Package leaflet: Information for the user

PROVERA G 5 mg tablets, 10 mg tablets

Medroxyprogesterone acetate
Please read all of this leaflet carefully before you start 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 their symptoms are the same as yours, as it may 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 G is and what it is used for
What you need to know before taking Provera G
How to take Provera G
Possible side effects
How to store Provera G
Contents of the pack and other information

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

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

counteracting the stimulatory effect of oestrogens (a type of hormone) on the inner lining of the uterus (endometrium) when administered to postmenopausal women as hormone replacement therapy
treating excessive menstrual blood loss or abnormal uterine bleeding occurring between menstrual periods
treating the absence of menstruation in women of reproductive age.

2. What you need to know before taking Provera G

Do not take Provera G:

if you are allergic to medroxyprogesterone acetate 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. You must 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) breast cancer, an early-stage cancer of the genital organs, or a type of tumour sensitive to oestrogen and progesterone, two female hormones;
if you have or have ever had a blood clot (thrombosis) in a blood vessel of the leg or lung;
if you suffer or have suffered from vein inflammation (phlebitis);
if you have or have ever had a haemorrhage in the brain;
if you have had a missed or incomplete miscarriage (where the foetus was not fully expelled).

Warnings and precautions
Talk to your doctor or pharmacist before taking Provera G.
Before Provera G is prescribed, your doctor will perform specific examinations, particularly of the breasts and genital area, to rule out the presence of tumours.
Talk to your doctor or pharmacist before taking Provera G if you think any of the following conditions apply to you:

you suffer from fluid retention in the body. Caution is needed if you have other conditions that may worsen due to increased fluid in the body;
you have or have had depression;
you have diabetes or intolerance to certain sugars;
you have high levels of calcium in the blood due to cancer that has spread to the bones;
you have kidney or liver problems;
you are a woman in pre-menopause. Taking this medicine may mask the onset of menopause;
someone in your family has or has had a tumour;
you experienced yellowing of the skin or whites of the eyes and itching during a previous pregnancy;
you have or have had heart problems;
you have or have had lumps and/or cysts in the breasts;
you suffer or have suffered from epilepsy;
you have or have had asthma;
you have or have had an ear disorder causing hearing loss (otospongiosis);
you have multiple sclerosis, a disease of the nervous system;
you have an autoimmune disease called systemic lupus erythematosus.

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

migraine or eye problems such as sudden loss of vision (partial or complete), protruding eyes, or double vision. In such cases, you must undergo an ophthalmological examination before restarting this medicine;
formation of blood clots in the veins. Symptoms may include swelling and pain in one leg, chest pain, and difficulty breathing. (See section “Do not take Provera G”).

Additional warnings for women who are already in menopause
If you are already in menopause and are taking Provera G together with other medicines containing oestrogens (female hormones), your risk of developing any of the following conditions may increase:

breast cancer; evidence shows that HRT (hormone replacement therapy) with oestrogen-progestin combinations or oestrogens alone increases the risk of breast cancer. This additional risk depends on the duration of HRT use. The increased risk becomes apparent within 3 years of use. After stopping HRT, the additional risk decreases over time, but may persist for 10 years or more if HRT has been used for more than 5 years.
heart attack and coronary heart disease (blood vessels supplying the heart);
stroke;
blood clots (thrombosis) in blood vessels, particularly in the legs and lungs;
dementia (in women aged 65 years or older);
ovarian cancer.

While taking Provera G, your doctor may advise you to take adequate amounts of calcium and vitamin D to help prevent bone weakening.
Laboratory tests
Provera G may alter the results of certain medical tests. If you are scheduled for blood tests or a uterine tissue examination, inform your doctor and/or laboratory staff 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 to inform your doctor if you are taking a medicine containing aminoglutethimide (used to treat breast cancer), as it may reduce the effectiveness of Provera G.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Do not take Provera G if you are or think you may be pregnant (see section “Do not take Provera G”) because this medicine may cause birth defects in the unborn child. If you become pregnant during treatment, you must immediately stop taking Provera G and consult your doctor.
Breastfeeding
Medroxyprogesterone acetate, the active ingredient in Provera G, passes into breast milk. Since its effects on the infant are unknown, consult your doctor before taking this medicine during breastfeeding.
Driving and using machines
It is not known whether Provera G affects the ability to drive or use machinery. If in doubt, 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 them before taking this medicine.

