Provera
(Medroxyprogesterone)

Prescription Settings Edit

Brand Name Choices

Provera 2.5mg
Provera 2.5mg

Medroxyprogesterone

Manufactured by Pfizer

Product of Canada

Dispensed by an approved Canadian pharmacy partner

Prescription Required

Provera 5mg
Provera 5mg

Medroxyprogesterone Acetate

Manufactured by Pfizer Ltd

Product of United Kingdom

Dispensed by a licensed pharmacy in the United Kingdom

Prescription Required

Parallel Import

Provera 10mg
Provera 10mg

Medroxyprogesterone Acetate

Manufactured by Pfizer Ltd

Product of New Zealand

Dispensed by an international pharmacy partner

Prescription Required

Provera 100mg
Provera 100mg

Medroxyprogesterone Acetate

Manufactured by Pfizer Ltd

Product of New Zealand

Dispensed by an international pharmacy partner

Prescription Required

Generic Choices

Medroxyprogesterone Acetate 2.5mg
Medroxyprogesterone Acetate 2.5mg

Marketed as Apo-Medroxy in Canada

Generic Equivalent of Provera 2.5mg

Manufactured by Apotex Inc.

Product of Canada

Dispensed by an approved Canadian pharmacy partner

Prescription Required

Medroxyprogesterone Acetate 5mg
Medroxyprogesterone Acetate 5mg

Marketed as Apo-Medroxyprogesterone in Canada

Generic Equivalent of Provera 5mg

Manufactured by Apotex Inc.

Product of Canada

Dispensed by an approved Canadian pharmacy partner

Prescription Required

Medroxyprogesterone Acetate 10mg
Medroxyprogesterone Acetate 10mg

Marketed as Apo-Medroxy in Canada

Generic Equivalent of Provera 10mg

Manufactured by Apotex Corporation

Product of Canada

Dispensed by an approved Canadian pharmacy partner

Prescription Required

Medroxyprogesterone Acetate 100mg
Medroxyprogesterone Acetate 100mg

Marketed as Apo-Medroxy in Canada

Generic Equivalent of Provera 100mg

Manufactured by Apotex Inc.

Product of Canada

Dispensed by an approved Canadian pharmacy partner

Prescription Required

What Provera is and what it is used for

Depo-Provera is a long acting contraceptive. This medicine contains the active substance medroxyprogesterone acetate (MPA), which is one of a group of medicines called ‘Progestogens’. It 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.

How to take Provera

This medicine will be given to you by your doctor or healthcare professional. (The last section of this leaflet contains instructions for your doctor or healthcare professional on how they should do this.) 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. The risk of heavy or pro-longed vaginal bleeding may be increased if Depo-Provera is used immediately following childbirth or termination of pregnancy. If you forget an injection of Depo-Provera If you forget your injection or are late getting your next injection (i.e. 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. Page 5 of 20 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 medicine, ask your doctor or healthcare professional.

Possible side effects

Like all medicines, this medicine can cause side effects although not everybody gets them. Seek medical help immediately if you notice any of the following side effects:
• Hypersensitivity (allergic) reaction (it is not known how frequently this occurs) Symptoms include sudden sudden skin rash, swelling of the face, lips, tongue or throat, wheezing or difficulty in breathing.
• A blood clot in the lungs (this occurs rarely
•may affect up to 1 in 1000 people) Symptoms include o Shortness of breath o Breath-related chest pains o Coughing up blood
• A blood clot in the leg (this occurs rarely
•may affect up to 1 in 1000 people)
• Deep vein thrombosis (DVT) is a condition in which a blood clot forms in one of your deep veins, usually in your leg. These are symptoms of a deep-vein thrombosis (DVT):
•You have pain, tenderness or swelling in your calf, ankle or foot
•You have painful or inflamed veins in your leg
•You find it difficult to put full weight on the affected leg
•You have purple discolouration of the skin of the leg or the skin becomes red and warm to touch.
• Jaundice (yellowing of the skin or the whites of the eyes). 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 DepoProvera increases the risk of osteoporosis (weak bones) and fractures in later life. Other side-effects include:

Very common: may affect more than 1 in 10 people
• nervousness
• headache
• stomach pain or discomfort
• weight increase or decrease

Common: may affect up to 1 in 10 people
• depression Page 6 of 20
• libido decreased (reduced sex drive)
• dizziness
• feeling sick
• feeling bloated
• hair loss
• acne
• back pain
• vaginal discharge
• breast tenderness
• difficult or painful period
• urinary tract infection
• oedema/fluid retention
• weakness

Uncommon: may affect up to 1 in 100 people
• appetite increased or decreased
• difficulty sleeping
• convulsions (fits)
• drowsiness
• tingling
• hot flush
• liver disorder
• facial hair growth
• nettle rash or hives
• itchy skin
• temporary brown patches
• difficult or painful period
• unexpected or unusual vaginal bleeding or spotting
• milky discharge from the breast when not pregnant or breastfeeding
• pelvic pain
• painful intercourse
• prevention of lactation

Rare: may affect up to 1 in 1,000 people
• breast cancer
• reduction in red blood cell
• blood disorder
• difficulty reaching orgasm
• behavior change
• mood change
• irritability
• anxiety
• migraine
• paralysis
• fainting
• feeling of dizziness or spinning
• heart beats more rapidly
• high blood pressure
• varicose veins
• rectal bleeding
• digestive disorder
• liver enzyme disorder Page 7 of 20
• accumulation of fat (at injection site)
• inflammation of the skin
• scar tissue formation
• stretch marks
• pain in a joint
• muscular cramps
• bone density decreased (osteoporosis)
• vaginal pain or inflammation
• stopping or extended break of your periods
• breast pain
• inflammation of the vagina
• stopping or extended break of your periods
• breast pain
• uterine bleeding or excessive bleeding
• periods with abnormally heavy or prolonged bleeding
• vaginal dryness
• change in breast size
• ovarian or vaginal cyst
• premenstrual syndrome
• excessive thickening of the lining of the womb
• breast lump
• nipple bleeding
• delayed egg release with longer menstrual cycles (periods)
• feel pregnant
• fever
• tiredness
• injection site pain or tenderness
• injection site lump or dimple
• feeling thirsty
• hoarseness
• facial nerve paralysis
• decreased sugar tolerance
• abnormal smear 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 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 Page 8 of 20 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 DepoProvera 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. Page 9 of 20 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 or pharmacist. 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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

How to Store Provera

Keep out of the sight and reach of children. Do not store above 25°C and protect from freezing. Do not use Depo-Provera after the last day of the month shown in the expiry date stated on the pre-filled syringe label and the carton after EXP. The expiry date is the last day of that month. Do not throw away medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

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