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DEPO-PROVERA 150 MG/ML

Active substance(s): MEDROXYPROGESTERONE ACETATE / MEDROXYPROGESTERONE ACETATE

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was 5-8 lbs. Women completing 4-6 years of therapy gained an average
of 14-16.5 lbs.

PACKAGE LEAFLET INFORMATION FOR THE USER

Depo-Provera® 150mg/ml
(medroxyprogesterone acetate)
• In teenagers only after other methods of contraception have been
Please read all of this leaflet carefully before you start using this
discussed with the healthcare professional who provides your
medicine because it contains important information for you.
contraception and considered to be unsuitable or unacceptable.
• Keep this leaflet. You may need to read it again.
• For just one or two occasions in the following cases:
• If you have any further questions, ask your doctor, pharmacist or nurse.

if your partner is undergoing a vasectomy, to give you protection
• This medicine has been prescribed for you only. Do not pass it on to
until the vasectomy becomes effective
others. It may harm them, even if their signs of illness are the same as

if you are being immunised against rubella, to prevent pregnancy
yours.
during the period of activity of the virus
• If you get any of the side effects, talk to your doctor, nurse or

if you are awaiting sterilisation.
healthcare provider. This includes any possible side effects not listed in
this leaflet. See section 4.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE DEPOIMPORTANT INFORMATION YOU SHOULD KNOW ABOUT DEPOPROVERA® 150MG/ML
®
PROVERA 150MG/ML

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. By reporting side effects you can help
provide more information on the safety of this medicine.
5. HOW TO STORE DEPO-PROVERA® 150 MG/ML
Keep out of the sight and reach of children.
Do not store above 25°C. Keep in the original container. Do not freeze.
Do not use after the expiry date printed on the label and carton.

Depo-Provera® 150mg/ml 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.

6. FURTHER INFORMATION
What Depo-Provera® 150 mg/ml contains:
Each 1ml of suspension contains 150mg of medroxyprogesterone acetate
as the active ingredient.
Each 1ml also contains macrogol, sodium chloride, polysorbate 80,
methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate
(E216), and water for injection.

Do not use Depo-Provera® 150mg/ml:
• If you are allergic (hypersensitive) to the active ingredient (MPA) or any
of the other ingredients (listed in section 6). There is a small risk of a
severe allergic reaction to Depo-Provera® 150mg/ml 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 bleeding from the womb (uterus).
• If you have liver disease.
• If you have not yet started your periods.

• You must have injections of this contraceptive regularly every 12
weeks; otherwise you may risk becoming pregnant (see section 3).
• Depo-Provera® 150mg/ml may not be suitable for every woman. You
will need to discuss with your doctor or healthcare professional
providing your contraception on whether it is suitable for you, especially
if you wish to use it for more than 2 years (See section 1).
• Depo-Provera® 150mg/ml may not be suitable for you if you have a
history of certain medical conditions (see section 2) or if you are taking
a medicine called aminoglutethiamide that thins the blood (see section
2). Your doctor or nurse should take a full medical history before
prescribing Depo-Provera® 150mg/ml.
• Regular use of Depo-Provera® 150mg/ml causes a gradual loss of bone
mineral density (see section 4). 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® 150mg/ml.
Teenagers who are rapidly developing their bones may be at particular
risk and should only use Depo-Provera® 150mg/ml if other methods of
contraception have been discussed and considered unsuitable or
unacceptable.
• Your doctor may plan to conduct a general medical as well as a
gynaecological examination before they decide to prescribe DepoProvera® 150mg/ml for you and may request you to visit the clinic for
similar examinations at appropriate intervals thereafter.
What is in this leaflet
1. WHAT DEPO-PROVERA® 150MG/ML IS AND WHAT IT IS USED
FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU USE DEPO-PROVERA®
150MG/ML
3. HOW TO USE DEPO-PROVERA® 150MG/ML
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE DEPO-PROVERA® 150MG/ML
6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Depo-Provera® 150 mg/ml looks like and contents of the pack:
It is a white, opaque suspension for injection. It is available in a clear
glass vial with a rubber stopper that has an aluminium seal and a purple
protective cap.
The vial contains 1 millilitre of suspension.
Who manufactured your medicine:
Manufactured by Pfizer Manufacturing Belgium N.V/S.A., Rijksweg 12, B2870 Puurs, Belgium. Procured from within the EU and repackaged by
Product Licence Holder Beachcourse Limited, 20 Alliance Court, London
W3 0RB.
PL16378/0534
POM
Revision date: 12.12.2016
Leaflet reference: Depo150S/UT
Depo-Provera® is a registered trademark of Pharmacia Limited.

Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Beachcourse, Tel: 020 8896 9054
for help.

Warnings and precautions
Talk to your doctor or healthcare professional before using DepoProvera® 150mg/ml.
Before your doctor or healthcare professional prescribes Depo-Provera®
150mg/ml, 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® 150mg/ml is suitable for you.
• Migraine headaches – if you develop migraine you should consult your
doctor before receiving further injections of Depo-Provera® 150mg/ml
• 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® 150mg/ml
• Problems with your eyesight while using Depo-Provera® 150mg/ml; 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
• Problems with your kidneys or kidney 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
• Asthma
• Epilepsy
• 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.

1. WHAT DEPO-PROVERA® 150MG/ML IS AND WHAT IT IS USED
FOR
Depo-Provera® 150mg/ml 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® 150mg/ml 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® 150mg/ml 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® 150mg/ml 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® 150mg/ml for more than 2 years your
doctor or healthcare professional may wish to re-evaluate the risks and
benefits of using Depo-Provera® 150mg/ml to make sure that it is still
the best option for you.

4

Cervical smear testing
The results of a cervical smear and some laboratory tests could also be
affected if you are using Depo-Provera® 150mg/ml so it is important that
you tell your doctor.
Protection against sexually transmitted diseases
Depo-Provera® 150mg/ml does not protect against HIV infection (AIDS)
and other sexually transmitted diseases.
Other medicines and Depo-Provera® 150mg/ml:
• Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines.

1

• 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® 150mg/ml
works.
• Always tell your doctor or healthcare professional who treats you that
you are using Depo-Provera® 150mg/ml 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.

The risk of heavy or pro-longed vaginal bleeding may be increased if
Depo-Provera® 150mg/ml is used immediately following childbirth or
termination of pregnancy.
If you forget an injection of Depo-Provera® 150mg/ml:
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®
150mg/ml and which type of contraception should be used in the
meantime.

Pregnancy, breast-feeding and fertility
• Your doctor will check that you are not pregnant before giving you the
first injection and also if any following injection is delayed beyond 89
days (12 weeks and 5 days).
• Depo-Provera® 150mg/ml must not be taken if you are pregnant as
hormonal medicines can affect the developing baby.
• If you think you may have become pregnant while using Depo-Provera®
150mg/ml for contraception, tell your doctor immediately.

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® 150mg/ml 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.

Effect on future fertility
• Your usual level of fertility should 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® 150mg/ml.
• In studies, over 80% of women trying to get pregnant conceived within
15 months of the last injection; however, this varied from 4 months after
the last injection to more than two years.
• Some women have got pregnant as early as 14 weeks after their last
injection.

4. 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 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 Depo-Provera 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
• 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

If you are breast-feeding
• Depo-Provera® 150mg/ml 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® 150mg/ml.
• 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® 150mg/ml for contraception.
• If a baby is exposed to Depo-Provera® 150mg/ml in the breast milk, no
harmful effects have been seen in babies and children.
Driving and using machines
®

Depo-Provera 150mg/ml 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.
Depo-Provera® 150mg/ml contains methylparaben (E218),
propylparaben (E216) and sodium
Methylparaben and propylparaben may cause allergic reactions (possibly
delayed), and exceptionally, bronchospasm.
This medicinal product contains less than 1 mmol sodium (23 mg) per 150
mg/ml, i.e. essentially ‘sodium free’.
3. HOW TO USE DEPO-PROVERA® 150MG/ML
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® 150mg/ml 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® 150mg/ml 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® 150mg/ml 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® 150mg/ml MUST be
given every 12 weeks. Make sure that you or your doctor makes your next
appointment for 12 weeks time.

2

• 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
• 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 effects on your bones
Depo-Provera® 150mg/ml 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 DepoProvera® 150mg/ml tend to have lower bone mineral density than women
of the same age who have never used it. The effects of Depo-Provera®
150mg/ml 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® 150mg/ml is stopped. It is not yet possible to say
whether Depo-Provera® 150mg/ml 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® 150mg/ml 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® 150mg/ml is stopped, but it is not yet known whether the
bone mineral density reaches the same levels as it would have if DepoProvera® 150mg/ml 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® 150mg/ml.
If you use Depo-Provera® 150mg/ml, 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® 150mg/ml 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® 150mg/ml 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® 150mg/ml is
greater in older women than in younger women.
In absolute terms this means that:
A 15 year old who uses Depo-Provera® 150mg/ml 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® 150mg/ml 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® 150mg/ml 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® 150mg/ml 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® 150mg/ml 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 effect on your periods
Depo-Provera® 150mg/ml 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® 150mg/ml your periods will return to
normal in a few months.

