Depo-provera

Package Leaflet: Information for the Patient

DEPO-PROVERA

150 mg/ml, suspension for injection
Medroxyprogesterone acetate

Read the package leaflet carefully before using 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 DEPO-PROVERA and what is it used for
• 2. Important information before using DEPO-PROVERA
• 3. How to use DEPO-PROVERA
• 4. Possible side effects
• 5. How to store DEPO-PROVERA
• 6. Contents of the pack and other information

1. What is DEPO-PROVERA and what is it used for

DEPO-PROVERA contains medroxyprogesterone acetate, which is a progestagen that affects the hormonal system.
DEPO-PROVERA is used:

• as adjuvant and/or palliative treatment in the case of recurrence or metastasis of endometrial or renal cancer;
• in the treatment of recurrence or metastasis of breast cancer in postmenopausal women.

2. Important information before using DEPO-PROVERA

When not to use DEPO-PROVERA

• if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6);
• in case of pregnancy or suspected pregnancy;
• in case of genital bleeding of unknown cause;
• in case of changes in the breast of unknown character;
• in case of severe liver failure;
• in case of thrombophlebitis, or current or past thromboembolic disorders, or cerebrovascular disease.

Warnings and precautions

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

When to exercise special caution when using DEPO-PROVERA

• in case of known hypersensitivity to steroids other than medroxyprogesterone acetate;
• in case of genital bleeding during treatment with DEPO-PROVERA;
• 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 during treatment with DEPO-PROVERA, symptoms similar to premenstrual depression may occur;
• in some patients taking DEPO-PROVERA, glucose tolerance may decrease;
• when a biopsy of the endometrium or cervical canal is sent for histopathological examination, the histopathologist (or laboratory) should be informed about the use of DEPO-PROVERA;
• the use of DEPO-PROVERA may reduce 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)
• DEPO-PROVERA may also cause partial adrenal insufficiency during metyrapone tests;
• if the patient experiences sudden, partial or complete vision loss or protrusion, double vision, or migraine, the administration of the medicine should be discontinued and a thorough ophthalmological examination should be performed. If the doctor confirms optic nerve edema or changes in the retinal vessels, the medicine should not be continued;
• the use of DEPO-PROVERA may lead to symptoms similar to Cushing's syndrome, such as obesity, stretch marks, acne, hypertension;
• if the patient experiences a prolonged period of amenorrhea with atrophy of the uterus and/or irregular menstrual cycles;
• in patients with a history of thromboembolic or thrombotic disorders;
• due to the possibility of decreased bone mineral density (BMD) in premenopausal women, which may increase the risk of osteoporosis in later life.

In a study involving women taking medroxyprogesterone acetate injections as a contraceptive method, a mean decrease in BMD values was observed.
In adult women after several years of discontinuing the medicine, a partial return of BMD to baseline values was observed, while a complete return was observed in adolescent 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 performing periodic bone density assessments.

DEPO-PROVERA and other medicines

Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Concomitant administration of aminoglutethimide with DEPO-PROVERA may significantly decrease the serum concentration of medroxyprogesterone acetate and reduce the effectiveness of DEPO-PROVERA.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.
Pregnancy
The use of DEPO-PROVERA during pregnancy is contraindicated.
In newborns born from unplanned pregnancies started between the first and second month after injection of DEPO-PROVERA, low birth weight may occur, which is associated with an increased risk of neonatal death. There are data indicating a link between the use of progestogen medications during the first trimester of pregnancy and the occurrence of developmental disorders in the genital system of fetuses of both sexes.
The patient should be informed about the possible risk to the fetus if DEPO-PROVERA is used during pregnancy or if the woman becomes pregnant while using the medicine.
Breastfeeding
Medroxyprogesterone acetate and its metabolites are excreted into human milk. There are insufficient data to suggest that their presence may pose a risk to the child; however, breastfeeding is not recommended during treatment with this medicine.
Fertility
DEPO-PROVERA administered intramuscularly at a dose of 150 mg/ml every 3 months has a contraceptive effect. In premenopausal women prescribed DEPO-PROVERA for the treatment of renal or endometrial cancer, irregular bleeding or amenorrhea may occur, and return of fertility (ovulation) may be delayed after discontinuation of treatment.

Driving and using machines

The effect of DEPO-PROVERA on the ability to drive and use machines has not been studied.

