Patient Information Leaflet

PROVERA 100 mg tablets, 250 mg tablets

Medroxyprogesterone acetate
Please 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 give it to other people, even if they have the same symptoms as you, because it could be harmful.
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Provera is and what it is used for
What you need to know before taking Provera
How to take Provera
Possible side effects
How to store Provera
Contents of the pack and other information

1. What Provera is and what it is used for

Provera contains the active substance medroxyprogesterone acetate. Medroxyprogesterone belongs to a group of medicines called progestins, which act by slowing the growth of certain hormone-sensitive tumours.
Provera is used:

for the treatment of cancer of the tissue lining the inner wall of the uterus (endometrial cancer), kidney cancer, and breast cancer in women who no longer have menstrual periods (post-menopausal). Provera is used in combination with other medicines when these cancers have spread to various parts of the body (metastases) or when they no longer respond to specific treatments.
in cases of excessive weight loss and marked reduction in normal body functions during advanced stages of cancer or in AIDS, a serious disease of the immune system.

2. What you should know before taking Provera

Do not take Provera:

if you are allergic to medroxyprogesterone or to any of the other ingredients of this medicine (listed in section 6);
if you are or think you may 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 diagnosed that you have a breast or genital organ tumour in its early stages.

Warnings and precautions
Talk to your doctor or pharmacist before taking Provera if you think any of the following conditions apply to you, as some of these conditions may require that your doctor performs regular check-ups while you are taking this medicine:

you have heavy vaginal bleeding, but do not know the cause. You must undergo medical examinations to determine the cause of this condition before taking Provera (see section Do not take Provera);
you have or have previously had fluid retention (oedema);
you have or have previously had depression;
you have diabetes or an intolerance to certain sugars;
you have high levels of calcium in the blood due to a tumour that has spread to the bones;
you have kidney problems (renal insufficiency);
you have liver problems (see section Do not take Provera);
you are a pre-menopausal woman, because taking this medicine may mask the end of your fertile period. Inform your doctor if any of the following conditions appear or worsen during treatment with this medicine (see also section 4 Possible side effects):
sudden partial or complete loss of vision, protruding eyes, double vision, or new-onset migraine. Immediately stop taking Provera and have an ophthalmological examination before restarting this medicine;
sudden swelling and pain in the limbs, especially in the legs, or sudden onset of chest pain and difficulty breathing. These may be symptoms of blood clot formation in the veins (thrombosis), or of these clots travelling to the lungs and blocking another blood vessel (thromboembolism). Immediately stop taking Provera and consult your doctor;
Cushing's syndrome, a disorder that may present with some or all of the following symptoms: fatigue or easy tiredness, rapid weight gain and obesity (especially in the trunk and face), loss of sexual desire, impotence, frigidity, increased blood pressure (arterial hypertension), menstrual cycle disturbances (dysmenorrhoea), cessation of menstruation (amenorrhoea), abnormal hair growth (hirsutism), sudden mood changes (depression, nervousness, irritability), skin problems such as red-purple striae, particularly on the hips, abdomen and lower limbs, increased sebum production (oily skin and/or hair), bone and joint pain, prolonged wound healing time, or increased susceptibility to infections.
During treatment with Provera, your doctor may advise you to take adequate amounts of calcium and vitamin D and to undergo regular tests to assess bone condition (bone mineral density tests), especially if you need to take this medicine for a prolonged period.

Laboratory tests

If you have been advised to go to a specialized laboratory for tests involving tissue biopsies from the uterus, you must inform the laboratory staff that you are taking Provera, as use of this medicine may alter 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, as use of this medicine may alter the levels of certain hormones in the blood.

Other medicines and Provera
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
It is particularly important that you inform your doctor if you are taking medicines containing aminoglutethimide, a substance used in the treatment of advanced breast or prostate cancer, as these may reduce the effectiveness of Provera.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
Provera must not be used during pregnancy (see section Do not take Provera), because taking this medicine during the first 3 months of pregnancy may cause genital malformations in the fetus. If you become pregnant while using this medicine, you must immediately stop taking Provera and consult your doctor.

