Depo-Provera 150mg/Ml
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Depo-Provera® 150 mg/ml Vial
Medroxyprogesterone Acetate
Please read all of this leaflet carefully before you start using this method of contraception
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, nurse or healthcare provider.
• This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or healthcare provider.
IMPORTANT INFORMATION YOU SHOULD KNOW ABOUT DEPO-PROVERA
Depo-Provera is a very effective injectable contraceptive which gives 12 weeks’ continuous contraception with each injection.
The effect is not reversible once the injection is given.
• You must have injections of this contraceptive regularly every 12 weeks, otherwise you may risk becoming pregnant (see Section 3 ‘How to use Depo-Provera').
• Depo-Provera may not be suitable for every woman. You will need to discuss with your doctor or healthcare professional providing your contraception whether it is suitable for you, especially if you wish to use it for more than 2 years (See Section 1 ‘What Depo-Provera is and what it is used for').
• Depo-Provera may not be suitable for you if you have a history of certain medical conditions (see Section 2 under ‘Before you use Depo-Provera') or if you are taking a medicine called aminoglutethiamide that thins the blood (see Section 2 under ‘Taking other medicines'). Your doctor or nurse should take a full medical history before prescribing Depo-Provera.
• Regular use of Depo-Provera causes a gradual loss of bone mineral density (see Section 4 ‘Possible side effects'). For a small number of patients that were followed-up, the average bone mineral density returned to average 1-3 years after they stopped using Depo-Provera. Teenagers who are rapidly developing their bones may be at particular risk and should only use Depo-Provera if other methods of contraception have been discussed and considered unsuitable or unacceptable.
In this leaflet:
1. What Depo-Provera is and what it is used for
2. Before you use Depo-Provera
3. How to use Depo-Provera
4. Possible side effects
5. How to store Depo-Provera
6. Further information
1. What Depo-Provera is and what it is used for
Depo-Provera is a long acting contraceptive. The active ingredient in Depo-Provera, medroxyprogesterone acetate (MPA), is similar to (but not the same as) the natural hormone progesterone that is produced in the ovaries during the second half of your menstrual cycle. Depo-Provera acts by preventing an egg from fully developing and being released from the ovaries during your menstrual cycle. If an egg is not released it cannot become fertilised by sperm and result in pregnancy. Depo-Provera also causes changes in the lining of your womb that makes it less likely for pregnancy to occur. It also thickens the mucus at the entrance of the womb, making it more difficult for sperm to enter.
Depo-Provera can be used:
• For long-term contraception where you and the person who provides your contraception (e.g. your doctor or healthcare professional) have decided that this method is the most suitable for you.
• If you wish to use Depo-Provera for more than 2 years your doctor or healthcare professional may wish to re-evaluate the risks and benefits of using Depo-Provera to make sure that it is still the best option for you.
• In teenagers only after other methods of contraception have been discussed with the healthcare professional who provides your contraception and considered to be unsuitable or unacceptable.
• For just one or two occasions in the following cases:
• if your partner is undergoing a vasectomy, to give you protection until the vasectomy becomes effective
• if you are being immunised against rubella, to prevent pregnancy during the period of activity of the virus
• if you are awaiting sterilisation.
2. Before you use Depo-Provera Do not use Depo-Provera:
• If you are allergic (hypersensitive) to the active ingredient (MPA) or any of the other ingredients. There is a small risk of a severe allergic reaction to Depo-Provera that will require emergency medical treatment.
• If you think you may be pregnant.
• If you have had, or think you may have, hormone-dependent cancer of the breast or reproductive organs.
• If you have unexplained vaginal bleeding.
• If you have liver disease.
• If you have never had a period.
• If you are using certain medicines such as high dose glucocorticoids (steroids), anti-epileptics, and thyroid hormones. Tell the person who provides your contraception if you are taking these or any other medicines - they may recommend a more suitable method of contraception.
Take special care with Depo-Provera:
Before your doctor or healthcare professional prescribes Depo-Provera, you may need to have a physical examination. It is important to tell your doctor or healthcare professional if you have, or have had in the past, any of the following conditions. Your doctor will then discuss with you whether Depo-Provera is suitable for you.
