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PROVERA 5MG TABLETS/ MEDROXYPROGESTERONE ACETATE 5MG TABLETS

Active substance(s): MEDROXYPROGESTERONE ACETATE

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Package Leaflet: Information for the User

Provera® 5mg 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.
• The name of your medicine is Provera 5mg Tablets but will be referred
to as Provera Tablets or Provera throughout the remainder of this
leaflet.
• Provera Tablets are also available in other strengths.
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:
o Heavy periods
o Painful periods
o Irregular periods or periods that are more frequent than normal
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.
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:
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
• 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:
o Aminoglutethimide, sometimes used in Cushing’s syndrome
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
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.
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.
Driving and using machines
No effect on the ability to drive or use machines has been seen with
Provera.
Provera contain lactose monohydrate and sucrose
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.
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)
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.

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.

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 lifethreatening 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.

5. How to store Provera Tablets





Keep out of the sight and reach of children.
Do not store above 25oC.
Protect from humidity.
Do not use Provera Tablets after the expiry date which is stated on the
label and carton. The expiry date refers to the last day of that month.
• If your medicine becomes discoloured or shows any sign of
deterioration, return it to your pharmacist.
• Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.
6. Contents of the pack and other information

If you get any of the following symptoms, you should stop taking the
tablets and see your doctor immediately.

What Provera Tablets contains
Each tablet contains medroxyprogesterone acetate 5mg.

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

The other ingredients are: lactose monohydrate, sucrose, purified water
maize starch, liquid paraffin, talc, calcium stearate and FD & C Blue No.
2 Aluminium Lake.

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:

What Provera Tablets looks like and contents of the pack
The Provera Tablets are blue, round tablets embossed with “U” on one
side and “286” either side of a break line on the other side.
Provera 5mg Tablets are available in blister packs of 10, 20, 60 and 100
tablets.
Manufactured by
Pfizer Italia S.r.l., (Fab. Ascoli Piceno), Via del Comercio,
Marino del Tronto, Ascoli Piceno, Italy.
Procured from within the EU by the Product Licence Holder:
MPT Pharma Ltd., Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall WS9 8ER.
Repackaged by MPT Pharma Ltd.
PL: 33532/0802
POM

Very common: may affect more than 1 in 10 people
• headache
• feeling sick
• unexpected or unusual vaginal bleeding or spotting

Leaflet dated 11th April 2017
Leaflet coded xxxxxxxxxxxx

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

To request a copy of this leaflet in
Braille, large print or audio please
call 01922 745645 and ask for the
Regulatory Department.

Uncommon: may affect up to 1 in 100 people
• facial hair growth
• milky discharge from the breast when not pregnant or breast-feeding
• oedema/fluid retention

Provera® is a registered trademark of Pharmacia Limited.

Package Leaflet: Information for the User

Medroxyprogesterone Acetate 5mg Tablets
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.
• The name of your medicine is Medroxyprogesterone Acetate 5mg
Tablets but will be referred to as Medroxyprogesterone Acetate
Tablets or Medroxyprogesterone Acetate throughout the remainder of
this leaflet.
• Medroxyprogesterone Acetate Tablets are also available in other
strengths.
What is in this leaflet
1. What Medroxyprogesterone Acetate Tablets are and what they are
used for
2. What you need to know before you take Medroxyprogesterone Acetate
Tablets
3. How to take Medroxyprogesterone Acetate Tablets
4. Possible side effects
5. How to store Medroxyprogesterone Acetate Tablets
6. Contents of the pack and other information
1. What Medroxyprogesterone Acetate Tablets are and what they
are used for
• Medroxyprogesterone Acetate 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.
• Medroxyprogesterone Acetate has several uses. You can take
Medroxyprogesterone Acetate to treat or manage:
o Heavy periods
o Painful periods
o Irregular periods or periods that are more frequent than normal
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.
2. What you need to know before you take Medroxyprogesterone
Acetate Tablets
Medroxyprogesterone Acetate 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 Medroxyprogesterone Acetate 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 Medroxyprogesterone
Acetate Tablets if you have any of the following conditions to help them
decide if Medroxyprogesterone Acetate 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
Medroxyprogesterone Acetate, 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
Medroxyprogesterone Acetate. You are more likely to get a clot whether
or not you are taking Medroxyprogesterone Acetate 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 Medroxyprogesterone Acetate. Section 4
of this leaflet ‘Possible side effects’, also has more information on the
warning signs of blood clots.
Other medicines and Medroxyprogesterone Acetate
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 Medroxyprogesterone Acetate may be altered
when taken at the same time as any of the following medicines:
o Aminoglutethimide, sometimes used in Cushing’s syndrome
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
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.
Medroxyprogesterone Acetate 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
Medroxyprogesterone Acetate, as it is not a contraceptive.
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.
Driving and using machines
No effect on the ability to drive or use machines has been seen with
Medroxyprogesterone Acetate.
Medroxyprogesterone Acetate contain lactose monohydrate and
sucrose
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.
3. How to take Medroxyprogesterone Acetate 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 Medroxyprogesterone Acetate 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 Medroxyprogesterone Acetate
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 Medroxyprogesterone Acetate 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 Medroxyprogesterone Acetate for 10 days. A few days
after you stop taking the tablets, you may have bleeding like a period
(breakthrough bleeding).

Taking Medroxyprogesterone Acetate 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
Medroxyprogesterone Acetate, check with your doctor in case you
are pregnant.
If you forget to take Medroxyprogesterone Acetate
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 Medroxyprogesterone Acetate than you should
If you take too many tablets, contact your doctor straight away.
If you stop taking Medroxyprogesterone Acetate
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.

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 Medroxyprogesterone Acetate Tablets

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 Medroxyprogesterone Acetate treatment
immediately
Rarely, Medroxyprogesterone Acetate 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
Medroxyprogesterone Acetate 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 breast-feeding
• oedema/fluid retention






Keep out of the sight and reach of children.
Do not store above 25oC.
Protect from humidity.
Do not use Medroxyprogesterone Acetate Tablets after the expiry date
which is stated on the label and carton. The expiry date refers to the
last day of that month.
• If your medicine becomes discoloured or shows any sign of
deterioration, return it to your pharmacist.
• Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.
6. Contents of the pack and other information
What Medroxyprogesterone Acetate Tablets contains
Each tablet contains medroxyprogesterone acetate 5mg.
The other ingredients are: lactose monohydrate, sucrose, purified water
maize starch, liquid paraffin, talc, calcium stearate and FD & C Blue No.
2 Aluminium Lake.
What Medroxyprogesterone Acetate Tablets looks like and contents
of the pack
The Medroxyprogesterone Acetate Tablets are blue, round tablets
embossed with “U” on one side and “286” either side of a break line on
the other side.
Medroxyprogesterone Acetate 5mg Tablets are available in blister packs
of 10, 20, 60 and 100 tablets.
Manufactured by
Pfizer Italia S.r.l., (Fab. Ascoli Piceno), Via del Comercio,
Marino del Tronto, Ascoli Piceno, Italy.
Procured from within the EU by the Product Licence Holder:
MPT Pharma Ltd., Westgate Business Park, Unit 5-7 Tintagel Way,
Aldridge, Walsall WS9 8ER.
Repackaged by MPT Pharma Ltd.
PL: 33532/0802
POM
Leaflet dated 11th April 2017
Leaflet coded xxxxxxxxxxxx

To request a copy of this leaflet in
Braille, large print or audio please
call 01922 745645 and ask for the
Regulatory Department.

+ Expand Transcript

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Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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