PROVERA Medroxyprogesterone acetate tablets 2.5mg, 5mg, 10mg, 100 mg, 200 mg tablets

What is in this leaflet establish a regular menstrual  breast cancer or breast lumps cycle not diagnosed by your doctor This leaflet answers some common  bleeding or discharge from questions about PROVERA. It does  certain types of cancer including your nipples not contain all the available cancer of the breast, kidney and information. It does not take the endometrium (the lining of the  miscarriage place of talking to your doctor or womb). pharmacist.  cancer of the womb or ovary PROVERA, in combination with an  uncontrolled high blood estrogen containing medicine, is All medicines have risks and pressure. benefits. Your doctor has weighed used to relieve symptoms of the risks of you taking PROVERA menopause in women with an intact Do not take PROVERA if you are against the benefits it is expected to uterus. This is called hormone pregnant or intend to become have for you. replacement therapy (HRT). pregnant. PROVERA is used to protect the If you have any concerns about lining of the uterus while the PROVERA may affect your taking this medicine, ask your estrogens relieve the symptoms of developing baby if you take it doctor or pharmacist. Keep this menopause. PROVERA is not during pregnancy. leaflet with your medicine. suitable as a HRT treatment in women who have undergone a Do not take PROVERA if the You may need to read it again. hysterectomy. packaging is torn or shows signs of tampering. Do not take Your doctor may have prescribed PROVERA after the expiry date What PROVERA is PROVERA for another purpose. (EXP) printed on the pack. used for Ask your doctor or pharmacist if you have any questions about why If you are not sure whether you PROVERA is a progestogen which PROVERA has been prescribed for should start taking PROVERA, comes from progesterone, a natural you. contact your doctor. sex hormone. PROVERA works in a similar way to progesterone. This medicine is available only with Before you start to take it a doctor's prescription. PROVERA is used to treat: You must tell your doctor if you have any allergies to any other Before you take medicines or any other  endometriosis – a condition in PROVERA which tissue similar to the substances, such as foods, lining of the uterus (womb) preservatives or dyes. grows outside the uterus, When you must not take it causing pain and bleeding. Do not take PROVERA if you Before prescribing PROVERA for PROVERA helps to stop the have an allergy to you, your doctor may conduct a growth of this tissue medroxyprogesterone acetate or physical examination which may any of the ingredients in include breast examinations or a  amenorrhoea (a lack of PROVERA listed at the end of mammogram and a Pap smear. menstrual periods) not due to this leaflet. Tell your doctor if you have or pregnancy. PROVERA with or without an estrogen helps to re- Do not take PROVERA if you have had any of the following establish a regular menstrual have or have had any of the medical conditions: cycle following medical conditions:  heart problems  kidney problems  abnormal bleeding from the  a stroke, blood clots or uterus, when the lining of the pulmonary embolism  migraine uterus breaks down during the  severe liver problems menstrual cycle rather than at  epilepsy the end resulting in vaginal  unusual or irregular vaginal  asthma spotting or bleeding. bleeding or blood in your urine PROVERA helps to re- that has not been diagnosed by  diabetes your doctor  depression  unusual or irregular vaginal How to take PROVERA Breast cancer - the recommended bleeding daily dose is 400 mg to 1500 mg.  genital or breast cancer. Follow all directions given to you by your doctor or pharmacist How to take PROVERA Talk to your doctor about how to carefully. Swallow the tablets whole with a avoid these diseases. They may differ from the full glass of water. Clinical studies suggest a slightly information contained in this leaflet. increased risk of developing ovarian When to take it cancer when using PROVERA If you do not understand the Take PROVERA at about the same combined with an estrogen instructions in this leaflet, ask time each day. Taking it at the containing medicine to relieve your doctor or pharmacist for same time each day will have the symptoms of menopause in women help. best effect. It will also help you with an intact uterus. remember when to take it. How much to take If you have any concerns about this, How long to take it please discuss it with your doctor. Your doctor will tell you how much PROVERA to take. This will vary Continue taking your medicine While the effect of PROVERA on depending on the