Patient leaflet - Provera 10 mg tablets
1. What Provera Tablets are and what they are used for
- Provera Tablets contain 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 Tablets have several uses. You can take Provera Tablets 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 Tablets 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 Tablets 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 or have ever had any of the following conditions to help them decide if Provera Tablets is suitable for you:
- Epilepsy
- Migraine headaches
- Asthma
- Heart problems
- Kidney problems
- Diabetes
- A meningioma (a usually benign tumour that forms in the layers of tissue that cover your brain and spinal cord)
- 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 Tablets, especially in high doses, may cause weight gain and fluid retention.
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 Tablets. You are more likely to get a clot whether or not you are taking Provera Tablets 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 Tablets. Section 4 of this leaflet ‘Possible side effects’, also has more information on the warning signs of blood clots.
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.
The effect of Provera Tablets 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 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
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 Tablets 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 Tablets, as it is not a contraceptive.
Breast-feeding
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.
Fertility
After finishing treatment with Provera Tablets women may experience a delay before they are able to become pregnant.
Driving and using machines
No effect on the ability to drive or use machines has been seen with Provera Tablets.
Provera Tablets 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 Tablets 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 Tablets 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).
608-7902 L-02-2656-01
Taking Provera Tablets 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 Tablets for 10 days. A few days after you stop taking the tablets, you may have bleeding like a period (breakthrough bleeding).
Taking Provera Tablets 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 Tablets, check with your doctor in case you are pregnant.
If you forget to take Provera Tablets
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 Tablets than you should
If you take too many tablets, contact your doctor straight away.
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 side effects, although not everyone gets them.
Reasons for stopping Provera Tablets treatment immediately
Rarely, Provera Tablets 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 Tablets 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
- 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.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.
5. How to store Provera Tablets
Keep out of the sight and reach of children.
Provera tablets should not be used after the expiry date which is stated on carton and blister strip after EXP. The expiry date refers to the last day of that month.
Do not store above 25°C.
If your medicine shows any signs of deterioration or discolouration, consult your doctor or pharmacist for advice. If damaged, please tell your doctor or pharmacist.
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 contain
The active substance is medroxyprogesterone acetate.
Each tablet contains 10mg medroxyprogesterone acetate.
The other ingredients are: lactose monohydrate, sucrose, maize starch, liquid paraffin, talc, calcium stearate.
What Provera Tablets look like and contents of the pack
Provera 10mg Tablets are round, white tablets embossed “UpJohn 50” one side and a score line on the other.
Each blister contains 10 tablets.
Available in packs of 10, 90 and 100 tablets.
Manufactured by: Pfizer Italia S.r.l. Localitá Marino del Tronto, 63100 Ascoli Piceno, Italy. Procured from within the EU. Product Licence Holder: Quadrant Pharmaceuticals Limited, Lynstock House, Lynstock Way, Lostock, Bolton, BL6 4SA. Repackaged by: Maxearn Limited, Unit 29, Oakhill Trading Estate, Devonshire Road, Worsley, Manchester, M28 3PT.
PL 20774/2656 Provera 10 mg Tablets
Provera is a registered trademark.
Leaflet revision date 1st June 2026
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Contact Quadrant Pharmaceuticals Ltd, Tel: 01204 471269
608-7902 L-02-2656-01