Document: leaflet MAH BRAND_PLPI 20636-1579 change

• leaflet MAH BRAND_PLPI 10383-1746
• leaflet MAH BRAND_PLPI 18799-2528
• leaflet MAH BRAND_PLPI 19488-1278
• leaflet MAH BRAND_PLPI 20636-1579
• leaflet MAH BRAND_PLPI 29510-0017

---

Provera® 5 mg Tablets Provera® 10 mg Tablets

(medroxyprogesterone acetate)

PATIENT INFORMATION LEAFLET

This medicine is available using one of the above names but will be referred to as Provera throughout the leaflet.

Provera Tablets are also available in other strengths.

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 is and what it is used for

2.    Before you take Provera

3.    How to take Provera

4.    Possible side effects

5.    Storing Provera

6.    Further information

1.    WHAT PROVERA IS AND WHAT IT IS USED FOR

-    Provera is 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)

2.    BEFORE YOU TAKE PROVERA

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 (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

Provera contains 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 (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.

3. HOW TO TAKE PROVERA

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.

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.

4.    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 breastfeeding (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.

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

Provera should not be used after the expiry date printed on the carton or blister strip.

Do not store above 25^oC. Store in the original pack.

As with all medicines, keep the tablets out of the sight and reach of children.

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.

If your tablets become discoloured or show any other signs of deterioration, consult your pharmacist who will tell you what to do.

6.    FURTHER INFORMATION

What Provera looks like and contents of the pack

Provera 5mg tablets are available as blue round tablets, marked ‘206 scoreline 206' on one side and ‘U' on the other side.

Provera 10mg tablets are available as white round biconvex tablets, marked ‘upjohn 50' on one side and scoreline on the other side.

Provera comes in blister strip packs of 30 tablets.

What Provera contains

Each Provera tablet contains either 5mg or 10mg of the active ingredient medroxyprogesterone acetate.

There are also inactive ingredients in the tablets. These are sucrose, maize starch, lactose, liquid paraffin, calcium stearate and talc.

5mg tablets also contain indigo carmine (E132).

Manufacturer and Production Licence holder:

Manufactured by Pfizer Italia S.r.l., 63046 Marino del Tronto, Ascoli Piceno, Italy. Procured from within the EU by the Product Licence holder Star Pharmaceuticals Ltd, 5 Sandridge Close, Harrow, Middlesex, HA1 1XD. Repackaged by Servipharm Ltd.

Leaflet revision and issue date (Ref) 26.05.15[14] Provera is a registered trademark of Pharmacia Ltd.