PROSPECTO : INFORMATION FOR THE USER

Depo-Progevera 150 mg/ml injectable suspension

Medroxiprogesterone

Read this prospectus carefully before starting to use Depo-Progevera 150 mg/ml injectable suspension

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider that any of the adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

1. What is Depo-progevera and for what it is used

2. Before using Depo-progevera

3. How to use Depo-progevera

4. Possible adverse effects

5. Conservation of Depo-Progevera

6. Additional information

Depo-Progevera is indicated as a contraceptive treatment, to prevent pregnancy.

Depo-Progevera belongs to a class of hormonal contraceptive medications called progestogens (progesterone derivatives), which primarily act by inhibiting the maturation of ova during the menstrual cycle and ovulation. By preventing the maturation and release of ova from the ovaries, sperm is unable to fertilize the ova and, therefore, pregnancy is prevented.

Depo-progevera is also indicated as an adjunctive treatment in the treatment of a certain type of endometrial cancer

No use Depo-Provera:

• If you are allergic (hypersensitive) to medroxyprogesterone acetate or to any of the other components of Depo-Provera.
• If you are pregnant or suspect that you may be.
• If your doctor has told you that you have or suspect that you have any tumors in the breasts or genitals that are sensitive to sex hormones.
• If you have abnormal vaginal bleeding (menstruation) of unknown cause (either too little or too much).
• If you have a disease of the blood vessels, 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 a serious liver disease.
• If you have had a delayed abortion.
• If you have a meningioma or have been diagnosed with a meningioma (a normally benign tumor of the tissue surrounding the brain and spinal cord) unless you use Depo-Provera to treat cancer.

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

Be especially careful with Depo-Provera

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

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

Only consider the use of Depo-Provera for a long period (more than 2 years) when your doctor has evaluated with you that other contraceptive methods are unsuitable or unacceptable for you. Before considering the use of this contraceptive for more than 2 years, your doctor should perform a careful reevaluation of your bone mineral density.

• If you have very intense or prolonged vaginal bleeding (periods). Depo-Provera normally alters your menstrual cycle. After the first injection, it is very likely that you will have an irregular period, probably longer or intermittent spotting, and after some time of treatment, your period usually stops completely. These symptoms are normal and you should not worry. However, if you experience very intense or prolonged bleeding during treatment with Depo-Provera, 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 these appear for the first time while you are on treatment with Depo-Provera

• If you have severe or inflamed legs (indicative of possible blood clots in the legs). Your doctor will monitor 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 family history

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

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

Depo-Provera 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 during treatment with Depo-Provera you notice a worsening.

You may experience weight gain during treatment with Depo-Provera. You should be aware of this if you have severe weight problems.

Mental health disorders

Some women who use hormonal contraceptives like Depo-Provera 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-Provera 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-Provera may slightly increase the risk of breast cancer, although the additional risk due to Depo-Provera treatment disappears gradually 10 years after treatment is stopped.

Meningioma

The use of medroxyprogesterone 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 reconsider your treatment with Depo-Provera. Contact your doctor immediately if you notice symptoms such as changes in vision (e.g., double vision or blurred vision), hearing loss or ringing in the ears, loss of smell, worsening headaches over time, memory loss, seizures, weakness in the arms or legs.

Use in girls

Depo-Provera is not indicated before the first menstruation.

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, even those purchased without a prescription.

Inform your doctor if you are being treated with aminoglutethimide (a medication for breast cancer treatment), as it may decrease the concentration of Depo-Provera in your blood and may, therefore, reduce its effectiveness.

Use of Depo-Provera with food and drinks

Depo-Provera 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 medication.

Inform your doctor if you are or think you may be pregnant, as Depo-Provera should not be used during pregnancy. Your doctor should check that you are not pregnant before starting treatment with Depo-Provera or before administering the next dose, if it has been more than 89 days since the previous dose was administered.

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

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

Breastfeeding

If you consider using Depo-Provera after delivery, you should consult your doctor to assess whether Depo-Provera is suitable for you. If you are breastfeeding, treatment with Depo-Provera should not be initiated before the sixth week after delivery.

Driving and using machines

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

Important information about some of the components of Depo-Provera

Containing parahydroxybenzoate of methyl and parahydroxybenzoate of propyl, Depo-Provera may cause allergic reactions (possibly delayed) and, exceptionally, bronchospasm (sudden sensation of choking). Go immediately to a hospital or medical center if you notice any signs or symptoms of an allergic reaction.

Follow exactly the administration instructions for Depo-Progevera as indicated by your doctor. 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 via 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 should check 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 on the most suitable dose for you depending on the characteristics of your disease.

Your doctor will perform regular check-ups to determine if Depo-Progevera remains an appropriate 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 Toxicological Information Service. Phone 91-562 04 20.

If you forgot to use Depo-Progevera

Do not administer a double dose to compensate for the missed doses. When using Depo-Progevera for contraceptive purposes, it should be noted 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 should check that you are not pregnant (see section 2. Pregnancy and breastfeeding).

If you interrupt treatment with Depo-Progevera

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

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

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

Frequent side effects (that may occur in at least 1 in 10 patients):

• Irregular menstrual periods
• Headache
• Dizziness, nausea, fatigue, abdominal pain
• Weight changes
• Nervousness

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

• Vaginal discomfort, white discharge from the vagina, breast pain
• Decreased libido
• Depression, insomnia
• Hot flashes
• Nausea
• Acne, hair loss, and lack of hair growth, skin rash
• Back pain, leg cramps, pelvic pain
• Swelling, edema

The less common side effects(that 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
• Sensation of pregnancy
• Seizures, drowsiness, numbness, inability to move muscles, inability to move facial muscles
• Difficulty breathing, snoring, pulmonary embolism (blood clot formation)
• Stomach or intestinal discomfort, rectal bleeding (red blood)
• Yellow discoloration of the skin or eyes
• Appearance of small dark spots on the face, skin hardening and retraction, itching
• Joint pain, osteoporosis (bone thinning and loss of bone density)
• Milk secretion, nipple bleeding, breast size changes, breast nodules or swelling, armpit swelling, painful or difficult intercourse, vaginal cysts, uterine enlargement, painful menstruation, infertility, lactation prevention
• Localized infection in the genital organs or urinary tract.
• Chest pain, fever
• Thirst, decreased glucose tolerance.
• Transient loss of consciousness
• Vein dilation and inflammation, appearance of blood clots in deep veins.

The side effects of unknown frequency(cannot be estimated from available data) include:

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

If you consider any of the side effects you are experiencing to be severe or if you notice any side effect not mentioned in this prospectus, inform your doctor or pharmacist.

Keep out of reach and sight of children.

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

Do not store at a temperature above 25°C.

Do not refrigerate or freeze.

Keep the packaging in an upright position (standing).

Store in the original packaging.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and medicines that you no longer need. This will help protect the environment.

Composition of Depo-Progevera

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

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

Appearance of the product and contents of the packaging

Depo-Progevera is a sterile suspension for injectable use. It is presented in containers that contain a 1 ml vial, provided with a stopper and an aluminum cap for closure. Each vial contains 150 mg of medroxyprogesterone acetate.

Holder of the marketing authorization and responsible for manufacturing

The Holder of the Marketing Authorization is:

Pfizer, S.L.

Avda. de Europa 20-B

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid)

Tel: +34 91 490 99 00

The Responsible for Manufacturing is:

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

Rijksweg 12

2870 Puurs

Belgium

Last review date of this leaflet: December 2024