PROVERA 5 mg Tablet

Зміст інструкції

1. PROVERA G 2,5 mg tablets, 5 mg tablets, 10 mg tablets
   1. What is Provera G and what it is used for
   2. What you need to know before taking Provera G
   3. How to take Provera G
   4. Possible side effects
   5. How to store Provera G
   6. Package contents and other information

PROVERA G 2,5 mg tablets, 5 mg tablets, 10 mg tablets

Medroxyprogesterone acetate

Read this leaflet carefully before you start taking this medicine as 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 they have the same symptoms as you, 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 G is and what it is used for
• 2. What you need to know before you take Provera G
• 3. How to take Provera G
• 4. Possible side effects
• 5. How to store Provera G
• 6. Contents of the pack and other information

1. What is Provera G and what it is used for

Provera G contains the active ingredient medroxyprogesterone acetate, which belongs to a group of
medicines called progestins that act like progesterone, a natural sex hormone.
Provera G is used in womenfor:

• counteracting the stimulus of estrogens (a type of hormone) on the inner lining of the uterus (endometrium) when administered to women in menopause as hormone replacement therapy
• treating excessive menstrual blood loss or abnormal uterine bleeding between periods
• treating the absence of menstruation in women of childbearing age.

2. What you need to know before taking Provera G

Do not take Provera G:

• if you are allergic to medroxyprogesterone acetate 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 noticed vaginal bleedingand do not know the cause. You should undergo medical examinations to determine the cause of this condition before taking Provera G;
• if you have severe liver problems;
• if you have (or suspect you may have) a breast tumor, an early-stage tumor of the genital organs, or a type of tumor sensitive to estrogen and progesterone, two female hormones;
• if you have or have ever had a blood clot(thrombus) in a blood vessel in the leg or lung;
• if you suffer from or have ever suffered from inflammation of the veins;
• if you have or have ever had a brain hemorrhage;
• if you have had an internal (without expulsion of the fetus) or incomplete (with incomplete expulsion of the fetus) miscarriage.

Warnings and precautions
Talk to your doctor or pharmacist beforetaking Provera G if you think any of the following conditions
apply to you:

• you suffer from fluid retentionwithin the body. Caution is necessary if you have other conditions that may worsen due to increased fluid in the body;
• you have or have ever suffered from depression;
• you have diabetesor an intolerance to certain sugars;
• you have high levels of calciumin the blood due to a tumor that has spread to the bones;
• you have kidney or liver problems;
• you are a pre-menopausalwoman. Taking this medicine may mask the onset of menopause;
• someone in your family has or has had a tumor;
• you have suffered from jaundice(yellowing of the skin or whites of the eyes) and itchingduring a previous pregnancy;
• you have or have ever had heart problems;
• you have or have ever had lumpsand/or cystsin the breasts;
• you suffer from or have ever suffered from epilepsy;
• you have or have ever had asthma;
• you have or have ever had an ear diseasethat causes hearing loss (otosclerosis);
• you have multiple sclerosis, a disease of the nervous system;
• you have an autoimmune disease called systemic lupus erythematosus.

Immediately stoptaking Provera G if any of the following conditions occur or worsen (see section 4 “Possible side effects”):

• migraineor eye problemssuch as sudden loss of vision (partial or total), bulging eyes and double vision. In this case, you should have an eye examination before starting to take this medicine again;
• formation of blood clotsin the veins. Symptoms may include swelling and pain in a leg, chest pain and difficulty breathing. (see section “Do not take Provera G”).

Further warnings for women who are already postmenopausal
If you are already postmenopausal and take Provera G together with other medicines containing estrogens (female hormones), it may increase the likelihood that you develop one of the following conditions:

• breast cancer;
• heart attack and coronary problems (blood vessels that carry blood to the heart);
• stroke;
• formation of blood clots (thrombi) in blood vessels, especially in the legs and lungs;
• dementia (in women aged 65 years or older);
• ovarian cancer.

Duringtaking Provera G, your doctor may advise you to take adequate amounts of calcium and vitamin D to prevent your bones from becoming brittle.

Laboratory tests
Provera G may alter the results of some medical tests. If you are to undergo blood tests or a uterine tissue examination, you should inform your doctor and/or laboratory personnel that you are being treated with this medicine.

Other medicines and Provera G
Tell 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 a medicine containing

aminoglutethimide(used for the treatment of breast cancer) because it may decrease the effectiveness of Provera G.

Pregnancy and breastfeeding
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Do not take Provera G if you are or think you might be pregnant (see section “Do not take Provera G”)
because this medicine can cause birth defects. If you become pregnant during treatment, you should immediately stoptaking Provera G and consult your doctor.
Breastfeeding
Medroxyprogesterone acetate, the active ingredient of Provera G, passes into breast milk. As its effect on the baby is unknown, ask your doctor for advice before taking this medicine during breastfeeding.

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

Provera G contains lactose and sucrose,two types of sugars. If your doctor has diagnosed you with an intolerance to certain sugars, contact him before taking this medicine.

