DEPO-PROGEVERA 150 mg/ml INJECTABLE SUSPENSION

2. Before using Depo-Progevera

Do not use Depo-Progevera:

• If you are allergic (hypersensitive) to medroxiprogesterone acetate or any of the other components of Depo-Progevera.
• If you are pregnant or think you may be pregnant.
• If your doctor has told you that you have or suspect you have any hormone-sensitive tumors in your breasts or genitals.
• If you have abnormal vaginal bleeding (menstruation) of unknown cause.
• If you have or have had a blood vessel disease, such as thrombophlebitis (formation of blood clots in the veins, with painful inflammation and cramps) or blood clots that block blood vessels (thromboembolic phenomena).
• If you have or have had severe liver disease.
• If you have had a delayed abortion.
• If you have a meningioma or have ever been diagnosed with a meningioma (a normally benign tumor of the tissue surrounding the brain and spinal cord), unless you are using Depo-Progevera to treat cancer.

Tell your doctor if any of the following conditions apply to you.

Be careful with Depo-Progevera

Before starting treatment with Depo-Progevera, your doctor will perform general medical and gynecological examinations to assess whether Depo-Progevera is suitable for you. Inform your doctor if you have or have had any of the situations described below. Similarly, if any of these situations appear for the first time or worsen during treatment with Depo-Progevera, inform your doctor immediately, as it is possible that your doctor may decide to suspend treatment with Depo-Progevera.

• If you have bone disorders. The administration of Depo-Progevera reduces estrogen levels (a naturally produced sex hormone) in the blood, which is associated with significant bone mineral density loss. Although partial recovery of bone mineral density occurs after stopping treatment, it is unknown whether the use of Depo-Progevera could increase the risk of fractures later in life. Your doctor will recommend taking calcium and vitamin D supplements while using Depo-Progevera to reduce bone mineral density loss. Your doctor will also recommend avoiding alcohol and tobacco consumption, as these habits contribute to bone demineralization.

Depo-Progevera should only be considered for long-term use (more than 2 years) when your doctor has assessed with you that other contraceptive methods are inadequate or unacceptable for you. Before considering the use of this contraceptive for more than 2 years, your doctor will perform a careful reevaluation of your bone mineral density.

• If you have very heavy or prolonged vaginal bleeding (periods). Depo-Progevera normally causes alterations in your menstrual cycle. After the first injection, it is very likely that you will have an irregular period, probably longer or with intermittent spotting, and after some time of treatment, your period will usually stop completely. These symptoms are normal and should not cause concern. However, if you experience very heavy or prolonged bleeding during treatment with Depo-Progevera, inform your doctor, as you may require treatment.

• If you have sudden visual disturbances (such as partial or total loss of vision, double vision, or other visual problems)

• If you have migraines or severe headaches, especially if they appear for the first time while you are being treated with Depo-Progevera

• If you have severe pain or swelling in your legs (indicative of a possible blood clot in your legs). Your doctor will monitor you for symptoms of thromboembolic disease (formation of blood clots in your blood vessels).

• If you have diabetes or a family history of diabetes

• If you have heart disease or cholesterol problems or a family history

• If you have a history of depression or feel very depressed during treatment with Depo-Progevera

During treatment with Depo-Progevera, your doctor may perform blood tests and/or medical examinations at regular intervals to assess whether Depo-Progevera is still suitable for you.

Depo-Progevera may cause fluid retention, so your doctor will pay special attention to diseases that may be influenced by fluid retention, such as epilepsy, asthma, liver and/or kidney dysfunction, and other diseases. Inform your doctor if you have any of these diseases and if you notice any worsening during treatment with Depo-Progevera.

You may experience weight gain during treatment with Depo-Progevera. You should take this into account if you have serious weight problems.

Psychiatric disorders

Some women who use hormonal contraceptives like Depo-Progevera have reported depression or a depressed mood. Depression can be severe and sometimes may induce suicidal thoughts. If you experience mood changes and depressive symptoms, contact your doctor for additional medical advice as soon as possible.

