PROVERA 250 mg Coated Tablets

Зміст інструкції

1. PROVERA 100 mg tablets, 250 mg tablets
   1. What is Provera and what is it used for
   2. What you need to know before taking Provera
   3. How to take Provera
   4. Possible side effects
   5. How to store Provera
   6. Contents of the pack and other information

PROVERA 100 mg tablets, 250 mg tablets

Medroxyprogesterone acetate

Read this leaflet carefully before taking this medicine because it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Provera is and what it is used for
• 2. What you need to know before you take Provera
• 3. How to take Provera
• 4. Possible side effects 5 How to store Provera
• 6. Contents of the pack and other information

1. What is Provera and what is it used for

Provera contains the active ingredient medroxyprogesterone acetate. Medroxyprogesterone belongs to a
group of medicines called progestins that work by slowing the growth of certain hormone-sensitive
tumors.
Provera is used:

• for the treatment of cancer of the tissue that lines the inner wall of the uterus (endometrial cancer), kidney cancer and breast cancer in women who no longer have menstrual periods (post-menopause). Provera is used in combination with other medicines when these tumors have spread to multiple areas of the body (metastases) or when they no longer respond to specific treatments.
• in case of excessive weight loss and significant reduction of normal bodily functions in advanced stages of cancer or in AIDS, a serious disease of the immune system.

2. What you need to know before taking Provera

Do not take Provera:

• if you are allergic to medroxyprogesterone or any of the other ingredients of this medicine (listed in section 6);
• if you are or think you might be pregnant (see section Pregnancy and breastfeeding);
• if you have experienced vaginal bleeding and do not know the cause;
• if you have severe liver problems (hepatic insufficiency);
• if your doctor suspects or has confirmed that you have breast or genital cancer in its early stages.

Warnings and precautions
Talk to your doctor or pharmacist beforetaking Provera if you think that any of the following conditions apply to you, because some of these conditions may require your doctor to perform frequent
checks while you are taking this medicine:

• if you have heavy vaginal bleeding, but do not know the cause. You should undergo medical examinations to determine the cause of this disorder before taking Provera (see section Do not take Provera);
• if you have or have ever suffered from fluid retention;
• if you have or have ever suffered from depression;
• if you have diabetes or an intolerance to certain sugars;
• if you have high levels of calcium in the blood due to a cancer that has spread to the bones;
• if you have kidney problems (renal insufficiency);
• if you have liver problems (see section Do not take Provera);
• if you are a pre-menopausal woman, because taking this medicine may mask the end of your fertile period. Tell your doctor if any of the following conditions occur or worsen duringtaking this medicine (see also section 4 Possible side effects):
• sudden partial or total loss of vision, bulging eyes, double vision or migraine headaches that you did not have before. Stop taking Provera immediatelyand have an eye examination before starting to take this medicine again;
• sudden swelling and pain in the limbs, especially the legs, or sudden chest pain and difficulty breathing. These may be symptoms of blood clots forming in the veins (thrombosis), or of these clots traveling to the lungs, where they become lodged and block another blood vessel (pulmonary embolism). Stop taking Provera immediatelyand see your doctor;
• Cushing's syndrome, a disorder that can manifest with some or all of the following symptoms: o fatigue or easy tiredness o rapid weight gain and obesity, especially on the trunk and face o loss of sexual desire, impotence, frigidity o increased blood pressure (hypertension) o changes in the menstrual cycle (dysmenorrhea) o cessation of the menstrual cycle (amenorrhea) o abnormal hair growth (hirsutism) o sudden changes in mood (depression, nervousness, irritability) o skin problems, such as reddish-purple stretch marks especially on the hips, abdomen and lower limbs and increased sebum production (oily skin and/or hair) o bone and joint pain o prolonged time to heal wounds o increased susceptibility to infections Duringtaking Provera, your doctor may advise you to take adequate amounts of calcium and vitamin D and to undergo regular examinations to assess the condition of your bones (bone mineral density tests), especially if you need to take this medicine for a long period of time.

Laboratory tests

• If you have been advised to go to a specialized laboratory for tests based on biopsies of tissue samples from the uterus, you must inform the laboratory staff that you are taking Provera because the use of this medicine may alter the test results;
• If you have been advised to have blood tests, you must inform your doctor and/or laboratory staff that you are taking Provera because the use of this medicine may alter the levels of some hormones in the blood.

Other medicines and Provera
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
It is particularly important that you tell your doctor if you are taking medicines containing aminoglutethimide, a substance used for the treatment of advanced breast or prostate cancer, because they can
decrease the effectiveness of Provera.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Provera should not be used during pregnancy (see section Do not take Provera) because taking this medicine during the first 3 months of pregnancy can cause birth defects of the fetal genital tract. If you become pregnant while using it, you should immediately stop taking Provera and
consult your doctor.
Breastfeeding
Medroxyprogesterone acetate, the active ingredient of Provera, passes into breast milk. As its effect on the infant is not known, ask your doctor for advice before taking this medicine during
breastfeeding.

Driving and operating machinery
It is not known whether Provera affects the ability to drive or operate machinery. If you have any doubts, ask your doctor or pharmacist.

