Patient leaflet - Medroxyprogesterone Acetate tablets 10 mg, Provera tablets 10 mg
1. What Provera Tablets are and what they are used for
have now or have had in the past blood clots forming in your veins (venous thrombosis)
Medicines for treating infections (e.g. rifampicin, rifabutin, nevirapine, efavirenz)
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
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:
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.
have now or have had in the past blood clots forming in your arteries (arterial thrombosis)
St John’s wort, a herbal treatment for depression
PAA142483 Provera®
Provera 2.5 mg Tablets also contain sunset yellow (E110) which may cause allergic reactions.
Pregnancy, breast-feeding and fertility Pregnancy
have liver problems
2.5mg, 5mg and 10mg Tablets
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)
Medroxyprogesterone acetate
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.
- 3. How to take Provera Tablets
- • are very overweight
- •
Provera has several uses. You can take Provera to treat or manage:
Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
- • have had a blood clot in the veins or lungs before
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
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.
Heavy periods
- have relatives who have had blood clots
Warnings and precautions
Painful periods
are unable to move for long periods of time (for example after an operation)
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.
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:
Irregular periods or periods that are more frequent than normal
Keep this leaflet. You may need to read it again.
- have a serious injury or have major surgery
If you have any further questions, please ask your doctor, pharmacist or nurse.
Absence of periods
- have a history of repeated miscarriage
- Epilepsy
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.
Breast-feeding
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.
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.
Migraine headaches
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. If you are breast-feeding, speak to your doctor who will advise whether you should use an alternative method of feeding your baby.
Asthma
Taking Provera for heavy or irregular bleeding and other period problems
- Heart problems
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.
Kidney 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).
2. What you need to know before you take Provera Tablets
Diabetes
Other medicines and Provera
Depression or a history of depression
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
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:
High blood pressure
Fertility
What is in this leaflet
Liver problems
After finishing treatment with Provera Tablets women may experience a delay before they are able to become pregnant.
- What Provera Tablets are and what they are used for
- Gallstones
- Systemic lupus erythematosus (SLE) = an allergic condition which causes joint pain, skin rashes and fever
What you need to know before you take Provera Tablets
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
Driving and using machines
3. How to take Provera Tablets
No effect on the ability to drive or use machines has been seen with Provera.
- Hearing problems
4. Possible side effects
Taking Provera when you have amenorrhoea (when you are not having periods)
Medicines for thinning the blood (e.g. warfarin) Medicines for treating convulsions (e.g. phenobarbital, phenytoin and carbamazepine)
Provera, especially in high doses, may cause weight gain and fluid retention.
- 5. How to store Provera Tablets
- 6.
Contents of the pack and other information
Provera contain lactose monohydrate, sucrose and sunset yellow (E110)
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
Ritonavir and nelfinavir, sometimes used to treat HIV and AIDS
Lactose monohydrate and sucrose are types of sugar.
PAA142483 menstrual cycle. Repeat the treatment for 3 consecutive cycles.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
These are symptoms of a deep-vein thrombosis (DVT):
Uncommon: may affect up to 1 in 100 people
The other ingredients are:
5. How to store Provera Tablets
Facial hair growth
2.5 mg: Lactose monohydrate, sucrose, maize starch,
Keep this medicine out of the sight and reach of children.
- You have severe pain, tenderness or swelling in your calf, ankle or foot
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).
liquid paraffin, talc, calcium stearate, sunset yellow (E110), purified water.
- milky discharge from the breast when not pregnant or breastfeeding
Possible side effects
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.
Like all medicines, this medicine can cause side effects, although not everyone gets them.
You have purple discolouration of the skin of the leg or the skin becomes red and warm to touch
oedema/fluid retention
5 mg: Lactose monohydrate, starch, sucrose, liquid
Reasons for stopping Provera treatment immediately
Not known: frequency cannot be estimated from the available data
paraffin, calcium stearate, talc, the colour FD & C Blue No. 2 Aluminium Lake, purified water.
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.
Tell your doctor if you get any other side effects reported with Provera which may include the following:
For the blister and carton presentation, do not store your tablets above 25°C.
- severe allergic reaction (anaphylactic reaction)
Taking Provera for endometriosis (where tissue from your womb is found outside your womb)
10 mg: Lactose monohydrate, sucrose, maize starch,
swelling in face/throat which may cause difficulty breathing
liquid paraffin, talc, calcium stearate, purified water.
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.
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.
Very common: may affect more than 1 in 10 people
- delayed egg release with longer menstrual cycle (periods)
headache
Provera contain lactose monohydrate, sucrose and sunset yellow (E110).
- feeling sick
- drowsiness
- unexpected or unusual vaginal bleeding or spotting
swelling in the veins due to blood clots
Marketing Authorisation Holder and Manufacturer
If you get any of the following symptoms, you should stop taking the tablets and see your doctor immediately.
6. Contents of the pack and other information
If you do not have a period after you finish a course of Provera, check with your doctor in case you are pregnant.
- tenderness or swelling in your calf, ankle or foot
Common: may affect up to 1 in 10 people
Marketing Authorisation Holder: Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom.
- rash
severe allergic reaction to the drug (e.g. wheezing, difficulty breathing)
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.
- stopping or extended break of your periods
- abnormality of cervix
These are symptoms of a blood clot in the lungs which may all occur together:
- depression
If you forget to take Provera
- decreased sugar tolerance
difficulty sleeping
Manufacturer: Pfizer Italia S.r.l., Località Marino del Tronto, 63100 Ascoli Piceno (AP), Italy.
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.
- weight decrease
- Sudden, severe, sharp pain in your chest
nervousness
Provera 5mg tablets are blue and are available in packs of 10, 20 or 100 tablets or in bottles containing 100 tablets.
- Coughing up blood
dizziness
Reporting of side effects
Company Contact Address:
- You suddenly become short of breath
hair loss
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 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.
For further information on your medicine, please contact Medical Information, Pfizer Limited, Walton Oaks, Dorking Road, Tadworth, Surrey, KT20 7NS, UK. Telephone: 01304 616161.
- Your heart beats more rapidly
acne
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.
If you take more Provera than you should
- nettle rash or hives
These can be symptoms of a blood clot in the brain (‘a stroke’):
If you take too many tablets, contact your doctor straight away.
- itchy skin
- vaginal discharge
You have an unusually severe or long headache
Not all pack sizes may be marketed.
breast pain
This leaflet was last revised in 09/2019
If you stop taking Provera
Your sight is affected in any way
breast tenderness
What Provera Tablets contains
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.
You find it difficult to speak
fever
Ref: PV LD 10_0
The active substance is medroxyprogesterone acetate. Each tablet contains either 2.5mg, 5mg or 10mg medroxyprogesterone acetate.
You collapse or faint
- tiredness
Any part of your body feels weak or numb
- weight increase