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Package leaflet: Information for the user

SAYANA® PRESS 104 mg/0.65 ml suspension for injection
medroxyprogesterone acetate

Single-dose container

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

What is in this leaflet:
1. What SAYANA PRESS is and what it is used for
2. What you need to know before you use SAYANA PRESS
3. How to use SAYANA PRESS
4. Possible side effects
5. How to store SAYANA PRESS
6. Contents of the pack and other information

1. What SAYANA PRESS is and what it is used for
SAYANA PRESS is a contraceptive. It can be used:
• For long-term contraception where you and the person who provides your contraception (e.g. your doctor,
nurse or healthcare provider) have decided that this method is the most suitable for you. However, if you wish
to use SAYANA PRESS for more than 2 years, your health professional/doctor/nurse may wish to re-evaluate
the risks and benefits of using SAYANA PRESS to make sure that it is still the best option for you.
• By teenagers, but only after other methods of contraception have been discussed with the person who
provides your contraception and are considered unsuitable or unacceptable.
The active ingredient in SAYANA PRESS, medroxyprogesterone acetate (MPA), is similar to (but not the same
as) the natural hormone progesterone that is produced in the ovaries during the second half of your menstrual
cycle. SAYANA PRESS 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

2. What you need to know before you use SAYANA PRESS
Make sure SAYANA PRESS is suitable for you before you have any injections.
Before you start using Sayana Press:
Before your doctor prescribes SAYANA PRESS, you may need to have a physical examination.
It is important to tell your doctor if you have, or have had in the past, any of the conditions or risk factors
mentioned in this leaflet.
Your doctor will then discuss with you whether SAYANA PRESS is suitable for you.
Do not use SAYANA PRESS:
SAYANA PRESS is not suitable for some women. Do not use:
• If you are allergic (hypersensitive) to medroxyprogesterone acetate (MPA) or any of the other ingredients of
this medicine (listed in section 6)
• If you think you may be pregnant
• If you have unexplained vaginal bleeding
• If you have liver disease
• If you have had or think you have cancer of the breast or sex organs
• If you have a blood clot in a vein in your leg (a ‘deep vein thrombosis’) or a blood clot that has travelled to
your lung or another part of your body (an ‘embolus’)
• If you have problems with your circulation (e.g. pains in your legs or chest when you walk), or with your blood
clotting too easily ('thrombosis' or 'embolism')
• If you have been diagnosed with thinning, softening or weakening of your bones
• If you have or have had a disease affecting the blood vessels of the brain
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using SAYANA PRESS.
Before you start using SAYANA PRESS tell your doctor if you have or had in the past any of the following
conditions. Some of the conditions can be made worse by taking hormone contraception or might make it less
suitable for you.
• Migraine headaches. If you develop migraine for the first time while using SAYANA PRESS, you should
consult your doctor before receiving further injections
• Diabetes or a family history of diabetes
• A history of heart disease or cholesterol problems including any family history
• Past history of depression
• Irregular, light, or heavy menstrual periods
• An unusual breast x-ray, fibrocystic breast disease, breast nodules or lumps, or bleeding from your nipples
• A stroke
• Family history of breast cancer
• Kidney disease
• High blood pressure
• Asthma
• Epilepsy

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 SAYANA PRESS 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 SAYANA PRESS
is stopped, but it is not yet known whether the bone mineral density reaches the same levels as it would have if
SAYANA PRESS 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 SAYANA PRESS
If you use SAYANA PRESS, 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).

SAYANA PRESS and possible effects on your periods
Most women using SAYANA PRESS will experience a change in their bleeding patterns. It is likely that fewer
women will experience irregular bleeding, and after 12 months of use 60% will experience little or no bleeding
at all.