condition for the amount of calcium stored in for as long as your doctor tells which you are being treated. you. your bones is unknown, clinical PROVERA should be used at the studies have shown that use of other lowest effective dose to treat your If you forget to take products with the same active condition. PROVERA ingredient as PROVERA (e.g., If it is almost time for your next DEPO-PROVERA) may result in a Your doctor may tell you to take PROVERA every day or in dose, skip the dose you missed and decrease in the amount of calcium repeating cycles with a break in take your next dose when you are stored in your bones. This could between. meant to. Otherwise, take it as soon increase your risk of developing as you remember, and then go back brittle bones (osteoporosis), which Endometriosis - the recommended to taking PROVERA as you would can lead to bone breakages in later dose is 10 mg of PROVERA three normally. life. times a day for 90 days starting on the first day of your menstrual Do not take a double dose to make Talk to your doctor if you have cycle. up for the dose that you missed. any concerns over the risk of developing osteoporosis. Amenorrhoea - the recommended This may increase the chance of getting unwanted side effects. Taking other medicines dose is 2.5 to 10 mg daily for 10 days. Tell your doctor if you are taking If you are not sure what to do, ask any other medicines, including Abnormal uterine bleeding - the your doctor or pharmacist. medicines you buy without a recommended dose is 2.5 to 10 mg prescription from a pharmacy, daily for 5 to 10 days. Treatment is If you have trouble remembering supermarket or health food shop. usually repeated for two-three to take your medicine, ask your Some medicines may interfere with cycles in a row. pharmacist for some hints. PROVERA. These include aminoglutethimide, a medicine used Your doctor may also ask you to If you take too much to treat breast cancer. This take a medicine containing (overdose) medicine may affect how well estrogens together with PROVERA PROVERA works. You may need tablets. Immediately telephone your different amounts of your medicine doctor or the National Poisons or you may need to take different Menopause symptoms together Information Centre (telephone medicines. Your doctor will advise with an estrogen containing 0800 POISON or 0800 764 766) or you. medicine - the recommended dose go to Accident and Emergency at is 10 to 20 mg per day for at least your nearest hospital. Do this Your doctor or pharmacist may 10 to 14 days of each cycle, or even if there are no signs of have more information on 2.5 mg to 5 mg per day discomfort or poisoning. medicines to be careful with or continuously for 28 days of each avoid while taking PROVERA. cycle. You may need medical attention.

Kidney and endometrial cancer - the recommended daily dose is 100 – 600 mg. While you are taking Do not take PROVERA to treat  sweating other complaints unless your doctor PROVERA tells you to.  irregular vaginal bleeding or spotting or unusual changes in vaginal secretions Things you must do Things to be careful of Take PROVERA exactly as your  lack of menstrual periods Be careful driving or operating doctor has prescribed. machinery until you know how  nausea or vomiting PROVERA affects you. If you become pregnant while you PROVERA generally does not  breast tenderness are taking PROVERA, tell your cause any problems with your doctor.  unusual secretion of breast milk ability to drive a car or operate machinery.  fever If you develop unexplained or persistent pains in the head, chest,  change in weight (increase or However, PROVERA may cause stomach or legs, you should see decrease) dizziness, drowsiness or fatigue in your doctor immediately. some people. Make sure you know  tremor how you react to PROVERA before  constipation or diarrhoea Tell all doctors and pharmacists driving a car or operating who are treating you that you are machinery.  dry mouth taking PROVERA.  breast tenderness If you are about to start taking Side effects any new medicines, tell your  changes in sexual drive Check with your doctor or doctor and pharmacist that you  leg cramps are taking PROVERA. pharmacist as soon as possible if you have any problems while taking  fluid retention If you are going to have any PROVERA, even if you do not think the problems are connected  impotence (mainly in cancer laboratory tests, tell your doctor treated patients). that you taking PROVERA. with the medicine or are not listed in this leaflet. Tell your doctor as soon as PROVERA may interfere with the possible if you notice the results of some tests. Like other medicines, PROVERA following: can cause some side effects. If they If you feel that PROVERA is not occur, most are likely to be minor  confusion or memory loss and temporary. However, some helping your condition, tell your  lumps or change in your breasts doctor. may be serious and need medical attention.  