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PROVERA TABLETS 200MG

Active substance(s): MEDROXYPROGESTERONE ACETATE

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Package leaflet: Information for the user

Provera® 100mg Tablet
Provera® 200mg Tablet
Provera® 400mg Tablet
Medroxyprogesterone acetate
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, please 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 side effects, talk to your doctor or
pharmacist. This includes any possible side effects
not listed in this leaflet. See section 4.

- Provera tablets are used in the treatment of cancer
in the breast, kidney (in men and women) and in
the lining of the womb (endometrial cancer). It is
also used to treat cancer which has spread to
other parts of the body (metastatic cancer) in post
menopausal women (women who have stopped
having their periods).
- It is not expected that Provera Tablets will be used
in children for the above indications. If you are not
certain why you are being given this medicine, ask
your doctor.
- You must talk to a doctor if you do not feel better
or if you feel worse.

1. What Provera Tablets are and what they are
used for
- This medicine contains medroxyprogesterone
acetate, which is one of a group of medicines
called ‘Progestogens’. Progestogens act like
progesterone, a natural sex hormone.
- Medroxyprogesterone acetate can slow down the
growth of certain tumours which are sensitive to
hormones.

2. What you need to know before you take Provera
Tablets
Do not take Provera Tablets:
- If you are hypersensitive (allergic) to
medroxyprogesterone acetate or other similar
hormone medicines or any of the other ingredients
of this medicine (listed in section 6).
- If you have liver problems
- If you have a heart condition where you feel pain
in your chest when you exert yourself (angina) or
have had a heart attack or if you have been told
that you are at risk of developing cardiovascular
diseases
- If you have raised levels of calcium in the blood
(hypercalcaemia) in patients with metastasised
bone cancer
- If you have suspected or recently diagnosed breast
cancer for the first time
- If you have undiagnosed vaginal bleeding
- If you have past or recent blood clot disorders,
including deep vein thrombosis (DVT), pulmonary
embolitis (clots in the lung), thrombophlebitis
(inflammation of the blood vessels) or if you have
been told that you are at risk of developing these
conditions

• wheezing
• difficulty breathing
• feeling faint
• swelling of the face or tongue
• swelling of the hands and feet
• intense itchy skin rash
Uncommon side-effects: may affect up to 1 in
100 people
• raised blood calcium levels (hypercalcaemia)
• increase symptoms of diabetes mellitus (e.g feeling
thirsty, passing urine more frequently)
Frequency unknown: cannot be estimated from
available data
• unusual vaginal bleeding
• loss of vision
• sudden onset of enlarged eyeball
• double vision
• migraine
• severe allergic reaction (anaphylactic reaction)
• nettle rash or hives

Rare side-effects: may affect up to 1 in 1,000 people
• heart attack
• stroke
These can be symptoms of a blood clot in the brain
(‘a stroke’)
• severe or long headache
• sight is affected in any way
• difficulty speaking
• collapse
• faint
Frequency unknown: cannot be estimated from
available data
• palpitation
These are symptoms of a deep-vein thrombosis
(DVT)
Rare side-effects: may affect up to 1 in 1,000 people
• pain, tenderness or swelling in your calf, ankle or
foot
• purple discolouration of the skin of the leg or the
skin becomes red and warm to touch

Effects on your heart and circulation:
Uncommon side-effects: may affect up to 1 in
100 people
• heart failure (e.g shortness of breath, swelling in
legs)
• swelling in the veins due to blood clots
• blood clots, including clots in the lung (e.g pain
and swelling in legs, sudden shortness of breath)
These are symptoms of a blood clot in the lungs
which may or may not all occur together:
• sudden, severe, sharp pain in your chest
• coughing up blood
• sudden short of breath
• heart beats more rapidly
• any part of your body feels weak or numb or cannot
move

Reasons for stopping Provera Tablets immediately
Rare side-effects: may affect up to 1 in 1,000 people
Your treatment will be discontinued if you have any
of the following rare symptoms:
• yellowing of the skin or whites of the eyes or liver
problems
• significant increase in blood pressure
• new onset of migraine-type headache

What is in this leaflet
1. What Provera Tablets are and what they are used
for
2. What you need to know before you take Provera
Tablets
3. How to take Provera Tablets
4. Possible side effects
5 How to store Provera Tablets
6. Contents of the pack and other information

