Package leaflet: Information for the patient

Provera'

2.5mg, 5mg and 10mg 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.

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.

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.

4. Possible side effects

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

Reasons forstopping 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 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

Uncommon: may affect up to 1 in 100 people

•    Facial hair growth

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 fortreating 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 5-1 Omg 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).

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•    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.aov.uk/vellowcard. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Provera Tablets

Keep this medicine out of the sight and reach of children.

Provera tablets should not be used after the expiry date which is stated on the carton, blister strip or bottle label after EXP The expiry date refers to the last day of that month.

For the blister and carton presentation, do not store your tablets above 25°C.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Provera looks like and contents of the pack Provera 2.5mg tablets are orange and are available in blisters containing 10, 30, 50, or 100 tablets or in bottles containing 100 tablets.

Provera 5mg tablets are blue and are available in packs of 10,20 or 100 tablets or in bottles containing 100 tablets.

Provera 10mg tablets are white and are available in packs of 10,20,30,50,90 or 100 tablets or in bottles containing 50 tablets.

Not all pack sizes may be marketed.

What Provera Tablets contains

The active substance is medroxyprogesterone acetate. Each tablet contains either 2.5mg, 5mg or 10mg medroxyprogesterone acetate.

The other ingredients are:

2.5 mg: Lactose monohydrate, sucrose, maize starch, liquid paraffin, talc, calcium stearate, sunset yellow (E110), purified water.

5 mg: Lactose monohydrate, starch, sucrose, liquid paraffin, calcium stearate, talc, the colour FD & C Blue No. 2 Aluminium Lake, purified water.

10 mg: Lactose monohydrate, sucrose, maize starch, liquid paraffin, talc, calcium stearate, purified water.

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

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom.

Manufacturer: Pfizer Italia S.r.l., Localita Marino del Tronto, 63100 Ascoli Piceno (AP), Italy.

Company Contact Address:

For further information on your medicine, please contact Medical Information, Pfizer Limited, Walton Oaks, Dorking Road, Tadworth, Surrey, KT20 7NS, UK. Telephone: 01304 616161.

This leaflet was last revised in 05/2016 Ref: PV LD 9_1

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