Provera 10mg Tablets
PATIENT INFORMATION LEAFLET PROVERA® 5mg TABLETS / PROVERA® 10mg TABLETS (medroxyprogesterone acetate)
This product is available using any of the above names but will be referred to as Provera Tablets throughout the following leaflet. Please note Provera Tablets is also available in other strengths (Provera 2.5mg Tablets).
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 T ablets 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
1. WHAT PROVERA TABLETS ARE AND WHAT THEY ARE USED FOI
• Provera Tablets are one of a group of medicines called 'progestogens'. Progestogens are similar to the natural female hormone progesterone. Provera Tablets contain the progestogen called medroxyprogesterone acetate as the active ingredient.
• 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)
2. 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 Provera Tablets (see Section 6 'Further information' for more details)
• 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)
Take special care with Provera Tablets
Tell your doctor if you have any of the following conditions to help him or her decide if Provera Tablets 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 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.
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 2.5mg 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 T ablets may be altered when they are taken at the same time:
• 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
Tell your doctor or pharmacist if you are taking any other medicines not listed above, including those bought without a prescription.
Pregnancy
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 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 Tablets.
3. HOW TO TAKE PROVERA TABLETS
You should follow your doctor's instructions carefully. 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 after your last period began. A few days after you stop taking the tablets you will usually have bleeding like a period.
To stop your periods causing problems again, your doctor may tell you to repeat this dose of Provera Tablets during your next cycle. 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.
Taking Provera Tablets 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 of your menstrual cycle. A few days after you stop taking the tablets you will usually have bleeding like a period.
Your treatment will be repeated for three cycles. In some cases, your doctor may also prescribe oestrogen to be taken at the same time as Provera T ablets at doses of 5-10mg for 10 days.
Taking Provera Tablets for endometriosis
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.
What do I do if I forget to take a tablet?
T ake the tablet as soon as you remember, and carry on taking the tablets at the normal times.
What if I take too many tablets at once?
If you take too many tablets, contact your doctor straight away. Make sure that nobody else takes your tablets.
4. POSSIBLE SIDE EFFECTS
Like all medicines Provera Tablets 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 could all be warning signs of thrombosis (a blood clot) which will need urgent treatment.
• Sudden, severe, sharp pain in your chest
• Coughing up blood
• You suddenly become short of breath
• Your heart beats more rapidly
These are symptoms of a blood clot in the lungs
• 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 can be symptoms of a blood clot in the brain ('a stroke')
• 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 These are symptoms of a deep-vein thrombosis (DVT).
Other side effects
You can also get the following side effects with medicines like Provera Tablets:
Effects on the reproductive system and breasts: breast pain and tenderness, a milky discharge from the breast when not pregnant or breast-feeding (galactorrhoea).
Effects on the nervous system: headache, depression, dizziness, fatigue, difficulty sleeping, feeling sleepy, nervousness.
Effects on the stomach and intestines: feeling sick.
Effects on your heart and circulation: blood clots, including clots in the lung, and swelling in the veins due to blood clots, stroke, heart attacks.
Effects on your skin, nose, throat or hair: generalised itching, rash, hives, acne, excessive hair growth on the face or body, hair loss.
Miscellaneous: fluid retention and swelling of hands and ankles, weight changes, decreased tolerance to sugars like glucose.
If you experience any of the above side effects or notice any other unusual effects not mentioned in the leaflet, tell your doctor at once.
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.
By reporting side effects, you can help provide more information on the safety of this medicine.
5. STORING PROVERA TABLETS
• Keep the tablets out of the sight and reach of children.
• Provera Tablets should not be used after the expiry date printed on the carton or blister strip.
• Do not store your tablets above 25°C and keep your blister strips securely in the outer carton.
• If the tablets become discoloured or show signs of any deterioration, you should seek the advice of your pharmacist.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Provera Tablets looks like and contents of the pack
Provera 5mg tablets are blue tablets scored on one side, with '286' either side of the score and marked ‘U’ on the other side.
Provera 10mg tablets are white, round tablets scored on one side and ‘UPJOHN 50' on the other side. Provera Tablets are available in packs of 10 and 30 tablets.
What Provera Tablets contain
The active ingredient is medroxyprogesterone acetate. In addition to the active ingredient, the tablets also contain the following inactive ingredients:
5 mg: Lactose, sucrose, liquid paraffin, calcium stearate, talc, starch, the colour FD & C Blue No. 2 Lake.
10 mg: Lactose, sucrose, liquid paraffin, calcium stearate, talc, maize starch.
PL No: 29510/0016 Provera 10mg Tablets |POM|
PL No: 29510/0017 Provera 5mg Tablets
This product is manufactured by Pfizer Italia S.r.l. - Ascoli Piceno Plant, Via del Commercio - Zona Industriale, 63046 Marino del Tronto, Italy OR Pharmacia Italia S.p.A- Ascoli Piceno Plant, Via del Commercio- Zona Industriale, 63046, Marino del Tronto, Italy OR Pfizer Italia S.r.l., Localita Marino del Tronto, 63100 Ascoli Piceno, Italy. Procured within the EU by the Product License holder: Pharma-XL Ltd, Colonial Way, Watford, Herts, WD24 4PR and repackaged by OPD Laboratories Ltd, Colonial Way, Watford, Herts, WD24 4PR.
Provera is a Registered Trademark of Pharmacia Ltd., UK.
Leaflet revision and issue date (ref): 12.06.2014.
To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.