What is it used for?

• Contraception.

How does it work?

Depo-Provera injection contains the active ingredient medroxyprogesterone acetate, which is a synthetic form of the naturally occurring female sex hormone, progesterone.

Depo-Provera injection is a long-term form of contraception. It is usually given into the muscle of the buttock or upper arm. The injection produces a reservoir of medroxyprogesterone in the muscle, which is then continuously released into the bloodstream over a period of 12 weeks.

The medroxyprogesterone prevents pregnancy in three main ways. Firstly, it prevents eggs from being released from the ovaries (ovulation). It also increases the thickness of the natural mucus at the neck of the womb, making it more difficult for sperm to cross from the vagina into the womb. By preventing sperm entering the womb, successful fertilisation of any eggs that are released is less likely. The hormone also changes the quality of the womb lining (endometrium), making it less receptive for any fertilised eggs to implant into.

The contraceptive effect of the injection lasts for three months.

It is very important that you discuss the pros and cons of this form of contraception with your doctor before you are given the injection, particularly with regards to having children after stopping the injections. Fertility does return once the injections are stopped, but the time varies from one woman to the next. Most women should start to ovulate 5 to 6 months after their last injection, but you may not conceive until 10 to 15 months after your last injection (or sometimes even longer). You should also be made aware of the potential side effects, as the injection cannot be reversed once it has been given.

When can I have it?

The first injection should be given in the first five days of a normal menstrual cycle (day one is the first day of your period). This will protect you from pregnancy immediately. The injection can also be given at any other time in your cycle if your doctor is sure that you are not pregnant, but you will need to use additional contraception, eg condoms for the first seven days after having the injection. Further injections should be given every 12 weeks to provide continued contraception.

For women who are using this method of contraception after having a baby, the injection should be given within the first five days after the birth if you are not breastfeeding. However, if it is given within this time you should aware that there is an increased risk of heavy and prolonged bleeding. If you are breastfeeding, you should not be given the first injection until at least six weeks after the birth. Again, further injections should be given every 12 weeks to provide continued contraception.

If you have had a miscarriage or abortion at under 24 weeks, you can have this injection immediately after and you will be protected against pregnancy straight away. If you have the injection more than seven days after the miscarriage or abortion, you will need to use extra contraception to prevent pregnancy for the first seven days after having the injection.

The injection can be used on a short-term basis for partners of men having a vasectomy (to provide protection until the vasectomy becomes effective), for women who are being immunised against rubella (to prevent pregnancy during the period of activity of the virus) and in women awaiting sterilisation.

What if I am late for my injection?

To provide effective contraceptive cover, Depo-Provera must be given every 12 weeks. Make sure thatyou or your doctor make your next appointment for 12 weeks time. If you are more than five days late for your next injection, you will not be protected against pregnancy. You will need to have a pregnancy test before your next injection can be given. If the injection is given more than five days late (ie more than 89 days since your last injection) you will need to use additional barrier methods of contraception, eg condoms, for the next 14 days.

Warning!

• It is very important that you discuss the pros and cons of Depo Provera with your doctor before you are given the injection. The injection cannot be reversed once it has been given and its effects (which may include any unwanted side effects) last for at least three months.
• All women should be counselled by their doctor prior to using Depot Provera about the delay in being able to have children once the injections have stopped. Some women may not be able to conceive for 10 to 15 months after having their last injection.
• This contraceptive usually disrupts the menstrual cycle. It may cause irregular bleeding or spotting, heavy or prolonged bleeding, or your menstrual bleeds to stop altogether. If you experience menstrual bleeding that is heavy or prolonged should inform your doctor.
• There is a tendency for women to put on weight while on Depo Provera. On average women gain about 5 to 8 lbs over the first one to two years of use. Ask your doctor for more information.
• Depo Provera decreases oestrogen levels. Over time, this can cause a loss of bone mineral density and increase the risk of osteoporosis. This is particularly important for adolescents and young women whose bones might not yet be fully developed, as it is unknown if the injection will lower their peak bone mass and hence increase the risk of osteoporotic fractures later in life. There is ongoing research to determine this. Adolescents should therefore only use Depo Provera after all other contraceptive methods have been discussed and are considered to be unsuitable or unacceptable. Women of all ages who want to continue using the injection for more than two years should only do so after all the risks and benefits have been re-eva luated. For more information talk to your doctor or pharmacist.
• It is important to be aware that women using hormonal contraceptives appear to have a small increase in the risk of being diagnosed with breast cancer, compared with women who do not use these contraceptives. However, this risk must be weighed against the benefits of using the contraceptive, which can be discussed with your doctor.
• Depo-Provera will not protect you against sexually transmitted infections, so you may still need to use condoms as well.
• Consult your doctor immediately if you get any of the following symptoms while on Depo-Provera: migraine or severe headaches, disturbance in vision, stabbing pains in the legs, pain on breathing or coughing, significant rise in blood pressure, itching of the whole body, yellowing of the skin or whites of the eyes (jaundice), severe abdominal complaints or if you think you could be pregnant.
• This medicine may influence the results of some laboratory tests, such as liver function or thyroid function tests. For this reason, if you have any blood tests make sure the person taking your blood is aware that you are on Depo-Provera.