SAYANA PRESS and possible risk of cancer
Studies of women who have used a range of medicine-based contraception found that women who used
injectable progestogen like SAYANA PRESS for contraception had no increased overall risk of developing cancer
of the ovary, womb, cervix, or liver.
Breast cancer is rare under 40 years of age, but the risk increases as a woman becomes older.
There seems to be a slightly increased risk of breast cancer in women who take injectable contraceptives
compared to women of the same age who do not use hormonal contraceptives.
This small extra risk of developing breast cancer has to be weighed against the known benefits of medicines
like SAYANA PRESS. It is not certain whether the injection causes the increased risk of breast cancer. It may be
that women receiving the injection are examined more often, so that breast cancer is noticed earlier. The breast
cancer seems less likely to have spread when found in women who receive medicines like SAYANA PRESS than
in women who do not.
The risk of finding breast cancer is not affected by how long a woman is on the injection, but by the age at
which she stops. This is because the risk of breast cancer strongly increases as a woman becomes older. Ten
years after stopping hormonal contraceptive injections, the risk of finding breast cancer is the same as for
women who have never used hormonal contraceptives.
In 10,000 women who receive injections like SAYANA PRESS for up to 5 years, but stop taking it by the time
they are aged 20, it is estimated that less than 1 additional case of breast cancer would be found up to
10 years afterwards, compared with the number found in 10,000 women who had never had the injection.
For 10,000 women who are on injections like SAYANA PRESS for 5 years and stop it by the age of 30, there
would be 2 or 3 extra cases of breast cancer found up to 10 years afterwards (in addition to the 44 cases of
breast cancer found in 10,000 women in this age group who had never had the injection).
For 10,000 women who take SAYANA PRESS for 5 years and stop it by the age of 40, there would be about
10 extra cases found up to 10 years afterwards (in addition to 160 cases of breast cancer found in
10,000 women in this age group who had never had the injection).

SAYANA PRESS and Liver problems
If you develop jaundice (yellowing of the skin or eyes) while using SAYANA PRESS you should consult your
doctor before receiving further injections.

Protection against sexually transmitted diseases
SAYANA PRESS does not protect against HIV infection (AIDS) and other sexually transmitted diseases.

Other medicines and SAYANA PRESS
Please tell your doctor, pharmacist or nurse if you are taking or have recently taken any other medicines,
including medicines obtained without a prescription. There are some medicines that may interact with SAYANA
PRESS. These include medicines that thin your blood (anticoagulants).
Medicines can sometimes interfere with each other. If you receive treatment from any other doctor, nurse or
qualified healthcare professional make sure they are aware that you are using SAYANA PRESS as a

Pregnancy and breast-feeding
Do not take SAYANA PRESS if you are pregnant. If you think you may have become pregnant while using
SAYANA PRESS tell your doctor immediately.
If you are breast-feeding, the injection should be given no sooner than 6 weeks after childbirth, when the baby
is more developed. SAYANA PRESS can be passed to the nursing infant in the breast milk, however no harmful
effects have been found in children.
Always ask your doctor, nurse, or healthcare professional for advice before taking any medicine.

SAYANA PRESS and blood clots

Driving and using machines

A clot can occur in a leg vein (deep vein thrombosis or DVT). Signs of a clot in the leg include pain swelling and
redness. However if it moves up the veins into the lungs it can cause chest pain, breathlessness, collapse or
even death. This is called a ‘pulmonary embolism’. Signs of a blood clot in your eye may result in sudden
changes in your eyesight (sudden loss of vision or blurred vision). Blood clots can also form in the blood vessels
of the brain causing a stroke. Symptoms of a stroke include sudden severe headache, slurred speech,
weakness or numbness in the limbs especially on one side. If you do get any of these symptoms, see your
doctor immediately and you should not receive any further injections.

3. How to use SAYANA PRESS

SAYANA PRESS and possible effects on your bones
SAYANA PRESS works by lowering levels of estrogen and other hormones. However, low estrogen levels can
cause bones to become thinner (by reducing bone mineral density). Women who use SAYANA PRESS tend to
have lower bone mineral density than women of the same age who have never used it. The effects of SAYANA
PRESS 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 SAYANA PRESS is stopped. It is not yet possible to say whether
SAYANA PRESS increases the risk of osteoporosis (weak bones) and fractures in later life.

No effects on the ability to drive or use machines have been seen with SAYANA PRESS.
SAYANA PRESS contains methyl parahydroxybenzoate (E218) & propyl parahydroxybenzoate (E216)
and sodium
These may cause allergic reactions (possibly delayed).
This medicinal product contains less than 1 mmol sodium (23 mg) per 104 mg/0.65 ml, i.e. essentially
Administration of SAYANA PRESS is initiated by a healthcare professional (HCP). If considered appropriate by
the HCP, you may be able to self-inject your injections following suitable instruction and training on injection
technique and schedule of administration.

Method and route of administration
SAYANA PRESS is injected under the skin into the front upper thigh or abdomen. The first injection should be
performed under the supervision of your doctor, nurse, or healthcare provider. If your doctor considers it
appropriate you may choose to give yourself the injections. You will be shown how to give yourself the injection
under supervision before you do this on your own at home. The detailed instructions on the injection
procedure are provided at the end of this leaflet and should be followed very carefully. You should continue to
receive SAYANA PRESS for as long as instructed by your doctor or until you want to have a baby or switch to a
different method of contraception.

SAYANA® PRESS can be given by a healthcare provider or the patient.

