TAMOXIFENE 20 mg Film-Coated Tablets

Зміст інструкції

1. Tamoxifene ratiopharm 20 mg film-coated tablets
   1. What is Tamoxifene ratiopharm and what is it used for
   2. What you need to know before you take Tamoxifene ratiopharm
   3. How to take Tamoxifene ratiopharm
   4. Possible side effects
   5. How to store Tamoxifene ratiopharm
   6. Contents of the pack and other information

Tamoxifene ratiopharm 20 mg film-coated tablets

tamoxifene citrate

Generic medicine

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

1. What is Tamoxifene ratiopharm and what is it used for

Tamoxifene ratiopharm contains tamoxifene, a substance with antitumoral properties that works by counteracting
the action of estrogens (sex hormones) present in your body. Tamoxifene is used for the treatment
of breast cancer.
Talk to your doctor if you do not feel better or if you feel worse.

2. What you need to know before you take Tamoxifene ratiopharm

Do not take Tamoxifene ratiopharm

• if you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant;
• if you are breastfeeding;
• to treat a child;
• if you are undergoing preventative cancer therapy, because you are at high risk of developing breast cancer;
• if you have a particular form of breast cancer (ductal carcinoma in situ) and require the simultaneous administration of anticoagulants (medicines that thin the blood) or if you have previously suffered from deep vein thrombosis or pulmonary embolism (formation of blood clots in a blood vessel or pulmonary artery), unless your doctor considers it strictly necessary. See also the section “Other medicines and Tamoxifene ratiopharm” for medicines whose use should be avoided together with tamoxifene.

Warnings and precautions
Talk to your doctor or pharmacist before taking Tamoxifene ratiopharm.
Pay particular attention and ask your doctor for advice before taking Tamoxifene ratiopharm if:

• your white blood cell levels in the blood are low (leukopenia);
• your calcium levels in the blood are high (hypercalcemia);
• your platelet levels in the blood are low (thrombocytopenia);
• you have previously had a stroke, stroke-like events, or suffered from thromboembolic events (blockage of peripheral vessels due to a blood clot) or have already had a uterine tumor, as these diseases could recur during treatment with Tamoxifene ratiopharm. Furthermore, during treatment with Tamoxifene ratiopharm you must pay particular attention, andimmediately inform your doctorif you experience even one of the following symptoms:
• unusual vaginal bleeding, keep in mind that it may occur even after stopping treatment. At any time bleeding occurs, your doctor will perform a gynecological examination, because this bleeding may be an expression of changes at the level of the endometrium (mucous membrane lining the inner cavity of the uterus), some of which may be serious and may include a tumor (hyperplasia, polyps and carcinoma);
• irregular periods, unusual vaginal discharge;
• feeling of pressure or abdominal pain: this may be a symptom of a uterine tumor;
• numbness of the face, weakness of the arms or legs, difficulty speaking and changes in vision: these may be symptoms of a stroke (sudden blockage or rupture of a blood vessel in the brain);
• chest pain or difficulty breathing (dyspnea): these may be symptoms of a pulmonary embolism (obstruction of a pulmonary artery due to a blood clot);
• cough and difficulty breathing (dyspnea): these may be symptoms of interstitial pneumonia (a rare form of pneumonia).

Also keep in mind that if you are a pre-menopausal woman, treatment with Tamoxifene ratiopharm
may stop your menstrual cycle; however, this does not alter the therapeutic action of the drug.
Laboratory tests
Depending on your previous health status before taking tamoxifene and based on your
response to the drug, your doctor may prescribe tests to check the levels of your blood components
(blood count), calcium levels in your blood, and your liver function.
Also, if you are taking medicines to thin the blood (dicoumarolic anticoagulants), your
doctor may subject you to periodic clinical checks to monitor your coagulation factor levels, especially at the beginning of treatment with Tamoxifene ratiopharm (see also “Other
medicines and Tamoxifene ratiopharm”).
For athletes
The use of the drug without a therapeutic need constitutes doping and may result in positive anti-
doping tests.

