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PROVERA 100MG TABLETS

Active substance(s): MEDROXYPROGESTERONE ACETATE

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®

Provera 100 mg Tablets

2099
04.10.16[8]

(medroxyprogesterone acetate)
PATIENT INFORMATION LEAFLET
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.
This medicine is available using the above name but will be referred to as
Provera Tablets throughout the following leaflet.
Provera Tablets are also available in other strengths.

- 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 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.
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.

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

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.

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.
- 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.

3. HOW TO TAKE PROVERA TABLETS
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.

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
- 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)
- 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

Laboratory Tests:
Please inform your doctor if you need to have any blood tests or
gynaecological assessment, as Provera Tablets may affect their results.

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 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.
If you take more Provera Tablets than you should
If you take too many Provera Tablets, contact your doctor straight away.
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:
- 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
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
- suddenly short of breath
- heart beats more rapidly
- any part of your body feels weak or numb or cannot move
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

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
Tell your doctor if you get any other side effects reported with Provera
Tablets which may include the following:
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
- 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
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 your digestive system:
Common side-effects: may affect up to 1 in 10 people
- vomiting
- constipation
- feeling sick
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
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 out of the sight and reach of children
- Do not store above 25°C.
- Provera Tablets should not be used after the expiry date printed on the
box and on the blister label.
- If the tablets become discoloured or show any other signs of
deterioration, consult your pharmacist or doctor who will tell you what to
do.
- Medicines should not be disposed of via wastewater or household waste.
Ask you pharmacist how to dispose of medicine no longer required.
These measures will help to protect the environment
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Provera Tablets contains
Each tablet contains 100 mg of medroxyprogesterone acetate.
Provera Tablets also contains microcrystalline cellulose, maize starch,
macrogol 400, docusate sodium, sodium benzoate, magnesium stearate,
sodium starch glycollate (Type A) and hydrolysed gelatin.
What Provera Tablets look like and contents of the pack
Provera 100 mg Tablets are white round tablets with a score line on one
side and marked 'U467' on the other side.
Provera Tablets are available in blister packs of 60 and 100 tablets

Product Licence Holder and Manufacturer
Manufactured by Pfizer Italia S.r.l., Localita Marino del Tronto,
63100 Ascoli Piceno (AP), Italy. Procured from within the EU by Product
Licence holder Tenolol Ltd., 5, Sandridge Close, Harrow, HA1 1XD.
Repackaged by Servipharm Ltd.
POM

PL 30900/2099

This leaflet does not contain all the information about your medicine. If you
have any questions or are not sure about anything, ask your doctor or
pharmacist.
Leaflet revision and issue date (Ref.) 04.10.16[8]
Provera is a trademark of Pharmacia Limited.

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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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