PROVERA TABLETS 100 MG - patient leaflet, side effects, dosage

2. what you need to know before you take provera tablets

Do not take Provera Tablets:

• – If you are hypersensitive (allergic) to medroxyprogesterone acetate or other similar hormone medicines or any of the other ingredients of this medicine (listed in section 6).

• – If you have liver problems

• – If you have a heart condition where you feel pain in your chest when you exert yourself (angina) or have had a heart attack or if you have been told that you are at risk of developing cardiovascular diseases

• – If you have raised levels of calcium in the blood (hypercalcaemia) in patients with metastasised bone cancer

• – If you have suspected or recently diagnosed breast cancer for the first time

• – If you have undiagnosed vaginal bleeding

• – If you have past or recent blood clot disorders, including deep vein thrombosis (DVT), pulmonary embolitis (clots in the lung), thrombophlebitis (inflammation of the blood vessels) or if you have been told that you are at risk of developing these conditions

• – If you have a history of a condition known as porphyria (an hereditary blood disorder)

• – If you have a missed abortion (where the woman’s body does not expel the dead foetus), miscarriage

or pregnancy.

Warnings and precautions

Talk to your doctor or pharmacist if you have any of the following conditions to help him or her decide if Provera Tablets are suitable for you:

• – fluid retention

• – diseases that affect the heart and blood vessels (cardiovascular disease)

• – epilepsy

• – migraine headaches

• – sudden vision disturbance

• – asthma

• – liver or kidney problems

• – diabetes

• – depression or a history of depression

• – hyperlipidaemia (raised levels of fat in the blood) – if you are taking or have recently taken any other medicines, even those not prescribed

• – jaundice (a condition which causes the skin or whites of the eye to appear yellow)

• – a significant increase in high blood pressure

• – hormonal imbalance

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 parts of the body. The chances of getting a clot are very slightly increased if you are taking a hormone medicine like Provera Tablets. You are more likely to get a clot whether or not you are taking Provera Tablets if you – are very overweight

• – have relatives who have had blood clots

• – have had a blood clot in the veins or lungs before – 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 Tablets.

(See section 4 on ‘Possible side effects’ for more information on the warning signs of blood clots).

Treatment with Provera Tablets may cause you to have symptoms associated with Cushings syndrome.

Other medicines and Provera Tablets:

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. Some drugs may affect the action of Provera Tablets in your body. Tell your doctor or pharmacist if you are taking:

• – anticonvulsants like phenobarbitol, phenytoin, carbamezapine for epilepsy (fits)

• – anti-infective medicines like rifampicin, rifabutin, efavirenz or nevirapine for infections caused by bacteria and yeast

• – ritonavir and nelfinavir, sometimes used to treat HIV and AIDS

• – cytotoxic drugs (drugs that kill cancerous cells) – ciclosporin for suppressing the immune system – herbal preparations containing St. John’s wort – aminogluthemide sometimes used in Cushings syndrome

• – anticoagulants like warfarin for thinning the blood – pain killers like aspirin, ibuprofen or naproxen and vasodilators like hydrazalazine, minoxidil may affect the way Provera Tablets work.

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. Avoid becoming pregnant while being treated with Provera Tablets. Provera Tablets must not be taken if you are pregnant as hormonal medicines may affect the developing baby. Tell your doctor if you have had an abortion or missed a period during treatment. Your doctor may give you a pregnancy test before starting treatment. If you are sexually active, you are advised to use effective birth control to prevent pregnancy while taking Provera Tablets.

Breast-feeding

You should stop breast feeding before starting treatment with Provera Tablets as this medicine may be harmful to infants being breast-fed.

You should wait at least 6 weeks after your baby has been born before you start using Provera Tablets as it is transferred to breastmilk.

Ask your doctor or pharmacist for advice before taking any medicine while breast-feeding.

Fertility

After finishing treatment with Provera Tablets women may experience a delay before they are able to become pregnant.