• Migraine headaches - if you develop migraine you should consult your doctor before receiving further injections of Depo-Provera
• Diabetes or a family history of diabetes
• Severe pain or swelling in the calf (indicating a possible clot in the leg, which may be called phlebitis)
• Blood clotting disorders such as deep vein thrombosis (blood clot in the legs), pulmonary embolus (blood clot in the lung) or a stroke you should not receive further injections of Depo-Provera
• Problems with your eyesight while using Depo-Provera; for example a sudden partial or complete loss of vision or double vision
• Past history of or current depression
• Problems with your liver or liver disease
• History of heart disease or cholesterol problems including any family history
• If you have recently had a ‘hydatidiform mole' which is a type of abnormal pregnancy.
Cervical smear testing:
The results of a cervical smear and some laboratory tests could also be affected if you are using Depo-Provera so it is important that you tell your doctor.
Protection against sexually transmitted diseases:
Depo-Provera does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
Taking other medicines:
• Tell your doctor or healthcare professional if you are taking a medicine called aminoglutethiamide or other medicines that thin your blood (anticoagulants) as these may affect the way Depo-Provera works.
• Always tell your doctor or healthcare professional who treats you that you are using Depo-Provera as a contraceptive if you are taking or have recently taken any other medicines, even those you bought yourself without a prescription, because medicines can sometimes interact with each other.
Pregnancy:
• Because Depo-Provera is such an effective contraceptive method, the risk of accidental pregnancy for women who have their injections regularly (every 12 weeks) is very low.
• If you think you may have become pregnant while using Depo-Provera for contraception, tell your doctor immediately.
Effect on future fertility:
• Your usual level of fertility will return when the effect of the injection has worn off.
• This takes different amounts of time in different women, and does not depend on how long you have been using Depo-Provera.
• In most women the effect will have worn off 5 to 6 months after the last injection.
• Over 80% of women trying to get pregnant will conceive within a year of the first missed injection.
• Some women have got pregnant in the first month after missing an injection.
If you are breast-feeding:
• Depo-Provera does not prevent the breast from producing milk so nursing mothers can use it, however, it is better for the baby that for the first few weeks after birth its mother's milk contains no traces of any medicines, including Depo-Provera.
• Your doctor or healthcare professional may advise that you wait until at least 6 weeks after your baby has been born before you start using Depo-Provera for contraception.
• If a baby is exposed to Depo-Provera in the breast milk, no harmful effects have been seen in babies and children.
Driving and using machines:
Depo-Provera may cause headaches and dizziness. Therefore be careful until you know whether this medicine affects your ability to drive or use machines. If you have any concerns discuss them with your doctor.
Important information about some of the ingredients of Depo-Provera:
The active ingredient in Depo-Provera is medroxyprogesterone acetate (MPA). Depo-Provera also contains methyl parahydroxybenzoate, macrogol, polysorbate 80, propyl parahydroxybenzoate, sodium chloride and water
Hydrochloric acid or sodium hydroxide may also be added when the product is being made to adjust the acidity or alkalinity of the product to the correct level.
3. How to use Depo-Provera
This medicine will be given to you by your doctor or healthcare professional.
Depo-Provera is given every 12 weeks as a single intramuscular injection of 1 ml (150 mg medroxyprogesterone acetate) into the buttock or upper arm. The injection is given during the first 5 days after the beginning of a normal menstrual period.
Following childbirth the first Depo-Provera injection can be given within 5 days after childbirth if you are not breast-feeding.
Provided that the injection is given at the times stated above, then you are protected from pregnancy straight away and there is no need to take extra precautions.
Depo-Provera works as a contraceptive for 12 weeks in your body. There is no way of reversing the injection once it is given.
For effective contraceptive cover Depo-Provera MUST be given every 12 weeks. Make sure that you or your doctor makes your next appointment for 12 weeks time.
If you miss an injection of Depo-Provera:
If you miss your injection or are late getting your next injection (ie wait longer than 12 weeks between injections), there is a greater risk that you could become pregnant. Ask your doctor or healthcare professional to find out when you should receive your next injection of Depo-Provera and which type of contraception should be used in the meantime.
Switching from other methods of contraception:
When you switch from other contraceptive methods, your doctor will make sure you are not at risk of becoming pregnant by giving you your first injection at the appropriate time. If you switch from oral contraceptives, you should have your first injection of Depo-Provera within 7 days after taking your last pill.
If you have any further questions on the use of this product ask your doctor or healthcare professional.
4. Possible side effects
Like all medicines Depo-Provera can cause side effects although not everybody gets them.
There is a low risk of anaphylactic responses (serious allergic reactions which may need urgent medical attention or hospitalization). Possible symptoms include: swelling of the face, lips, tongue or throat, or difficulty breathing or swallowing, skin rashes, shock or collapse.
