Provera

Package Leaflet: Information for the Patient

PROVERA, 5 mg, tablets

PROVERA, 10 mg, tablets

Medroxyprogesterone acetate

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is PROVERA and what is it used for
• 2. Important information before taking PROVERA
• 3. How to take PROVERA
• 4. Possible side effects
• 5. How to store PROVERA
• 6. Package contents and other information

1. What is PROVERA and what is it used for

PROVERA has several proven pharmacological effects on the endocrine system:

• inhibits the secretion of pituitary gonadotropins (FSH and LH);
• decreases the concentration of ACTH and hydrocortisone in the blood;
• decreases the concentration of testosterone in the peripheral blood;
• decreases the concentration of estrogens in the peripheral blood.

PROVERA, when taken orally in recommended doses to women with normal estrogen secretion, causes a change in the endometrium from the proliferative phase to the secretory phase. PROVERA is used to treat:

• secondary amenorrhea,
• functional (anovulatory) uterine bleeding caused by hormonal imbalance,
• mild to moderate endometriosis,
• and to prevent endometrial hyperplasia (endometrial thickening) in women taking estrogens.

2. Important information before taking PROVERA

When not to take PROVERA:

• if the patient is hypersensitive to medroxyprogesterone acetate or any of the other ingredients of this medicine (listed in section 6),
• in case of pregnancy or suspected pregnancy,
• in pregnancy diagnosis,
• in case of genital or urinary tract bleeding of unknown cause,
• in case of venous thromboembolic disease,
• in case of a history of stroke,
• in case of severe liver failure,
• in case of diagnosed or suspected malignant breast or genital tumor,
• in case of missed abortion.

Warnings and precautions

Before starting PROVERA, discuss it with your doctor or pharmacist.

When to exercise special caution when taking PROVERA

• in case of known hypersensitivity to steroids other than the active substance medroxyprogesterone acetate;
• in case of uterine bleeding during PROVERA treatment;
• in patients with concomitant diseases, such as epilepsy, migraine, asthma, heart or kidney disorders, where weight gain or fluid retention may worsen the condition;
• in patients with a history of depression;
• in some patients taking PROVERA, symptoms similar to premenstrual depression may occur;
• in some patients taking PROVERA, glucose tolerance may decrease. Patients with diabetes should be closely monitored during treatment;
• when a biopsy of the endometrium or a biopsy from the cervical canal is sent for histopathological examination, the pathologist (or laboratory) should be informed about the use of PROVERA;
• the use of PROVERA may decrease the levels of the following hormonal biomarkers: a) steroids in serum and/or urine (e.g., cortisol, estrogen, pregnanediol, progesterone, testosterone) b) gonadotropins in serum and/or urine (e.g., LH and FSH) c) sex hormone-binding globulin (SHBG)
• if the patient experiences sudden, partial or complete vision loss or sudden onset of exophthalmos, double vision, or migraine, they should stop taking the medicine and undergo a thorough ophthalmological examination. If papilledema or changes in retinal vessels are diagnosed, the medicine should not be continued;
• in patients with a history of thromboembolic or thrombotic disorders.

Before starting hormonal therapy and periodically after its initiation, the doctor should recommend physical examinations: blood pressure measurements, breast, abdominal, and pelvic examinations, including a cervical smear test. The use of hormonal therapy is associated with the risk of venous thromboembolic disease, i.e., deep vein thrombosis or pulmonary embolism. Hormonal therapy should not be used to prevent cardiovascular disease - estrogens alone or in combination with progestogens. An increased risk of such cardiovascular events as myocardial infarction, ischemic heart disease, stroke, and venous thromboembolic disease has been found in postmenopausal women taking combined estrogen and progestogen therapy. It has been shown that the risk of cardiovascular disease may increase in the first year of concurrent use of estrogens and medroxyprogesterone acetate in a continuous combined regimen. An increased risk of stroke has been observed in women receiving estrogens in combination with medroxyprogesterone acetate. The concurrent use of estrogens and progestogens by postmenopausal women increases the risk of breast cancer. The risk increases with the duration of treatment. Hormonal therapy is not recommended for the prevention of dementia or mild cognitive impairment in women. There is an increased risk of probable dementia and mild cognitive impairment in postmenopausal women aged 65 or older. No studies have been conducted on the effect of PROVERA on bone mineral density (BMD). In a study involving women taking medroxyprogesterone acetate injections as a contraceptive method, a mean decrease in BMD values was noted. In adult women, after several years of stopping the medicine, a partial return of BMD to baseline values has been observed, while a complete return has been noted in young women. It is not known whether the use of medroxyprogesterone acetate injections during adolescence and early adulthood, a critical period for bone mass growth, reduces peak bone mass. The doctor may recommend taking calcium and vitamin D and periodic assessment of bone mineral density.

