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DEPO-PROVERA 150MG/ML

Active substance(s): MEDROXYPROGESTERONE ACETATE

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DT

Q.A.
APPROVED:

CUSTOMER
APPROVED:

28/08/14

DATE:

DATE:

CUSTOMER: Waymade

PRE-PRESS NO.:

02-1808

PRODUCT:

Depo Provera 150mg

ARTWORKER:

CODE:

6464/2582E

DATE OF PROOF:

PROOF HISTORY:
v.2 - waymade - 28/08/14

ÄG¥FÞ±
Leaflet Flat Size = 296 x 317

TVT CHECKED

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

UK PIL DATED OCTOBER 2013
REPORTING OF SIDE EFFECTS
VIAL INJECTION
Pg 1

Pg 4

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 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
Do not use after the expiry date printed on the carton label or syringe. This date refers to the last day of the
month.
Depo-Provera 150mg/ml should be stored at your doctor’s surgery, local pharmacy or your clinic. Your doctor
or pharmacist will ensure that the product is not stored above 25°C and not allowed to freeze.
KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN.

6. Contents of the pack and other information
Each dose (1 millilitre) contains 150mg of the active ingredient medroxyprogesterone acetate in a sterile,
milky-white suspension for injection.
Depo-Provera is a sterile suspension. Each syringe contains 1 millilitre (ml) of Depo-Provera 150mg/ml.
Depo-Provera also contains the following:
methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), macrogol 3000, polysorbate 80,
sodium chloride and water for injections. Sodium hydroxide or hydrochloric acid may also be added when the
product is being made to adjust the acidity or alkalinity of the product to the correct level.
POM

PL No: 6464/2582

This product is manufactured by Pfizer Manufacturing Belgium N.V./S.A., Rijksweg 12, B-2870 Puurs,
Belgium and is procured from within the EU and repackaged by the Product Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR

DEPO-PROVERA® 150mg/ml
(medroxyprogesterone acetate)
Patient Information Leaflet
This product is known as Depo-Provera 150mg/ml, but will be referred to as Depo-Provera in this leaflet.
Please read all of this leaflet carefully before you start using this medicine because it contains
important information for you.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, pharmacist or nurse.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.

If you get any of the side effects, talk to your doctor, nurse or healthcare provider. This includes
any possible side effects not listed in this leaflet. See section 4.
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).

Depo-Provera 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 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.

Regular use of Depo-Provera 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. 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.

Your doctor may plan to conduct a general medical as well as a gynaecological examination before
they decide to prescribe Depo-Provera 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 is and what it is used for
2. What you need to know before you use Depo-Provera
3. How to use Depo-Provera
4. Possible side effects
5. How to store Depo-Provera
6. Contents of the pack and other information

1. What Depo-Provera is and what it is used for
Depo-Provera is a long acting contraceptive. This medicine contains 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.

2. What you need to know 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
(listed in section 6). 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 bleeding from the womb (uterus).

If you have liver disease.

If you have not yet started your periods.

Leaflet revision and issue date (Ref.) 28.08.2014
Depo-Provera is a registered trademark of Pharmacia Limited

Pg 2 !

WARNING!

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

:G»GUN
G­¥$<

h»­$Ã

WARNING!

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

DT

Q.A.
APPROVED:

CUSTOMER
APPROVED:

28/08/14

DATE:

DATE:

CUSTOMER: Waymade

PRE-PRESS NO.:

02-1808

PRODUCT:

Depo Provera 150mg

ARTWORKER:

CODE:

6464/2582E

DATE OF PROOF:

PROOF HISTORY:
v.2 - waymade - 28/08/14

ÄG¥FÞ±
Leaflet Flat Size = 296 x 317

TVT CHECKED

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

UK PIL DATED OCTOBER 2013
REPORTING OF SIDE EFFECTS
VIAL INJECTION
Pg 2

Pg 3

Warnings and precautions
Talk to your doctor or healthcare professional before using Depo-Provera.

