150 mg / mL injection, suspension or injection, suspension prefilled syringe
medroxyprogesterone
1. What Depo-Provera is and what it is used for
Depo-Provera contains medroxyprogesterone acetate. Medroxyprogesterone acetate is a synthetic hormone similar to the naturally occurring hormone et progesterone(corpus luteum hormone). Injection of medroxyprogesterone acetate prevents ovulation and thus you can not get pregnant. Pregnancy protection is enhanced by the fact that medroxyprogesterone acetate affects the uterine lining so that it is not susceptible to a fertilized egg and affects the mucus in the cervix so that it becomes impermeable to sperm.
Depo-Provera is used as a contraceptive, but also for symptom relief in endometriosis, for the treatment of various gynecological diseases, or the treatment of cancer of the breast and uterus.
Depo-Provera should only be used by young (<18 years) women when other methods of contraception are inappropriate.
Medroxyprogesterone acetate contained in Depo-Provera may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
2. What you need to know before using Depo-Provera
Do not use Depo-Provera
- if you are allergic to medroxyprogesterone acetate or any of the other ingredients of this medicine (listed in section 6)
- if you are pregnant or if you suspect you are pregnant
Warnings and cautions
Talk to your doctor or pharmacist before using Depo-Provera if you:
- have any liver disease
- previously had diabetes (diabetes) in connection with pregnancy
- usually have sparse periods. Also, tell your doctor if you have had abnormal bleeding between periods; Depo-Provera should not be used unless your doctor knows the cause of these hemorrhages
- experienced depression with previous use of birth control pills or other drugs that contain progesterone
Impact on your period
If the bleeding pattern deviates from what is expected when you are treated with Depo-Provera, you should consult a gynecologist. This is especially true if heavy and prolonged bleeding occurs after a long period of bleeding freedom.
Impact on your skeleton
Depo-Provera works by lowering the levels of estrogen and other hormones. Low estrogen levels can lead to osteoporosis (by reducing bone density). Women who use Depo-Provera tend to have lower bone density than women who have never used this medicine. The effect of Depo-Provera is greatest during the first 2-3 years after starting treatment. Thereafter, bone density appears to stabilize and recover when treatment is complete. It is not known if Depo-Provera increases the risk of osteoporosis and fracture later in life (after menopause, ie the time when menstruation definitely stops).
The use of Depo-Provera may increase the risk of osteoporosis in women with risk factors for osteoporosis. You should therefore discuss with your doctor before starting treatment if any of the following apply to you:
- high alcohol consumption and/or smoking
- long-term use of other drugs that may reduce bone density (eg anticonvulsants and corticosteroids ).
- low weight (low BMI ) or eating disorder ( anorexia or bulimia )
- previous fracture er not caused by fall/injury
- hereditary predispositions for osteoporosis
Young people 12-18 years
Normally, both the skeleton grows rapidly and increases in strength in adolescents. A strong skeleton in adulthood means better protection against osteoporosis later in life. As Depo-Provera may reduce the bone density of growing adolescents, this effect may be relevant for this age group. Bone density recovers when treatment with Depo-Provera is stopped, but it is unknown if bone density reaches the same levels as if Depo-Provera had not been used.
You should therefore discuss with your doctor if there are other alternative treatment methods before starting treatment with Depo-Provera.
When treatment with Depo-Provera is stopped, it will take some time before ovulation and menstrual bleeding resume. Only then does the opportunity to become pregnant also return. This time period varies from woman to woman but for most ovulation occurs 6-8 months after the last injection of Depo-Provera. In some people, ovulation can occur very soon after the expected protective effect of 3 months has ceased. In exceptional cases, it can take up to 1.5 years before the ability to conceive returns.
This drug does not protect against HIV – infection ( AIDS ) or other sexually transmitted infection you. Only condoms protect against HIV and other sexually transmitted diseases.
Mental disorders:
Some women who use hormonal contraceptives, including Depo-Provera, have reported depression or depression. Depression can be severe and can sometimes lead to suicidal thoughts. If you experience mood swings and symptoms of depression, you should contact a doctor as soon as possible for advice.
Other medicines and Depo-Provera
Tell your doctor, midwife, or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines can reduce the effect of hormonal contraceptives. Examples are medicines for epilepsy (eg primidone, phenobarbital, phenytoin, carbamazepine), certain antibiotics (rifampicin and rifabutin), and herbal medicines containing St. John’s wort ( Hypericum perforatum ).
