Depo-provera

Leaflet attached to the packaging: patient information

DEPO-PROVERA, 150 mg/ml, suspension for injection
Medroxyprogesterone acetate

Read the 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 any not listed in this leaflet, please tell 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 packaging and other information

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

DEPO-PROVERA is used as a hormonal contraceptive. Medroxyprogesterone acetate, the active substance of the medicine, is a progestogen and a chemical compound similar to the natural hormone - progesterone.
DEPO-PROVERA:

• inhibits the secretion of gonadotropins, thereby controlling ovarian function,
• prevents the maturation of Graafian follicles and the full development of egg cells, preventing their release from the ovaries (ovulation) during the menstrual cycle,
• also leads to a decrease in the thickness of the uterine lining. An egg cell that is not released from the ovaries cannot be fertilized by sperm and therefore cannot lead to pregnancy,
• causes an increase in the density of cervical mucus, making it impossible for sperm to enter the uterus.

In women of all ages, using DEPO-PROVERA for a long period may lead to a decrease in bone mineral density (BMD), so the doctor should consider the benefit-risk assessment of using this medicine, also taking into account the decrease in BMD that occurs during pregnancy and/or lactation.
It should also be considered that the return to fertility (ovulation) may be delayed for a period of up to one year.

2. Important information before using DEPO-PROVERA

When not to use DEPO-PROVERA

• if the patient is hypersensitive to the active substance or any of the other ingredients of this medicine (listed in section 6);
• in pregnant or suspected pregnant women;
• in women with unexplained vaginal bleeding until a final diagnosis is made and malignant tumors of the genital organs are excluded;
• in women with a diagnosis or suspected hormone-dependent malignant tumors of the breast or reproductive system;
• in women with severe liver failure;
• in women with active venous thrombosis or a history of thromboembolic disorders or cerebrovascular disease;
• if the patient has a meningioma or has been diagnosed with a meningioma (usually a benign tumor of the tissue surrounding the brain and spinal cord).

Using DEPO-PROVERA is not recommended before the first menstrual period.

Warnings and precautions

Before prescribing DEPO-PROVERA, the doctor should examine the patient. Before starting treatment, this should be discussed with the doctor. The patient should inform the doctor if they have or have had any of the following conditions. The doctor should discuss with the patient whether DEPO-PROVERA is suitable for them.
DEPO-PROVERA can be used in adolescent girls, but only after discussing other contraceptive methods with the patient and considering them inappropriate or unacceptable.
The patient should inform the doctor about:

• hypersensitivity to steroids other than medroxyprogesterone acetate;
• vaginal bleeding;
• concomitant diseases, such as epilepsy, migraine, asthma, heart or kidney disorders, where weight gain or fluid retention may worsen the condition, (medroxyprogesterone acetate may cause fluid retention in the body);
• past depression;
• symptoms of premenstrual depression during DEPO-PROVERA treatment;
• diabetes, as people taking DEPO-PROVERA may experience decreased glucose tolerance;
• transferring a cervical or endometrial biopsy for histopathological examination;
• DEPO-PROVERA may decrease the levels of hormonal biomarkers;
• sudden, partial or complete loss of vision, exophthalmos, double vision, migraine (ophthalmological examinations should be performed, and if optic disc edema or retinal changes are diagnosed, DEPO-PROVERA treatment should be discontinued);
• thromboembolic events occurring in the past or during DEPO-PROVERA treatment; the doctor will then consider discontinuing the treatment;
• risk factors for osteoporosis, such as excessive alcohol consumption and/or smoking, chronic use of medications that may decrease bone mass (e.g., antiepileptic or corticosteroid medications), low body mass index or eating disorders (e.g., anorexia nervosa or bulimia), previous low-energy fractures, family history of osteoporosis, as DEPO-PROVERA injections lead to a decrease in bone mineral density;
• irregular, scanty, heavy or prolonged menstrual bleeding;
• weight gain;
• jaundice; the doctor will then consider discontinuing the treatment.

Psychiatric disorders

Some women using hormonal contraceptives, including DEPO-PROVERA, have reported depression or low mood. Depression can be severe and sometimes lead to suicidal thoughts. If mood changes and symptoms of depression occur, the patient should contact the doctor as soon as possible for further medical advice.

