What is the Provera tablet used for?

Package leaflet: Information for the patient. Provera 5 mg tablets Provera 10 mg tablets medroxyprogesterone acetate

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1 Package leaflet: Information for the patient Provera 5 mg tablets Provera 10 mg tablets medroxyprogesterone acetate Read all of this leaflet carefully before you start taking this medicine because it contains important information for you. Please keep this leaflet. You might want to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you personally. Do not pass it on to others. It can harm other people, even if they have the same symptoms as you. If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this leaflet. See section 4. What is in this leaflet 1. What Provera is and what it is used for? 2. What you need to know before you take Provera? 3. How to take Provera 4. What side effects are possible? 5. How to store Provera 6. Contents of the pack and other information 1. What is Provera and what is it used for? Provera contains medroxyprogesterone acetate, a progestogen that belongs to the group of female sex hormones. Provera is used: for certain menstrual problems (irregular or prolonged menstrual bleeding, absent menstrual bleeding, etc.) for endometriosis (presence of uterine tissue outside the uterus) as a supplement to treatment with estrogens (female hormones) 2. What you should do before taking Provera note? Do not take Provera: if you are allergic to medroxyprogesterone acetate or any of the other ingredients of this medicine (listed in section 6). if you are or could be pregnant. if you have vaginal bleeding of unknown origin. if you are suspected of having breast cancer or if you have had breast cancer in the past. if you have breast cancer (unless taking high doses of medroxyprogesterone acetate is part of your treatment). 1/6

2 if you have active thrombophlebitis (inflammation of the veins with clot formation) or if you have had a history of obstruction of the blood vessels with clot formation (thromboembolism). if you have severe liver disease. Warnings and precautions Talk to your doctor before taking Provera. This medicine was given to you as part of a specific medical treatment. It should not be taken by other people. As with any hormonal treatment, you must undergo a medical examination before starting any treatment with Provera and regularly during this treatment. A sufficient supply of calcium and vitamin D is recommended. Ask your doctor about this. No data are available on the effects of Provera 5 mg and 10 mg on bone mineral density. Your doctor may want you to have bone density tests if you are using Provera long-term. Certain studies suggest that taking estrogens with progestatives like Provera during menopause may increase the risk of breast cancer, ovarian cancer, cardiovascular disease, thromboembolic events (blood clots that can block the main blood vessels), and mental disorders . These studies show that the risk of breast cancer increases the longer the combined treatment with estrogens and progestatives increases. Please inform your doctor in the following cases: If unexplained vaginal bleeding occurs during prolonged treatment with Provera. if you are known to have any of the following conditions: high blood pressure, epilepsy, migraines, asthma, heart, kidney or liver disorders. if you have suffered from depression. if you have diabetes; Your treatment for diabetes may need to be adjusted during and after taking Provera. if you have porphyria (rare metabolic disease). if you have or have suffered from thrombosis (clot in the blood vessels), phlebitis (inflammation of the veins) or venous thromboembolism. Tell your doctor straight away if a leg swells painfully, if you suddenly experience chest pain or have difficulty breathing, as your treatment may need to be stopped. if you notice a change in the chest area. if you are taking any other medication. Also read under Other medicines and Provera. Other medicines and Provera: Tell your doctor or pharmacist if you are taking, have recently taken, or may take any other medicines. Certain medicines can influence each other, especially in terms of how they work and / or side effects. Consult your doctor or pharmacist about taking Provera with the following medicines: ciclosporin (an immune suppressing medicine) certain medicines used to treat epilepsy (e.g. barbiturates, phenytoin, carbamazepine) 2/6

3 certain medicines used to treat infections (e.g. rifampicin, rifabutin, nevirapine) oral anticoagulants (medicines that reduce blood clotting) medicines containing aminoglutethimide or herbal preparations made from St. John's wort (ask your doctor or pharmacist) if you have a blood test, as taking Provera may cause the results of some tests to be wrong. Taking Provera with food and drink Consult your doctor or pharmacist about using Provera with alcohol. Pregnancy, breastfeeding and fertility / childbearing ability Provera must not be used during pregnancy. It is not recommended to use Provera while breastfeeding. Ask your doctor or pharmacist for advice before taking this medicine if you are pregnant or breast-feeding, if you suspect you may be pregnant or planning to become pregnant. Driving and using machines The effects of Provera on the ability to drive or use machines have not been systematically studied. Provera contains lactose and sucrose. Please only take Provera after consulting your doctor if you know that you suffer from an intolerance to certain sugars. 3. How to take Provera Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. If Provera has been prescribed for you to supplement estrogenic treatment during menopause, the dose to be taken must be as small as possible and the duration of treatment as short as possible. Your doctor will do regular checkups. Take the tablet (s) with half a glass of water during a meal. The dosage will be determined by your doctor. Usual dosages: - for menstrual disorders: 5 to 10 mg per day for 10 days of the cycle. The doctor will determine when to start treatment and how long it should last. Menstrual periods will occur three to seven days after stopping Provera treatment. - in the case of endometriosis (presence of uterine tissue outside the uterus): 10 mg three times per day from the 1st day of the cycle for 90 consecutive days. Bleeding occurs three to seven days after stopping Provera treatment. - as a supplement to treatment with estrogens during menopause (hormone replacement treatment): 3/6