yellowing of the skin or eyes Also, tell your doctor if, for any  abnormal liver function test reason, you have not taken Ask your doctor or pharmacist to PROVERA exactly as prescribed. answer any questions you may  changes in body fat (e.g., an have. increased amount of fat in the Visit your doctor regularly. upper back, neck, breast, and Tell your doctor if you notice any trunk, and loss of fat from the of the following and they worry Your doctor needs to check your legs, arms, and face. progress and see whether you need you: Although these side effects are not to keep taking PROVERA.  nervousness or difficulty common, they may require further Regularly check your breasts for concentrating medical assessment for serious any lumps and have regular  trouble sleeping conditions, such as dementia or professional breast examination and breast cancer.  drowsiness or sleepiness mammograms as recommended by Tell your doctor immediately or your doctor.  fatigue go to Accident and Emergency at your nearest hospital if any of the If you are taking PROVERA for  depression or excitation following happen: prolonged periods, your doctor may  dizziness also need to evaluate your bone  signs of allergy such as rash, mineral density (BMD).  headache itching or hives on the skin, swelling of the face, lips, Things you must not do  skin conditions, such as hives, itching, rash or acne tongue or other parts of the Do not give PROVERA to anyone body, shortness of breath,  unusual hair loss or thinning or else, even if they have the same wheezing or trouble breathing increased hairiness condition as you. (anaphylaxis)  severe headaches or changes in Product description PO Box 3998 speech or vision Auckland New Zealand.  painful swelling in the arms or What it looks like legs PROVERA tablets are available in Toll Free Number: 0800 736 363.  swollen or tender veins 2.5 mg, 5 mg, 10 mg, 100 mg and 200 mg strengths. This leaflet was prepared in  sudden blocking of a blood November 2016. vessel PROVERA 2.5 mg tablets are  blood clots orange, round and convex with one  Pfizer Australia Pty Ltd 2016. side scored and marked “U64”. The  blood clots in the retina at the 2.5 mg tablets are available in  Registered Trademark. back of the eye blister packs of 30 tablets.  chest pain or shortness of breath. PROVERA 5 mg tablets are pale blue, round and convex with one These are rare, but serious side side marked “U” and the other side effects. You may need urgent scored and marked “286” both sides medical attention. of the scoreline. The 5 mg tablets are available in blister packs of 100 Other side effects not listed above tablets. may also occur in some patients. Tell your doctor if you notice PROVERA 10 mg tablets are white, anything else that is making you round and convex with one side feel unwell. Do not be alarmed by scored and marked “UPJOHN 50”. this list of possible side effects. The 10 mg tablets are available in You may not experience any of blister packs of 30. them. PROVERA 100 mg tablets are After taking PROVERA white, scored and marked “U467”. The 100 mg tablets are available in Storage blister packs of 100 tablets. Keep PROVERA in a cool, dry PROVERA 200 mg tablets are place where the temperature stays white, scored and marked “U320”. below 30°C. The 200 mg tablets are available in blister packs of 30 tablets. Do not store PROVERA, or any other medicine, in a bathroom or Ingredients near a sink. Do not leave it in the car or on window sills. Heat and The active ingredient in PROVERA dampness can destroy some tablets is medroxyprogesterone medicines. acetate.

Keep your PROVERA tablets PROVERA 2.5 mg , 5 mg and 10 where children cannot reach mg tablets also contain lactose, them. A locked cupboard at least sucrose, maize starch, liquid one-and a-half metres above the paraffin, purified talc, calcium ground is a good place to store stearate, purified water, and the medicines. colouring agents sunset yellow FCF (2.5 mg) and indigo carmine (5 mg). Disposal PROVERA 100 mg and 200 mg If your doctor tells you to stop tablets also contain sodium starch taking PROVERA or it has passed glycollate, microcrystalline its expiry date, ask your pharmacist cellulose, maize starch, gelatin, what to do with any tablets left docusate sodium, macrogol 400, over. sodium benzoate, isopropyl alcohol, magnesium stearate and purified water.

Supplier Pfizer New Zealand Limited