Driving and using machines

There are no special precautions, and you can drive or operate machines as long as you feel well and able to do so.

Laboratory Tests:

Please inform your doctor if you need to have any blood tests or gynaecological assessment, as Provera Tablets may affect their results.

Provera Tablets contain sodium benzoate and sodium

This medicine contains 0.139 mg (100 mg tablet), 0.278 mg (200 mg tablet), 0.555 mg (400 mg tablet) sodium benzoate in each tablet. Sodium benzoate may increase jaundice (yellowing of the skin and eyes) in newborn babies (up to 4 weeks old). However, this medicine is normally only used by adults, this warning is only included for completeness.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

3. how to take proveratablets

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

You will be closely monitored and regularly assessed before and during your treatment with Provera Tablets, especially if you are prescribed large doses of the tablet.

Cancer of the Endometrium (womb lining) and Kidney:

The usual dose is 200mg to 600mg a day.

Breast Cancer:

The usual dose is 400mg to 1500mg a day. The chance of having a minor side effect, such as indigestion and weight gain, increases as the dose increases.

Swallow each tablet whole. Take your tablets at the same time each day. Follow your doctors’ instructions. These can be found in the label of your pack. If you are not sure ask your doctor.

Treatment may be required for 8 to 10 weeks before any effect can be found.

If you take more Provera Tablets than you should If you take too many Provera tablets, contact your doctor straight away.

If you forget to take Provera Tablets

If you forget to take your dose, take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Provera Tablets

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 some

PAA158226

side effects although not everybody gets them. If they occur, they are most likely to be minor and temporary. If you get any of the symptoms mentioned below, you should stop taking the tablets and see your doctor immediately.

Reasons for seeking immediate medical advice Rare side-effects: may affect up to 1 in 1,000 people Rarely, Provera Tablets may cause a severe allergic reaction which can be life-threatening in some cases. If you think you are reacting badly to the medicine, get emergency medical help immediately. The symptoms of an allergic reaction could be the following:

• wheezing
• difficulty breathing
• feeling faint
• swelling of the face or tongue
• swelling of the hands and feet
• intense itchy skin rash

Uncommon side-effects: may affect up to 1 in 100 people

• raised blood calcium levels (hypercalcaemia)
• increase symptoms of diabetes mellitus (e.g feeling thirsty, passing urine more frequently)

Frequency unknown: cannot be estimated from available data

• unusual vaginal bleeding
• loss of vision
• sudden onset of enlarged eyeball
• double vision
• migraine
• severe allergic reaction (anaphylactic reaction)
• nettle rash or hives

Effects on your heart and circulation:

Uncommon side-effects: may affect up to 1 in 100 people

• heart failure (e.g shortness of breath, swelling in legs)
• swelling in the veins due to blood clots
• blood clots, including clots in the lung (e.g pain and swelling in legs, sudden shortness of breath) These are symptoms of a blood clot in the lungs which may or may not all occur together:
• sudden, severe, sharp pain in your chest
• coughing up blood
• sudden short of breath
• heart beats more rapidly
• any part of your body feels weak or numb or cannot move

Rare side-effects: may affect up to 1 in 1,000 people

• heart attack
• stroke

These can be symptoms of a blood clot in the brain (‘a stroke’)

• severe or long headache
• sight is affected in any way
• difficulty speaking
• collapse
• faint

Frequency unknown: cannot be estimated from available data

• palpitation

These are symptoms of a deep-vein thrombosis (DVT)

Rare side-effects: may affect up to 1 in 1,000 people

• pain, tenderness or swelling in your calf, ankle or foot
• purple discolouration of the skin of the leg or the skin becomes red and warm to touch

Reasons for stopping Provera Tablets immediately Rare side-effects: may affect up to 1 in 1,000 people Your treatment will be discontinued if you have any of the following rare symptoms:

• yellowing of the skin or whites of the eyes or liver problems
• significant increase in blood pressure
• new onset of migraine-type headache