Your doctor will advise you that Depo-Progevera does not prevent the transmission of HIV (AIDS) or any other sexually transmitted disease.

Your doctor will advise you that, like other hormonal contraceptives, the use of Depo-Progevera may slightly increase the risk of breast cancer, although it has been shown that the additional risk due to treatment with Depo-Progevera disappears gradually after 10 years of stopping treatment.

Meningioma

The use of medroxiprogesterone acetate has been associated with the development of a normally benign tumor in the tissue surrounding the brain and spinal cord (meningioma). The risk increases especially when the medication is used for a longer period (several years). If you are diagnosed with a meningioma, your doctor will reassess your treatment with Depo-Progevera. Contact your doctor immediately if you notice symptoms such as changes in vision (e.g., double or blurred vision), hearing loss or ringing in the ears, loss of smell, worsening headaches, memory loss, seizures, weakness in the arms or legs.

Use in girls

Depo-Progevera is not indicated before the first menstruation.

Use of other medicines

Tell your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

Inform your doctor if you are being treated with aminoglutethimide (a medicine for the treatment of breast cancer), as it may decrease the concentration of Depo-Progevera in your blood and could, consequently, lose its effectiveness.

Use of Depo-Progevera with food and drinks

Depo-Progevera is administered by intramuscular injection and, therefore, does not interfere with food or drink consumption.

Pregnancy and breastfeeding

Pregnancy

Consult your doctor or pharmacist before using any medicine.

Tell your doctor if you are or think you may be pregnant, as Depo-Progevera should not be used during pregnancy. Your doctor must ensure that you are not pregnant before starting treatment with Depo-Progevera or before administering the next dose, if more than 89 days have passed since the previous dose.

If you have used Depo-Progevera during pregnancy or if you become pregnant while using Depo-Progevera, inform your doctor immediately, who will assess with you the possibility of interrupting your pregnancy.

If you want to become pregnant after stopping treatment with Depo-Progevera, consult your doctor about how long you should wait before trying. Although the use of Depo-Progevera alters fertility, and it is normal not to be fertile until 5 or 6 months after the last injection, it is not ruled out that you may become pregnant before this period, while there may still be a risk to the fetus.

Breastfeeding

If you are considering using Depo-Progevera after childbirth, you should consult your doctor to assess whether Depo-Progevera is suitable for you. If you are breastfeeding, you should not start treatment with Depo-Progevera before the sixth week after childbirth.

Driving and using machines

No effects on the ability to drive and use machines have been reported.

Important information about some of the ingredients of Depo-Progevera

As Depo-Progevera contains methylparaben (E-218) and propylparaben (E-216), it may cause allergic reactions (possibly delayed) and, exceptionally, bronchospasm (sudden feeling of suffocation). Go to the hospital or medical center immediately if you notice any signs or symptoms of an allergic reaction.

3. How to use Depo-Progevera

Follow your doctor's instructions for administering Depo-Progevera exactly. Consult your doctor or pharmacist if you have any doubts.

The normal dose of Depo-Progevera, when used for contraceptive purposes, is 150 mg (1 vial) administered by deep intramuscular injection, every 3 months (12 weeks). The first dose of Depo-Progevera should be administered within the first 5 days of the menstrual cycle. Depo-Progevera may not be effective if the time interval between each dose is more than 89 days (12 weeks and 5 days). If more than 89 days have passed since the previous dose, your doctor must ensure that you are not pregnant before administering the next dose (see section 2. Pregnancy and breastfeeding).

Your doctor may have prescribed Depo-Progevera to treat a type of endometrial cancer. In this case, your doctor will decide what dose is most convenient for you, depending on the characteristics of your disease.

Your doctor will perform periodic checks to determine if Depo-Progevera is still a suitable treatment for you and will indicate how long you can continue using Depo-Progevera.

If you use more Depo-Progevera than you should

Consult your doctor or pharmacist immediately.

In case of overdose or accidental ingestion, consult the Toxicology Information Service. Phone: 91-562 04 20.

