Provera 10mg Tablets
1. What Provera Tablets are and what they are used for
2. Before you take Provera Tablets
PACKAGE LEAFLET: INFORMATION FOR THE USER PROVERA® 10mg tablets
(medroxyprogesterone acetate)
Your medicine is available as the above name but will be
referred to as Provera throughout this leaflet.
This product is available in multiple strengths and all strengths
will be referred to throughout this leaflet.
Read all of this leaflet carefully before you start using this
medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, please ask your doctor or pharmacist.
- This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet
1. What Provera Tablets are and what they are used for
2. Before you take Provera Tablets
3. How to take Provera Tablets
4. Possible side effects
5. Storing Provera Tablets
6. Further information
• Provera Tablets are one of a group of medicines called 'progestogens'. Progestogens are similar to the natural female hormone progesterone. Provera contains the progestogen called medroxyprogesterone acetate as the active ingredient.
• Provera has several uses. You can take Provera to treat or manage:
o Heavy periods o Painful periods
o Irregular periods or periods that are more frequent than normal o Absence of periods
o Mild to moderate endometriosis (where tissue from your womb is found outside your womb)
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:
o are allergic to medroxyprogesterone acetate or other similar hormone medicines, or to any of the other ingredients of Provera tablets (see Section 6 'Further information' for more details) o 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. o have now or have had in the past breast cancer o have now or have had in the past blood clots forming in your veins (venous thrombosis) o have now or have had in the past blood clots forming in your arteries (arterial thrombosis) o have liver problems
o 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)
Take special care with Provera
Tell your doctor if you have any of the following conditions to
help him or her 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
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
• h ave 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.
Important information on some of the ingredients of Provera Tablets
Provera Tablets contain lactose and sucrose which 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.
Taking other medicines
Tell your doctor or pharmacist if you are taking any of the following medicines, as the effect of Provera may be altered when they are taken at the same time:
o Aminoglutethimide, sometimes used in Cushing's Syndrome o Medicines for thinning the blood (e.g. warfarin) o Medicines for treating convulsions (e.g. phenobarbital, phenytoin and carbamezapine) o Ritonavir and nelfinavir, sometimes used to treat HIV and AIDS
o Medicines for treating infections (e.g. rifampicin, rifabutin, nevirapine, efavirenz)
o St John's wort, a herbal treatment for depression Tell your doctor or pharmacist if you are taking any other medicines not listed above, including those bought without a prescription.
Pregnancy
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 reliable as 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 machinery
No effect on the ability to drive or use machinery has been seen with Provera.
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