PROVERA and other medicines

Tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you plan to take. The concurrent administration of aminoglutethimide and high doses of medroxyprogesterone acetate may significantly decrease the concentration of medroxyprogesterone acetate in the serum and the effectiveness of PROVERA. Medroxyprogesterone acetate may affect the results of the metyrapone test.

Using PROVERA with food and drink

Administration of the medicine during a meal leads to increased bioavailability.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor or pharmacist for advice before taking this medicine. PregnancyPROVERA is contraindicated in pregnant women. There are data indicating a possible link between the use of progestogen drugs in the first trimester of pregnancy and the occurrence of developmental disorders in the genital system of both sexes. You should be informed about the possible risk to the fetus if PROVERA is used during pregnancy or if you become pregnant while taking the medicine. BreastfeedingPROVERA and its metabolites pass into breast milk. There is no evidence to suggest that this may pose a risk to the breastfed child, however, the use of the medicine during breastfeeding is not recommended.

Driving and using machines

No effect of PROVERA on the ability to drive and use machines has been observed.

PROVERA contains lactose monohydrate

PROVERA 5 mg contains lactose monohydrate (84.20 mg) and PROVERA 10 mg contains lactose monohydrate (110 mg). If you have been diagnosed with intolerance to some sugars, you should consult your doctor before taking the medicine.

3. How to take PROVERA

This medicine should always be taken exactly as advised by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist. Treatment of secondary amenorrhea5 mg to 10 mg per day for 5 to 10 days. Bleeding should occur within 3 to 7 days after stopping the medicine. Treatment of functional (anovulatory) uterine bleeding caused by hormonal imbalance5 mg to 10 mg per day for 5 to 10 days, starting on approximately the 16th to 21st day of the cycle. Bleeding should occur within 3 to 7 days after stopping PROVERA. The dose (5 to 10 mg) can be repeated, starting from the 16th day of the cycle, for 2-3 consecutive cycles. Then, treatment should be discontinued to check if the functional disorders have resolved. Treatment of mild to moderate endometriosisThe recommended dosage of PROVERA is 10 mg three times a day for 90 consecutive days, starting from the first day of the menstrual cycle. In 30-40% of patients, self-limiting spotting may occur. In such cases, no additional hormone therapy is recommended. Prevention of endometrial hyperplasia (endometrial thickening) in women taking estrogensThe dose and regimen are determined individually by the doctor. The most commonly used dosing regimens are:

• continuous regimen: 2.5 mg to 5 mg per day
• sequential regimen: 5 mg to 10 mg per day for 10 to 14 consecutive days of a 28-day cycle. Withdrawal bleeding or spotting occurs in 75-80% of women treated in this way.

The use of combined estrogen and progestogen therapy for the treatment of menopausal symptoms should be limited to the smallest effective dose and duration. It is recommended to perform periodic examinations in patients. Their type and frequency should depend on the patient's condition. Progestogens should not be administered to women who have had a hysterectomy, except in cases where endometriosis has been diagnosed.