Tell your doctor if you get any other side effects reported with Provera Tablets which may include the following:

Effects on the reproductive system and breasts:

Common side-effects: may affect up to 1 in 10 people

• impotence

Uncommon side-effects: may affect up to 1 in

100 people

• breast pain and tenderness
• unexpected or unusual vaginal bleeding or spotting
• changes in libido (sex drive)

Frequency unknown: cannot be estimated from available data

• stopping or extended break of your periods and vaginal discharge
• milky discharge from the breast when not pregnant or breastfeeding

Effects on your central nervous system:

Common side-effects: may affect up to 1 in 10 people

• difficulty sleeping
• tiredness
• dizziness
• tremors
• effects like fine hand tremors
• headache

Uncommon side-effects: may affect up to 1 in

100 people

• euphoria (a state of extreme well-being and pleasure)
• depression
• muscular cramps

Rare side-effects: may affect up to 1 in 1,000 people

• nervousness
• drowsiness

Frequency unknown: cannot be estimated from available data

• confusion
• loss of concentration
• vision disorders

Effects on your digestive system:

Common side-effects: may affect up to 1 in 10 people

• vomiting
• constipation
• feeling sick

Uncommon side-effects: may affect up to 1 in 100 people

• diarrhoea
• dry mouth

Effects on your skin, nose, throat or hair:

Uncommon side-effects: may affect up to 1 in 100 people

• acne
• facial hair growth

Rare side-effects: may affect up to 1 in 1,000 people

• hair loss
• rash

Effect on your metabolism:

Common side-effects: may affect up to 1 in 10 people

• weight fluctuation
• Change in appetite
• sweating
• fluid retention

Uncommon side-effects: may affect up to 1 in 100 people

• Cushingoid syndrome (e.g. puffiness, moon face, weight gain)

Rare side-effects: may affect up to 1 in 1,000 people

• decreased sugar tolerance
• fever
• any part of your body feels weak or numb or cannot move

Frequency unknown: cannot be estimated from available data

• cloudy vision
• cramps in calves at night
• glucose present in urine

Other general effect

Frequency unknown: cannot be estimated from available data

• raised white blood cells and platelets

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store. 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.

• – The unopened bottles should be stored in the original container until ready for use.

• – Provera 100mg Tablets: Store below 25°C.

• – Provera 200mg Tablets: Store below 25°C.

• – Provera 400mg Tablets: Store at room temperature (15°C – 30°C).

• – Provera Tablets should not be used after the expiry date printed on the blister or bottle label and carton after EXP. The expiry date refers to the last day of that month.

• – 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 tablets contains

Each Provera tablet contains either 100 mg, 200mg or 400mg of the active ingredient medroxyprogesterone acetate.

Provera Tablets also contain the following inactive ingredients: microcrystalli­necellulose, maize starch, byco C, macrogol 400, sodium starch glycollate, docusate sodium, sodium benzoate (E 211) and magnesium stearate.

See section 2 “Provera tablets contain sodium benzoate and sodium”.

What Provera tablets look like and contents of the pack

Provera Tablets are available in the following pack sizes:

Provera 100 mg Tablets: 30, 60 and 100 tablets in blister strips and 100 tablets in bottle.

Provera 200 mg Tablets: 30 and 100 tablets in blister strips and 100 tablets in bottle.

Provera 400 mg Tablets: 30 tablets in blister strips and 60 tablets in bottle.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder:

Pfizer Limited

Ramsgate Road

Sandwich, Kent

CT13 9NJ

UK

Manufacturer:

Pfizer Italia S.r.l.

Localita Marino del Tronto

63100 Ascoli Piceno (AP)

Italy

Company Contact Address:

For further information on this medicine, please contact Medical Information at Pfizer Limited in Walton Oaks, Tadworth, Surrey, UK.

Tel.: 01304 616161

This leaflet was last revised in 01/2021.

Ref: PV HD 9_1

PAA158226