Depo-Provera works as a contraceptive for 12 weeks in your body. There is no way of reversing the injection
once it is given.

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

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.

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.

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.

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.
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.

4. Possible side effects
Like all medicines, this medicine 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.

Protection against sexually transmitted diseases:
Depo-Provera does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
Other medicines and Depo-Provera:

Tell your doctor or pharmacist if you are taking, have recently taken or might take any 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:

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 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 for contraception, tell your
doctor immediately.
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.

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.
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.
Depo-Provera contains methylparaben (E218), propylparaben (E216) and sodium:
Methylparaben and propylparaben also known as methyl parahydroxybenzoate and propyl parahydroxybenzoate 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
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.

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.
The following other side effects may occur:
Common (may affect up to 1 in 10 people)
Abdominal pain or discomfort, bloating, feeling sick, vaginal discharge or inflammation, changes in appetite,
back pain, 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 (may affect up to 1 in 100 people)
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 (may affect up to 1 in 1,000 people)
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).
Not known (frequency cannot be estimated from the available data)
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 DepoProvera, 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).
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 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.
Pg 4 !

Pg 3 !

WARNING!

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

:G»GUN
G­¥$<

h»­$Ã

WARNING!

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

Pg 4

DT

Q.A.
APPROVED:

CUSTOMER
APPROVED:

28/08/14

DATE:

DATE:

CUSTOMER: Waymade

PRE-PRESS NO.:

02-1808

PRODUCT:

Deop-Provera doctor &

ARTWORKER:

Pharmacist leaflet

DATE OF PROOF:

6464/2582G

TVT CHECKED

CODE:

PROOF HISTORY:
v.2 - waymade - 28/08/14

Yµ¹¾ó”
Leaflet Flat Size = 296 x 420
ARIAL REGULAR FONT SIZE 8
ARIAL BOLD FONT SIZE 10
BRIDGED TO
TRANSTEC 6464/2327 2328 2329

UK HPUL DATED OCTOBER 2013
REPORTING OF SIDE EFFECTS

Pg 1

Pg 4

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)
Time in
Study

5 years*
7 years**

Spine
Medroxyprogesterone
acetate
n=33
-5.38%
n=12
-3.13%

Total Hip
Control
n=105
0.43%
n=60
0.53%

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

Femoral Neck
Control
n=65
0.19%
n=39
0.94%

Medroxyprogesterone
acetate
n=35
-6.12%
n=13
-5.38%

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

*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.
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.
Shelf life
The shelf life is printed on the carton label and syringe. Do not use Depo-Provera 150mg/ml after this date.
Storage of the Product
Do not store above 25°C and protect from freezing. Do not mix with other agents. Discard any remaining
contents after use.
Name and address of the manufacturer
Pfizer Manufacturing Belgium N.V./S.A., Rijksweg 12, B-2870 Puurs, Belgium
Procured from within the EU and repackaged by the Product Licence holder
Waymade Plc, Miles Gray Road, Basildon, Essex SS14 3FR
PL: 6464/2582
Ref: 28.08.2014