3. How to take Provera G

Take this medicine exactly as directed by your 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 intended for splitting the tablet.

If you are taking Provera G to counteract the effect of oestrogens (a type of hormone) on the endometrium (the inner lining of the uterus) administered as hormone replacement therapy in postmenopausal women
The recommended dose is 5 mg to 10 mg daily for at least 10 days. Each cycle of oestrogen treatment lasts 21 days. Start taking Provera G on the 11th day of the oestrogen treatment cycle. Withdrawal bleeding (bleeding) usually occurs 3–7 days after stopping Provera G.
If you are taking Provera G for the treatment of excessive menstrual blood loss or abnormal uterine bleeding
The recommended starting dose is 5 mg to 10 mg daily for 10 days.
You should start taking Provera G tablets on the 16th day of your menstrual cycle. During
treatment with this medicine, you should not experience vaginal bleeding.
Withdrawal bleeding (bleeding) usually occurs 3–7 days after stopping treatment.
Treatment with Provera G may be repeated for 2 or 3 cycles. After this, treatment should be
stopped to assess whether normal menstrual cycles resume.
If you are taking Provera G for the treatment of absence of menstruation in women of reproductive age
The recommended dose is 5 mg to 10 mg daily for 10 days. Withdrawal bleeding (bleeding) usually occurs 3–7 days after stopping 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 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 everyone gets them.
Stop taking this medicine and contact your doctor immediately if you experience any of the following side effects, as they may be serious:

severe allergic reaction (anaphylactic shock)
swelling of the face, tongue, and throat, leading to 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 clots forming in the veins (thrombosis) (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, or reduced)

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 discharge from the lower part of the uterus (cervix)
breast pain or tenderness
fever
fatigue
increase in body weight

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

dizziness
increased hair growth or abnormal growth in areas of the body where hair is normally absent (hirsutism)
abnormal milk secretion from the breast even when not in the breastfeeding phase
fluid retention in the body, with swelling in various parts of the body, especially legs, ankles, and feet (edema)

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

prolonged absence of ovulation
drowsiness
yellowish discoloration of the skin, tongue, mouth mucosa, or whites of the eyes (jaundice and cholestatic jaundice)
skin rash
abnormal absence of menstruation (amenorrhea)
changes in the mucosa (erosions) of the part of the uterus visible from the vagina (cervix)
excessive weakness (asthenia)
changes in blood glucose levels after undergoing a glucose tolerance test. This condition is known as “impaired glucose tolerance”.
decrease in body weight

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via 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 stated on the carton and blister after "Expiry". The expiry date refers to the last day of that month.
Store below 30°C.
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 G contains
The active substance is medroxyprogesterone acetate.
Each Provera G 5 mg tablet contains 5 mg of medroxyprogesterone acetate.
The other components are: monohydrate lactose, talc, maize starch, sucrose, calcium stearate, liquid paraffin,
indigotine (E132), aluminium oxide hydrate.
Each Provera G 10 mg tablet contains 10 mg of medroxyprogesterone acetate.
The other components are: monohydrate lactose, talc, maize starch, sucrose, calcium stearate, liquid paraffin.

Description of the appearance of Provera G and package contents
The 5 mg Provera G tablets are round, blue tablets, scored on one side with "286" on both sides of the break line and engraved with "U" on the other side. The tablets are available in PVC/Aluminium blisters in packs of 12 and 25 tablets.
The 10 mg Provera G tablets are round, convex, white tablets, engraved on one side and marked with "UPJOHN 50" on the other side. The tablets are available in PVC/Aluminium blisters in packs of 12 and 25 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)