SAYANA® PRESS 104 mg/0.65 ml suspension for injection
medroxyprogesterone acetate
Single-dose container

Preparing and giving an injection with
Sayana® Press

Step 4

Mixing the medicine

• Hold the injector firmly by the port.
• Shake the injector vigorously for at least
30 seconds to mix the medicine.

Sayana Press is a disposable injector that contains a single dose of medicine sealed in
a reservoir. These instructions show step-by-step how to prepare and give the

Step 1

Getting ready

You will need
– A Sayana Press injector (in its sealed foil pouch).
– A suitable container for the used injector.
– A clean cotton pad or clean paper tissue.
• Wash and dry your hands thoroughly before starting.
• Check that the pouch does not appear to be
• Check that the expiry date has not passed.
• Ensure the pouch is at room temperature.

Step 2

Selecting an injection area

• Choose a suitable area for the injection, either
the abdomen or the front upper thigh. Avoid bony areas
and the navel (belly button).

• The medicine should appear white and uniform.
If it is not, discard the injector and use a new one.
• If you see liquid leaking out or any other problem,
discard the injector and use a new one.
• If there is a delay before injecting, you must
repeat the mixing step.

Step 5

Activating the injector

• Hold the injector firmly by the port, making sure
the needle shield is pointing upwards. Take care
not to squeeze the reservoir.
• Hold the needle shield with the other hand.

• The area of skin must be free from scars and skin
conditions such as eczema or psoriasis.
• Change the site with each injection
• Clean the area of skin as your healthcare provider has told you.

Step 3

• Push the needle shield firmly towards the port
until it will go no further. The injector is now

Preparing the injector

• Carefully tear open the foil pouch at the tear notch.
• Take out the injector. Do not remove the needle
shield from the injector yet.
• Pull the needle shield off, and discard it.

• Check the injector. There should be a gap between
the needle shield and the port.

Process Black

• Discard the injector and use a new one if:
- There is no gap.
- The injector is damaged.
- The needle shield has come off or is missing.


First injection
A dose of 104 mg of SAYANA PRESS is given subcutaneously (into the fatty layer just under the skin), into the
front upper thigh or abdomen every 3 months (12 to 13 weeks). SAYANA PRESS will only be effective if you
receive your injection at the proper time. To ensure that you are not pregnant at the time of the first injection, it
is essential that your first injection be given ONLY during the first 5 days of your normal menstrual cycle.
After childbirth: If you use SAYANA PRESS after having a baby and you are not breast-feeding, the first injection
MUST be given within 5 days.
There is evidence that women prescribed SAYANA PRESS immediately after childbirth or termination of
pregnancy can experience prolonged and heavy bleeding. Because of this, SAYANA PRESS should be used with
caution at this time.

Further injections
Further doses of SAYANA PRESS will then be given every 12 to 13 weeks, (but no later than 14 weeks past
your last injection), regardless of when and how much menstrual bleeding you have.

It is important that you have your next injections at the right time.
Planning your injections
• If you are giving yourself injections, ensure you have a way of reminding yourself (for example a calendar,
diary or phone alert) so you know when to give yourself the next injection.
Preparing for an injection
1. Choose an injection site (abdomen or front upper thigh) that you find easy to see and reach with both hands
and find a sitting position which is comfortable for you. Try to use a different injection site for each injection
so you are not injecting into the same place too often.
2. Make sure the medicine is at room temperature. Carefully tear open the foil pouch at the tear notch and take
out the injector.
3. Hold the injector firmly and shake it vigorously for at least 30 seconds to mix the medicine.
Giving yourself injections:
Carefully follow the step by step instructions at the end of this leaflet on how to give yourself the injection.
Important points to note:
When giving yourself the injection, you must squeeze the injector with slow even pressure over 5-7 seconds to
push out the medicine. If you try to squeeze too quickly you may feel resistance and be unable to inject the
medicine. If this happens adjust your grip if necessary and squeeze more gently to fully push out the medicine.
It is normal for a very small amount of medicine to be left around the edges of the blister (reservoir). If you have
had a problem during the injection or if you feel for any reason you might not have given yourself the full dose,
do NOT give yourself an additional injection. It is important you get advice from your doctor, nurse or
healthcare provider because a partial dose may not prevent pregnancy.
If, at any time, you don’t want to continue injecting yourself for any reason, speak to your doctor, nurse or
healthcare provider before your next injection is due, so they can arrange to give it to you at the right time.
It is recommended that you continue to see your doctor or healthcare provider periodically as recommended by
your HCP at least once a year as a minimum so they can check SAYANA PRESS is still the best option for you
and for you to have routine contraceptive health checks.
If you have any questions or worries ask your doctor, nurse, or healthcare professional for advice, particularly if
there have been any problems during or immediately after the injection.

