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PROVERA 10 MG TABLETS

Active substance(s): MEDROXYPROGESTERONE ACETATE

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Provera® 5 mg Tablets
Provera® 10 mg Tablets

1579 / 1580
26.05.15[14]

(medroxyprogesterone acetate)
PATIENT INFORMATION LEAFLET
This medicine is available using one of the above names but will be referred
to as Provera throughout the leaflet.
Provera Tablets are also available in other strengths.
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.
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
1. WHAT PROVERA IS AND WHAT IT IS USED FOR
- Provera is one of a group of medicines called ‘progestogens’.
Progestogens are 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)
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.
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)
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
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 2.5 mg tablets also contain 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.
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 oestrogen to be taken at the same time as
Provera at doses of 5-10mg for 10 days.
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 oestrogen to be taken at the same time as
Provera at doses of 5-10mg for 10 days.
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.
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.
4. POSSIBLE SIDE EFFECTS
Like all medicines Provera 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.
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).
Other side effects
You can also get the following side effects with medicines like Provera:
Effects on the reproductive system and breasts: breast pain and
tenderness, a milky discharge from the breast when not pregnant or breastfeeding (galactorrhoea).
Effects on the nervous system: headache, depression, dizziness, fatigue,
difficulty sleeping, feeling sleepy, nervousness.
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.
Miscellaneous: fluid retention and swelling of hands and ankles, weight
changes, decreased tolerance to sugars like glucose.
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. STORING PROVERA
Provera should not be used after the expiry date printed on the carton or
blister strip.
Do not store above 25oC. Store in the original pack.
As with all medicines, keep the tablets out of the sight and reach of
children.
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.
If your tablets become discoloured or show any other signs of deterioration,
consult your pharmacist who will tell you what to do.
6. FURTHER INFORMATION
What Provera looks like and contents of the pack
Provera 5mg tablets are available as blue round tablets, marked ‘206
scoreline 206’ on one side and ‘U’ on the other side.
Provera 10mg tablets are available as white round biconvex tablets,
marked ‘upjohn 50’ on one side and scoreline on the other side.
Provera comes in blister strip packs of 30 tablets.

What Provera contains
Each Provera tablet contains either 5mg or 10mg of the active ingredient
medroxyprogesterone acetate.
There are also inactive ingredients in the tablets. These are sucrose, maize
starch, lactose, liquid paraffin, calcium stearate and talc.
5mg tablets also contain indigo carmine (E132).
Manufacturer and Production Licence holder:
Manufactured by Pfizer Italia S.r.l., 63046 Marino del Tronto, Ascoli Piceno,
Italy. Procured from within the EU by the Product Licence holder
Star Pharmaceuticals Ltd, 5 Sandridge Close, Harrow, Middlesex, HA1 1XD.
Repackaged by Servipharm Ltd.
POM

Provera 5mg Tablets PL 20636/1579
Provera 10mg Tablets PL 20636/1580

Leaflet revision and issue date (Ref) 26.05.15[14]
Provera is a registered trademark of Pharmacia Ltd.

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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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