Other medicines and Tamoxifene ratiopharm
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
The use of Tamoxifene ratiopharm should be avoided together with:

• hormonal medicines, especially estrogens, such as oral contraceptives, because they may reduce the effect of the drug;
• medicines that inhibit platelet aggregation (antiplatelet agents) to reduce the risk of bleeding when your platelet levels in the blood are low (thrombocytopenia). It is important to pay particular attention and inform your doctor if you are using one of the following medicines:
• dicoumarolic anticoagulants (act as blood thinners) because they significantly increase their anticoagulant activity, increasing the risk of bleeding when administered in combination with tamoxifene;
• cytotoxic drugs (used in cancer treatment) as they may increase the formation of blood clots (thromboembolic events) when administered in combination with tamoxifene.

Furthermore, the following medicines, if taken together with Tamoxifene ratiopharm, may reduce its effect:

• some antidepressant medicines (paroxetine, fluoxetine);
• medicines containing quinidine, used in the treatment of some heart function disorders (cardiac arrhythmias);
• medicines containing cinacalcet, used in case of hyperparathyroidism (dysfunction of the parathyroid gland) and in case of hypercalcemia in patients affected by parathyroid tumor (tumor of the parathyroid glands);
• medicines containing bupropion, used as antidepressants or as support to quit smoking.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Tamoxifene ratiopharm should not be used during pregnancy (see section “Do not take
Tamoxifene ratiopharm”).
You should avoid pregnancy during treatment with tamoxifene and for two months after stopping
therapy; if you are sexually active, you should use a barrier contraceptive method (e.g. condom
or diaphragm) or other non-hormonal contraceptive methods, as there may be risks to the
baby (miscarriages, congenital anomalies and fetal deaths).
If you are premenopausal, before starting treatment, your doctor will perform careful checks to
exclude the possibility of an ongoing pregnancy.
Breastfeeding
Tamoxifene ratiopharm should not be used during breastfeeding, as serious adverse effects may occur
in your baby.

Driving and using machines
Tamoxifene ratiopharm may impair your ability to drive vehicles or operate machinery.
This medicine may cause visual disturbances or dizziness. Therefore, if
these symptoms occur, do not drive vehicles or operate machinery.

Tamoxifene ratiopharm contains:
lactose:if your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking
this medicine;

sodium:this medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially
“sodium-free”.

3. How to take Tamoxifene ratiopharm

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
The recommended dose is 1 - 2 tablets of 20 mg, to be taken 1 or 2 times a day, as directed
by your doctor.
The tablets must be taken during meals with a little water, preferably always at the same
time. You must swallow the tablets whole, without chewing them.
Treatment with tamoxifen is usually of long duration. In particular, in the treatment performed after
surgery for a particular type of breast cancer (early hormone receptor-positive breast
cancer) a treatment of at least 5 years is recommended.

If you take more Tamoxifene ratiopharm than you should
If you take a dose of Tamoxifene ratiopharm higher than that prescribed, immediately inform your
doctor or go to the nearest hospital.
Some of the symptoms that may occur are: dizziness, tremors, exaggerated reflexes (hyperreflexia),
problems with movements (dysmetria), seizures and a heart problem called “prolonged QT
interval” (which is shown on the electrocardiogram, ECG).

If you forget to take Tamoxifene ratiopharm
If you forget to take a dose of the medicine, take it as soon as you remember, unless it is almost
time to take the next dose. Do not take a double dose to make up for a missed dose.

If you stop taking Tamoxifene ratiopharm
Ask your doctor for advice if you intend to stop treatment.
If you have any further questions on 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.
During treatment with Tamoxifene ratiopharm you should pay particular attention, and immediately inform
your doctorif you experience even just one of the following symptoms (see also the section
“Warnings and precautions”):

• unusual vaginal bleeding or discharge;
• irregular periods;
• feeling of pressure or abdominal pain;
• numbness of the face, weakness of the arms or legs, difficulty speaking and changes in vision;
• cough, chest pain or difficulty breathing (dyspnea);
• skin rashes and itching, difficulty breathing (bronchospasm) or swallowing, swelling of the face, hands and feet, eyes, lips and/or tongue (angioedema). These may be signs of serious allergic reactions (hypersensitivity reaction).