Possible risk of weight gain
Some women gained weight while using Depo-Provera® 150mg/ml.
Studies show that over the first 1-2 years of use, the average weight gain

3

A study to assess the BMD effects of medroxyprogesterone acetate IM (Depo-Provera® 150mg/ml, DMPA) in
adolescent females showed that its use was associated with a significant decline in BMD from baseline. In the
small number of women who were followed-up, mean BMD recovered to around baseline values by 1- 3 years
after discontinuing treatment. In adolescents, Depo-Provera® 150mg/ml may be used, but only after other
methods of contraception have been discussed with the patients and considered to be unsuitable or
unacceptable.
In women of all ages, careful re-evaluation of the risks and benefits of treatment should be carried out in those
who wish to continue use for more than 2 years. In particular, in women with significant lifestyle and/or medical
risk factors for osteoporosis, other methods of contraception should be considered prior to use of Depo-Provera®
150mg/ml.
Significant risk factors for osteoporosis include:
• Alcohol abuse and/or tobacco use
• Chronic use of drugs that can reduce bone mass, e.g., anticonvulsants or corticosteroids
• Low body mass index or eating disorder, e.g., anorexia nervosa or bulimia
• Previous low trauma fracture
• Family history of osteoporosis
A retrospective cohort study using data from the General Practice Research Database (GPRD) reported that
women using MPA injections (DMPA), have a higher risk of fracture compared with contraceptive users with no
recorded use of DMPA (incident rate ratio 1.41, 95% CI 1.35-1.47 for the five year follow-up period); it is not
known if this is due to DMPA, or to other related lifestyle factors which have a bearing on fracture rate. By
contrast, in women using DMPA, the fracture risk before and after starting DMPA was not increased (relative risk
1.08, 95% CI 0.92-1.26). Importantly, this study could not determine whether use of DMPA has an effect on
fracture rate later in life.
For further information on BMD changes in both adult and adolescent females, as reported in recent clinical
studies, refer to section 5.1 of the SPC. Adequate intake of calcium and Vitamin D whether from the diet or from
supplements is important for bone health in women of all ages.
Menstrual Irregularity The administration of Depo-Provera® 150mg/ml usually causes disruption of the normal
menstrual cycle. Bleeding patterns include amenorrhoea (present in up to 30% of women during the first 3
months and increasing to 55% by month 12 and 68% by month 24); irregular bleeding and spotting; prolonged
(>10 days) episodes of bleeding (up to 33% of women in the first 3 months of use decreasing to 12% by month
12). Rarely, heavy prolonged bleeding may occur. Evidence suggests that prolonged or heavy bleeding requiring
treatment may occur in 0.5-4 occasions per 100 women years of use. If abnormal bleeding persists or is severe,
appropriate investigation should take place to rule out the possibility of organic pathology and appropriate
treatment should be instituted when necessary. Excessive or prolonged bleeding can be controlled by the coadministration of oestrogen. This may be delivered either in the form of a low dose (30 micrograms oestrogen)
combined oral contraceptive pill or in the form of oestrogen replacement therapy such as conjugated equine
oestrogen (0.625-1.25 mg daily). Oestrogen therapy may need to be repeated for 1-2 cycles. Long-term coadministration of oestrogen is not recommended.
Return to Fertility There is no evidence that Depo-Provera® 150mg/ml causes permanent infertility. Pregnancies
have occurred as early as 14 weeks after a preceding injection, however, in clinical trials, the mean time to return
of ovulation was 5.3 months following the preceding injection. Women should be counselled that there is a
potential for delay in return to full fertility following use of the method, regardless of the duration of use, however,
83% of women may be expected to conceive within 12 months of the first "missed" injection (i.e. 15 months after
the last injection administered). The median time to conception was 10 months (range 4-31) after the last
injection.
Cancer Risks Long-term case-controlled surveillance of Depo-Provera® 150mg/ml users found no overall
increased risk of ovarian, liver, or cervical cancer and a prolonged, protective effect of reducing the risk of
endometrial cancer in the population of users. Breast cancer is rare among women under 40 years of age
whether or not they use hormonal contraceptives.
Results from some epidemiological studies suggest a small difference in risk of the disease in current and recent
users compared with never-users. Any excess risk in current and recent DMPA users is small in relation to the
overall risk of breast cancer, particularly in young women (see below), and is not apparent after 10 years since
last use. Duration of use does not seem to be important.
Possible number of additional cases of breast cancer diagnosed up to 10 years after stopping injectable
progestogens*
Age at last use of DMPA
No of cases per 10,000 women
Possible additional cases per
who are never-users
10,000 DMPA users
20
Less than 1
Much less than 1
30
44
2-3
40
160
10
*based on use for 5 years
Weight Gain There is a tendency for women to gain weight while on Depo-Provera® 150mg/ml therapy. Studies
indicate that over the first 1-2 years of use, average weight gain was 5-8 lbs. Women completing 4-6 years of
therapy gained an average of 14-16.5 lbs. There is evidence that weight is gained as a result of increased fat
and is not secondary to an anabolic effect or fluid retention.
Anaphylaxis Reports of anaphylactic responses (anaphylactic reactions, anaphylactic shock, anaphylactoid
reactions) have been received.
Thromboembolic Disorders Should the patient experience pulmonary embolism, cerebrovascular disease or
retinal thrombosis while receiving Depo-Provera® 150mg/ml, the drug should not be readministered.
Psychiatric Disorders Patients with a history of endogenous depression should be carefully monitored. Some
patients may complain of premenstrual-type depression while on Depo-Provera® 150mg/ml therapy.
Abscess formation As with any intramuscular injection, especially if not administered correctly, there is a risk of
abscess formation at the site of injection, which may require medical and/or surgical intervention.