4 For women taking 0.625 mg conjugated oestrogens or an equivalent daily dose of another estrogen, Provera can be given in one of two ways: - Continuous use of Provera tablets, 2.5 to 5 mg daily. - Consecutive intake of Provera tablets, 5 to 10 mg daily for 12 to 14 consecutive days of a monthly cycle or 28 days. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. If you take more Provera than you should, you may feel sick and / or be sick. Bleeding may occur a few days later. In the event of an overdose, symptomatic supportive treatment is given. If you have used too much Provera, contact your doctor, pharmacist or the Anti-Poison Center (070 /) immediately. If you stop taking Provera Always ask your doctor for advice if you are considering stopping treatment. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4. What side effects are possible? Like all medicines, this medicine can have side effects, although not everybody gets them. If the following symptoms occur, the treatment must be discontinued and the attending physician consulted immediately: Sudden visual disturbances, e.g. partial or total loss of vision, double vision or severe headache. Very common (may affect more than 1 in 10 people): vaginal bleeding outside of the menstrual cycle: irregular, unpredictable, increased, decreased bleeding headache nausea Common (may affect 1 to 10 in 100 people): allergic reactions to the medicine depression insomnia nervousness dizziness Acne severe hair loss itching hives joint pain altered discharge painful breasts hypersensitivity of the breasts 4/6

Intermenstrual bleeding Fatigue Fever Weight gain Uncommon (may affect 1 to 10 in 1,000 people): abnormal body hair in women galactorrhea (secretion of milk from the breasts in women who are not breastfeeding) edema water retention Frequency not known (cannot be estimated from the available data): severe allergic Reactions with a potentially fatal outcome (anaphylactic reaction, anaphylactoid reaction), Quincke edema Delayed ovulation Drowsiness Embolism (obstruction of a blood vessel), thrombosis (formation of a blood clot in the blood vessels) Jaundice Skin rash Absence of menstrual bleeding Glucose increased Cervical erosion Weight loss Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this leaflet. You can also report side effects directly via the Federal Agency for Medicines and Health Products - Vigilance Department, Eurostation II, Victor Hortaplein, 40/40, B-1060 Brussels (Website: By reporting side effects you can help provide more information about the 5. How to store Provera Keep out of the reach and sight of children Store at room temperature (15-25 C) Do not use this medicine after the expiry date which is stated on the carton after EXP The expiry date refers to the last day of that month. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. You will help protect the environment. 6. Contents of the pack and other information What Provera contains 5/6

6 The active substance is: medroxyprogesterone acetate. Provera 5 mg tablets and Provera 10 mg tablets contain 5 mg and 10 mg medroxyprogesterone acetate, respectively. The other ingredients are: lactose monohydrate, corn starch, sucrose, liquid paraffin, calcium stearate and talc. Provera 5 mg tablets also contain aluminum lacquer with indigotine (E132) as a color. What Provera looks like and contents of the pack Provera 5 mg tablets: Packs of 24 tablets. Provera 10 mg tablets: box of 30 tablets. Not all pack sizes may be marketed. Marketing Authorization Holder and Manufacturer Pfizer S.A., 17 Boulevard de la Plaine, 1050 Brussels, Belgium. Manufacturer: Pfizer Italia S.r.l., Via del Commercio, Marino del Tronto, Ascoli Piceno, Italy. Approval numbers: Provera 5 mg tablets: BE Provera 10 mg tablets: BE Delivery form: Subject to a prescription. This leaflet was last revised in: 04/2017 This leaflet was last approved in: 04 / The following information is intended for healthcare professionals only: If endocervical or endometrial tissue is taken for a sample, the anatomist-pathologist must inform about the treatment with medroxyprogesterone acetate become. The doctor / laboratory must be informed that the use of medroxyprogesterone acetate may decrease the concentration of the following endocrine biological markers: a. Plasma / urine steroids (e.g. cortisol, estrogen, pregnanediol, progesterone, testosterone) b. Plasma / urine gonadotropins (e.g. luteinizing and follicle-stimulating hormone) c. Sex hormone binding globulin. 6/6