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PROVERA TABLETS 2.5MG

Active substance(s): MEDROXYPROGESTERONE ACETATE MICRONISED

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Package leaflet: Information for the patient

Provera

®

2.5mg, 5mg and 10mg Tablets
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,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet. See section 4.
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

1. What Provera Tablets are and what they are used
for
• Provera contains the active substance
medroxyprogesterone acetate, which is one of
a group of medicines called ‘progestogens’.
Progestogens are similar to the natural female
hormone, progesterone.
• Provera has several uses. You can take Provera to
treat or manage:
• Heavy periods
• Painful periods
• Irregular periods or periods that are more frequent
than normal
• Absence of periods
• Mild to moderate endometriosis (where tissue from
your womb is found outside your womb)
You must talk to a doctor if you do not feel better or
if you feel worse.
2. What you need to know before you take Provera
Tablets
Provera may not be suitable for all women. Please
read the following list carefully to see if any of these
apply to you. Consult your doctor if you are not sure.
Do not take Provera if you:
• are allergic to medroxyprogesterone acetate or other
similar hormone medicines, or to any of the other
ingredients of this medicine (listed in section 6)
• are pregnant, or think you might be pregnant. Your
doctor may give you a pregnancy test before starting
treatment or if you miss a period during treatment
• have now or have had in the past breast cancer

• have now or have had in the past blood clots forming
in your veins (venous thrombosis)
• have now or have had in the past blood clots forming
in your arteries (arterial thrombosis)
• have liver problems
• have porphyria where your body lacks the ability to
correctly produce certain enzymes and it manifests
with either neurological complications or with skin
problems (or occasionally both)
Warnings and precautions
Talk to your doctor or pharmacist before taking Provera
Tablets if you have any of the following conditions to
help them decide if Provera is suitable for you:
• Epilepsy
• Migraine headaches
• Asthma
• Heart problems
• Kidney problems
• Diabetes
• Depression or a history of depression
• High blood pressure
• Liver problems
• Gallstones
• Systemic lupus erythematosus (SLE) = an allergic
condition which causes joint pain, skin rashes and
fever
• Hearing problems
Provera, especially in high doses, may cause weight
gain and fluid retention.

• Medicines for treating infections (e.g. rifampicin,
rifabutin, nevirapine, efavirenz)
• St John’s wort, a herbal treatment for depression

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 part of the
body. The chances of getting a clot are very slightly
higher 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 had a blood clot in the veins or lungs before
• have relatives who have had blood clots
• 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

Pregnancy, breast-feeding and fertility
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.
Provera must not be taken if you are pregnant as
hormonal medicines can affect the developing baby. It
is important you use another method of contraception
(e.g. a condom) while taking Provera, as it is not a
contraceptive.

Tell your doctor if you have just had an operation or if
you are going to have an operation while taking Provera.
Section 4 of this leaflet ‘Possible side effects’, also has
more information on the warning signs of blood clots.

Breast-feeding
If you are breast-feeding, speak to your doctor who will
advise whether you should use an alternative method
of feeding your baby.

Other medicines and Provera
Tell your doctor or pharmacist if you are taking, have
recently taken or might take any other medicines,
including medicines obtained without a prescription.
The effect of Provera may be altered when taken at the
same time as any of the following medicines:
• Aminoglutethimide, sometimes used in Cushing’s
syndrome
• Medicines for thinning the blood (e.g. warfarin)
• Medicines for treating convulsions (e.g. phenobarbital,
phenytoin and carbamazepine)
• Ritonavir and nelfinavir, sometimes used to treat HIV
and AIDS

Driving and using machines
No effect on the ability to drive or use machines has
been seen with Provera.
Provera contain lactose monohydrate, sucrose and
sunset yellow (E110)
Lactose monohydrate and sucrose are types of sugar.
If you have been told by your doctor that you have an
intolerance to some sugars, contact your doctor before
taking this medicinal product.
Provera 2.5 mg Tablets also contain sunset yellow
(E110) which may cause allergic reactions.