Provera G 2.5 mg tabletscontainsalso the coloring agent sunset yellow (E110)which may cause allergic reactions.

3. How to take Provera G

Take this medicine following strictly the instructions of the doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Swallow the Provera G tablets whole with a little water. Do not chew or cut the tablets.
The score line is not designed to break the tablet.

• If you take Provera G to counteract the stimulus of estrogens (a type of hormone) on theinner lining of the uterus (endometrium) administered as hormone replacement therapyin postmenopausal womenThe recommended dose is from 5 mg to 10 mg per day for at least 10 days. Each treatment cycle with estrogens lasts 21 days. Start taking Provera G on the 11th day from the start of the estrogen treatment cycle. Withdrawal bleeding (blood loss) normally occurs after 3-7 days from the interruption of treatment with Provera G.
• If you take Provera G for the treatment of excessive menstrual blood loss or ofabnormal uterine bleedingThe recommended initial dose is from 5 mg to 10 mg per day for 10 days. You must start taking Provera G tablets on the 16th day of the menstrual cycle. During the intake of this medicine you should not have any vaginal bleeding. Withdrawal bleeding (blood loss) normally occurs after 3-7 days from the suspension of treatment. Treatment with Provera G can be repeated for 2 or 3 cycles. Subsequently the treatment should be interrupted to verify a regular resumption of the menstrual cycle.
• If you take Provera G for the treatment of absence of menstruation in women of childbearing ageThe recommended dose is from 5 mg to 10 mg per day for 10 days. Withdrawal bleeding (blood loss) normally occurs after 3-7 days from the suspension of treatment.

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

4. Possible side effects

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

Stoptreatment with this medicine and contact your doctor immediatelyif you experience the
following side effects because they can be serious:

• severe allergic reaction (anaphylactic shock)
• swelling of the face, tongue and throat, with resulting difficulty swallowing and breathing (angioedema)
• migraine(see section 2 “Warnings and precautions”)
• swelling and pain in one leg, chest pain and difficulty breathing. These may be symptoms of blood clotsforming in the veins (thrombi) (see section 2 “Warnings and precautions”).

Other side effects:
Very common(may affect more than 1 in 10 people):

• nausea
• abnormal vaginal bleeding (irregular, increased, decreased) Common(may affect up to 1 in 10 people)
• hypersensitivity to the medicine
• depression
• insomnia
• irritability
• migraine
• urticaria, itching
• acne
• hair loss (alopecia)
• presence of secretion from the lower part of the uterus (cervix)
• breast pain or tenderness
• fever
• fatigue
• increased body weight

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

• dizziness
• increased hair growth or abnormal growth in areas of the body normally absent (hirsutism)
• abnormal secretion of milk from the breast even when not breastfeeding
• fluid retention in the body, with swelling in various parts of the body especially legs, ankles and feet (edema) Frequency not known(the frequency cannot be estimated from the available data):
• prolonged absence of ovulation
• drowsiness
• yellowing of the skin, tongue or mucous membranes of the mouth and the white of the eye (jaundice and cholestatic jaundice)
• skin rash
• abnormal absence of menstruation (amenorrhoea)
• alterations of the mucosa (erosions) of the part of the uterus visible from the vagina (cervix)
• excessive weakness (asthenia)
• alteration of blood glucose levels (glycaemia) after performing the glucose tolerance test. This condition is known as “reduced glucose tolerance”.
• decreased body weight

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects you can help provide more information on the safety of
this medicine.

5. How to store Provera G

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 on the blister 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. Package contents and other information

What the medicine containsProvera G
The active ingredient is medroxyprogesterone acetate.
Each Provera G 2.5 mg tablet contains 2.5 mg of medroxyprogesterone acetate.
The other ingredients are: lactose monohydrate, talc, corn starch, sucrose, calcium stearate, liquid paraffin, sunset yellow (E110).
Each Provera G 5 mg tablet contains 5 mg of medroxyprogesterone acetate.
The other ingredients are: lactose monohydrate, talc, corn starch, sucrose, calcium stearate, liquid paraffin, indigotin (E132), hydrated aluminum oxide.
Each Provera G 10 mg tablet contains 10 mg of medroxyprogesterone acetate.
The other ingredients are: lactose monohydrate, talc, corn starch, sucrose, calcium stearate, liquid paraffin.

Description of the appearance of Provera G and contents of the pack
Provera G 2.5 mg tablets are round, convex tablets, orange in color, notched on one side and marked with “U64” on the other side. The tablets are available in PVC/Aluminum blisters in packs of 20 tablets.
Provera G 5 mg tablets are round, blue tablets, notched on one side with “286” on both sides of the fracture line and with “U” on the other side. The tablets are available in PVC/Aluminum blisters in packs of 12 and 25 tablets.
Provera G 10 mg tablets are round, convex tablets, white in color, notched on one side and marked with “UPJOHN 50” on the other side. The tablets are available in PVC/Aluminum blisters in packs of 12 and 25 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)