FARLUTAL 10 mg Tabletka

Treść ulotki

1. FARLUTAL 500 mg tablets
   1. What is Farlutal and what is it used for
   2. What you need to know before taking Farlutal
   3. How to take Farlutal
   4. Possible side effects
   5. How to store Farlutal
   6. Contents of the pack and other information

FARLUTAL 500 mg tablets

medroxyprogesterone acetate

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

1. What is Farlutal and what is it used for

Farlutal contains the active substance medroxyprogesterone acetate. Medroxyprogesterone belongs to a
group of medicines called progestins that work by slowing the growth of some hormone-sensitive
tumors.
Farlutal is used for the treatment of:

• breast cancer, uterine lining cancer (endometrial cancer), prostate cancer and kidney cancer;
• a condition characterized by enlargement of the prostate gland (prostate adenoma);
• excessive weight loss and significant reduction of normal bodily functions in the advanced stage of cancer or AIDS, a severe disease of the immune system.

2. What you need to know before taking Farlutal

Do not take Farlutal:

• 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 early-stage breast cancer.

Warnings and precautions
Talk to your doctor or pharmacist beforetaking Farlutal 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 during the use of this medicine:

• if you have vaginal bleeding, but do not know the cause. You should undergo medical examinations to determine the cause of this disorder before taking Farlutal (see section Do not take Farlutal);
• 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 your 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 Farlutal);
• if you are a pre-menopausal woman, because taking this medicine may mask the onset of menopause.

Tell your doctor if any of the following conditions occur or worsen duringthe use of
Farlutal (see also section 4 Possible side effects):

• sudden partial or total loss of vision, bulging eyes, double vision or headache that you have not had before. Stop taking Farlutal 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 (thrombi), or of these thrombi traveling to the lungs, where they can block another blood vessel (thromboembolism). Stop taking Farlutal immediatelyand see your doctor;
• Cushing's syndrome, a disorder that can manifest with some or all of the following symptoms: o fatigue o easy fatigue 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 wound healing time o increased susceptibility to infections

Duringthe use of Farlutal, 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 to undergo tests based on samples (biopsies) of tissue fragments from the uterus, you must inform the laboratory staff that you are taking Farlutal 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 the laboratory staff that you are taking Farlutal because the use of this medicine may alter the values of some hormones in the blood.

Other medicines and Farlutal
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 to treat advanced breast or prostate cancer, because they can
decrease the effectiveness of Farlutal.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Farlutal should not be used during pregnancy (see section Do not take Farlutal) because taking
this medicine during the first 3 months of pregnancy can cause birth defects in the fetal genitals.
If you become pregnant during use, you should immediately stop taking Farlutal and
consult your doctor.
If you are a sexually active woman, during treatment with this medicine you should use an
effective method of contraception to avoid pregnancy.
Breastfeeding
Medroxyprogesterone acetate, the active ingredient of Farlutal, passes into breast milk. Because its
effect on the infant is unknown, ask your doctor or pharmacist for advice before taking this
medicine while breastfeeding.

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

Farlutal 500 mg tablets contains lactose
Farlutal 500 mgtablets contains 212.50 mg of lactose per tablet.
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this
medicine.

3. How to take Farlutal

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

• Breast cancer, endometrial cancer (internal uterine lining tissue), prostate cancer, kidney cancer, prostate adenomaThe recommended dose is from 100 mg to 1000 mg per day. You can divide the daily dose into 2 or 3 smaller daily doses, if the amount to be taken is very high. Your doctor will advise you on the dosage and duration of treatment most suitable for you.
• Excessive weight loss and significant reduction of normal body functions in the advanced stage of cancer and a severe disease of the immune system called AIDSThe recommended dose is 1000 mg per day, which you can take in a single administration or in 2 different administrations.

If you take more Farlutal than you should
If you take an excessive dose of this medicine, contact your doctor immediately.

4. Possible side effects

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

Stoptaking this medicine and contact your doctor immediatelyif you experience the
following side effects as they may 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 in the veins (thrombi)
• 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
• poor vision in one half of the visual field
• clumsy movements, loss of balance, dizziness
• severe and sudden headache if someone near you suspects that a stroke is occurring, go to the emergency roomof a hospital immediately.
• sudden chest pain, which 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

Uncommon(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 to the medicine
• 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 blood glucose levels (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 the available data):

• prolonged absence of ovulation
• confusion
• loss of concentration
• tremors in the hands, sweating, night-time calf cramps (adrenergic-like effects)
• visual impairment 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 own heartbeat (palpitations)
• urticaria, itching
• presence of sugars 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 breast even when not breastfeeding
• alteration of liver function tests
• increased number of white blood cells and platelets

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 Farlutal

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date that is stated on the pack after “Expiry”. The expiry date refers to the last day of that month.
Farlutal 500 mg tablets: Store at a temperature below 30°C.
Do not dispose of any medicine in waste water 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 containsFarlutal
The active ingredient is medroxyprogesterone acetate.
Farlutal tablets:
Each Farlutal 500 mg tablet contains 500 mg of medroxyprogesterone acetate.
The other ingredients are: lactose(see section 2 “Farlutal 500 mg tablets contains lactose”),
crospovidone, povidone K25, polysorbate 80, microcrystalline cellulose, magnesium stearate.

Description of the appearance of Farlutal and contents of the packs
Farlutal 500 mg tablets are oblong, convex tablets with “FCE 500” and a breaking line on both sides. The tablets are available in Al/PVC blisters in packs of 30 tablets.
The score line is not designed for breaking the tablet.
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
Farlutal 500 mg tablets
Pfizer Italia S.r.l.
Località Marino del Tronto,
63100
Ascoli Piceno (AP)