TAMOXIFENE 10 mg Film-Coated Tablets

Зміст інструкції

1. TAMOXIFENE EG 10 mg film-coated tablets, 20 mg film-coated tablets
   1. What is TAMOXIFENE EG and what it is used for
   2. What you need to know before taking TAMOXIFENE EG
   3. How to take TAMOXIFENE EG
   4. Possible side effects
   5. How to store TAMOXIFENE EG
   6. Package contents and other information

TAMOXIFENE EG 10 mg film-coated tablets, 20 mg film-coated tablets

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

1. What is TAMOXIFENE EG and what it is used for

TAMOXIFENE EG contains tamoxifene, which belongs to a class of medicines called “anti-estrogens”.
Estrogens are a substance naturally present in the body, known as “sex hormones”.
TAMOXIFENE EG works by blocking the effects of estrogens on your body.
TAMOXIFENE EG is indicated:

• in the treatment of breast cancer;
• in men in the prevention and treatment of breast enlargement (gynecomastia) and breast pain (mastalgia) caused by medicines called antiandrogens and used in the treatment of prostate cancer (prostatic carcinoma), a gland that in men produces seminal fluid.

Talk to your doctor if you do not feel better or if you feel worse.

2. What you need to know before taking TAMOXIFENE EG

Do not take TAMOXIFENE EG

• if you are allergic to tamoxifen or any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant (see “Pregnancy and breastfeeding”);
• if you are taking preventative 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 concomitant therapy to thin the blood or if you have had a blood clot in a blood vessel (deep vein thrombosis or pulmonary embolism) in the past.

Warnings and precautions
Talk to your doctor before taking TAMOXIFENE EG:

• if you have a low level of white blood cells (leukopenia) or platelets (thrombocytopenia), your doctor will ask you to undergo periodic blood tests;
• if you experience unusual vaginal bleeding, both during treatment with TAMOXIFENE EG and at any time after stopping it. Your doctor will ask you to undergo periodic checks of the genital tract, because changes at the level of the uterus (endometrium) can occur, some of which may be serious and could include a tumor;
• if you have had a stroke in the past, stroke-like events, diseases due to the formation and detachment of blood clots (thromboembolic) or uterine cancer, as these diseases could recur during treatment with TAMOXIFENE EG (see section 4. Possible side effects);
• if you have a particular form of breast cancer (ductal carcinoma in situ). The decision to start therapy with tamoxifen must be discussed with your doctor, jointly evaluating the potential risks and benefits;
• if you experience symptoms such as numbness of the face, weakness of the arms or legs, speech problems or vision changes;
• in case of cough, chest pain or difficulty breathing;
• in case of excessive nausea, vomiting and thirst;
• if you have a history of hereditary angioedema as TAMOXIFENE EG may cause or worsen the symptoms of hereditary angioedema. If you experience symptoms such as swelling of the face, lips, tongue and/or throat with difficulty swallowing or breathing, seek immediate medical attention.

The doctor will inform you that at the beginning of treatment you may notice a worsening of the symptoms of the disease
such as increased pain and/or size of the affected area.
When you start treatment, the doctor will also prescribe you an eye exam; tamoxifen can cause
cataracts and the risk increases with the duration of treatment.
Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with treatment with TAMOXIFENE EG.
Stop treatment with TAMOXIFENE EG and consult your doctor immediately if you notice any of the
symptoms related to these severe skin reactions described in section 4.
If you are a woman of childbearing potential, you must use an effective barrier method of contraception (e.g. the
condom) for the entire duration of therapy and for at least two months after its conclusion; talk to your doctor
about the possible methods of contraception to use during treatment with TAMOXIFENE EG, as
tamoxifen can affect the effectiveness of some contraceptives. It is important that you do not become pregnant during the
treatment (see Pregnancy and breastfeeding).
In the event of hospitalization, inform the medical staff that you are being treated with
TAMOXIFENE EG.
In breast reconstruction surgery (weeks or years after breast surgery to remove the
tumor) TAMOXIFENE EG may increase the risk of blood clots in the small vessels of the
flap of tissue used to shape the new breast, which can lead to complications.

Children and adolescents
The use of TAMOXIFENE EG in children is not recommended, as safety and efficacy have not been established.

Other medicines and TAMOXIFENE EG
Tell your doctor if you are taking, have recently taken or might take any other medicines.
In particular, tell your doctor if you are taking:

• paroxetine, fluoxetine (examples of antidepressants);
• bupropion (antidepressant or medication to help you quit smoking);
• quinidine (for example used in the treatment of heart arrhythmias);
• cinacalcet (for the treatment of parathyroid gland dysfunction);
• warfarin and other antiplatelet agents (medicines used to thin the blood);
• cytotoxic drugs (used in the treatment of cancer) as they may increase the formation of blood clots;
• hormones, especially estrogens (e.g. the birth control pill).