Meningioma

The use of medroxyprogesterone acetate is associated with the development of usually benign tumors of the tissue surrounding the brain and spinal cord (meningioma). This risk increases, especially during long-term use (several years). If a meningioma is diagnosed, the doctor will discontinue DEPO-PROVERA treatment (see "When not to use DEPO-PROVERA"). If the patient experiences any of the following symptoms, such as vision disturbances (e.g., double vision or blurred vision), hearing loss or tinnitus, loss of smell, worsening headaches, memory loss, seizures, weakness of the arms or legs, they should immediately inform the doctor.
Using DEPO-PROVERA is associated with a significant decrease in bone mineral density due to the known effect of estrogen deficiency on bone remodeling. Bone loss is greater the longer DEPO-PROVERA is used, while after discontinuation of treatment, bone mineral density increases.
The decrease in bone mineral density is particularly important in adolescence and early adulthood, i.e., during periods of life that are crucial for bone mass growth.
It is not known whether the use of DEPO-PROVERA in young women causes a decrease in maximum bone mass and an increased risk of fractures in later life, i.e., after menopause.
The doctor may recommend taking calcium and vitamin D and performing periodic bone mineral density assessments.

DEPO-PROVERA does not protect against HIV infection, including AIDS, or other sexually transmitted diseases.

Safe sexual practices, including proper and consistent use of condoms, reduce the risk of sexually transmitted diseases, including HIV infection.
The patient should consult a healthcare professional for information on ways to reduce the risk of sexually transmitted diseases, including HIV infection.

DEPO-PROVERA and other medicines

The patient should tell the doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Before using a new medicine with DEPO-PROVERA, the patient should inform the doctor.
Concomitant use of aminoglutethimide may decrease the concentration of medroxyprogesterone acetate in the blood, thereby reducing the effectiveness of DEPO-PROVERA.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before using this medicine.
Pregnancy
Using this medicine during pregnancy is contraindicated.
In newborns born from unplanned pregnancies started between the first and second month after injection of the contraceptive DEPO-PROVERA, low birth weight may occur, which is associated with an increased risk of neonatal death. This risk is very small, as such pregnancies are very rare.
However, there are data suggesting 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 of the potential 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 pass into human milk. There is no sufficient data suggesting that their presence may pose a risk to the child, but breastfeeding is not recommended during treatment with this medicine.

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-type reactions).

DEPO-PROVERA contains sodium

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

3. How to use DEPO-PROVERA

This medicine should always be used as directed by the doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

Route and method of administration:

The recommended dose is 150 mg every 3 months.
DEPO-PROVERA is administered by deep intramuscular injection into the gluteal or deltoid muscle. Injections should be given for as long as the doctor recommends. The medicine is administered after vigorous shaking of the vial to obtain a uniform suspension.

Administration of the first dose of DEPO-PROVERA:

To ensure that the patient is not pregnant at the time of the first injection of DEPO-PROVERA, the injection may be given ONLYwithin the first five days of a normal menstrual cycle.
If DEPO-PROVERA is to be used after childbirth, the first dose MUSTbe given within five days of delivery, provided that the patient is not breastfeeding.
DEPO-PROVERA is given at six weeks postpartum if the mother is breastfeeding.
DEPO-PROVERA is effective only if injections are performed regularly, exactly at the scheduled time.

Subsequent doses

Subsequent doses of DEPO-PROVERA are given every 12 weeks. If the time between injections is longer than 89 days, pregnancy should be ruled out before administration, and the patient should use additional (e.g., mechanical) contraceptive methods for 14 days after the next injection.

Replacing other contraceptive methods with DEPO-PROVERA

In the case of switching from other contraceptive methods to DEPO-PROVERA, DEPO-PROVERA should be administered in a way that ensures continuous contraceptive protection, taking into account the mechanism of action of both methods (e.g., in patients who have been using oral contraceptives, the first injection of DEPO-PROVERA should be given within 7 days of taking the last contraceptive pill). It is very important to take subsequent injections exactly at the scheduled time.
It is not recommended to use the medicine before the first menstrual period. Using DEPO-PROVERA in adolescence between 12 and 18 years of age is associated with a statistically significant decrease in bone mineral density.
There are data available on the use of DEPO-PROVERA in adolescent girls (from 12 to 18 years of age). In addition to concerns about decreased bone mineral density, it is expected that the safety and efficacy of DEPO-PROVERA in adolescent girls who have already had their first menstrual period and in adult women are the same.