INFORMATION FOR DOCTORS AND PHARMACISTS
Depo-Provera® 150 mg/ml
(medroxyprogesterone acetate)
The following information is intended for medical or healthcare professionals only:
(For further information, consult the Summary of Product Characteristics.)
Description
Depo-Provera® 150mg/ml is a white, opaque suspension for injection.
Each 1ml of suspension contains 150 mg medroxyprogesterone acetate. Excipients are macrogol, sodium
chloride, polysorbate 80, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), and water
for injection. Hydrochloric acid or sodium hydroxide may be present as pH adjusters.
Uses
Depo-Provera® 150mg/ml is a long-term contraceptive agent suitable for use in women who have been
appropriately counselled concerning the likelihood of menstrual disturbance and the potential for a delay in return
to full fertility.
Depo-Provera® 150mg/ml may also be used for short-term contraception in the following circumstances:
(i) For partners of men undergoing vasectomy, for protection until the vasectomy becomes effective.
(ii) In women who are being immunised against rubella, to prevent pregnancy during the period of activity of the
virus.
(iii) In women awaiting sterilisation.
Since loss of bone mineral density (BMD) may occur in females of all ages who use Depo-Provera® 150mg/ml
injection long-term, a risk/benefit assessment, which also takes into consideration the decrease in BMD that
occurs during pregnancy and/or lactation, should be considered.
Use in adolescents (12 – 18 years)
In adolescents, Depo-Provera® 150mg/ml may be used, but only after other methods of contraception have been
discussed with the patient and considered unsuitable or unacceptable.
It is of the greatest importance that adequate explanations of the long-term nature of the product, of its possible
side-effects and of the impossibility of immediately reversing the effects of each injection are given to potential
users and that every effort is made to ensure that each patient receives such counselling as to enable her to fully
understand these explanations. Patient information leaflets are supplied by the manufacturer. It is recommended
that the doctor uses these leaflets to aid counselling of the patient before giving the injection of Depo-Provera®
150mg/ml.
Consistent with good clinical practice, a general medical as well as a gynaecological examination should be
undertaken before administration of Depo-Provera® 150mg/ml and at appropriate intervals thereafter.
Dosage
Each ml of suspension contains 150 mg medroxyprogesterone acetate. The sterile aqueous suspension of
Depo-Provera® 150mg/ml should be vigorously shaken just before use to ensure that the dose being given
represents a uniform suspension of Depo-Provera® 150mg/ml. Doses should be given by deep intramuscular
injection into the buttock or arm.
Care should be taken to ensure that the depot injection is given into the muscle tissue, preferably the gluteus
maximus, but other muscle tissue such as the deltoid may be used and the site of injection should be cleansed
using standard methods prior to administration of the injection.
Assembly of syringe for single use:
1. Remove tip cap.
2. Position needle using aseptic technique.
3. Remove needle shield. The syringe is now ready for use.
Administration
Adults
First injection: To provide contraceptive cover in the first cycle of use, an injection of 150 mg i.m. should be given
during the first five days of a normal menstrual cycle. If the injection is carried out according to these instructions,
no additional contraceptive cover is required.
Postpartum: To increase assurance that the patient is not pregnant at the time of first administration, this
injection should be given within 5 days postpartum if not breast-feeding.
There is evidence that women prescribed Depo-Provera® 150mg/ml in the immediate puerperium can experience
prolonged and heavy bleeding. Because of this, the drug should be used with caution in the puerperium. Women
who are considering use of the product immediately following delivery or termination should be advised that the
risk of heavy or prolonged bleeding may be increased.
Doctors are reminded that in the non breast-feeding postpartum patient, ovulation may occur as early as week 4.
If the puerperal woman will be breast-feeding, the initial injection should be given no sooner than six weeks
postpartum, when the infant’s enzyme system is more fully developed. Further injections should be given at 12
week intervals.
Further doses: These should be given at 12 week intervals, however, as long as the injection is given no later
than five days after this time, no additional contraceptive measures (e.g. barrier) are required.
(NB For partners of men undergoing vasectomy a second injection of 150 mg i.m. 12 weeks after the first may be
necessary in a small proportion of patients where the partner’s sperm count has not fallen to zero.) If the interval
from the preceding injection is greater than 89 days (12 weeks and five days) for any reason, then pregnancy
should be excluded before the next injection is given and the patient should use additional contraceptive
measures (e.g. barrier) for fourteen days after this subsequent injection.
Paediatric population (12-18 years): Depo-Provera® 150mg/ml is not indicated before menarche. Data in
adolescent females (12-18 years) is available. Other than concerns about loss of BMD, the safety and
effectiveness of Depo-Provera® 150mg/ml is expected to be the same for adolescents after menarche and adult
females.
Switching from other Methods of Contraception: Depo-Provera® 150mg/ml should be given in a manner that
ensures continuous contraceptive coverage. This should be based upon the Mechanism of action of other
methods (e.g. patients switching from oral contraceptives should have their first injection of Depo-Provera®
150mg/ml within 7 days of taking their last active pill).
Hepatic Insufficiency: The effect of hepatic disease on the pharmacokinetics of Depo-Provera® 150mg/ml is
unknown. As Depo-Provera® 150mg/ml largely undergoes hepatic elimination it may be poorly metabolised in
patients with severe liver insufficiency (see Contraindications).
Renal Insufficiency: The effect of renal disease on the pharmacokinetics of Depo-Provera® 150mg/ml is
unknown. No dosage adjustment should be necessary in women with renal insufficiency, since Depo-Provera®
150mg/ml is almost exclusively eliminated by hepatic metabolism.