Your doctor will subject you to frequent blood tests if you are taking medicines to thin the blood,
called coumarinic anticoagulants (e.g. warfarin). Tamoxifen can in fact significantly increase
the activity of these medicines.
The use of tamoxifen in combination with another medicine for the treatment of breast cancer (aromatase inhibitor) as adjuvant therapy has not shown better efficacy than tamoxifen alone.
In some studies, a reduced efficacy of tamoxifen has been reported when administered concurrently
with some SSRI antidepressants (e.g. paroxetine).

Pregnancy and breastfeeding

Pregnancy
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.
Do not take TAMOXIFENE EG if you are pregnant (see section 2. Do not take
TAMOXIFENE EG); avoid pregnancy and if sexually active, use barrier contraceptives (e.g.
condom or diaphragm) or other non-hormonal methods of contraception during treatment with
TAMOXIFENE EG and for nine months after stopping therapy, as there may be
risks to the baby. Consult your doctor for advice on contraception.
If you are premenopausal, before starting treatment, your doctor will perform careful checks to
exclude the possibility of an ongoing pregnancy.

Breastfeeding
The use of TAMOXIFENE EG during breastfeeding is not recommended, as it is not known whether it passes
into breast milk. The doctor will assess whether to stop breastfeeding or therapy with TAMOXIFENE EG.

Driving and operating machinery
Do not drive or operate machinery if you notice that your abilities are impaired.
TAMOXIFENE EG can cause fatigue, vision problems and drowsiness.

TAMOXIFENE EG contains lactose and sodium
If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking this
medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.
For those who practice sports: the use of the drug without therapeutic need constitutes doping and may
still result in positive doping tests.

3. How to take TAMOXIFENE EG

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 in breast cancer treatmentis from 20 to 40 mg in one or two daily
administrations. The doctor will decide the most suitable dose for you and will indicate how many tablets
to take.
The recommended dose in prevention and treatment of breast enlargement and paincaused by
antiandrogen medications, used in the treatment of prostate cancer is 20 mg once a day.
Always follow your doctor's instructions regarding the dose and frequency of taking the
tablets.
Do not chew the tablets, take them whole with a little water during meals, preferably always at the
same time.

If you take more TAMOXIFENE EG than you should
In case of accidental ingestion/intake of an excessive dose of TAMOXIFENE EG, immediately
inform your doctor or go to the nearest hospital.

If you forget to take TAMOXIFENE EG
Take the forgotten dose as soon as you remember, unless it is almost time to take the next
dose. In this case, continue to take TAMOXIFENE EG at the usual time and at the dose prescribed by
your doctor. Do not take a double dose to make up for the forgotten dose.

If you stop taking TAMOXIFENE EG
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.
Treatment with tamoxifen should not be interrupted, even if your health improves, unless
requested by your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Experience relating to the use of TAMOXIFENE EG in women is extensive. Although in men it is much more
limited, the overall profile of side effects appears similar, with the exception of events limited to the female
sex.

Stop treatment with TAMOXIFENE EG and consult your doctor immediately if you observe
any of the following symptoms:

• difficulty breathing;
• swelling of the face, lips, tongue or throat, difficulty swallowing or breathing (angioedema). TAMOXIFENE EG may cause or worsen the symptoms of hereditary angioedema;
• swelling of the hands, feet or ankles;
• reddish, non-raised spots on the trunk in the shape of a target or circular, often with central blisters, skin peeling, ulcers of the mouth, throat, nose, genitals and eyes. These serious skin rashes may be preceded by fever and flu-like symptoms [Stevens-Johnson syndrome, toxic epidermal necrolysis] - these side effects occur rarely;
• hives.

Inform your doctor immediatelyif you experience any of the following symptoms:

• numbness of the face or weakness of the arms or legs and changes in speech or vision that may indicate a lack of blood flow to the brain (stroke);
• chest pain or shortness of breath (dyspnea) which may be symptoms of a blood clot in the pulmonary artery (pulmonary embolism);
• abdominal pain or abnormal vaginal bleeding which may indicate a possible tumor of the uterus;
• cough and shortness of breath which may be symptoms of inflammation of the lungs (interstitial pneumonia) characterized by fever, cough, shortness of breath, increased white blood cells, a type of blood cell (neutrophilia).

During treatment with tamoxifene, as with any other medicine, side effects may occur, according to the following frequency:

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

• nausea;
• fluid retention causing swelling;
• vaginal bleeding;
• vaginal discharge;
• skin rash;
• hot flushes;
• fatigue;
• depression;
• change or absence of menstruation.