If you miss an injection of SAYANA PRESS
If you miss your injection or wait longer than 14 weeks between injections, there is a greater risk that you could
become pregnant. Tell your doctor, pharmacist, or healthcare professional to find out when you should have
your next injection of SAYANA PRESS 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 SAYANA PRESS within 7 days after taking your last pill.

What if you decide you want to get pregnant
Your usual level of fertility will return when the effect of the last injection has worn off. The time this takes
varies in different women, and does not depend on how long you have been using SAYANA PRESS. In most
women the effect will have worn off 5 to 6 months after the last injection. Over 80 % of women will get
pregnant within a year of stopping SAYANA PRESS. It is possible to get pregnant in the first month after missing
an injection.

4. Possible side effects
Like all medicines, SAYANA PRESS can cause side effects, although not everybody gets them. If any of the side
effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or
If you are injecting SAYANA PRESS yourself and not seeing your doctor as regularly, it is important you are
aware of possible side effects, how to recognise them and when to get urgent medical help. Please
familiarise yourself with this section of the leaflet and re-read it regularly.
If you are worried about any unusual symptoms or changes in your health, talk to your doctor, nurse or
healthcare provider.
If you experience any of the following serious side effects, seek medical help immediately:
• A serious allergic reaction (it is not known how frequently this occurs)
Symptoms include sudden wheeziness, difficulty in breathing or dizziness, swelling of the eyelids, face, lips
or throat, skin rash, hives.
Allergic reactions may happen soon after injection or can take time to develop in some people. If any of these
symptoms appear at any time, even if you have used Sayana Press before, seek medical help immediately.
• A blood clot in the lungs (it is not known how frequently this occurs)
Symptoms include
• an unusual sudden cough (which may bring up blood)
• severe pain in the chest which may increase with deep breathing
• sudden unexplained breathlessness or rapid breathing
• severe light headedness or dizziness
• rapid or irregular heartbeat
• severe pain in your abdomen
• A blood clot in the leg (it is not known how frequently this occurs)
Symptoms include severe pain or swelling in either of your legs or feet that may be accompanied by
tenderness, warmth or discoloured skin
• A blood clot in the eye (it is not known how frequently this occurs)
Symptoms include loss of vision, pain and swelling of the eye especially if sudden
• A stroke (it is not known how frequently this occurs)
Symptoms include
• weakness or numbness of the face, arm or leg, especially on one side of the body
• sudden confusion, trouble speaking or understanding
• sudden trouble seeing in one or both eyes
• sudden trouble walking, dizziness, loss of balance or coordination
• sudden, severe or prolonged headache with no known cause
• loss of consciousness or fainting with or without seizure.
Other side effects include:
Common: (may affect up to 1 in 10 people)
• Weight increase
• Abdominal pain (cramps)
• Nausea
• Acne
• Amenorrhea (very light or no period)
• Heavy, frequent and/or unexpected bleeding
• Irregular periods
• Period pains
• Breast pain / tenderness
• Depression
• Weakness or tiredness
• Headache
• Injection site reactions (including pain, tenderness, lump, persistent skin indentation/dimpling). You may feel
some soreness or see redness around the injection site immediately after an injection. Mild reactions like this

Step 6

Injecting the dose

are common. If you get a reaction that worries you in any way, is particularly painful, or does not get better
after a short time please talk to your doctor.
• Irritability
• Anxiety
• Difficulty sleeping
• Decreased sexual feeling
• Vaginal irritation or itching
• Mood changes
• Dizziness
• Back pain
• Pain in limbs
• Abnormal cervical smear
Uncommon: (may affect up to 1 in 100 people)
• Drug allergy
• Hirsutism (abnormal hairiness)
• Feeling bloated
• Fluid retention
• Vaginal discharge
• Vaginal dryness
• Pain during sexual intercourse
• Ovarian cyst
• Pelvic pain
• Premenstrual syndrome
• Change in breast size
• Milky discharge from breasts in women who are not breast-feeding
• Change in appetite
• Muscle cramps
• Joint pain
• Sleepiness
• Migraine
• Vertigo (a spinning sensation)
• Hot flushes
• High blood pressure
• Rapid heart rate
• Varicose veins
• Rash
• Itching
• Hives
• Hair loss
• Skin irritation
• Bruising
• Facial discoloration
• Inflammation in the veins (felt as tenderness or redness in the affected area)
• Nervousness
• Loss of bone mineral density (a test used to diagnose osteoporosis or weak bones)
• Weakness
• Decreased glucose tolerance (excess sugar level in the blood)
• Emotional disturbance
• Inability to achieve a sexual climax
Rare: (may affect up to 1 in 1,000 people)
• Breast cancer
• Fever
• Weight decrease
• Deformation of skin at the injection site
• Abnormal liver function test results (blood tests to measure liver injury)
Not known: frequency cannot be estimated from the available data
• Osteoporosis (weak bones) including osteoporotic fractures
• Seizures
• Abnormal liver function such as yellowing of the skin or eyes (jaundice)
• Skin stretch marks
Reporting of side effects
If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not
listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme at: By
reporting side effects you can help provide more information on the safety of this medicine.