Not to be used in

• Known or suspected pregnancy.
• Women who want to have a baby in the next year (see warnings above).
• Women with abnormal vaginal bleeding, the cause of which has not yet been diagnosed.
• Breast cancer.
• Women who have had a blood clot in the lung (pulmonary embolism), stroke, or blood clot in the eye (retinal thrombosis) when previously on Depo Provera.
• Hereditary blood disorders called acute porphyrias.

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy. If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Use with caution in

• Adolescents aged 12 to 18 years (see warning section above).
• Women with lifestyle or medical risk factors for osteoporosis, for example smoking, heavy alcohol drinking, low body mass index (BMI), anorexia, bulimia, long-term use of corticosteroid or anticonvulsant medicines, or a family history of osteoporosis (see warning section above).
• Women who are going to have major surgery with prolonged immobilisation.
• Women with an active blood clot in a vein, eg in the legs (deep vein thrombosis) or the lungs (pulmonary embolism), or a history of this.
• Women with disorders that increase the risk of blood clots in the veins, eg antiphospholipid syndrome, antithrombin deficiency or factor V Leiden.
• Long-term condition called systemic lupus erythematosus (SLE).
• History of breast cancer (though this injection may be considered for women who have had no evidence of the disease for five years).
• Women with gene mutations that are associated with breast cancer, eg BRCA1.
• Cervical cancer.
• Liver cancer.
• Severe liver cirrhosis.
• Gallbladder disease.
• Women with a history of jaundice or itching caused by previous use of an oral contraceptive.
• History of serious disease of the arteries, eg that has caused a stroke, angina or heart attack.
• Women with multiple risk factors for heart disease, such as smoking, high cholesterol, high blood pressure, diabetes.
• Deterioration of a disorder causing worsening deafness (otosclerosis) during a previous pregnancy.
• Women with raised levels of fats such as cholesterol or triglycerides in their blood.
• Diabetes.
• History of migraine.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

• This medicine is used to prevent pregnancy and should not be given to women who are pregnant. Your doctor should check that you are not pregnant before giving you the first injection. If you are more than five days late for any subsequent injection you will also need to have a pregnancy test. Seek medical advice from your doctor.
• You should not have this injection if you want to have a baby in the next year. Most women start to ovulate five to six months after their last injection, but you may not be able to conceive until 10 to 15 months after your last injection (or sometimes even longer).
• This medicine passes into breast milk, however there are no reported harmful effects on the nursing infant when this contraceptive is used by breastfeeding mothers. If you are breastfeeding, you should not be given your first Depo-Provera injection until at least six weeks after the birth.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Just because a side effect is stated here does not mean that all people using this medicine will experience that or any side effect.

Very common (affect more than 1 in 10 people)

• Abdominal pain or discomfort.
• Headache.

Common (affect between 1 in 10 and 1 in 100 people)

• Menstrual changes, eg irregular bleeding or spotting, heavy bleeding, or stopping of menstrual bleeding.
• Discharge of white fluid from the vagina (leukorrhoea).
• Inflammation of the lining of the vagina (vaginitis).
• Breast tenderness or pain.
• Backache.
• Bloating.
• Nausea.
• Change in appetite.
• Dizziness.
• Hot flushes.
• Acne.
• Hair loss (alopecia).
• Rash.
• Feeling weak or fatigued.
• Pain or abscess at injection site.
• Pins and needles sensations.
• Nervousness.
• Depression.
• Decreased sex drive and difficulty reaching orgasm.
• Mood swings, irritability.
• Difficulty sleeping (insomnia).

Uncommon (affect between 1 in 100 and 1 in 1000 people)

• Weight gain.
• Excessive fluid retention in the body tissues, resulting in swelling (oedema).
• Leg cramps.
• Aching joints.
• Spinning sensation.
• Sleepiness.
• Migraine.
• Vaginal dryness.
• Painful sex.
• Painful periods.
• Change in breast size.
• Premenstrual syndrome.
• Ovarian cysts.
• Increased blood pressure.
• Blood clot in the lungs (pulmonary embolism).

Unknown frequency

• Osteoporosis (see warnings and cautions above).
• Blood clot in a vein (deep vein thrombosis).

The side effects listed above do not include all of the side effects reported by the medicine's manufacturer. For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

How can this medicine affect other medicines?

You should tell your doctor or pharmacist what medicines you areor have recently been using before you have thiscontraceptive injection. This includes those bought without a prescription and herbalmedicines. Likewise, check with your doctor or pharmacist before taking anynew medicines while you are using this contraceptive, so they can check thatthecombination is safe.

The emergency contraceptive ulipristal (Ellaone) has the potential to make this contraceptive less effective. If you take Ellaone as an emergency contraceptive while you are using Depo-Provera for contraception, you should use an additional method of contraception such as condoms for 14 days after you take it.

This injection may antagonise the blood sugar lowering effect of medicines for diabetes. If you have diabetes youshould monitor your blood sugar and seek advice from your doctor or pharmacistif your blood sugar control seems to be altered after starting thiscontraceptive.

Progestogens may increase the blood levels of the following medicines and this could possibly increase the risk of their side effects:

• selegiline
• tizanidine.

Other medicines containing the same active ingredient