PROVERA 5MG TABLETS

Active substance: MEDROXYPROGESTERONE ACETATE

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THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

PROVERA® 5mg TABLETS
(medroxyprogesterone acetate)
Patient Information Leaflet
This product is known as the above name but will be referred to as Provera throughout this leaflet. Other
strengths (2.5mg & 10mg) are also available.









2. Before you take Provera
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.

DATE:
DATE:

UK PIL DATED JANUARY 2012

6464/0893 D

04/12/12
CODE:

DT

WARNING!

Take special care with Provera
Tell your doctor if you have any of the following conditions to help him or her 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

DATE OF PROOF:

PRODUCT:

Provera 5mg tabs

ARTWORKER:

CUSTOMER
APPROVED:
05-0269

Q.A.
APPROVED:

Do not take Provera if you:
• are allergic to medroxyprogesterone acetate or other similar hormone medicines, or to any of the
other ingredients of Provera (see Section 6 ‘Further information’ for more details)
• 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)

PRE-PRESS NO.:
CUSTOMER: Waymade

1. What Provera is and what it is used for
Provera is one of a group of medicines called ‘progestogens’. Progestogen is similar to the
natural female hormone progesterone. Provera contains the progestogen called
medroxyprogesterone acetate as the active ingredient.
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)

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.
Important information on some of the ingredients of Provera
Provera contains lactose and sucrose which 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 2.5mg also contains sunset yellow (E110) which may cause allergic reactions.
Taking other medicines
Tell your doctor or pharmacist if you are taking any of the following medicines, as the effect of Provera
may be altered when they are taken at the same time:
• 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
Tell your doctor or pharmacist if you are taking any other medicines not listed above, including those
bought without a prescription.
Pregnancy
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
reliable as 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 machinery
No effect on the ability to drive or use machinery has been seen with Provera.

Colour
Swatch

Black

WARNING!

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

Notes:

In this leaflet
1. What Provera is and what it is used for
2. Before you take Provera
3. How to take Provera
4. Possible side effects
5. Storing Provera
6. Further information

PROOF HISTORY:
v.1 - waymade - 04/12/12

Leaflet Flat Size = 148 x 400

Read all of this leaflet carefully before you start using this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or pharmacist.
• This medicine has been prescribed for you personally and you should not pass it on to others. It may
harm them, even if their symptoms are the same as yours.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell
your doctor or pharmacist.

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

27mm

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

3. How to take Provera
You should follow your doctor’s instructions carefully. 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 after your last period began. A few
days after you stop taking the tablets you will usually have bleeding like a period.
To stop your periods causing problems again, your doctor may tell you to repeat this dose of Provera
during your next cycle. In some cases, your doctor may also prescribe estrogen to be taken at the same
time as Provera at doses of 5-10mg for 10 days.

What do I do if I forget to take a tablet?
Take the tablet as soon as you remember, and carry on taking the tablets at the normal times.
What if I take too many tablets at once?
If you take too many tablets, contact your doctor straight away. Make sure that nobody else takes your
tablets.

WARNING!

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 could all be warning signs of thrombosis (a blood clot) which will need urgent
treatment.
• Sudden, severe, sharp pain in your chest
• Coughing up blood
• You suddenly become short of breath
• Your heart beats more rapidly
These are symptoms of a blood clot in the lungs
• 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 can be symptoms of a blood clot in the brain (‘a stroke’)
• 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
These are symptoms of a deep-vein thrombosis (DVT).

Effects on the reproductive system and breasts: breast pain and tenderness, a milky discharge from
the breast when not pregnant or breast-feeding (galactorrhoea).
Effects on the nervous system: headache, depression, dizziness, fatigue, difficulty sleeping, feeling
sleepy, nervousness.

DATE:
04/12/12
DATE OF PROOF:

Effects on the stomach and intestines: feeling sick.
Effects on your heart and circulation: blood clots, including clots in the lung, and swelling in the veins
due to blood clots, stroke, heart attacks.
Effects on your skin, nose, throat or hair: generalised itching, rash, hives, acne, excessive hair growth
on the face or body, hair loss.

UK PIL DATED JANUARY 2012

6464/0893 D

Miscellaneous: fluid retention and swelling of hands and ankles, weight changes, decreased tolerance to
sugars like glucose.
If you experience any of the above side effects or notice any other unusual effects not mentioned
in the leaflet, tell your doctor at once.

CODE:

DT
ARTWORKER:
Provera 5mg tabs
PRODUCT:

CUSTOMER: Waymade

PRE-PRESS NO.:

05-0269

Q.A.
APPROVED:

Other side effects
You can also get the following side effects with medicines like Provera:







5. Storing Provera
Provera 5mg Tablets should be stored in the manufacturer's original foil packaging below 25°C.
Do not use after the expiry date printed on the carton, label or blister strip.
KEEP ALL MEDICINES OUT OF THE SIGHT AND REACH OF CHILDREN.
If your doctor tells you to stop taking the tablets, please take them back to the pharmacist for safe
disposal. Only keep the tablets if your doctor tells you to.
If the tablets become discoloured or show any other signs of deterioration, you should seek the
advice of your pharmacist who will tell you what to do.

6. Further Information
Your medicine is called Provera 5mg Tablets. Each blue round tablet contains 5mg of the active ingredient
medroxyprogesterone acetate and is marked ‘U’ on one side and ‘286’ either side of a breakline on the
other side.
Provera 5mg Tablets also contain the following:
lactose, maize starch, sucrose, liquid paraffin, calcium stearate, indigo carmine aluminium lake (E132)
and talc.
Provera 5mg Tablets are available as blister packs of 60 tablets.
POM

PL No: 6464/0893

This product is manufactured by Pfizer Italia S.r.I., Via del Commercio, Zone Industriale, Ascoli Piceno,
Italy and is procured from within the EU and repackaged by the Product Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref.) 04.12.2012
Provera is a registered trademark of PHARMACIA LIMITED

Colour
Swatch

Black

WARNING!

DATE:

CUSTOMER
APPROVED:

4. Possible side effects
Like all medicines Provera can cause side effects, although not everyone gets them.

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
CRESTOR 6464/2069 2070

Notes:

Taking Provera for endometriosis
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.

PROOF HISTORY:
v.1 - waymade - 04/12/12

Leaflet Flat Size = 148 x 400

Taking Provera 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 of your menstrual cycle. A few days after you stop taking the tablets you will
usually have bleeding like a period.
Your treatment will be repeated for three cycles. In some cases, your doctor may also prescribe estrogen
to be taken at the same time as Provera at doses of 5-10mg for 10 days.

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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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