Depo-Provera 150 mg/ml
medroxyprogesterone acetate
PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU DECIDE ABOUT USING THIS METHOD OF CONTRACEPTION.
It provides you with some useful information about Depo-Provera 150 mg/ml. The information in this leaflet applies only to Depo-Provera 150 mg/ml. If you have any questions or if you are not sure about anything, ask your doctor, nurse or clinic.
What is in Depo-Provera?
The active ingredient in Depo-Provera is medroxyprogesterone acetate. 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.
Depo-Provera is a sterile suspension. Each syringe contains 1 millilitre (ml) of Depo-Provera.
How does Depo-Provera work?
Medroxyprogesterone acetate is similar to (but not the same as) the natural hormone progesterone that is produced by your ovaries during the second half of your menstrual cycle.
Depo-Provera acts by preventing your egg cells from ripening. If an egg is not released from the ovaries during your menstrual cycle, 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.
Who makes Depo-Provera?
Depo-Provera is made by
is licensed to sell Depo-Provera in the UK.
What is Depo-Provera for?
Depo-Provera is a contraceptive. It can be used:
- for long-term contraception where you and the person who provides your contraception have decided that this method is the most suitable for you. However, if you wish to use Depo-Provera for more than 2 years your health professional/doctor/nurse 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 person who provides your contraception and considered unsuitable or unacceptable;
- for just one or two occasions in the following cases:
- (i) if your partner is undergoing vasectomy, to give you protection until the vasectomy becomes effective;
- (ii) if you are being immunised against rubella, to prevent pregnancy during the period of activity of the virus.
- (iii) if you are awaiting sterilisation.
Will Depo-Provera suit you?
Most women who use Depo-Provera find this method of contraception to be fully acceptable, however, not all women should use Depo-Provera.
You should not use Depo-Provera for contraception if you have any of the following conditions:
- if you have had cancer of the breast or sex organs;
- if you have unusual vaginal bleeding the cause of which is unknown;
- if you are allergic to medroxyprogesterone acetate or any of the other ingredients of Depo-Provera;
- if you think you may be pregnant;
- if you have not started getting your periods;
- 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.
Things to consider before choosing Depo-Provera
Before your doctor prescribes Depo-Provera, you will have a physical examination. It is important to tell your doctor 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;
- 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);
- past pulmonary embolism or stroke while using Depo-Provera;
- problems with your eyesight while using Depo-Provera;
- past history of 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;
How will Depo-Provera affect my periods?
Depo-Provera usually disturbs the pattern of women’s periods.
After the first injection it is most likely that you will have irregular, possibly lengthy bleeding or spotting. This continues 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 easily.
When you stop using Depo-Provera your periods will return to normal in a few months.
What if I want a baby?
Your usual level of fertility will return when the effect of the injection has worn off. This takes different times 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 will conceive within a year of the first missed injection.
Pregnancies have been recorded in the first month after missing an injection.
Will I put on weight?
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.
What about cancer risks?
Studies of women who have used different forms of contraception found that women who used Depo-Provera for contraception had no increased overall risk of developing cancer of the ovary, womb, cervix, or liver.
Every woman is at risk of breast cancer whether or not she receives injections of medicines like Depo-Provera. Breast cancer is rare under 40 years of age, but the risk increases as a woman becomes older.
There seems to be a slightly increased risk of breast cancer in women who take injectable contraceptives compared to women of the same age who do not use hormonal contraceptives.
This small extra risk of developing breast cancer has to be weighed against the known benefits of medicines like Depo-Provera. It is not certain whether the injection causes the increased risk of breast cancer. It may be that women receiving the injection are examined more often, so that breast cancer is noticed earlier. The breast cancer seems less likely to have spread when found in women who receive medicines like Depo-Provera than in women who do not.
The risk of finding breast cancer is not affected by how long a woman is on the injection, but by the age at which she stops. This is because the risk of breast cancer strongly increases as a woman becomes older. Ten years after stopping hormonal contraceptive injections, the risk of finding breast cancer is the same as for women who have never used hormonal contraceptives.
In 10, 000 women who receive injections like Depo-Provera for up to 5 years, but stop taking it by the time they are aged 20, it is estimated that less than 1 additional case of breast cancer would be found up to 10 years afterwards, compared with the number found in 10,000 women who had never had the injection.
For 10, 000 women who are on injections like Depo-Provera for 5 years and stop it by the age of 30, there would be 2 or 3 extra cases of breast cancer found up to 10 years afterwards (in addition to the 44 cases of breast cancer found in 10,000 women in this age group who had never had the injection).