Precautions
History or emergence of the following conditions requires careful consideration and appropriate investigation:
migraine or unusually severe headaches, acute visual disturbances of any kind, pathological changes in liver
function and hormone levels.
Patients with thromboembolic or coronary vascular disease should be carefully evaluated before using DepoProvera® 150mg/ml.
A decrease in glucose tolerance has been observed in some patients treated with progestogens. The
mechanism for this decrease is obscure. For this reason, diabetic patients should be carefully monitored while
receiving progestogen therapy.
Rare cases of thromboembolism have been reported with use of Depo-Provera® 150mg/ml, but causality has not
been established.
The effects of medroxyprogesterone acetate on lipid metabolism have been studied with no clear impact
demonstrated. Both increases and decreases in total cholesterol, triglycerides and low-density lipoprotein (LDL)
cholesterol have been observed in studies. The use of Depo-Provera® 150mg/ml appears to be associated with a
15-20 % reduction in serum high density lipoprotein (HDL) cholesterol levels which may protect women from
cardiovascular disease. The clinical consequences of this observation are unknown.
The potential for an increased risk of coronary disease should be considered prior to use. Doctors should
carefully consider the use of Depo-Provera® 150mg/ml in patients with recent trophoblastic disease before levels
of human chorionic gonadotrophin have returned to normal.
Physicians should be aware that pathologists should be informed of the patient’s use of Depo-Provera®
150mg/ml if endometrial or endocervical tissue is submitted for examination.
The results of certain laboratory tests may be affected by the use of Depo-Provera® 150mg/ml. These include
gonadotrophin levels (decreased), plasma progesterone levels (decreased), urinary pregnanediol levels
(decreased), plasma oestrogen levels (decreased), plasma cortisol levels (decreased), glucose tolerance test,
metyrapone test, liver function tests (may increase), thyroid function tests (protein bound iodine levels may
increase and T3 uptake levels may decrease). Coagulation test values for prothrombin (Factor II), and Factors
VII, VIII, IX and X may increase.