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 milky-white sterile suspension for injection. Each 1ml contains 150mg
medroxyprogesterone acetate. Excipients are methyl parahydroxybenzoate, (E218), propyl
parahydroxybenzoate, (E216), macrogol 3000, polysorbate 80, sodium chloride and water for injections.
Sodium hydroxide or hydrochloric acid may also be added when the product is being made to adjust the
acidity or alkalinity of the product to the correct level.
Uses
Depo-Provera 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 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 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 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.
Consistent with good clinical practice, a general medical as well as a gynaecological examination should be
undertaken before administration of Depo-Provera and at appropriate intervals thereafter.
Dosage
Each ml of suspension contains 150 mg medroxyprogesterone acetate. The sterile aqueous suspension of
Depo-Provera should be vigorously shaken just before use to ensure that the dose being given represents a
uniform suspension of Depo-Provera. 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 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 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 is expected to be the same for adolescents after menarche and adult females.
Switching from other Methods of Contraception: Depo-Provera 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 within 7 days
of taking their last active pill).
Hepatic Insufficiency: The effect of hepatic disease on the pharmacokinetics of Depo-Provera is unknown. As
Depo-Provera 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 is unknown. No
dosage adjustment should be necessary in women with renal insufficiency, since Depo-Provera is almost
exclusively eliminated by hepatic metabolism.
Contraindications
Depo-Provera is contraindicated in patients with a known sensitivity to medroxyprogesterone acetate or any
ingredient of this medicine.
Depo-Provera should not be used during pregnancy, either for diagnosis or therapy.
Depo-Provera is contraindicated as a contraceptive at the above dosage in known or suspected
hormone-dependent malignancy of breast or genital organs.
Depo-Provera 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 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
Warnings:
Loss of Bone Mineral Density:
Use of Depo-Provera 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 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 by younger women will reduce peak bone mass and increase
the risk for fracture in later life.
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CUSTOMER: Waymade
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DT

Q.A.
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CUSTOMER
APPROVED:

28/08/14

DATE:

DATE:

PRE-PRESS NO.:

02-1808

Deop-Provera doctor &

ARTWORKER:

Pharmacist leaflet

DATE OF PROOF:

6464/2582G

TVT CHECKED

PROOF HISTORY:
v.2 - waymade - 28/08/14

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BRIDGED TO
TRANSTEC 6464/2327 2328 2329

UK HPUL DATED OCTOBER 2013
REPORTING OF SIDE EFFECTS

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A study to assess the BMD effects of medroxyprogesterone acetate IM (Depo-Provera, 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 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 DepoProvera.
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 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 co-administration 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 co-administration of oestrogen is not recommended.
Return to Fertility: There is no evidence that Depo-Provera 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 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
20
30
40

No of cases per 10,000 women
who are never-users
Less than 1
44
160

Possible additional cases
per 10,000 DMPA users
Much less than 1
2-3
10

*based on use for 5 years
Weight Gain: There is a tendency for women to gain weight while on Depo-Provera 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, 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 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.
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 Depo-Provera.
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, 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 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 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 if
endometrial or endocervical tissue is submitted for examination.
The results of certain laboratory tests may be affected by the use of Depo-Provera. 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.