- If you have a history of a condition known as
porphyria (an hereditary blood disorder)
- If you have a missed abortion (where the woman’s
body does not expel the dead foetus), miscarriage
or pregnancy.
Warnings and precautions
Talk to your doctor or pharmacist if you have any of
the following conditions to help him or her decide if
Provera Tablets are suitable for you:
- fluid retention
- diseases that affect the heart and blood vessels
(cardiovascular disease)
- epilepsy
- migraine headaches
- sudden vision disturbance
- asthma
- liver or kidney problems
- diabetes
- depression or a history of depression
- hyperlipidaemia (raised levels of fat in the blood)
- if you are taking or have recently taken any other
medicines, even those not prescribed
- jaundice (a condition which causes the skin or
whites of the eye to appear yellow)
- a significant increase in high blood pressure
- hormonal imbalance
Risk of Venous Thromboembolism (VTE)
All women have a small chance of having a blood clot
in the veins of the leg, in the lung or other parts of the
body. The chances of getting a clot are very slightly
increased if you are taking a hormone medicine like
Provera Tablets. You are more likely to get a clot
whether or not you are taking Provera Tablets if you
- are very overweight
- have relatives who have had blood clots
- have had a blood clot in the veins or lungs before
- are unable to move for long periods of time ( for
example after an operation)

• breast pain and tenderness
• unexpected or unusual vaginal bleeding or spotting
• changes in libido (sex drive)
Frequency unknown: cannot be estimated from
available data
• stopping or extended break of your periods and
vaginal discharge
• milky discharge from the breast when not pregnant
or breastfeeding

Tell your doctor if you get any other side effects
reported with Provera Tablets which may include
the following:

Effects on your central nervous system:
Common side-effects: may affect up to 1 in 10
people
• difficulty sleeping
• tiredness
• dizziness
• tremors
• effects like fine hand tremors
• headache
Uncommon side-effects: may affect up to 1 in
100 people
• euphoria (a state of extreme well-being and
pleasure)
• depression
• muscular cramps
Rare side-effects: may affect up to 1 in 1,000 people
• nervousness
• drowsiness
Frequency unknown: cannot be estimated from
available data
• confusion
• loss of concentration
• vision disorders

Effects on the reproductive system and breasts:
Common side-effects: may affect up to 1 in 10
people
• impotence
Uncommon side-effects: may affect up to 1 in
100 people

Effects on your digestive system:
Common side-effects: may affect up to 1 in 10
people
• vomiting
• constipation
• feeling sick

- have a serious injury or have major surgery
- have a history of repeated miscarriage
Tell your doctor if you have just had an operation or
if you are going to have an operation while taking
Provera Tablets.
(See section 4 on ‘Possible side effects’ for more
information on the warning signs of blood clots).
Treatment with Provera Tablets may cause you to
have symptoms associated with Cushings syndrome.
Other medicines and Provera Tablets:
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines,
including medicines obtained without a prescription.
Some drugs may affect the action of Provera Tablets
in your body. Tell your doctor or pharmacist if you
are taking:
- anticonvulsants like phenobarbitol, phenytoin,
carbamezapine for epilepsy (fits)
- anti-infective medicines like rifampicin, rifabutin,
efavirenz or nevirapine for infections caused by
bacteria and yeast
- ritonavir and nelfinavir, sometimes used to treat
HIV and AIDS
- cytotoxic drugs (drugs that kill cancerous cells)
- ciclosporin for suppressing the immune system
- herbal preparations containing St. John’s wort
- aminogluthemide sometimes used in Cushings
syndrome
- anticoagulants like warfarin for thinning the blood
- pain killers like aspirin, ibuprofen or naproxen and
vasodilators like hydrazalazine, minoxidil may affect
the way Provera Tablets work.
Pregnancy
If you are pregnant, think you may be pregnant or
are planning to have a baby, ask your doctor or
pharmacist for advice before taking this medicine.
Avoid becoming pregnant while being treated with
Provera Tablets. Provera Tablets must not be taken if

Uncommon side-effects: may affect up to 1 in
100 people
• diarrhoea
• dry mouth
Effects on your skin, nose, throat or hair:
Uncommon side-effects: may affect up to 1 in
100 people
• acne
• facial hair growth
Rare side-effects: may affect up to 1 in 1,000 people
• hair loss
• rash
Effect on your metabolism:
Common side-effects: may affect up to 1 in 10
people
• weight fluctuation
• Change in appetite
• sweating
• fluid retention
Uncommon side-effects: may affect up to 1 in
100 people
• Cushingoid syndrome (e.g. puffiness, moon face,
weight gain)
Rare side-effects: may affect up to 1 in 1,000 people
• decreased sugar tolerance
• fever
• any part of your body feels weak or numb or cannot
move
Frequency unknown: cannot be estimated from
available data
• cloudy vision
• cramps in calves at night
• glucose present in urine
Other general effect
Frequency unknown: cannot be estimated from
available data
• raised white blood cells and platelets

you are pregnant as hormonal medicines may affect
the developing baby. Tell your doctor if you have had
an abortion or missed a period during treatment. Your
doctor may give you a pregnancy test before starting
treatment. If you are sexually active, you are advised
to use effective birth control to prevent pregnancy
while taking Provera Tablets.