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.
The number of tablets will depend on the condition
you are being treated for. This information can also be
found on the label on the box the tablets come in. The
following information will help you see what the usual
dose is for a particular problem.
Taking Provera for heavy or irregular bleeding and
other period problems
You will usually take 2.5mg-10mg for 5-10 days
beginning 16 days to 21 days after your last period
began. Treatment should be given for 2 consecutive
cycles. In some cases, your doctor may also prescribe
oestrogen to be taken at the same time as Provera at
doses of 5-10mg for 10 days. A few days after you
stop taking the tablets you may have bleeding like a
period (breakthrough bleeding).
Taking Provera when you have amenorrhoea (when
you are not having periods)
You will usually take 2.5mg-10mg for 5-10 days
beginning on a day which has been calculated or
assumed to represent Day 16 to Day 21 of your
menstrual cycle. Repeat the treatment for 3 consecutive
cycles.
In some cases, your doctor may also prescribe
oestrogen to be taken at the same time as Provera for
10 days. A few days after you stop taking the tablets,
you may have bleeding like a period (breakthrough
bleeding).
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Taking Provera for endometriosis (where tissue from
your womb is found outside your womb)
You will usually take 10mg 3 times a day (30mg) for 3
months (90 days) starting on the first day of your period.
If you have any irregular spotting or bleeding during
treatment this is normal and nothing to worry about.
If you do not have a period after you finish a course
of Provera, check with your doctor in case you are
pregnant.
If you forget to take Provera
Take the tablet as soon as you remember, and carry
on taking the tablets at the normal times.
Do not take a double dose to make up for a
forgotten dose.
If you take more Provera than you should
If you take too many tablets, contact your doctor
straight away.
If you stop taking Provera
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 side effects,
although not everyone gets them.

Reasons for stopping Provera treatment immediately
Rarely, Provera may cause a severe allergic reaction
which can be life-threatening in some cases. You can
get some or all of the following symptoms: wheezing,
difficulty breathing, feeling faint, swelling of the face
or tongue, hands and feet, intense itchy skin rash. If
you think you are reacting badly to the medicine, get
emergency medical help immediately.
If you get any of the following symptoms, you
should stop taking the tablets and see your doctor
immediately.
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
These are symptoms of a deep-vein thrombosis
(DVT):
• You have severe 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
Tell your doctor if you get any other side effects
reported with Provera which may include the
following:
Very common: may affect more than 1 in 10 people
• headache
• feeling sick
• unexpected or unusual vaginal bleeding or spotting
Common: may affect up to 1 in 10 people
• severe allergic reaction to the drug (e.g. wheezing,
difficulty breathing)
• depression
• difficulty sleeping
• nervousness
• dizziness
• hair loss
• acne
• nettle rash or hives
• itchy skin
• vaginal discharge
• breast pain
• breast tenderness
• fever
• tiredness
• weight increase
Uncommon: may affect up to 1 in 100 people
• Facial hair growth

• milky discharge from the breast when not pregnant
or breastfeeding
• oedema/fluid retention
Not known: frequency cannot be estimated from the
available data
• severe allergic reaction (anaphylactic reaction)
• swelling in face/throat which may cause difficulty
breathing
• delayed egg release with longer menstrual cycle
(periods)
• drowsiness
• swelling in the veins due to blood clots
• tenderness or swelling in your calf, ankle or foot
• rash
• stopping or extended break of your periods
• abnormality of cervix
• decreased sugar tolerance
• weight decrease
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 this medicine out of the sight and reach of
children.

Provera tablets should not be used after the expiry
date which is stated on the carton, blister strip or bottle
label after EXP. The expiry date refers to the last day
of that month.
For the blister and carton presentation, do not store
your tablets above 25°C.
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 looks like and contents of the pack
Provera 2.5mg tablets are orange and are available
in blisters containing 10, 30, 50, or 100 tablets or in
bottles containing 100 tablets.
Provera 5mg tablets are blue and are available in
packs of 10, 20 or 100 tablets or in bottles containing
100 tablets.
Provera 10mg tablets are white and are available in
packs of 10, 20, 30, 50, 90 or 100 tablets or in bottles
containing 50 tablets.
Not all pack sizes may be marketed.
What Provera Tablets contains
The active substance is medroxyprogesterone acetate.
Each tablet contains either 2.5mg, 5mg or 10mg
medroxyprogesterone acetate.

The other ingredients are:
2.5 mg: Lactose monohydrate, sucrose, maize starch,
liquid paraffin, talc, calcium stearate, sunset
yellow (E110), purified water.
5 mg:

Lactose monohydrate, starch, sucrose, liquid
paraffin, calcium stearate, talc, the colour FD
& C Blue No. 2 Aluminium Lake, purified water.

10 mg: Lactose monohydrate, sucrose, maize starch,
liquid paraffin, talc, calcium stearate, purified
water.
Provera contain lactose monohydrate, sucrose and
sunset yellow (E110).
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder: Pfizer Limited,
Ramsgate Road, Sandwich, Kent, CT13 9NJ, United
Kingdom.
Manufacturer: Pfizer Italia S.r.l., Località Marino del
Tronto, 63100 Ascoli Piceno (AP), Italy.
Company Contact Address:
For further information on your medicine, please contact
Medical Information, Pfizer Limited, Walton Oaks,
Dorking Road, Tadworth, Surrey, KT20 7NS, UK.
Telephone: 01304 616161.
This leaflet was last revised in 05/2016
Ref: PV LD 9_1
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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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