatment. Your doctor should re-evaluate the While you are taking Procur treatment periodically as long-term use should be avoided. Things you must do Postmenopausal or have had a hysterectomy If you are postmenopausal or have had a If you are about to be started on any new hysterectomy, Procur maybe administrated alone. medicine tell your doctor and pharmacist that The average dose is 25-50 mg of Procur once daily you are taking Procur. for 21 days, followed by a 7-day tablet-free interval. If you become pregnant while taking this medicine, tell your doctor immediately. How to take it If you are about to have any blood tests, tell your doctor that you are taking this medicine. It may interfere with the results of some tests. Procur from working as well as it should in reducing abnormal sex drive. If you feel shortness of breath, tell you doctor. Shortness of breath has been reported in patients taking this medicine at high doses. In case of overdose

Keep all of your doctor’s appointments so that If you take too much (overdose) your progress can be checked. Your doctor may do some tests from time to time Immediately telephone your doctor or the to make sure the medicine is working and to National Poisons Centre (telephone 0800 POISON prevent unwanted side effects. or 0800 764 766) or go to accident and emergency at your nearest hospital, if you think that you or Your doctor will check your liver function during anyone else may have taken too much Procur. treatment with Procur and whenever any symptoms or signs suggesting liver problems are Do this even if there are no signs of discomfort or observed. poisoning. You may need urgent medical attention. If you have diabetes, your doctor will monitor you to ensure that you receive the appropriate dose of oral antidiabetic or insulin whilst taking Procur. Side effects

Your doctor will also check you red-blood cell Tell your doctor or pharmacist as soon as possible count to ensure you do not become anaemic if you do not feel well while you are taking during treatment with Procur. Procur.

If you are a female taking an oral contraceptive All medicines can have side effects. Sometimes during treatment, tell your doctor if your period they are serious, most of the time they are not. does not occur during the tablet-free/placebo You may need medical treatment if you get some interval. Your doctor may need to check whether of the adverse effects. you are pregnant before you can continue treatment. Do not be alarmed by this list of possible adverse effects. You may not experience any of them. Things you must not do Ask your doctor or pharmacist to answer any questions you may have. Do not give Procur to anyone else, even if they have the same condition as you. Tell your doctor or pharmacist if you notice any of the following and they worry you: Do not stop taking Procur, or lower the dosage, Men: without checking with your doctor. • decreased sex drive (decreased libido) • inability to obtain or maintain an erection Things to be careful of • breast enlargement Men- Other adverse effects include: • Be careful driving or operating machinery until reduced sperm count you know how Procur affects you. It may cause • thinning of the bones (osteoporosis) tiredness and can impair the ability to concentrate. Women: • decreased or increased sex drive Be careful when drinking while you are • a feeling of tension in breasts taking this medicine. • menstrual cycle irregularity, spotting If you drink alcohol, tiredness and the ability to concentrate may be worse. Alcohol may prevent Both: • weight decrease or increase Keep it where children cannot it. A locked • tiredness, fatigue cupboard at least one-and-a-half metres above • the ground is a good place to store medicines. • depressive mood • and other gastrointestinal complaints Disposal • hot flushes, sweating If your doctor tells you to stop taking this medicine • shortness of breath or they have passed their expiry date, ask your

pharmacist what to do with any unused medicine. If any of the following happen, stop taking Procur Return any unused medicine to your pharmacist. and tell your doctor immediately, or go to Accident and Emergency at your nearest hospital: • swelling of the face, lips, mouth or throat Product description which may cause difficulty in swallowing or breathing; hives; fainting These are very serious side effects. If you have What it looks like them, you may have had a serious allergic reaction Procur 50 mg – 50 mg tablets are white to off- to Procur. You may need urgent medical attention white, round, flat, tablets having a score and or hospitalisation. These side effects are very rare. embossed 50 on one side and plain on the other. • general malaise, fever, nausea, vomiting, loss of appetite, general itching, yellowish skin and Procur 100 mg – 100 mg tablets are white to off- eyes, light-coloured stools and dark urine. white, capsule shaped tablets having a score on • severe upper abdominal pain one face and embossed 100 on the other. • swelling of the calf or leg, chest pain, shortness of breath or sudden feeling of weakness. Ingredients • sudden severe headache, loss of vision, loss of Active ingredient(s): coordination, weakness in arms or legs. cyproterone acetate

These may be serious of Procur. You Inactive ingredients: may need urgent medical attention. Serious side croscarmellose sodium, stearate, effects are uncommon. microcrystalline cellulose, povidone, lactose

monohydrate Tell your doctor if you notice any other effects. Other adverse effects not listed above may also occur in some patients. Sponsor details

After taking Procur Procur is supplied in New Zealand by: Douglas Pharmaceuticals Ltd Storage P O Box 45 027 Keep your tablets in the bottle or blister pack Auckland 0651 until it is time to take them. If you take the tablets New Zealand out of the pack, they may not keep well. Phone: (09) 835 0660

Keep your tablets in a cool dry place where the temperature stays at or below 30 °C. Date of preparation

Do not store Procur in the bathroom or near a 16 June 2020 sink. Do not leave it in the car or on a windowsill. (based on data sheet dated 09 June 2020) Heat and dampness can destroy some medicines.