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Interaction with other medicinal products and other forms of interaction
Aminoglutethimide administered concurrently with Depo-Provera may significantly depress the bioavailability
of Depo-Provera.
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.
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
Doctors should check that patients are not pregnant before the initial injection of Depo-Provera, 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 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.
Effects on ability to drive and use machines
Depo-Provera may cause headaches and dizziness. Patients should be advised not to drive or operate
machinery if affected.
Undesirable effects
In a large clinical trial of over 3900 women, who were treated with Depo-Provera for up to 7 years, the
following adverse events were reported.
The following adverse events were commonly (by more than 5% of subjects) reported:
menstrual irregularities (bleeding and/or amenorrhoea), weight changes, headache, nervousness, abdominal
pain or discomfort, dizziness, asthenia (weakness or fatigue).
Adverse events reported by 1% to 5% of subjects using Depo-Provera were: decreased libido or anorgasmia,
backache, leg cramps, depression, nausea, insomnia, leucorrhoea, acne, vaginitis, pelvic pain, breast pain, no
hair growth or alopecia, bloating, rash, oedema, hot flushes.
Adverse reactions are listed according to the following categories:
Very Common >10%, Common ≥1% and < 10%, Uncommon >0.1% and <1%, Rare < 0.1%,
Not known (frequency cannot be estimated from the available data)
Ear and Labyrinth Disorders: Uncommon: Vertigo.
Gastrointestinal Disorders: Very common: Abdominal pain or discomfort. Common: Bloating, nausea.
Uncommon: Abdominal distension, gastrointestinal disturbances. Rare: Rectal bleeding.
Infection & Infestations: Common: Vaginitis.
Metabolism & Nutrition Disorders: Common: Appetite decrease, appetite increase
Uncommon: Weight increase, weight decrease, fluid retention.
Musculoskeletal, Connective Tissue & Bone Disorders: Common: Back pain. Uncommon: Arthralgia, muscle
cramps, pain in limbs. Not known: Osteoporosis including osteoporotic fractures, loss of bone mineral density,
axillary swelling.
Nervous System Disorders: Very common: Headaches. Common: Dizziness. Uncommon: Somnolence,
migraine, convulsions. Rare: Paralysis. Not known: Syncope.
Reproductive System & Breast Disorders: Common: Amenorrhea, breast pain/tenderness,
intermenstrual bleeding, menometrorrhagia, menorrhagia, pelvic pain, leucorrhoea. Uncommon: Vaginal
discharge, vulvovaginal dryness, dysmenorrhea, change in breast size, dyspareunia, ovarian cyst,
premenstrual syndrome, genitourinary infection, uterine hyperplasia. Rare: Breast lumps or nipple bleeding.
Not known: Abnormal uterine bleeding (irregular, increase, decrease), galactorrhea, vaginal cysts, prevention
of lactation, sensation of pregnancy, lack of return to fertility.
Vascular Disorders: Common: Hot flushes. Uncommon: Hypertension, varicose veins, thrombophlebitis,
pulmonary embolism. Not known: Thromboembolic disorders, deep vein thrombosis.
Cardiovascular Disorders: Rare: Tachycardia.
Immune System Disorders: Uncommon: Hypersensitivity reactions (e.g. anaphylaxis & anaphylactoid
reactions, angioedema).
Hepato-biliary disorders: Uncommon: Abnormal liver enzymes, jaundice. Not known: Disturbed liver function.
Skin & Subcutaneous Tissue Disorders: Common: Acne, alopecia, rash. Uncommon: Chloasma, dermatitis,
ecchymosis, hirsutism, pruritus, melasma, urticaria, oedema. Not known: Skin striae, scleroderma.
General Disorders and Administration Site Conditions: Common: Fatigue, injection site reactions (such as pain
or abscess), asthenia, paraesthesia. Uncommon: Chest pain, pyrexia.
Rare: Thirst, hoarseness, paralysis. Not known: Facial palsy.
Investigations: Uncommon: Cervical smear abnormal. Rare: Decreased glucose tolerance.
Psychiatric Disorders: Common: Anorgasmia, depression, nervousness, emotional disturbance, libido
decreased, mood disorder, irritability, insomnia. Uncommon: Anxiety.
Neoplasms Benign, Malignant and Unspecified (Incl. Cysts and Polyps): Rare: Breast cancer.
Blood and lymphatic system disorders: Rare: Anaemia. Not known: Blood dyscrasia.
Respiratory, thoracic, and mediastinal disorders: Uncommon: Dyspnoea.
Reporting of 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
Overdose
No positive action is required other than cessation of therapy.
Pharmacodynamic properties
Pharmacotherapeutic group: Progestogens, ATC code: G03AC06
Medroxyprogesterone acetate exerts anti-oestrogenic, anti-androgenic and antigonadotrophic effects.
BMD Changes in Adult Women: A study comparing changes in BMD in women using Depo-Provera 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
group are listed in Table 1
Table 1. Mean Percent Change from Baseline in BMD in Women Using DEPO-PROVERA by Skeletal Site
Lumbar Spine
N
Mean % Change
(95% CI)

Time on
Treatment
1 year

166

2 year

106

-2.7
(-3.1 to -2.3)
-4.1
(-4.6 to -3.5)

Total Hip
N
Mean % Change
(95% CI)
166
106

-1.7
(-2.1 to -1.3)
-3.5
(-4.2 to -2.7)

N

166
106

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

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
post-therapy period. A longer duration of treatment was associated with a slower rate of BMD recovery.
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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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