DEPO-PROVERA contains methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216)

The medicine may cause allergic reactions (possible late reactions).

DEPO-PROVERA contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e. the medicine is considered "sodium-free".

3. How to use DEPO-PROVERA

This medicine should always be used as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
Endometrial and renal cancer: initially, doses of 400 mg to 1000 mg of medroxyprogesterone acetate per week are recommended, administered intramuscularly. If improvement occurs within a few weeks or months and the patient's condition appears to be stable, a maintenance dose of 400 mg per month may be used.
Breast cancer: the recommended initial dose is 500 mg to 1000 mg of medroxyprogesterone acetate per day, administered intramuscularly for 28 days. Then, maintenance doses of 500 mg twice a week should be used as long as the patient responds to treatment.

Using a higher dose of DEPO-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 DEPO-PROVERA than recommended, consult your doctor immediately.

Missing a dose of DEPO-PROVERA

If you miss a dose of DEPO-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 treatment with DEPO-PROVERA

Only your doctor can decide to stop treatment. Do not stop treatment without consulting your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common(may affect up to 1 in 10 people):

• weight changes, increased appetite
• insomnia
• headache, dizziness, tremors
• vomiting, constipation, nausea
• excessive sweating
• erectile dysfunction
• edema, fluid retention, fatigue, injection site reactions

Uncommon(may affect up to 1 in 100 people):

• angioedema (a skin and mucous membrane disease characterized by limited swelling)
• actions similar to those caused by corticosteroids (a group of medicines with anti-inflammatory, anti-allergic, and immunosuppressive effects), such as those seen in Cushing's syndrome
• a syndrome of symptoms associated with elevated cortisol levels in the blood
• worsening of diabetes, hypercalcemia (elevated calcium levels in the blood)
• depression, euphoria, changes in sexual desire
• congestive heart failure
• thrombophlebitis
• pulmonary embolism
• diarrhea, dryness of the mucous membranes
• acne, excessive hair growth
• muscle cramps
• abnormal uterine bleeding (irregular, heavy, or light), breast tenderness
• pain or tenderness at the injection site

Rare(may affect up to 1 in 1,000 people):

• hypersensitivity to the medicine
• nervousness
• stroke, drowsiness
• myocardial infarction
• thromboembolic and thrombotic disorders
• jaundice
• alopecia, rash
• malaise, fever
• decreased glucose tolerance (pre-diabetic state), increased blood pressure

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

• anaphylactic reaction (a sudden, severe allergic or non-allergic reaction that can be life-threatening), anaphylactoid reaction (a sudden reaction that affects the whole body, similar to anaphylaxis, but not an allergic reaction)
• prolonged period of amenorrhea
• confusional state
• disturbances of attention, actions similar to those caused by activation of the sympathetic nervous system (part of the autonomic nervous system)
• thrombosis and embolism of the retinal vessels, diabetic cataract, vision disturbances
• tachycardia, palpitations
• acquired lipodystrophy, urticaria, pruritus
• osteoporosis, including osteoporotic fractures
• glycosuria
• amenorrhea, cervical erosion, cervical discharge, galactorrhea, vaginal discharge, breast tenderness
• persistent indentation at the injection site, nodule at the injection site
• abnormal liver function test results, increased white blood cell count, increased platelet count

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, please inform your doctor or nurse. 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
Phone: +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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store DEPO-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. Contents of the pack and other information

What DEPO-PROVERA contains

• The active substance of the medicine is medroxyprogesterone acetate. 1 ml of the suspension contains 150 mg of medroxyprogesterone acetate (Medroxyprogesterone acetate).
• The other ingredients are: sodium chloride (see section 2 "DEPO-PROVERA contains sodium"), methyl parahydroxybenzoate (E 218) [see section 2 "DEPO-PROVERA contains methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216)], propyl parahydroxybenzoate (E 216) [see section 2 "DEPO-PROVERA contains methyl parahydroxybenzoate (E 218) and propyl parahydroxybenzoate (E 216)], polysorbate 80, macrogol 3350, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment), water for injections.

DEPO-PROVERA is a white suspension.
The medicine is available in glass vials in a cardboard box. The vials contain 3.3 ml or 6.7 ml of suspension.

Marketing authorization holder:

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

Manufacturer:

Pfizer Manufacturing Belgium NV
Rijksweg 12
2870 Puurs
Belgium