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MEDROXYPROGESTERONE ACETATE 10MG TABLETS

Active substance(s): MEDROXYPROGESTERONE ACETATE / MEDROXYPROGESTERONE ACETATE

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Ref: 1219/200617/1/F

®

Provera 10mg Tablets
(medroxyprogesterone acetate)
Patient Information 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.
Your medicine is called Provera 10mg Tablet but will be referred to as
Provera Tablets throughout this leaflet. Please note that the leaflet also
contains information about other strengths of the medicine, Provera 2.5mg
and Provera 5mg
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.

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:
* 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
* Medicines for treating infections (e.g. rifampicin, rifabutin, nevirapine,
efavirenz)
* 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, 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).

Ref: 1219/200617/1/B

®

Provera 10mg Tablets
(medroxyprogesterone acetate)
Patient Information Leaflet (continued)
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.

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

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.

How to store Provera Tablets

Keep out of the sight and reach of children.
Provera tablets should not be used after the expiry date printed on the
carton or blister strip.
Do not store above 25°C.
If your tablets become discoloured or show any other signs of deterioration,
consult your pharmacist (chemist) who will tell you what to do
Tablets should not be thrown in your bin or put down the drain. If they are
out of date, or no longer suitable for you, return them to your pharmacist.

If you get any of the following symptoms, you should stop taking the tablets
and see your doctor immediately.
6
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

Contents of the pack and other information

What Provera Tablets contain
Each tablet contains 10mg of medroxyprogesterone acetate as the active
ingredient.
Provera Tablets also has the following inactive ingredients: lactose, sucrose,
maize starch, liquid paraffin, talc, calcium stearate and purified water.
What Provera looks like and contents of the pack
Provera Tablets are a white, round tablet, embossed with UPJOHN 50 on
one side and a break line on the other side.
Provera Tablets comes in packs of 30, 90 and 100 Tablets.
Manufacturer and Licence Holder
The tablets are manufactured by Pfizer Italia S.r.L., Via del Commercio 63100 Marino del Tronto, Ascoli Piceno, Italy and are procured from within
the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited,
Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire,
B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL 15184/1219

Provera 10mg Tablets

Provera is a registered trademark of Pharmacia Limited.
Revision date: 20/06/17

Blind or partially sighted?
Is this leaflet hard to see or read? Phone Lexon
(UK) Limited, Tel: 01527 505414 to
obtain the leaflet in a format suitable for you

Ref: 1219/200617/2/F

Medroxyprogesterone Acetate 10mg Tablets
Patient Information 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.
Your medicine is called Medroxyprogesterone Acetate 10mg Tablet but will
be referred to as Medroxyprogesterone Tablets throughout this leaflet.
Please note that the leaflet also contains information about other strengths
of the medicine, Medroxyprogesterone Acetate 2.5mg and
Medroxyprogesterone Acetate 5mg
In this leaflet:
1 What Medroxyprogesterone Tablets are and what they are used for
2 What you need to know before you take Medroxyprogesterone Tablets
3 How to take Medroxyprogesterone Tablets
4 Possible side effects
5 How to store Medroxyprogesterone Tablets
6 Contents of the pack and other information

1

What Medroxyprogesterone Tablets are and what they
are used for

* Medroxyprogesterone 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 has several uses. You can take
Medroxyprogesterone 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
Medroxyprogesterone Tablets

Medroxyprogesterone 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 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 Medroxyprogesterone
Tablets if you have any of the following conditions to help them decide if
Medroxyprogesterone 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, 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.
You are more likely to get a clot whether or not you are taking
Medroxyprogesterone 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. Section 4 of this leafl et
‘Possible side effects’, also has more information on the warning signs of
blood clots.
Other medicines and Medroxyprogesterone
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 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
* Medicines for treating infections (e.g. rifampicin, rifabutin, nevirapine,
efavirenz)
* 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 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,
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.
Medroxyprogesterone 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.
Medroxyprogesterone 2.5 mg Tablets also contain sunset yellow (E110)
which may cause allergic reactions.

3

How to take Medroxyprogesterone 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 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 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).

Ref: 1219/200617/2/B

Medroxyprogesterone Acetate 10mg Tablets
Patient Information Leaflet (continued)
Taking Medroxyprogesterone 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 for 10 days. A few days after you stop
taking the tablets, you may have bleeding like a period (breakthrough
bleeding).
Taking Medroxyprogesterone 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, check with your doctor in case you are
pregnant.
If you forget to take Medroxyprogesterone
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 than you should
If you take too many tablets, contact your doctor straight away.
If you stop taking Medroxyprogesterone
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.

* 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 leafl et. 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.
5
4

Possible side effects

Like all medicines, this medicine can cause side effects, although not
everyone gets them.
Reasons for stopping Medroxyprogesterone treatment immediately
Rarely, Medroxyprogesterone 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

How to store Medroxyprogesterone Tablets

Keep out of the sight and reach of children.
Medroxyprogesterone tablets should not be used after the expiry date
printed on the carton or blister strip.
Do not store above 25°C.
If your tablets become discoloured or show any other signs of deterioration,
consult your pharmacist (chemist) who will tell you what to do
Tablets should not be thrown in your bin or put down the drain. If they are
out of date, or no longer suitable for you, return them to your pharmacist.

6

Contents of the pack and other information

What Medroxyprogesterone Tablets contain
Each tablet contains 10mg of medroxyprogesterone acetate as the active
ingredient.
Medroxyprogesterone Tablets also has the following inactive ingredients:
lactose, sucrose, maize starch, liquid paraffin, talc, calcium stearate and
purified water.
What Medroxyprogesterone looks like and contents of the pack
Medroxyprogesterone Tablets are a white, round tablet, embossed with
UPJOHN 50 on one side and a break line on the other side.
Medroxyprogesterone Tablets comes in packs of 30, 90 and 100 Tablets.
Manufacturer and Licence Holder
The tablets are manufactured by Pfizer Italia S.r.L., Via del Commercio 63100 Marino del Tronto, Ascoli Piceno, Italy and are procured from within
the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited,
Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire,
B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or
pharmacist. They will have additional information about this medicine and
will be able to advise you.

POM

PL 15184/1219

Medroxyprogesterone Acetate 10mg Tablets

Revision date: 20/06/17

Blind or partially sighted?
Is this leaflet hard to see or read? Phone Lexon
(UK) Limited, Tel: 01527 505414 to obtain the
leaflet in a format suitable for you

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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