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PROVERA TABLETS 100MG

Active substance: MEDROXYPROGESTERONE ACETATE

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100mg, 200mg, 400mg Tablets

FRONTE

Medroxyprogesterone acetate
Read all of this leaflet carefully
before you start using this medicine






Keep this leaflet. You may need to
read it again.
If you have any further questions, please ask
your doctor or pharmacist.
This medicine has been prescribed for you
personally and you should not pass it on
to others. It may harm them, even if their
symptoms are the same as yours.
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 pharmacist.







In this leaflet

of medicines called ‘Progestogens’.
Progestogens act like progesterone, a natural
sex hormone
Provera Tablets contain the progestogen called
medroxyprogesterone acetate.
Medroxyprogesterone acetate can slow down
the growth of certain tumours which are
sensitive to hormones
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 will be used
in children for the above indications. If you
are not certain why you are being given this
medicine, ask your doctor.

1. What Provera Tablets are
and what they are used for
2. Before you take Provera Tablets
3. How to take Provera Tablets
4. Possible side effects
5. How to store Provera Tablets
6. Further information

You will be closely monitored and regularly
assessed before and during your treatment with
Provera, especially if you are prescribed large
doses of the tablet.

Like all medicines Provera can cause some
side effects. 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. These could all be warning signs
of thrombosis (a blood clot) which will need
urgent treatment.

RETRO

Breast Cancer:
The usual dose is 400mg to 1500mg a day. The
chance of having a minor side effect, such as
indigestion and weight gain, increase 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.

Reasons for seeking immediate
medical advice

If you take too many tablets



If you forget to take a dose of
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.












4. Possible side effects

If you take too many Provera tablets, contact your
doctor straight away.

Do not use Provera Tablets if you have the
following conditions:



3. How to take Provera Tablets

Cancer of the Endometrium (womb lining)
and Kidney:
The usual dose is 200mg to 600mg a day.

2. Before you take Provera Tablets



Rarely, Provera 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: wheezing,
difficulty breathing, feeling faint, swelling of
the face or tongue, hands and feet, intense
itchy skin rash.
There have also been reported cases of
raised blood calcium levels (hypercalcaemia)
in patients with breast cancer. Please report
any unusual vaginal bleeding, loss of vision or
if there is a sudden onset of enlarged eyeball,
double vision or migraine.

These are symptoms of a blood clot in the
lungs which may all occur together:
• Sudden, severe, sharp pain in your chest





hypersensitivity (allergy) to Provera tablets or
other similar hormone medicines or any of the
other ingredients in Provera (see Section 6 for
further information).
liver problems
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
raised levels of calcium in the blood
(hypercalcaemia) in patients with metastasised
bone cancer
suspected or recently diagnosed breast
cancer for the first time
undiagnosed vaginal bleeding
past or recent blood clot disorders, including
deep vein thrombosis (DVT), pulmonary
embolitis, thrombophelbitis (inflammation of
the blood vessels) or if you have been told that
you are at risk of developing these conditions
a history of a condition known as porphyria
(an hereditary blood disorder)
missed abortion (where the woman’s body
does not expel the dead foetus), miscarriage
or pregnancy.

Coughing up blood
You suddenly become short of breath
Your heart beats more rapidly.

These can be symptoms of a blood clot in the
brain (‘a stroke’)
• You have an unusually severe or long
headache
• Your sight is affected in any way
• You find it difficult to speak
• You collapse or faint
• Any part of your body feels weak or numb or
cannot move.
These are symptoms of a deep-vein
thrombosis (DVT).
• You have pain, tenderness or swelling in your
calf, ankle or foot
• You have purple discolouration of the skin of
the leg or the skin becomes red and warm
to touch.

Reasons for stopping Provera Tablets
immediately
Your treatment will be discontinued if you have
any of the following symptoms:
• yellowing of the skin or whites of the eyes
or liver problems
• a significant increase in blood pressure
• new onset of migraine-type headache.

Take special care with Provera Tablets
Tell your doctor if you have any of the following
conditions to help him or her decide if Provera is
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 eyes to appear yellow)
• a significant increase in high blood pressure.