Breastfeeding
Medroxyprogesterone acetate, the active substance in Provera, passes into breast milk. Since its effect on the infant is unknown, consult your doctor before taking this medicine during breastfeeding.

Driving and using machines
It is not known whether Provera affects the ability to drive or use machinery. If you have any doubts, consult your doctor or pharmacist.

3. How to take Provera

Take this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.

Endometrial (lining tissue of the uterus) and kidney cancer The recommended dose is 200 mg to 400 mg per day.
Breast cancer The recommended minimum dose is 400 mg per day.

Your doctor will advise you on the most appropriate duration of treatment with Provera.
Treatment may require 8–10 weeks before effects are observed.
Treatment with Provera should be discontinued if there is rapid progression of the disease during
administration of this medicine.

Significant weight loss and marked reduction in normal body functions in advanced stages of cancer or in severe immunodeficiency disease known as AIDS The recommended dose is 1000 mg per day (taken in one or two doses)

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 how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Stop taking this medicine and contact your doctor immediately if you experience any of the following side effects, as they may be serious (see section 2, Warnings and precautions):

severe allergic reaction (e.g. anaphylactic shock);
swelling of the face, tongue, and throat, which may cause difficulty swallowing or breathing (angioedema);
sudden partial or total loss of vision, protruding eyes, double vision, or headache;
sudden swelling and pain in the limbs, especially in the legs, or sudden onset of chest pain and breathing difficulties. These may be symptoms of blood clots forming in the veins (thrombosis);
stroke. Symptoms of a stroke may include:
speech disturbances
loss of strength on one side of the body (half of the face, arm, and leg, on the right or left side)
tingling sensations or loss of sensation on one side of the body
impaired vision in one half of the visual field
uncoordinated movements, loss of balance, dizziness
severe and sudden headache
Other symptoms not listed in this leaflet may also occur. If you, or someone near you, suspects a stroke is occurring, go immediately to the hospital emergency department.
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 in the ankles and/or legs (oedema)
fatigue

Uncommon (may affect up to 1 in 100 people):

corticosteroid-like effects, 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, leading to thrombus formation
diarrhoea
dry mouth
acne
abnormal growth of body hair (hirsutism)
abnormal vaginal bleeding (irregular, increased, or decreased)
breast pain
muscle spasms

Rare (may affect up to 1 in 1,000 people):

hypersensitivity
nervousness
somnolence
yellowish discoloration of the skin, the white part of the eye, and the oral mucosa (jaundice)
patchy hair loss (alopecia)
skin rash
malaise
fever
altered blood glucose levels (glycaemia) following a glucose tolerance test. This condition is known as “impaired glucose tolerance”
high blood pressure (arterial hypertension)

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

prolonged absence of ovulation
confusion
loss of concentration
hand tremors, sweating, nocturnal leg cramps (adrenergic-like effects)
visual damage due to blockage of an artery supplying blood to the eye (retinal embolism and thrombosis)
cataract (as a complication of diabetes)
visual disturbances
rapid heartbeat (tachycardia)
heightened awareness of your heartbeat (palpitations)
urticaria, itching
presence of sugar in the urine
absence of menstruation (amenorrhoea)
ulcers of the mucosa in the lower part of the uterus (cervix)
discharge from the cervix (lower part of the uterus)
abnormal milk secretion from the breasts even when not in the breastfeeding period
impotence (in young males with AIDS)
altered liver function test results
increased number of white blood cells and platelets

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, speak to your doctor or pharmacist. You can also report side effects directly via 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 carton and container after
"Expiry". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Provera contains
The active substance 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 components are: microcrystalline cellulose, maize starch, sodium benzoate, magnesium stearate,
macrogol 400, sodium starch glycolate, sodium docusate, gelatin (Byco C).

Description of the appearance of Provera and package contents
The 100 mg Provera tablets are round, flat, white tablets, engraved on one side and marked "U 467" on the other side. The tablets are available in glass bottles containing 50 tablets.
The 250 mg Provera tablets are round, flat, white tablets, engraved on one side and marked "U 403" on the other side. The tablets are available in glass bottles containing 30 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization 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)