Deep vein thrombosis (DVT) is a condition in which a blood clot forms in one of your deep veins, usually in your leg. Signs of possible DVT include: swelling of the affected leg, pain and tenderness in the affected leg (you may also find it difficult to stand properly with your full weight on the affected leg), a change in the colour of your skin, for example, redness or skin that feels warm or hot to the touch.
Women who use Depo-Provera tend to have lower bone mineral density than women of the same age who have never used it. The effects of Depo-Provera are greatest in the first 2-3 years of use. Following this, bone mineral density tends to stabilise and there appears to be some recovery when Depo-Provera is stopped. It is not yet possible to say whether Depo-Provera increases the risk of osteoporosis (weak bones) and fractures in later life.
Tell your doctor immediately if you experience any of the above symptoms.
Common side effects (occur in more than 10 out of every 1,000 patients)
These include:
abdominal pain or discomfort, bloating, feeling sick, vaginal discharge or inflammation, changes in appetite, backpain, headaches, dizziness, irregular periods, very light or no periods (amenorrhoea), breast pain or tenderness, pelvic pain, hot flushes, acne, hair loss, rash, weakness or tiredness, injection site reactions, feeling of weakness, tingling or numbness in the hands and feet, depression, nervousness, insomnia (difficulty sleeping), irritability, anorgasmia (failure to climax during sexual intercourse), emotional disturbance, intermenstrual bleeding (bleeding between periods), menorrhagia (heavy periods).
Uncommon side effects (occurs in fewer than 10 out of every 1,000 patients)
These include:
jaundice (this will cause yellowing of the skin and the whites of the eyes), hypertension, varicose veins, thrombophlebitis (inflammation of part of a vein), pulmonary embolism (blood clot in the lungs which causes chest pain and breathlessness), allergic reactions (such as swelling on the face and throat), abnormal liver enzymes (blood tests used to measure liver function), feeling of dizziness or ‘spinning', abdominal discomfort, change in weight, fluid retention, joint pain, muscle cramps, pain in legs and arms, somnolence (sleepiness), migraine, convulsion (‘fit'), vaginal dryness, painful periods, change in breast size, painful intercourse, ovarian cyst, premenstrual syndrome, infections of the urinary tract or reproductive organs, an increase in thickness of the lining of the womb, dark patches on the skin, bruising, excessive hair growth, itching, skin rash, swelling, chest pain, fever, abnormal cervical smear results, anxiety, difficulty breathing.
Rare side effects (occurs in less than 1 out of every 1,000 patients) These include: tachycardia (faster heart beat), breast lumps or nipple bleeding, thirst, hoarseness, rectal bleeding (bleeding from the anus), paralysis, decreased glucose tolerance (abnormal blood sugar levels), breast cancer, anaemia (reduction in red blood cells which can make the skin pale and cause weakness or breathlessness).
Other side effects that have been observed include:
Blood clotting disorders, deep vein thrombosis (blood clots forming in the veins, usually the legs), disturbed liver function. osteoporosis (thinning of the bones) including fractures, loss of bone mineral density (a test to measure the strength of bones), swelling of ankles or wrists, abnormal uterine bleeding (irregular, increase, decrease), milky discharge from breasts in women who are not breastfeeding, vaginal cysts, milk supply stopping (in breastfeeding mothers), feeling pregnant, delay in becoming pregnant after stopping Depo-Provera, scaling of skin, scleroderma (a rare autoimmune disease that affects the skin and other parts of the body),weakness in the face muscles, fainting, blood disorder, skin striae (stretch marks).
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or healthcare professional.
Possible effect on your periods:
Depo-Provera will usually disturb the pattern of a woman's period.
After the first injection it is most likely that you will have irregular, possibly lengthy bleeding or spotting. This will continue in some women. This is quite normal and nothing to worry about.
One third of women will not have any bleeding at all after the first injection. After 4 injections, most women find that their periods have stopped completely. Not having periods is nothing to worry about.
If you experience very heavy or prolonged bleeding you should talk to your doctor. This happens rarely but can be treated.
When you stop taking Depo-Provera your periods will return to normal in a few months.
Possible effects on your bones:
Depo-Provera works by lowering levels of estrogen and other hormones. However, low estrogen levels can cause bones to become thinner (by reducing bone mineral density). Women who use Depo-Provera tend to have lower bone mineral density than women of the same age who have never used it. The effects of Depo-Provera are greatest in the first 2-3 years of use. Following this, bone mineral density tends to stabilise and there appears to be some recovery when Depo-Provera is stopped. It is not yet possible to say whether Depo-Provera increases the risk of osteoporosis (weak bones) and fractures in later life.