weight gain, increases as the dose increases.
Swallow each tablet whole. Take your tablets at the
same time each day. Follow your doctors’ instructions.
These can be found in the label of your pack. If you
are not sure ask your doctor.
Treatment may be required for 8 to 10 weeks before
any effect can be found.

Breast feeding
You should stop breast feeding before starting
treatment with Provera Tablets as this medicine may
be harmful to infants being breast-fed.
Ask your doctor or pharmacist for advice before taking
any medicine while breast feeding.

If you take more Provera Tablets than you should
If you take too many Provera tablets, contact your
doctor straight away.

Driving and using machines
There are no special precautions, and you can drive
or operate machines as long as you feel well and
able to do so.
Laboratory Tests:
Please inform your doctor if you need to have any
blood tests or gynaecological assessment, as Provera
Tablets may affect their results.
3. How to take ProveraTablets
Always take this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor or
pharmacist if you are not sure.
You will be closely monitored and regularly assessed
before and during your treatment with Provera Tablets,
especially if you are prescribed large doses of the
tablet.
Cancer of the Endometrium (womb lining) and
Kidney:
The usual dose is 200mg to 600mg a day.
Breast Cancer:
The usual dose is 400mg to 1500mg a day. The chance
of having a minor side effect, such as indigestion and

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 Provera Tablets
- Keep this medicine out of the sight and reach of
children.
- The unopened bottles should be stored in the
original container until ready for use.
- Provera 100mg Tablets: Store below 25°C.
- Provera 200mg Tablets: Store below 25°C.
- Provera 400mg Tablets: Store at room temperature
(15°C - 30°C).
- Provera Tablets should not be used after the expiry
date printed on the blister or bottle label and carton
after EXP. The expiry date refers to the last day of
that month.
- Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These
measures will help protect the environment.
6. Contents of the pack and other information
What Provera tablets contains
Each Provera tablet contains either 100 mg, 200mg or
400mg of the active ingredient medroxyprogesterone
acetate.
Provera Tablets also contain the following inactive
ingredients: microcrystallinecellulose, maize starch,
byco C, macrogol 400, sodium starch glycollate,
docusate sodium, sodium benzoate and magnesium
stearate.

If you forget to take Provera Tablets
If you forget to take your dose, take the next dose at
the usual time. Do not take a double dose to make
up for a forgotten dose.
If you stop taking Provera Tablets
Do not stop taking your medicine or alter the dose
you are currently taking without seeing your doctor
first. It is important to keep taking your medicine.
If you have any further questions on the use of this
medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause some
side effects although not everybody gets them. If they
occur, they are most likely to be minor and temporary.
If you get any of the symptoms mentioned below, you
should stop taking the tablets and see your doctor
immediately.
Reasons for seeking immediate medical advice
Rare side-effects: may affect up to 1 in 1,000 people
Rarely, Provera Tablets may cause a severe allergic
reaction which can be life-threatening in some cases.
If you think you are reacting badly to the medicine, get
emergency medical help immediately. The symptoms
of an allergic reaction could be the following:
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What Provera tablets look like and contents of
the pack
Provera Tablets are available in the following pack
sizes:
Provera 100 mg Tablets: 30, 60 and 100 tablets in
blister strips and 100 tablets in bottle.
Provera 200 mg Tablets: 30 and 100 tablets in blister
strips and 100 tablets in bottle.
Provera 400 mg Tablets: 30 tablets in blister strips
and 60 tablets in bottle.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Pfizer Limited
Ramsgate Road
Sandwich, Kent
CT13 9NJ
UK
Manufacturer:
Pfizer Italia S.r.l.
Località Marino del Tronto
63100 Ascoli Piceno (AP)
Italy
Company Contact Address:
For further information on this medicine, please
contact Medical Information at Pfizer Limited in Walton
Oaks, Tadworth, Surrey, UK.
Tel.: 01304 616161
This leaflet was last revised in 07/2015.
Ref: PV HD 7_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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