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PROVERA 5MG TABLETS

Active substance(s): MEDROXYPROGESTERONE ACETATE / MEDROXYPROGESTERONE ACETATE

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Previously assessed against UK PIL dated May 2016

S1278 LEAFLET Provera 20170126

PACKAGE LEAFLET: INFORMATION FOR THE USER

PROVERA 5mg TABLETS
(medroxyprogesterone acetate)
Your medicine is called Provera 5mg Tablets but will be referred to
as Provera or Provera Tablets throughout the remainder of the
leaflet.
Information for other strengths of Provera (Provera 2.5mg Tablets
and Provera 10mg Tablets) 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

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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.

3. How to take Provera Tablets

Other medicines and Provera

4. Possible side effects

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:

5. How to store Provera Tablets
6. Contents of the pack and other information

o Aminoglutethimide, sometimes used in Cushing’s syndrome
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:

o Medicines for thinning the blood (e.g. warfarin)
o Medicines for treating convulsions (e.g. phenobarbital, phenytoin
and carbamazepine)
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 Heavy periods

Pregnancy, breast-feeding and fertility

o Painful periods

Pregnancy

o Irregular periods or periods that are more frequent than
normal

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.

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.

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:

Provera contain lactose monohydrate, sucrose and sunset
yellow (E110)

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

No effect on the ability to drive or use machines has been seen with
Provera.

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)



breast tenderness



fever

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.



tiredness



weight increase

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).



Facial hair growth



milky discharge from the breast when not pregnant or
breastfeeding



oedema/fluid retention

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.

Uncommon: may affect up to 1 in 100 people

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

If you stop taking Provera

Reporting of side effects

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 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.

If you have any further questions on the use of this medicine, ask
your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS

5. HOW TO STORE PROVERA TABLETS


KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not store above 25°C.

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.

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 gel, please take it back
to the pharmacist for safe disposal. Only keep the gel 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.

Like all medicines, this medicine can cause side effects, although
not everyone gets them.

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:

6. CONTENTS OF THE PACK AND OTHER INFORMATION



Sudden, severe, sharp pain in your chest

What Provera contains



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’):



Each tablet contains 5mg of the active ingredient
medroxyprogesterone acetate.



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



You have an unusually severe or long headache

What Provera looks like and contents of the pack



Your sight is affected in any way



You find it difficult to speak

Provera are Small, round blue tablets marked ‘286’ on either side of
a scoreline on one side and ‘U’ on the other side.



You collapse or faint

Provera are available as blister pack of 10, 30 or 90 tablets.



Any part of your body feels weak or numb

Product Licence holder

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:

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 are manufactured by Pfizer Italia S.r.l, Localita Marino del
Tronto, 63100 Ascoli Piceno, Italy.
POM

PL No. 19488/1278

Very common: may affect more than 1 in 10 people

Leaflet revision date: 26 January 2017



headache



feeling sick



unexpected or unusual vaginal bleeding or spotting



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



depression

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.



difficulty sleeping

Provera is a registered trade mark of Pharmacia Limited, UK.



nervousness



dizziness



hair loss



acne



nettle rash or hives



itchy skin



vaginal discharge



breast pain

Common: may affect up to 1 in 10 people

S1278 LEAFLET Provera 20170126

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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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