Provera 10mg Tablets
Ref: 1219/280415/1/F
Provera®10mg Tablets
(medroxyprogesterone acetate)
Patient Information 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.
Your medicine is called Provera 10mg Tablet but will be referred to as Provera Tablets throughout this leaflet. Please note that the leaflet also contains information about other strengths of the medicine, Provera 2.5mg and Provera 5mg
In this leaflet:
What Provera Tablets are and what they are used for ^ Before you take Provera Tablets ,3 How to take Provera Tablets Possible side effects ^ Storing Provera Tablets ^ Further information
^ What Provera Tablets are and what they are used for
* 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:
- 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)
Before you take Provera Tablets
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 :
* 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
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
* 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. 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:
* 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 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 (eg 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.
^ 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 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 during your next cycle. 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.
Taking Provera 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 at doses of 5-10mg for 10 days.
Taking Provera 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.
Provera® 10mg Tablets
(medroxyprogesterone acetate)
Patient Information Leaflet (continued)
If you do not have a period after you finish a course of Provera, check with your doctor in case you are pregnant.
What do I do if I forget to take a tablet?
Take 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.
[a Storing Provera Tablets
Keep 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 above 25°C.
If your tablets become discoloured or show any other signs of deterioration, consult your pharmacist (chemist) who will tell you what to do
Tablets should not be thrown in your bin or put down the drain. If they are out of date, or no longer suitable for you, return them to your pharmacist.
Possible side effects
Like all medicines Provera can cause side effects, although not everyone gets them.
Reasons for stopping Provera treatment immediately
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 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:
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.
[a Further information
What Provera Tablets contain
Each tablet contains 10mg of medroxyprogesterone acetate as the active ingredient.
Provera Tablets also has the following inactive ingredients: lactose, sucrose, maize starch, liquid paraffin, talc, calcium stearate and purified water.
What Provera looks like and contents of the pack
Provera Tablets are a white, round tablet, embossed with UPJOHN 50 on one side and a break line on the other side.
Provera Tablets comes in packs of 30, 90 and 100 Tablets.
Manufacturer and Licence Holder
The tablets are manufactured by Pfizer Italia S.r.L., Via del Commercio -63100 Marino del Tronto, Ascoli Piceno, Italy and are procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire,
B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.
POM PL 15184/1219 Provera 10mg Tablets
Provera is a registered trademark of Pharmacia Limited.
Revision date: 28/04/15
Blind or partially sighted?
Is this leaflet hard to see or read?
Phone Lexon (UK) Limited, Tel: 01527 505414 for help.
Medroxyprogesterone Acetate 10mg Tablets
Patient Information 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.
Your medicine is called Medroxyprogesterone Acetate 10mg Tablet but will be referred to as Medroxyprogesterone Tablets throughout this leaflet. Please note that the leaflet also contains information about other strengths of the medicine, Medroxyprogesterone Acetate 2.5mg and Medroxyprogesterone Acetate 5mg
In this leaflet:
^ What Medroxyprogesterone Tablets are and what they are used for Before you take Medroxyprogesterone Tablets How to take Medroxyprogesterone Tablets [4) Possible side effects
Storing Medroxyprogesterone Tablets Further information
[1) What Medroxyprogesterone Tablets are and what they are used for
* Medroxyprogesterone Tablets are one of a group of medicines called ‘progestogens'.
Progestogens are similar to the natural female hormone progesterone. Medroxyprogesterone contains the progestogen called medroxyprogesterone acetate as the active ingredient.
* Medroxyprogesterone has several uses. You can take Medroxyprogesterone 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)
Before you take Medroxyprogesterone Tablets
Medroxyprogesterone 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 Medroxyprogesterone if you :
* are allergic to medroxyprogesterone acetate or other similar hormone medicines, or to any of the other ingredients of Medroxyprogesterone 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 Medroxyprogesterone
Tell your doctor if you have any of the following conditions to help him or her decide if Medroxyprogesterone 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 edroxyprogesterone. You are more likely to get a clot whether or not you are taking Medroxyprogesterone 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 Medroxyprogesterone. 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 Medroxyprogesterone Tablets
Medroxyprogesterone 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 Medroxyprogesterone 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
Medroxyprogesterone 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 (eg a condom) while taking Medroxyprogesterone, 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 Medroxyprogesterone.
How to take Medroxyprogesterone 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 Medroxyprogesterone 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 Medroxyprogesterone during your next cycle. In some cases, your doctor may also prescribe oestrogen to be taken at the same time as Medroxyprogesterone at doses of 5-10mg for 10 days.
Taking Medroxyprogesterone 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 Medroxyprogesterone at doses of 5-10mg for 10 days.
Medroxyprogesterone Acetate 10mg Tablets
Patient Information Leaflet (continued)
Taking Medroxyprogesterone 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 Medroxyprogesterone, check with your doctor in case you are pregnant.
What do I do if I forget to take a tablet?
Take 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.
Possible side effects
Like all medicines Medroxyprogesterone can cause side effects, although not everyone gets them.
Reasons for stopping Medroxyprogesterone treatment immediately
Rarely, Medroxyprogesterone 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 Medroxyprogesterone:
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.
Storing Medroxyprogesterone Tablets
Keep out of the sight and reach of children.
Medroxyprogesterone tablets should not be used after the expiry date printed on the carton or blister strip.
Do not store above 25°C.
If your tablets become discoloured or show any other signs of deterioration, consult your pharmacist (chemist) who will tell you what to do
Tablets should not be thrown in your bin or put down the drain. If they are out of date, or no longer suitable for you, return them to your pharmacist.
[m Further information
What Medroxyprogesterone Tablets contain
Each tablet contains 10mg of medroxyprogesterone acetate as the active ingredient.
Medroxyprogesterone Tablets also has the following inactive ingredients: lactose, sucrose, maize starch, liquid paraffin, talc, calcium stearate and purified water.
What Medroxyprogesterone looks like and contents of the pack
Medroxyprogesterone Tablets are a white, round tablet, embossed with UPJOHN 50 on one side and a break line on the other side. Medroxyprogesterone Tablets comes in packs of 30, 90 and 100 Tablets.
Manufacturer and Licence Holder
The tablets are manufactured by Pfizer Italia S.r.L., Via del Commercio -63100 Marino del Tronto, Ascoli Piceno, Italy and are procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire,
B98 0RE.
If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.
[POM1 PL 15184/1219 Medroxyprogesterone Acetate 10mg Tablets Revision date: 28/04/15