5. How to store SAYANA PRESS
• Keep out of the sight and reach of children.
• Do not refrigerate or freeze.
• Do not use SAYANA PRESS after the expiry dates stated on the injector, foil pouch and carton after EXP. The
expiry date refers to the last day of that month.
Carefully and properly dispose of SAYANA PRESS after use. The injector should NEVER be reused. Do not throw
used injectors into household waste. The used injector should not be recapped after use and should be
disposed of safely in a special container, in accordance with local authority requirements for the disposal of
sharps. Ask your pharmacist for guidance on disposal of medicines.

6. Contents of the pack and other information
What SAYANA PRESS contains
The active substance is medroxyprogesterone acetate (MPA).
The pre-filled injector contains 104 mg medroxyprogesterone acetate (MPA) in 0.65 ml.
The other ingredients are macrogol, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216),
sodium chloride, polysorbate 80, monobasic sodium phosphate monohydrate, disodium phosphate
dodecahydrate, methionine, povidone, sodium hydroxide and/or hydrochloric acid for pH adjustment and water
for injection.

What SAYANA PRESS looks like and contents of the pack
SAYANA PRESS is a white to off-white suspension for subcutaneous injection (an injection given under the
skin). It is supplied in a single-dose container in the form of a pre-filled injector. SAYANA PRESS is available
with a pack size of one single-dose container.

Marketing Authorisation Holder


Pfizer Limited
Pfizer Manufacturing Belgium NV
Ramsgate Road
Rijksweg 12, B-2870 Puurs
Sandwich, Kent
CT13 9NJ
United Kingdom
For any information about this medicinal product, please contact the local representative of the Marketing
Authorisation Holder:
United Kingdom
Pfizer Limited
Ramsgate Road
Sandwich, Kent
CT13 9NJ
Telephone: +44 (0) 1304 616161

This medicinal product is authorised in the Member States of the EEA under the
following names:
Hungary, Netherlands, United Kingdom

SAYANA PRESS 104 mg/0,65 ml Injektionssuspension
SAYANA PRESS 104 mg/0,65 ml suspension for injection

This leaflet was last revised in 03/2016
Ref: SNb 5_1

• Gently pinch a large area of skin. Keep the skin
pinched all through this step.
• Hold the injector by the port with the needle
pointing straight downwards.
• Insert the needle into the skin so that the port
just touches the skin.

• Squeeze the reservoir slowly to inject the
medicine. You should take about 5-7 seconds
to do this.
• Gently pull the needle out of the skin. Let go of
the skin.
• Check whether any medicine has leaked out
of the injector or has appeared on the skin.
• Do not replace the needle shield.
• Use a clean cotton pad to press lightly on the
injection area for a few seconds. Do not rub
the area.

Important advice
• After the injection a small amount of medicine
will be left around the inside edge of the
reservoir. This is normal.
• However, if any medicine has leaked out of the
injector or appeared on the skin, then a
problem may have occurred.
• If you believe for any reason that the full
dose has not been given, speak to your
healthcare provider about alternative
methods of contraception until the next
scheduled injection.
• Do not inject an additional dose.
After injection care:
• If you get any symptoms of allergic reaction (see leaflet Section 4 above) seek medical help immediately.
• Monitor the appearance of the injection site until the next injection. If you notice any skin indentation or
dimpling at the injection site, tell your healthcare provider.

Step 7

Disposing of the injector

• Immediately dispose of the used injector into a suitable container in accordance with your local authority
requirements or as you have been told by your healthcare provider.
• The injector is for a single injection only and must not be re-used.

Step 8

Record the date of your injection and should you wish to
continue, calculate the date of your next scheduled
injection of Sayana Press

Date of Next Injection
(add 3 months)
Retain this leaflet for your records.

Process Black

Ref: SNb 5_1


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