Using a higher dose of PROVERA than recommended

Do not take a higher dose of the medicine than recommended by your doctor. If you have taken a higher dose of PROVERA than recommended, consult your doctor immediately. Oral doses up to 3 g per day have been well tolerated. Treatment of overdose is symptomatic and supportive.

Missing a dose of PROVERA

If you forget to take a dose of PROVERA, take it as soon as possible, unless it is almost time for the next dose. In this case, take the next dose at the scheduled time.

Stopping PROVERA treatment

The decision to stop treatment is made by the doctor. Do not stop treatment without consulting your doctor.

4. Possible side effects

Like all medicines, PROVERA can cause side effects, although not everybody gets them. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. Very common(may affect more than 1 in 10 people)

• headache,
• nausea,
• abnormal uterine bleeding (irregular, excessive, too scarce, spotting).

Common(may affect up to 1 in 10 people)

• hypersensitivity to the medicine,
• depression, insomnia, nervousness,
• dizziness,
• hair loss, acne, hives, itching,
• cervical discharge, breast tenderness, breast pain,
• fever, feeling of tiredness, reactions at the injection site, persistent indentation at the injection site,
• weight gain.

Uncommon(may affect up to 1 in 100 people)

• excessive hair growth,
• galactorrhea,
• edema, fluid retention, nodule at the injection site, pain and/or tenderness at the injection site.

Frequency not known(cannot be estimated from the available data)

• sudden, severe allergic or non-allergic reaction that can be life-threatening, skin and mucous membrane disease characterized by limited edema (angioedema),
• prolonged period of anovulation,
• drowsiness,
• thromboembolic events,
• jaundice, cholestatic jaundice,
• atrophy or impaired development of fatty tissue (acquired lipodystrophy), rash,
• amenorrhea, cervical erosion,
• decreased glucose tolerance, weight loss.

side effects occurring after the use of the medicine in injectable form

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products Al. Jerozolimskie 181C 02-222 Warsaw Tel.: +48 22 49 21 301 Fax: +48 22 49 21 309 Website: https://smz.ezdrowie.gov.pl Side effects can also be reported to the marketing authorization holder or its representative. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store PROVERA

Keep the medicine out of the sight and reach of children. Store in a temperature below 25°C. Do not use this medicine after the expiry date stated on the packaging after (EXP). The expiry date refers to the last day of the month. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What PROVERA contains

Each tablet contains 5 mg of medroxyprogesterone acetate (Medroxyprogesteroni acetas). The active substance is medroxyprogesterone acetate. The other ingredients are: lactose monohydrate, cornstarch, sucrose, liquid paraffin, talc, calcium stearate, indigo carmine (E132). Each tablet contains 10 mg of medroxyprogesterone acetate (Medroxyprogesteroni acetas). The active substance is medroxyprogesterone acetate. The other ingredients are: lactose monohydrate, cornstarch, sucrose, liquid paraffin, talc, calcium stearate.

What PROVERA looks like and contents of the package

5 mg tablets: round, blue, with a dividing line on one side and an embossed mark "286" above and below the dividing line, and an embossed mark "U" on the other side. The package contains: 10 tablets in a PVC/Al blister pack, 3 blister packs in a cardboard box 10 mg tablets: round, white, with an embossed mark "Upjohn 50" on one side and a dividing line on the other side. The package contains: 10 tablets in a PVC/Al blister pack, 3 blister packs in a cardboard box

Marketing authorization holder

Pfizer Europe MA EEIG Boulevard de la Plaine 17 1050 Bruxelles Belgium

Manufacturer

Pfizer Italia S.r.l. Localitá Marino del Tronto 63100 Ascoli Piceno Italy

To obtain more detailed information about this medicine, please contact the local representative of the marketing authorization holder:

Pfizer Polska Sp. z o.o. tel. 22 335 61 00

Date of last revision of the leaflet:

Detailed and up-to-date information about this product can be obtained by scanning the QR code on the outer packaging using a mobile device. The same information is also available at the URL: https://pfi.sr/ulotka-provera and on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products http://www.urpl.gov.pl .