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PROVERA 10MG TABLETS

Active substance(s): MEDROXYPROGESTERONE ACETATE / MEDROXYPROGESTERONE ACETATE MICRONISED / MEDROXYPROGESTERONE ACETATE / MEDROXYPROGESTERONE ACETATE MICRONISED / MEDROXYPROGESTERONE ACETATE / MEDROXYPROGESTERONE ACETATE MICRONISED

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Add/Amend to correct the leaflet revision date.
Previously assessed against UK PIL dated May 2016

S1807 LEAFLET Provera 20170126

PACKAGE LEAFLET: INFORMATION FOR THE USER

PROVERA® 10mg TABLETS
(medroxyprogesterone acetate)
Your medicine is called Provera 10mg Tablets but will be referred to
as Provera throughout the remainder of the leaflet.
Information for other strengths of Provera also may be present in
this 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, 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

By Aneela Mahmood at 10:37 am, May 12, 2017

 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.
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
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.
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:

1. WHAT PROVERA TABLETS ARE AND WHAT THEY ARE
USED FOR

o Aminoglutethimide, sometimes used in Cushing’s syndrome



o Medicines for treating convulsions (e.g. phenobarbital, phenytoin
and carbamazepine)

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:
o Heavy periods

o Medicines for thinning the blood (e.g. warfarin)

o Ritonavir and nelfinavir, sometimes used to treat HIV and AIDS
o Medicines for treating infections (e.g. rifampicin, rifabutin,
nevirapine, efavirenz)
o St John’s wort, a herbal treatment for depression

o Painful periods

Pregnancy, breast-feeding and fertility

o Irregular periods or periods that are more frequent than
normal

Pregnancy

o Absence of periods
o 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.

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.
Breast-feeding

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PROVERA
TABLETS

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

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.

Driving and using machines

Do not take Provera if you:
o

are allergic to medroxyprogesterone acetate or other similar
hormone medicines, or to any of the other ingredients of this
medicine (listed in section 6)

o

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

o

have now or have had in the past breast cancer

o

have now or have had in the past blood clots forming in your
veins (venous thrombosis)

o

have now or have had in the past blood clots forming in your
arteries (arterial thrombosis)

o

have liver problems

o

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

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).

Taking Provera for endometriosis (where tissue from your
womb is found outside your womb)

Uncommon: may affect up to 1 in 100 people


Facial hair growth

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.



milky discharge from the breast when not pregnant or
breastfeeding



oedema/fluid retention

If you do not have a period after you finish a course of Provera,
check with your doctor in case you are pregnant.

Not known: frequency cannot be estimated from the available data


severe allergic reaction (anaphylactic reaction)

If you forget to take Provera



swelling in face/throat which may cause difficulty breathing

Take the tablet as soon as you remember, and carry on taking the
tablets at the normal times.



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

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.

Reporting of side effects

4. POSSIBLE 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.

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.

5. HOW TO STORE PROVERA TABLETS


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store above 25°C.



Keep your blister strips securely in the outer carton.



Do not use after the expiry date printed on the carton label or
blister strip. The expiry date refers to the last day of that month.



If your doctor tells you to stop using the medicine, please take it
back to the pharmacist for safe disposal. Only keep the
medicine if your doctor tells you to.



If the medicines becomes discoloured or shows any signs of
deterioration, you should ask your doctor or pharmacist before
using it.

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’):

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Provera contains



You have an unusually severe or long headache



Your sight is affected in any way



You find it difficult to speak

Provera also contain the following inactive ingredients: lactose,
maize starch, sucrose, paraffin liquid, calcium stearate and talc.



You collapse or faint

What Provera looks like and contents of the pack



Any part of your body feels weak or numb

Provera is white, round tablet marked with a score-line on one side
and ‘UPJOHN 50’ on the other side.

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

Each tablet contains 10mg medroxyprogesterone acetate.

Provera is available as blister pack of 10, 30, 90 or 100 tablets.
Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Ltd, Chemilines House, Alperton
Lane, Wembley, HA0 1DX.
Manufacturer
Provera is manufactured by Pfizer Italia S.r.l., Localita Marino del
Tronto, 63100 Ascoli Piceno, Italy.
POM

PL. 19488/1807

Common: may affect up to 1 in 10 people

Leaflet revision date: 26 January 2017



severe allergic reaction to the drug (e.g. wheezing, difficulty
breathing)



depression



difficulty sleeping



nervousness



dizziness



hair loss



acne

Blind or partially sighted? Is
this leaflet hard to see or read?
Call 02087997607 to obtain the
leaflet in large print, tape, CD
or Braille.



nettle rash or hives



itchy skin



vaginal discharge



breast pain



breast tenderness



fever



tiredness



weight increase

Provera® is a registered trade mark of Pharmacia Limited, UK.
S1807 LEAFLET Provera 20170126

Expand Transcript

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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