3. How to take Provera

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.

• Endometrial (internal uterine lining tissue) and kidney cancerThe recommended dose is from 200 mg to 400 mg per day.
• Breast cancerThe minimum recommended dose is 400 mg per day.

Your doctor will advise you on the most suitable duration of treatment with Provera. The treatment
may require 8-10 weeks before effects are observed.
Therapy with Provera must be discontinued in case of rapid disease progression during
taking this medicine.

• Excessive weight loss and significant reduction of normal body functions in cases ofadvanced stages of cancer or severe disease of the immune system called AIDSThe recommended dose is 1000 mg per day (taken in one or two administrations per day)

If you take more Provera than you should
If you take too many Provera tablets, contact your doctor immediately.
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
manifest.

Stoptreatment with this medicine and contact your doctor immediatelyif you experience the
following side effects because they can be serious(see section 2 Warnings and precautions):

• severe allergic reaction (such as anaphylactic shock);
• swelling of the face, tongue and throat, which can cause problems with swallowing and breathing (angioedema);
• sudden partial or total loss of vision, bulging eyes, double vision or headache;
• sudden swelling and pain in the limbs, especially the legs, or sudden chest pain and difficulty breathing. These may be symptoms of blood clots forming in the veins (thrombosis);
• stroke. The symptoms of a stroke can be:
• speech disturbances
• loss of strength in half of the body (half of the face, arm and leg, on the right or left side)
• tingling or loss of sensation in half of the body
• blurred vision in one half of the visual field
• clumsy movements, loss of balance, dizziness
• severe and sudden headache if you or someone near you suspects that a stroke is occurring, go to the emergency roomof a hospital immediately.
• Sudden chest pain, as it may be a symptom of a heart attack or pulmonary embolism;
• heart problems (congestive heart failure).

Other side effects:
Common(may affect up to 1 in 10 people):

• change in body weight
• increased appetite
• insomnia
• headache
• dizziness
• tremors
• vomiting, constipation, nausea
• excessive sweating
• impotence
• fluid retention in the body, swelling in various parts of the body, especially the ankles and/or legs (edema)
• fatigue

Not common(may affect up to 1 in 100 people):

• effects similar to those of corticosteroids, such as Cushing's syndrome (see section 2 “Warnings and precautions”)
• worsening of diabetes mellitus
• high levels of calcium in the blood
• depression
• euphoria
• change in sexual desire
• inflammation of the veins, especially in the legs, with resulting formation of thrombi
• diarrhea
• dry mouth
• acne
• abnormal hair growth (hirsutism)
• abnormal vaginal bleeding (irregular, increased or decreased)
• breast pain
• muscle spasms

Rare(may affect up to 1 in 1000 people):

• hypersensitivity
• nervousness
• drowsiness
• yellowing of the skin, the white of the eye and the mucous membranes of the oral cavity (jaundice)
• patchy hair loss (alopecia)
• skin rash
• malaise
• fever
• alteration of glucose levels in the blood (glycemia) after performing the glucose tolerance test. This condition is known as “impaired glucose tolerance”
• high blood pressure (hypertension)

Frequency not known(frequency cannot be estimated from available data):

• prolonged absence of ovulation
• confusion
• loss of concentration
• tremors in the hands, sweating, night-time calf cramps (adrenergic-like effects)
• damage to vision due to blockage of an artery that carries blood to the eye (retinal embolism and thrombosis)
• cataract (as a complication of diabetes)
• visual disturbances
• fast heartbeat (tachycardia)
• increased awareness of one's heartbeat (palpitations)
• urticaria, itching
• presence of sugar in the urine
• absence of menstruation (amenorrhea)
• ulcers of the mucous membrane of the lower part of the uterus (cervix)
• discharge from the cervix (the lower part of the uterus)
• abnormal secretion of milk from the breasts even when not breastfeeding
• impotence (in young male AIDS patients)
• alteration of liver function tests
• increased number of white blood cells and platelets

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national reporting system at http://www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Provera

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package and bottle after
“Expiry”. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What containsProvera
The active ingredient is medroxyprogesterone acetate.
Each 100 mg Provera tablet contains 100 mg of medroxyprogesterone acetate.
Each 250 mg Provera tablet contains 250 mg of medroxyprogesterone acetate.
The other ingredients are: microcrystalline cellulose, corn starch, sodium benzoate, magnesium stearate,
macrogol 400, sodium starch glycolate, sodium docusate, gelatin (Byco C).

Description of the appearance of Provera and contents of the pack
Provera 100 mg tablets are round, flat, white tablets scored on one side and with
“U 467” imprinted on the other side. The tablets are available in glass bottles in packs of 50
tablets.
Provera 250 mg tablets are round, flat, white tablets scored on one side and with
“U 403” imprinted on the other side. The tablets are available in glass bottles in packs of 30
tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Pfizer Italia S.r.l.
Via Isonzo, 71
04100 Latina

Manufacturer
Pfizer Italia S.r.l.
Località Marino del Tronto
63100 Ascoli Piceno (AP)