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PROVERA 100MG TABLETS

Active substance(s): MEDROXYPROGESTERONE ACETATE

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Provera® 100 mg Tablets

2099
05.08.15[6]

(medroxyprogesterone acetate)
PATIENT INFORMATION LEAFLET
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.
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:
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
1. WHAT PROVERA TABLETS ARE AND WHAT THEY ARE USED
FOR
- Provera Tablets belong to a group 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 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.
2. BEFORE YOU TAKE PROVERA TABLETS
Do not use Provera Tablets if you have the following conditions:
- hypersensitivity (allergy) to Provera Tablets or other similar hormone
medicines or any of the other ingredients in Provera Tablets (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
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
- 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.
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.
Please tell your doctor if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription
Pregnancy
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 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 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.
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 Tablets may affect their results
3. HOW TO TAKE PROVERA TABLETS
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 200 mg to 600 mg a day.
Breast Cancer:
The usual dose is 400 mg to 1500 mg 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.
If you take too many tablets
If you take too many Provera Tablets, contact your doctor straight away.
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
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.
Reasons for seeking immediate medical advice
- 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, 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
- 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
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.
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 Tablets, 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.
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:
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. FURTHER 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.) 05.08.15[6]
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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