The following are risk factors in the development of osteoporosis in later life. You should discuss with your doctor before starting treatment if you have any of the following as an alternative contraceptive may be more suitable to your needs;
• Chronic alcohol and/or tobacco use
• Chronic use of drugs that can reduce bone mass, e.g. epilepsy medication or steroids
• Low body mass index or eating disorder, e.g. anorexia nervosa or bulimia
• Previous low trauma fracture that was not caused by a fall
• Strong family history of osteoporosis
Teenagers (up to 18 years): Normally, the bones of teenagers are rapidly growing and increasing in strength. The stronger the bones are when adulthood is reached, the greater the protection against osteoporosis in later life. Since Depo-Provera may cause teenage bones to become thinner at a time when they should be growing, its effect may be particularly important in this age group. Bones start to recover when Depo-Provera is stopped, but it is not yet known whether the bone mineral density reaches the same levels as it would have if Depo-Provera had never been used. You should therefore discuss whether another form of contraception might be more suitable for you with the person who provides your contraception before starting Depo-Provera.
If you use Depo-Provera, it may help your bones if you take regular weight-bearing exercise and have a healthy diet, including an adequate intake of calcium (e.g. in dairy products) and vitamin D (e.g. in oily fish).
Possible risk of cancer: Studies of women who have used different forms of contraception found that women who used Depo-Provera for contraception had no increase in overall risk of developing cancer of the ovary, womb, cervix or liver.
Possible risk of breast cancer
Breast cancer is rare among women under 40 years of age whether or not they use hormonal contraceptives. Depo-Provera may increase the risk of breast cancer slightly compared with women who have never used it. However, any excess risk is small in relation to the overall risk of breast cancer, particularly in young women.
Older women have a higher baseline risk of breast cancer and therefore the increase in the number of cases due to Depo-Provera is greater in older women than in younger women.
In absolute terms this means that:
A 15 year old who uses Depo-Provera for 5 years increases her chance of developing breast cancer by a negligible amount by the age of 30.
A 25 year old who uses Depo-Provera for 5 years increases her chance of developing breast cancer by the age of 40 from 44 cases per 10,000 women (without Depo-Provera use) to up to 47 cases per
10.000 women i.e. an extra 3 cases/10,000.
A 35 year old who uses Depo-Provera for 5 years increases her chance of developing breast cancer by the age of 50 from 160 cases per 10,000 women (without Depo-Provera use) to 170 cases per
10.000 women i.e. an extra 10 cases/10,000.
Possible risk of forming an abscess at the injection site:
As with any intramuscular injection, there is a risk of an abscess forming at the site of injection. This may require medical or surgical attention.
Possible risk of weight gain:
Some women gained weight while using Depo-Provera. Studies show that over the first 1-2 years of use, the average weight gain was 5-8 lbs. Women completing 4-6 years of therapy gained an average of 14-16.5 lbs.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store Depo-Provera
Keep out of sight and reach of children.
Do not refrigerate or freeze.
Do not use Depo-Provera after the last day of the month shown in the expiry date stated on the vial and the carton.
6. Further Information What Depo-Provera contains:
The active ingredient in Depo-Provera is medroxyprogesterone acetate (MPA). Each dose (1 millilitre) of Depo-Provera contains 150 mg of medroxyprogesterone acetate. Depo-Provera also contains methyl parahydroxybenzoate, macrogol, polysorbate 80, propyl parahydroxybenzoate, sodium chloride and water. Hydrochloric acid or sodium hydroxide may also be added when the product is being made to adjust the acidity or alkalinity of the product to the correct level.
What Depo-Provera looks like and contents of the pack:
Depo-Provera is a white sterile suspension. Each vial contains 1 millilitre (ml) of Depo-Provera. Depo-Provera is supplied in cartons containing one vial.
Manufacturer:
Pfizer Manufacturing Belgium NV/SA, Rijksweg 12, B-2870 Puurs Belgium.
Procured from within the E.U, and repackaged by product licence holder: Munro Wholesale Medical Supplies Ltd., 3 Young Place,
East Kilbride, G75 0TD.
PL: 03243/0693 Depo-Provera® 150 mg/ml
This leaflet was revised: 23.12.2013 0693/6-P
® is a registered trademark of Pharmacia Ltd
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