Contraindications
Hypersensitivity to medroxyprogesterone acetate or to any of the excipients of this medicine.
Depo-Provera® 150mg/ml should not be used during pregnancy, either for diagnosis or therapy.
Depo-Provera® 150mg/ml is contraindicated as a contraceptive at the above dosage in known or suspected
hormone-dependent malignancy of breast or genital organs.
Depo-Provera® 150mg/ml is contraindicated in patients with the presence or history of severe hepatic disease
whose liver function tests have not returned to normal.
Whether administered alone or in combination with oestrogen, Depo-Provera® 150mg/ml should not be
employed in patients with abnormal uterine bleeding until a definite diagnosis has been established and the
possibility of genital tract malignancy eliminated.
Special warnings and precautions for use

Interaction with other medicinal products and other forms of interaction

Warnings

Aminoglutethimide administered concurrently with Depo-Provera® 150mg/ml may significantly depress the
bioavailability of Depo-Provera® 150mg/ml.
Interactions with other medicinal treatments (including oral anticoagulants) have rarely been reported, but
causality has not been determined. The possibility of interaction should be borne in mind in patients receiving
concurrent treatment with other drugs.
The clearance of medroxyprogesterone acetate is approximately equal to the rate of hepatic blood flow. Because
of this fact, it is unlikely that drugs which induce hepatic enzymes will significantly affect the kinetics of
medroxyprogesterone acetate. Therefore, no dose adjustment is recommended in patients receiving drugs
known to affect hepatic metabolising enzymes.

Loss of Bone Mineral Density:
Use of Depo-Provera® 150mg/ml reduces serum oestrogen levels and is associated with significant loss of BMD
due to the known effect of oestrogen deficiency on the bone remodelling system. Bone loss is greater with
increasing duration of use; however BMD appears to increase after Depo-Provera® 150mg/ml is discontinued
and ovarian oestrogen production increases.
This loss of BMD is of particular concern during adolescence and early adulthood, a critical period of bone
accretion. It is unknown if use of Depo-Provera® 150mg/ml by younger women will reduce peak bone mass and
increase the risk for fracture in later life.

1

Medroxyprogesterone acetate (MPA) is metabolized in-vitro primarily by hydroxylation via the CYP3A4. Specific
drug-drug interaction studies evaluating the clinical effects with CYP3A4 inducers or inhibitors on MPA have not
been conducted and therefore the clinical effects of CYP3A4 inducers or inhibitors are unknown. Fertility,
pregnancy and lactation

Overdose
No positive action is required other than cessation of therapy.

Doctors should check that patients are not pregnant before the initial injection of Depo-Provera® 150mg/ml, and
also if administration of any subsequent injection is delayed beyond 89 days (12 weeks and five days).
Infants from accidental pregnancies that occur 1-2 months after injection of Depo-Provera® 150mg/ml may be at
an increased risk of low birth weight, which in turn is associated with an increased risk of neonatal death. The
attributable risk is low because such pregnancies are uncommon.
Children exposed to medroxyprogesterone acetate in utero and followed to adolescence, showed no evidence of
any adverse effects on their health including their physical, intellectual, sexual or social development.
Medroxyprogesterone acetate and/or its metabolites are secreted in breast milk, but there is no evidence to
suggest that this presents any hazard to the child. Infants exposed to medroxyprogesterone acetate via breast
milk have been studied for developmental and behavioural effects to puberty. No adverse effects have been
noted.

Pharmacotherapeutic group: Progestogens, ATC code: G03AC06 Medroxyprogesterone acetate exerts antioestrogenic, anti-androgenic and antigonadotrophic effects.

Pharmacodynamic properties

Mechanism of action
DMPA, when administered parenterally at the recommended dose to women, inhibits the secretion of
gonadotropins which, in turn, prevents follicular maturation and ovulation and causes thickening of cervical
mucus which inhibits sperm entry into the uterus.
BMD Changes in Adult Women: A study comparing changes in BMD in women using Depo-Provera® 150mg/ml
with women using medroxyprogesterone acetate injection (150 mg IM) showed no significant differences in BMD
loss between the two groups after two years of treatment. Mean percent changes in BMD in the Depo-Provera®
150mg/ml group are listed in Table 1
Table 1. Mean Percent Change from Baseline in BMD in Women Using DEPO-PROVERA® 150MG/ML by
Skeletal Site