Using a higher dose of DEPO-PROVERA than recommended

Do not take a higher dose of the medicine than recommended by the doctor. If a higher dose of DEPO-PROVERA than recommended is taken, the doctor should be contacted immediately.

Missing a dose of DEPO-PROVERA

If a dose of DEPO-PROVERA is missed or the time between two consecutive injections is more than 12 weeks, there is a risk of pregnancy. Therefore, the patient should consult the doctor to decide whether to take the next dose of DEPO-PROVERA.

4. Possible side effects

Like all medicines, DEPO-PROVERA can cause side effects, although not everybody gets them.
Very common(may affect more than 1 in 10 people):

• nervousness
• headache
• weight gain, weight loss

Common(may affect up to 1 in 10 people):

• depression, decreased libido
• dizziness
• varicose veins
• abdominal pain, discomfort in the upper abdomen, nausea, abdominal bloating
• acne, hair loss, rash
• back pain
• discharge, breast tenderness, painful menstruation
• fatigue, fluid retention

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

• urinary tract infections
• hypersensitivity to the medicine
• increased appetite, decreased appetite
• insomnia
• seizures, drowsiness
• rapid heartbeat (tachycardia)
• hot flashes
• shortness of breath
• liver function disorders
• excessive hair growth, itching, skin discoloration on the face (chloasma), hives
• abnormal uterine bleeding (irregular, heavy, or prolonged), breast tenderness, painful intercourse, pelvic pain, galactorrhea, absence of lactation
• chest pain

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

• endometritis, injection site abscess
• breast cancer
• anemia, blood disorders
• sudden, severe allergic or non-allergic reaction that can be life-threatening
• prolonged period of anovulation
• inability to achieve orgasm despite sexual arousal, emotional disturbances, mental disorders, hyperactivity, anxiety
• migraine, paralysis, fainting, paresthesia
• dizziness
• hypertension, venous thrombosis, embolism, and thromboembolic disorders, deep vein thrombosis, pulmonary embolism
• hoarseness
• gastrointestinal disorders
• jaundice
• skin and mucous membrane disease characterized by limited edema (angioedema), skin inflammation, petechiae, striae, acquired lipodystrophy
• muscle cramps, joint pain, limb pain, osteoporosis, osteoporotic fractures, swelling of the axillary region, excessive and pathological skin fibrosis (scleroderma)
• amenorrhea, breast tenderness, metrorrhagia, menorrhagia, vaginal dryness, changes in breast size, ovarian cysts, premenstrual syndrome, endometrial hyperplasia, breast nodules, galactorrhea, vaginal infections, subjective symptoms of pregnancy
• injection site reactions, pain, and tenderness at the injection site, persistent atrophy, and indentation at the injection site, nodule at the injection site, fever, fatigue, swelling
• decreased bone mineral density, decreased glucose tolerance (prediabetic state), abnormal liver function tests, abnormal cervical smear

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

• usually benign tumor of the tissue surrounding the brain and spinal cord (meningioma) (see section 2 "Warnings and precautions").

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, please tell 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.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store DEPO-PROVERA

The medicine should be stored out of 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 stated.
Any unused medicine or waste material should be disposed of. Medicines should not be disposed of via wastewater or household waste. The patient should ask the pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What DEPO-PROVERA contains

• The active substance of the medicine is medroxyprogesterone acetate. Each vial contains 150 mg of medroxyprogesterone acetate in 1 ml of solution for injection. The prefilled syringe contains 150 mg of medroxyprogesterone acetate in 1 ml of solution for injection.
• 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 (to adjust pH), hydrochloric acid (to adjust pH), water for injections.

What DEPO-PROVERA looks like and contents of the packaging

White suspension.
The packaging contains:
1 vial of 1 ml
10 vials of 1 ml
1 prefilled syringe of 1 ml
The vial is made of colorless glass, closed with a rubber stopper, in a cardboard box.
The prefilled syringe, together with a sterile needle, is in a cardboard box.

Marketing authorization holder:

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

Manufacturer:

Pfizer Manufacturing Belgium NV
Rijksweg 12
2870 Puurs-Sint-Amands
Belgium

For more 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: 06/2025