Patient Leaflet Updated 11-Feb-2020 | Pfizer Limited
Provera Tablets 2.5 mg, Provera Tablets 5 mg & Provera Tablets 10 mg
Provera® 2.5mg, 5mg and 10mg Tablets
Medroxyprogesterone acetate
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
You must talk to a doctor if you do not feel better or if you feel worse.
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.
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:
Provera, especially in high doses, may cause weight gain and fluid retention.
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:
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.
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:
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
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.
No effect on the ability to drive or use machines has been seen with Provera.
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.
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.
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).
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).
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.
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 too many tablets, contact your doctor straight away.
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.
Like all medicines, this medicine can cause side effects, although not everyone gets them.
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:
These can be symptoms of a blood clot in the brain (‘a stroke’):
These are symptoms of a deep-vein thrombosis (DVT):
Very common: may affect more than 1 in 10 people
Common: may affect up to 1 in 10 people
Uncommon: may affect up to 1 in 100 people
Not known: frequency cannot be estimated from the available data
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.
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.
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.
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:
Manufacturer:
Company Contact Address:
For further information on your medicine, please contact Medical Information,
This leaflet was last revised in 09/2019
Ref: PV LD 10_0
Ramsgate Road, Sandwich, Kent, CT13 9NJ
+44 (0)1304 616161
+44 (0)1304 616 161
www.pfizermedicalinformation.co.uk