For 10, 000 women who take Depo-Provera for 5 years and stop it by the age of 40, there would be about 10 extra cases found up to 10 years afterwards (in addition to 160 cases of breast cancer found in 10,000 women in this age group who had never had the injection).
Will Depo-Provera affect my bones?
Depo-Provera works by lowering levels of oestrogen and other hormones. However, low oestrogen 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. Research is being carried out to find out how completely the bones recover after long-term use of Depo-Provera. It is not yet known whether the effect of Depo-Provera on bone mineral density increases the risk of osteoporosis (weak bones) and fractures in later life.
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).
Is there a risk of infection at the injection site?
As with any intramuscular injection, there is a risk of an infection at the site of injection. This may require medical or surgical attention.
Could I be allergic to Depo-Provera?
There is a very low risk of severe allergic reactions.
Taking other medicines
Tell your doctor if you are taking aminoglutethimide as this may affect the way your Depo-Provera works. Also tell your doctor if you are taking any other medicines. This includes ’over the counter’ medicines from the pharmacy (chemist).
Tell any other doctor who treats you that you are using Depo-Provera as a contraceptive.
Are you breastfeeding?
Although Depo-Provera can be passed to the nursing infant in the breast milk, no harmful effects have been found in these children. Depo-Provera does not prevent the breasts from producing milk, so it can be used by nursing mothers.
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 may suggest that you wait until at least 6 weeks after your baby has been born before you start using Depo-Provera for contraception.
Are you having any laboratory tests done?
If you are scheduled for any laboratory tests, tell your doctor or nurse that you are using Depo-Provera for contraception. Certain blood tests are affected by hormones such as Depo-Provera. This also applies if a sample of tissue is taken from your womb (D&C), cervix or vagina for examination.
How is Depo-Provera given?
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.
If used following childbirth the first Depo-Provera injection can be given within 5 days after childbirth if you are not breast-feeding or at least 6 weeks after childbirth if you are 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 make your next appointment for 12 weeks time. If you are late coming back for your next injection, you will need to discuss what to do with your doctor.
Can I become pregnant?
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, see your doctor.
Does Depo-Provera have side-effects?
Possible side-effects might include: irregular periods; amenorrhoea (very light or no periods); weight changes; headache; nervousness; abdominal cramps; dizziness; weakness or tiredness.
Other less common side-effects are: loss of hair; hirsutism (abnormal hairiness) backache; leg cramps; depression; nausea; difficulty sleeping; vaginal discharge or inflammation; acne; pelvic or breast pain; decreased sexual feelings; feeling bloated; rash; swelling of ankles or wrists; hot flushes.
Very occasionally, other problems have been reported. These include: breasts starting to produce milk (when you are not breastfeeding); brown patches appearing on the skin; convulsions (fits); changes in appetite; gastrointestinal disturbances; jaundice (this will cause yellowing of the skin and the whites of the eyes); urinary tract infections; lumps or swellings in the vagina; painful sexual intercourse; altered sensation in the skin e.g. pins-and-needles; pain in the chest; blood clots in the lung; allergic reactions; anaemia; fainting; breathlessness; thirst; hoarseness; pain at injection site; abscess at the injection site; blood disorders; bleeding from the back passage; changes in breast size; lumps in the breast; bleeding from the nipple; swelling under the armpit; milk supply stopping (in breastfeeding mothers); feeling pregnant; delay in becoming pregnant; complete or partial loss of controlled movement of one or more muscles; sleepiness; joint pain; feverishness; increased blood sugar levels; skin itching; weakness in the face muscles; scleroderma (an autoimmune disorder); osteoporosis (thinning of the bones) including fractures; enlargement of the womb; varicose veins; painful menstrual periods; inflammation of part of a vein; blood clots forming in the veins, usually the legs. These problems have also been reported by people who have never used Depo-Provera. If these or any other problems occur during your use of Depo-Provera, discuss them with your doctor.
Care of Depo-Provera
Depo-Provera will be carefully stored at your doctor’s surgery, local pharmacy or your clinic.
Your doctor or pharmacist will ensure that the syringe is stored at 25° C and not allowed to freeze. It should not be used after the expiry date printed on the label and carton.
This leaflet was last revised in August 2006.
(Pharmacia Limited)
Depo-Provera
This leaflet was last revised in July 2007
Pharmacia Limited
Depo-Provera is a registered trademark
Company Ref: DP2_0
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