Common (may affect up to 1 in 10 people)

• temporary decrease in the number of red blood cells in the blood (anemia);
• opacification of the lens, the lens of the eye used to focus images (cataract);
• disease of the retina, the innermost membrane of the eye (retinopathy);
• drowsiness, headache;
• allergic reactions;
• hair loss and eyelashes (alopecia);
• elevated levels of fats in the blood (triglycerides);
• leg cramps;
• muscle pain (myalgia);
• bone pain and pain in the affected area at the beginning of treatment;
• benign growths in the uterus (uterine fibroids);
• sudden onset of weakness, paralysis of the arms or legs, sudden difficulty speaking, walking, difficulty holding things or difficulty thinking that may be due to reduced blood flow to the brain (e.g. stroke);
• dizziness;
• sensory disturbances (including numbness and altered taste);
• itching of the external genitals;
• changes in the endometrium, the lining of the uterus (including hyperplasia and polyps);
• vomiting;
• diarrhea;
• constipation;
• changes in liver enzyme levels;
• liver with fat accumulation (steatotic);
• formation and detachment of blood clots in blood vessels (including deep vein thrombosis, microvascular thrombosis and pulmonary embolism).

Uncommon (may affect up to 1 in 100 people)

• decrease in the number of platelets (thrombocytopenia);
• decrease in the number of white blood cells (leukopenia);
• increased calcium in the blood (hypercalcemia), in patients with tumors spread to the bones;
• cancer of the endometrium, the lining of the uterus (endometrial cancer);
• visual disturbances;
• inflammation of the pancreas, a gland of the body (pancreatitis);
• inflammation of the lungs (interstitial pneumonia) characterized by fever, cough, shortness of breath, increased white blood cells;
• severe liver disease (cirrhosis).

Rare (may affect up to 1 in 1000 people)

• disorders and inflammation of the optic nerve (rarely vision loss);
• jaundice, which causes yellowing of the skin and eyes;
• swelling of ovarian cysts;
• tumor of the uterus;
• decrease in the number of a type of white blood cells (neutropenia);
• severe decrease in the number of white blood cells (agranulocytosis);
• changes in the transparent membrane covering the eye (cornea);
• disease of the optic nerve, nerve that transmits images from the eye to the brain (optic neuropathy);
• tumor of the uterus;
• growths (polyps) of the vagina;
• worsening of a tumor (tumor recurrence);
• endometriosis (when cells that are normally found only in the lining of the uterus are present in other districts of the body, usually in other systems near the uterus);
• severe inflammation of the optic nerve, nerve that transmits images from the eye to the brain (optic neuritis);
• inflammation of the liver (hepatitis);
• bile stasis (cholestasis);
• liver abnormalities;
• liver damage (hepatocellular);
• death of liver cells (hepatic necrosis);
• allergic reaction characterized by swelling of the face, lips and throat (angioedema);
• inflammation of blood vessels with formation of swellings and spots on the skin (cutaneous vasculitis);
• immune system disease characterized by the formation of swellings under the skin (bullous pemphigoid);
• allergic reaction characterized by spots on the skin (erythema multiforme).

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

• immune system disease that affects the skin with the formation of erythema, lesions, hair loss (cutaneous lupus erythematosus);
• disease caused by the accumulation in the blood of certain liver proteins, porphyrins, which leads to the formation of blisters, lesions that turn into crusts and cysts on the skin (cutaneous porphyria tarda);
• rash on the skin characterized by redness, swelling and/or formation of blisters after radiotherapy (radiation recall reaction).

Other side effects reported in the literature are: dizziness, depression, confusion and fatigue.
From the results of a large study, lasting 5 years involving about 13,000 women at high risk for
breast cancer onset, an increase in the incidence of the following adverse reactions was observed in
women treated with tamoxifen compared to those not treated: uterine cancer (endometrial adenocarcinoma
and uterine sarcoma), pulmonary embolism, deep vein thrombosis, stroke, cataract formation and cataract surgery. Some of the cases of uterine malignancies, cerebral stroke and
pulmonary embolism were fatal.
Uterine fibroids, endometriosis and other endometrial alterations including hyperplasia and polyps have been reported.
Interstitial pneumonia may occur, which may present with the same symptoms as pneumonia, such as dyspnea
and cough.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your
doctor or pharmacist. 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 EG

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 pack after Exp. The expiry date refers to the last day of that month.
Store at a temperature below 30°C and protect from light.
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. Package contents and other information

What TAMOXIFENE EG contains

• The active ingredient is tamoxifene. One tablet contains 10 or 20 mg of tamoxifene (as tamoxifene citrate).
• The other ingredients are lactose, corn starch, gelatin, sodium croscarmellose, magnesium stearate, hypromellose, macrogol 300, titanium dioxide.

Description of the appearance of TAMOXIFENE EG and package contents
Film-coated tablets of white color.
TAMOXIFENE EG is available in packs of 30 tablets for the 10 mg dosage and in packs of
20 tablets for the 20 mg dosage.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
EG S.p.A., Via Pavia, 6 – 20136 Milano

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