Pregnancy, breastfeeding, and fertility
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Depo-Provera should not be given during pregnancy. If pregnancy occurs during treatment, treatment should be stopped immediately.
Medroxyprogesterone acetate passes into breast milk but is unlikely to affect breastfed infants. However, consult a physician if more than temporary use of Depo-Provera during breast-feeding.
Driving and using machines
Depo-Provera does not affect the ability to drive and use machines.
Depo-Provera contains methyl parahydroxybenzoate and propyl parahydroxybenzoate
May cause an allergic reaction (possibly delayed) and exceptionally spasm of the trachea.
3. How to use Depo-Provera
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Depo-Provera is injected deeply intramuscularly by healthcare professionals.
Recommended dose:
Contraceptives: 150 mg every 3 months. The first injection is given within the first 3 days of the menstrual cycle or, in non-breastfeeding women, no later than 3 weeks after delivery. In breastfeeding women, the first injection should be given no earlier than 6 weeks after delivery. In this way, you get maximum protection against pregnancy from the first day of injection. If the injection is given later in the menstrual cycle, there is a risk that you are already pregnant or that the protection is not maximum during the first weeks after injection.
Symptom relief for endometriosis: 100 mg every two weeks for at least 6 months.
Treatment for breast cancer: 500 mg per day for 4 weeks ( loading dose ), then 1000 mg per week as a maintenance treatment. This dose can be divided into 500 mg twice a week. Maintenance treatment should last as long as the tumor responds to the treatment.
Treatment for uterine cancer: 1000 mg per week. The treatment continues for life. After one year or more of continued tumor reduction, the dose can be reduced to 500 mg per week.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur when Depo-Provera is used as a contraceptive
At the beginning of treatment, irregular bleeding usually occurs at unpredictable intervals.
Contact a doctor immediately if you get any of the following symptoms which may be due to an anaphylactic reaction which is a serious side effect ( may affect up to 1 in 1000 users) :
- itching
- rash
- local fluid swelling ( edema )
- respiratory distress
Other side effects ar
Very common side effects (may affect more than 1 user in 10):
- headache
- abdominal pain, stomach upset
- weight gain
Common side effects (may affect up to 1 in 10 people) :
- Depression
- decreased sex drive
- nausea
- acne (pimples)
- hair loss
- rash
- back pain
- impotence
- sore breasts
Uncommon side effects (may affect up to 1 in 100 people) :
- increased sex drive
- insomnia
- unpredictable vaginal bleeding (irregular, increased, decreased, spotting)
Rare side effects (may affect up to 1 in 1,000 people) :
- concern
- altered body shape due to redistribution of fat
- leg pain
- joint pain
- missed menstruation
- fever
- the local reaction at the injection site (pain, decreased tissue under the skin, a lump under the skin)
The following side effects may occur when Depo-Provera is used in cancer treatment
Common side effects (may affect up to 1 in 10 people) :
- weight gain
- tremor ( tremor )
- sweating
- fluid accumulation in the body
- the local reaction at the injection site
Uncommon side effects (may affect up to 1 in 100 people) :
- thicker in the face (moon face)
- inflammation of superficial blood vessels
- unpredictable vaginal bleeding (irregular, increased, decreased, spotting)
- the local reaction at the injection site (pain, tenderness)
Rare side effects (may affect up to 1 in 1,000 people) :
- fever
Has been reported (occurs in an unknown number of users):
- altered body shape due to redistribution of fat
- Osteoporosis including osteoporotic fractures
- the local reaction at the injection site (decreased tissue under the skin, a lump under the skin)
- deviating liver values.
5. How to store Depo-Provera
Keep this medicine out of the sight and reach of children.
The vial should be stored upright. Store in a cold place. Do not freeze.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
- The active substance is medroxyprogesterone acetate 150 mg/ml.
- The other ingredients are macrogol, polysorbate, sodium chloride, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), sodium hydroxide / hydrochloric acid, water for injections.
What the medicine looks like and the contents of the pack
Suspension for injection: 1 ml, 10 × 3.3 ml, 10 × 6.7 ml in a glass bottle
Injection, suspension pre-filled syringe 1 mL in a single dose
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Pfizer AB, 191 90 Sollentuna. Tel: 08-550 520 00. Email: eumedinfo@pfizer.com