Effects on ability to drive and use machines
Depo-Provera® 150mg/ml may cause headaches and dizziness. Patients should be advised not to drive or
operate machinery if affected.
Undesirable effects
The table below provides a listing of adverse drug reactions with frequency based on all-causality data from
clinical studies that enrolled more than 4200 women who received DMPA for contraception for up to 7 years.
Those most frequently (>5%) reported adverse drug reactions were weight increased (69%), weight decreased
(25%), headache (16%), nervousness (11%), abdominal pain or discomfort (11%), dizziness (6%), and decrease
in libido (6%).
The following lists of adverse reactions are listed within the organ system classes, under headings of frequency
(number of patients expected to experience the reaction), using the following categories:
Very common (≥1/10)
Common (≥1/100 to <1/10);
Uncommon (≥1/1000 to <1/100);
Rare (≥1/10,000 to <1/1000);
Very rare (<1/10,000);
Not known (cannot be estimated from the available data).
System Organ Class

Very
Common ≥
1/10

Common ≥ 1/100
to < 1/10

Neoplasms Benign,
Malignant
and Unspecified
(Incl. Cysts and
Polyps)
Blood and
lymphatic system
disorders
Immune system
disorders

Time on
Treatment

N

Mean % Change
(95% CI)

N

1 year

166

-2.7
(-3.1 to -2.3)

166

2 year

106

-4.1
(-4.6 to -3.5)

106

Rare ≥ 1/10,000
to < 1/1000

Time in
Study

Anaemia, Blood
disorder
Drug
hypersensitivity

Psychiatric
disorders

Nervousness

Depression, Libido
decreased

Nervous system
disorders

Headache

Dizziness

Ear and Labyrinth
Disorder
Cardiac disorder
Vascular disorders

Increased appetite,
decreased
appetite
Insomnia

Seizure,
Somnolence,
Paraesthesia

Anaphylactic reaction,
Anaphylactoid reaction,
Angioedema

5 years*
7 years**

Anorgasmia, Emotional
disturbance, Affective
disorder, Irritability,
Anxiety
Migraine, Paralysis,
Syncope

Hot flush

Dyspnoea

Abdominal
pain,
Abdominal
discomfort

Nausea,
Abdominal
distension

Skin and
subcutaneous
tissue disorders

Alopecia, Acne,
Rash

Musculoskeletal
and connective
tissue disorders

Back pain, Pain in
extremity

Reproductive
system and breast
disorders

Vaginal discharge,
Breast
tenderness,Dysme
norrhea,
Genitourinary tract
infection

General disorders
and administration
site conditions

Odema/Fluid
retention, Asthenia

Weight
increased,
Weight
decreased

Tachycardia
Embolism and
thrombosis, Deep vein
thrombosis,
Thrombophlebitis,
Hypertension, Varicose
veins
Pulmonary embolism

Rectal haemorrhage,
Gastrointestinal
disorder
Hepatic
function abnormal

Jaundice, Hepatic
enzyme abnormal

Hirsutism,
Urticaria, Pruritus,
Chloasma

Lipodystrophy
acquired*, Dermatitis,
Ecchymosis,
Scleroderma, Skin
striae

Chest pain

Mean %
Change
(95% CI)
-1.7
(-2.1 to -1.3)

N

-3.5
(-4.2 to -2.7)

106

Mean %
Change
(95% CI)
-1.9
(-2.5 to
-1.4)
-3.5
(-4.3 to
- 2.6)

166

Spine

Total Hip

Femoral Neck

Medroxypro
gesterone
acetate

Control

Medrox
yproge
sterone
acetate

Control

Medroxyp
rogestero
ne
acetate

Control

n=33
-5.38%
n=12
-3.13%

n=105
0.43%
n=60
0.53%

n=21
-5.16%
n=7
-1.34%

n=65
0.19%
n=39
0.94%

n=34
-6.12%
n=13
-5.38%

n=106
-0.27%
n=63
-0.11%

Pharmacokinetic properties
Parenteral medroxyprogesterone acetate (MPA) is a long acting progestational steroid. The long duration of
action results from its slow absorption from the injection site.
Immediately after injection of 150 mg/ml MPA, plasma levels were 1.7 ± 0.3 nmol/l. Two weeks later, levels were
6.8 ± 0.8 nmol/l. Concentrations fell to the initial levels by the end of 12 weeks. At lower doses, plasma levels of
MPA appear directly related to the dose administered. Serum accumulation over time was not demonstrated.
MPA is eliminated via faecal and urinary excretion. Plasma half-life is about six weeks after a single
intramuscular injection. At least 11 metabolites have been reported. All are excreted in the urine, some, but not
all, conjugated.