If you forget to use Depo-Progevera

Do not administer a double dose to make up for forgotten doses. When using Depo-Progevera for contraceptive purposes, you should be aware that if more than 89 days (12 weeks and 5 days) have passed since the previous dose, Depo-Progevera may have lost its effectiveness, and you may have become pregnant. In these cases, before administering the next dose, your doctor must ensure that you are not pregnant (see section 2. Pregnancy and breastfeeding).

If you stop using Depo-Progevera

If you have any further questions about the use of this product, ask your doctor or pharmacist.

The use of Depo-Progevera alters fertility, returning to normal after stopping the use of Depo-Progevera, regardless of the duration of treatment. Normally, the contraceptive effect disappears between 5 and 6 months after the last injection. However, if you want to become pregnant after using Depo-Progevera, consult your doctor about how long you should wait after stopping treatment with Depo-Progevera (see section 2. Pregnancy and breastfeeding).

4. Possible side effects

Like all medicines, Depo-Progevera can cause side effects, although not everyone will experience them.

Very common side effects(which may occur in at least 1 in 10 patients):

• menstrual disorders
• headache
• dizziness, nausea, fatigue, abdominal pain
• weight changes
• nervousness

Common side effects(which may occur in at least 1 in 100 patients):

• vaginal discomfort, appearance of white discharge from the vagina, breast pain
• decreased libido
• depression, insomnia
• hot flashes
• nausea
• skin rash, hair loss, and lack of hair growth, acne
• back pain, leg cramps, pelvic pain
• edema, swelling

Uncommon side effects(which may occur in at least 1 in 1,000 patients) include:

• inflammation and pain at the injection site
• anemia, alteration of blood cells
• allergic reactions
• excessive hair growth
• changes in appetite
• feeling of pregnancy
• seizures, drowsiness, tingling sensation, inability to move muscles, inability to move facial muscles
• breathing difficulties, hoarseness, pulmonary embolism (blood clot formation)
• stomach or intestinal disorders, rectal bleeding (red blood)
• yellowish discoloration of the skin or eyes
• appearance of small dark spots on the skin of the face, skin hardening and contraction, itching
• joint pain, osteoporosis (thinning of bone tissue along with loss of bone density)
• milky secretion, bleeding from the nipple, breast size changes, lumps or swellings in the breasts, swelling in the armpits, difficult or painful intercourse, vaginal cysts, enlarged uterus, painful menstruation, absence of fertility return, prevention of lactation
• localized infection in the genital or urinary tract organs.
• chest pain, fever
• thirst, decreased glucose tolerance.
• transient loss of consciousness
• vein dilation and inflammation, formation of blood clots in deep veins.

Side effects of unknown frequency(which cannot be estimated from the available data) include:

• Normally benign tumor in the tissue surrounding the brain and spinal cord (meningioma) (see section 2 "Be careful with Depo-Progevera").

If you experience any side effects, consult your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

5. Storage of Depo-Progevera

Keep out of the reach and sight of children.

Do not use Depo-Progevera after the expiration date stated on the packaging. The expiration date is the last day of the month indicated.

Do not store above 25°C.

Do not refrigerate or freeze.

Keep the container in an upright position (standing).

Store in the original packaging.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Further information

Composition of Depo-Progevera

The active ingredient is medroxiprogesterone acetate. Each vial of Depo-Progevera (1 ml) contains 150 mg of medroxiprogesterone acetate.

The other ingredients are: polyethylene glycol, polysorbate 80, sodium chloride, methylparaben (E-218), propylparaben (E-216), and water for injectable preparations.

Appearance of the product and packaging contents

Depo-Progevera is a sterile injectable suspension. It is presented in packaging containing a 1-ml vial, provided with a stopper and an aluminum cap for closure. Each vial contains 150 mg of medroxiprogesterone acetate.

Marketing authorization holder and manufacturer

The Marketing Authorization Holder is:

Pfizer, S.L.

Avda. de Europa 20-B

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid)

Phone: +34 91 490 99 00

The Manufacturer is:

Pfizer Manufacturing Belgium N.V./S.A.

Rijksweg 12

2870 Puurs

Belgium

Date of the last revision of this leaflet: December 2024