Other side effects may be:

Very Common (may affect more than 1 in 10 people)

• vaginal discharge;
• changes in the menstrual cycle (including disappearance in pre-menopausal women);
• hot flushes;
• fatigue

Common (may affect up to 1 in 10 people)

• development of fatty liver (hepatic steatosis);
• excessive decrease in red blood cells (anemia);
• excessive fluid retention in your body causing abnormal swelling (fluid retention);
• increased triglycerides in the blood (severe hypertriglyceridemia);
• feeling lightheaded (confusion);
• headache;
• visual disturbances (cataract, retinopathy and corneal pathology) only partially reversible;
• insufficient blood supply to a more or less extensive area of the brain (cerebrovascular ischemic events);
• embolism (including deep vein thrombosis, pulmonary embolism and pulmonary infarction);
• severe sudden muscle pain, caused by involuntary contraction of one or more muscles (spasms);
• nausea;
• skin rash;
• hair loss (alopecia);
• vulvovaginal itching;
• vaginal bleeding;
• benign tumors (uterine leiomyoma);
• abnormal growth of cells in the endometrium tissue (endometrial pathology, uterine polyp, endometrial hyperplasia);
• an abnormal mass of tissue that grows excessively from the endometrium mucosa (endometrial polyps);
• pain in the bones and in the tissue area affected by the tumor;
• alteration of your normal liver enzyme values.

Uncommon (may affect up to 1 in 100 people)

• reduction of white blood cells in the blood (leukopenia, neutropenia);
• temporary reduction in the number of blood cells called platelets (thrombocytopenia) with values between 80,000 and 90,000/µl;
• increased calcium levels in the blood (hypercalcemia), especially in patients with bone metastases, and particularly at the beginning of treatment;
• alteration of normal blood flow to the heart (infarction);
• vomiting;
• endometrial tumor (endometrial cancer).
• swelling of the face, hands and feet, eyes, lips and/or tongue (angioedema).
• serious allergic reactions (hypersensitivity reaction);
• liver cirrhosis.

Rare (may affect up to 1 in 1000 people)

• neurodegenerative disease affecting the optic nerve (optic neuropathy);
• inflammation of the optic nerve (optic neuritis);
• alteration of normal bile flow (cholestasis);
• alteration of liver function (hepatitis and jaundice);
• damage to liver cells;
• insufficient liver function;
• irreversible loss of liver function (hepatic necrosis);
• uterine tumor (uterine sarcoma - mixed mullerian malignant tumor of the uterus);
• ovarian cysts.

Very Rare (may affect up to 1 in 10,000 people)

• severe reduction in the number of white blood cells (neutropenia);
• reduction in the number of all cells present in the blood (pancytopenia);
• a particular form of pneumonia called interstitial lung disease;
• changes in the skin, such as urticaria, formation of red papules or widespread blisters and scaling, especially on legs, arms, hands and feet, which may extend to the face and lips, occasionally accompanied by fever (Stevens-Johnson Syndrome and pemphigoid);
• alteration of pancreatic function (pancreatitis). Not known (frequency cannot be estimated from available data)
• severe decrease in the number of white blood cells (agranulocytosis);
• uterine fibroids;
• endometriosis;
• diarrhea;
• constipation;
• disease of the immune system that affects the skin with formation of erythema, lesions, hair loss (cutaneous lupus erythematosus);
• pain caused by the tumor;
• skin rash characterized by redness, swelling and/or formation of blisters after radiotherapy (recall phenomenon);
• growths of the vagina (vaginal polyp).

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any 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 Tamoxifene ratiopharm

Keep this medicine out of the sight and reach of children.
Store in the original package to protect the medicine from light.
Do not use this medicine after the expiry date which is stated on the pack after “Exp.”. The expiry date
refers to the last day of that month.
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 Tamoxifene ratiopharm contains

• The active ingredient is tamoxifen citrate. Each film-coated tablet contains 20 mg of tamoxifen base (equivalent to 30.4 mg of tamoxifen citrate).
• The other ingredients are: lactose monohydrate, corn starch, gelatin, sodium croscarmellose, magnesium stearate, hypromellose, macrogols and titanium dioxide.

Description of the appearance of Tamoxifene ratiopharm and contents of the pack
Tamoxifene ratiopharm is presented in a carton containing 20 film-coated tablets in blisters.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
ratiopharm GmbH - Graf-Arco Strasse 3 - 89079 Ulm (Germany)

Manufacturer
Doppel Farmaceutici S.r.l. - Via Martiri delle Foibe,1 - 29016 Cortemaggiore (PC)