Arthralgia, Muscle
spasms, Osteoporosis,
Osteoporotic fractures
Dysfunctional
uterine bleeding
(irregular,
increase,
decrease spotting,
Galactorrhoea
Pelvic pain,
Dyspareunia,
Suppressed
lactation

Femoral Neck

*The treatment group consisted of women who received medroxyprogesterone acetate injection (150 mg IM) for
5 years and the control group consisted of women who did not use hormonal contraception for this time period.
** The treatment group consisted of women who received medroxyprogesterone acetate Injection (150 mg IM)
for 5 years and were then followed up for 2 years post-use and the control group consisted of women who did
not use hormonal contraceptive for 7 years.
BMD Changes in Adolescent Females (12-18 years)
Results from an open-label, non-randomised, clinical study of medroxyprogesterone acetate Injection (150 mg
IM every 12 weeks for up to 240 weeks (4.6 years), followed by post–treatment measurements) in adolescent
females (12-18 years) also showed that medroxyprogesterone acetate IM use was associated with a significant
decline in BMD from baseline. Among subjects who received ≥ 4 injections/60-week period, the mean decrease
in lumbar spine BMD was - 2.1 % after 240 weeks (4.6 years); mean decreases for the total hip and femoral
neck were -6.4 % and -5.4 %, respectively. Post-treatment follow-up showed that, based on mean values,
lumbar spine BMD recovered to baseline levels approximately 1 year after treatment was discontinued and that
hip BMD recovered to baseline levels approximately 3 years after treatment was discontinued. However, it is
important to note that a large number of subjects discontinued from the study, therefore these results are based
on a small number of subjects (n=71 at 60 weeks and n=25 at 240 weeks after treatment discontinuation). In
contrast, a non-comparable cohort of unmatched, untreated subjects, with different baseline bone parameters
from the DMPA users, showed mean BMD increases at 240 weeks of 6.4%, 1.7% and 1.9% for lumbar spine,
total hip and femoral neck, respectively.

Vertigo

Hepatobiliary
disorders

Investigation

Total Hip

In another controlled, clinical study adult women using medroxyprogesterone acetate injection (150 mg IM) for
up to 5 years showed spine and hip mean BMD decreases of 5-6%, compared to no significant change in BMD
in the control group. The decline in BMD was more pronounced during the first two years of use, with smaller
declines in subsequent years. Mean changes in lumbar spine BMD of –2.86%, -4.11%, -4.89%, -4.93% and –
5.38% after 1, 2, 3, 4 and 5 years, respectively, were observed. Mean decreases in BMD of the total hip and
femoral neck were similar. Please refer to Table 2 below for further details. After stopping use of
medroxyprogesterone acetate injection (150 mg IM), BMD increased towards baseline values during the posttherapy period. A longer duration of treatment was associated with a slower rate of BMD recovery.
Table 2. Mean Percent Change from Baseline in BMD in Adults by Skeletal Site and Cohort after 5 Years of
Therapy with medroxyprogesterone acetate 150 mg IM and after 2 Years Post-Therapy or 7 Years of
Observation (Control)

Breast cancer

Metabolism &
Nutrition Disorder

Respiratory,
thoracic, and
mediastinal
disorders
Gastrointestinal
disorders

Uncommon ≥
1/1000 to < 1/100

Lumbar Spine

Shelf-life

Vaginitis,
Amenorrhoea, Breast
pain, Metrorrhagia,
Menometrorrhagia,
Menorrhagia,
Vulvovaginal dryness,
Breast atrophy, Ovarian
cyst, Premenstrual
syndrome, Endometrial
hyperplasia, Breast
mass, Nipple exudate
bloody, Vaginal cyst,
Breast enlargement,
Lack of return to
fertility, Sensation of
pregnancy
Pyrexia, Fatigue,
Injection site reaction*,
Injection site persistent
atrophy/indentation/dim
pling*, Injection site
nodule/lump*, Injection
site pain/tenderness*
Thirst,Dysphonia, VIIth
nerve paralysis, Axillary
swelling
Bone density
decreased, Glucose
tolerance decreased,
Cervical smear
abnormal

The shelf-life is printed on labels and cartons. Do not use Depo-Provera® 150mg/ml after this date.
Storage of the product
Do not store above 25°C. Do not freeze. Keep in the original container. Do not mix with other agents. Discard
any remaining contents after use.
Manufacturer and Product Licence Holder
Manufactured by Pfizer Manufacturing Belgium N.V/S.A., Rijksweg 12, B-2870 Puurs, Belgium. Procured from
within the EU and repackaged by Product Licence Holder Beachcourse Limited., 20 Alliance Court. London W3
0RB.
PL16378/0534

POM

Revision date: 12.12.2016
Leaflet Reference: Depo150S/3
Depo-Provera® is a registered trademark of Pharmacia Limited

Reporting suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows
continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to
report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard

2

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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