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. You are more likely
to get a clot whether or not you are taking Provera
if you
• are very overweight
• have relatives who have had blood clots
• have had a blood clot in the veins or
lungs before

Other Side effects reported with
Provera Tablets include the following:
Effects on the reproductive system and
breasts: breast pain and tenderness, a milky
discharge from the breast when not pregnant or
breastfeeding, unexpected or unusual vaginal
bleeding or spotting, the stopping or extended
break of your periods and vaginal discharge.
Effects on your central nervous system:
confusion, euphoria (a state of extreme wellbeing
and pleasure), loss of concentration,
nervousness, difficulty sleeping, drowsiness,
tiredness, dizziness, depression, vision
disorders, and headache.
Effects on your digestive system: constipation,
diarrhoea, dry mouth, yellowing of the skin or
whites of the eyes, feeling sick and indigestion.
Effects on your heart and circulation: blood
clots, including clots in the lung, and swelling
in the veins due to blood clots, stroke, heart
attacks, the sensation of feeling your heartbeat
and may effect certain blood tests (causing
raised white blood cells).
Effects on your skin, nose, throat or hair:
sensitivity reactions ranging from itchy skin,
nettle rash or hives, swelling in face/throat
which may cause difficulty breathing to a
general rash and severe allergic reactions.
There have been cases of acne and hair loss
or facial hair growth reported.



are unable to move for long periods of time
(for example after an operation)
• 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.
(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.

Taking other medicines
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
• cytotoxics 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.

Effect on your metabolism: lack of appetite,
feeling thirsty, effects like fine hand tremors,
sweating, tremors, cramps in calves at night,
Cushingoid Syndrome, decreased sugar
tolerance, cloudy vision, an increase in your
symptoms of diabetes mellitus and may effect
both blood and urine tests.
When you are being given Provera, if you feel
any change in appetite, change in libido (sex
drive), fluid retention, weight gain, tiredness,
high fevers, or facial swelling, you must tell
your doctor.
If you experience any of the above side
effects or notice any other unusual effects not
mentioned in the leaflet, tell your doctor at once.

Please tell your doctor if you are taking or have
recently taken any other medicines, including
medicines obtained without a prescription.

Pregnancy

4201546.05.3

Provera



1. What Provera Tablets are and
what they are used for
• Provera Tablets belong to a group

Avoid becoming pregnant while being treated
with Provera. Provera must not be taken if you
are pregnant as hormonal medicines may affect
the developing baby. Tell your doctor if you are
pregnant, 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.

Breast-feeding
You should stop breast feeding before starting
treatment with Provera 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.

Driving and using machinery
There are no special precautions, and you can
drive or operate machinery 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 may affect their results.
Continued overleaf...

6. Further information
What Provera Tablets contains
Each Provera Tablet contains either 100 mg,
200mg or 400mg of the active ingredient
medroxyprogesterone acetate.
The other ingredients are microcrystalline
cellulose, maize starch, Byco C, polyethylene
glycol, sodium starch glycollate, docusate
sodium, sodium benzoate, magnesium stearate,
isopropyl alcohol and purified water.

4201546.05.3

PATIENT INFORMATION LEAFLET

What Provera tablets look like and
contents of the pack
Provera Tablets are available in the following
pack sizes:
Provera Tablets 100mg: 60 and 100 tablets in blister strips
Provera Tablets 200mg: 30 and 100 tablets in blister strips
Provera Tablets 400mg: 30 tablets in blister strips.

Marketing Authorisation Holder:
Pfizer Limited, Ramsgate Road, Sandwich,
Kent, CT13 9NJ, United Kingdom.

5. How to store Provera Tablets
The unopened bottles should be stored in the
original container until ready for use.
Do not store above 25 °C.
Keep out of the reach and sight of children.
Provera should not be used after the expiry date
printed on the box and on the bottle label.

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.
Tel: 01304 616161.
This leaflet was last revised in
09/2012

Ref: PV 5_0

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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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