Tamoxifen EG

Italy
Brand name Tamoxifen EG
Form tablets, film-coated
Active substance / Dosage
TAMOXIFENE
Prescription type Prescription only
ATC code
L02BA01
Registration number 033688
Manufacturer EG S.P.A.
Tamoxifen EG tablets, film-coated

Table of Contents

Patient Information Leaflet

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

Please 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 give it to others, even if their symptoms are the same as yours, as it may be harmful.
  • If you experience any side effect, including those not listed in this leaflet, talk to 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 taking 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 TAMOXIFENE EG is and what it is used for

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

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

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

2. What you should know before taking TAMOXIFENE EG

Do not take TAMOXIFENE EG

  • if you are allergic to tamoxifen or to any of the other ingredients of this medicine (listed in section 6);
  • if you are pregnant (see "Pregnancy and breastfeeding");
  • if you are undergoing preventive treatment because you are at high risk of developing breast cancer;
  • if you have a particular type of breast cancer (ductal carcinoma in situ) and require concomitant anticoagulant therapy, or if you have previously had a blood clot in a blood vessel (deep vein thrombosis or pulmonary embolism).

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

  • if you have low levels of white blood cells (leucopenia) or platelets (thrombocytopenia); your doctor will ask you to undergo periodic blood tests;
  • if you experience unusual vaginal bleeding, either during treatment with TAMOXIFENE EG or at any time after stopping it. Your doctor will ask you to undergo periodic gynaecological examinations, as changes in the uterus (endometrium) may occur, some of which may be serious and could include cancer;
  • if you have previously had a stroke, stroke-like events, diseases caused by formation and dislodgement of blood clots (thromboembolic disorders), or uterine cancer, as these conditions may recur during treatment with TAMOXIFENE EG (see section 4. Possible side effects);
  • if you have a particular type of breast cancer (ductal carcinoma in situ). The decision to start tamoxifen therapy should be discussed with your doctor, weighing together the potential risks and benefits;
  • if you experience symptoms such as facial numbness, weakness in arms or legs, speech problems, or vision changes;
  • if you develop cough, chest pain, or breathing difficulties;
  • if you have excessive nausea, vomiting, or thirst;
  • if you have a history of hereditary angioedema, as TAMOXIFENE EG may cause or worsen symptoms of hereditary angioedema. If you experience symptoms such as swelling of the face, lips, tongue, and/or throat with difficulty swallowing or breathing, contact your doctor immediately.

Your doctor will inform you that at the beginning of treatment you may notice a worsening of disease symptoms, such as increased pain and/or enlargement of the affected area.
When starting treatment, your doctor will prescribe an eye examination; tamoxifene may cause cataracts, and the risk increases with longer duration of treatment.
Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in association with TAMOXIFENE EG treatment.
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 age, you must use an effective barrier contraceptive method (e.g. condom) throughout the duration of treatment and for at least two months after stopping it. Discuss with your doctor the possible contraceptive methods to use during treatment with TAMOXIFENE EG, as tamoxifen may affect the effectiveness of certain contraceptives. It is important that you do not become pregnant during treatment (see Pregnancy and breastfeeding).
If you are admitted to hospital, inform medical staff that you are being treated with TAMOXIFENE EG.
During breast reconstruction surgery (weeks or years after breast cancer surgery), TAMOXIFENE EG may increase the risk of blood clots forming in the small blood vessels of the tissue flap used to shape the new breast, potentially leading 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
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking:

  • paroxetine, fluoxetine (examples of antidepressants);
  • bupropion (an antidepressant or smoking cessation aid);
  • quinidine (used, for example, in the treatment of cardiac arrhythmias);
  • cinacalcet (for the treatment of parathyroid gland dysfunction);
  • warfarin and other antiplatelet agents (medicines used to thin the blood);
  • cytotoxic drugs (used in cancer treatment), as they may increase the risk of blood clot formation;
  • hormones, especially estrogens (e.g. oral contraceptive pill).

Your doctor will perform frequent blood tests if you are taking blood-thinning medicines known as dicoumarol-type anticoagulants (e.g. warfarin). Tamoxifene may significantly enhance the effect of these medicines.
The use of tamoxifene in combination with another medicine for the treatment of breast cancer (an aromatase inhibitor) as adjuvant therapy has not shown greater efficacy compared to tamoxifene alone.
In some studies, reduced efficacy of tamoxifene has been reported when administered concomitantly with certain SSRI antidepressants (e.g. paroxetine).

Pregnancy and breastfeeding
Pregnancy
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist 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 contraception (e.g. condom or diaphragm) or other non-hormonal contraceptive methods during treatment with TAMOXIFENE EG and for nine months after stopping treatment, as there may be risks to the unborn child. Consult your doctor for advice on contraception.
If you are premenopausal, your doctor will perform careful tests before starting treatment to rule out the possibility of an existing pregnancy.

Breastfeeding
The use of TAMOXIFENE EG during breastfeeding is not recommended, as it is unknown whether it passes into breast milk. Your doctor will decide whether to discontinue breastfeeding or the treatment with TAMOXIFENE EG.

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

TAMOXIFENE EG contains lactose and sodium
If your doctor has diagnosed you with an intolerance to certain sugars, contact him/her before taking this medicine.
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially 'sodium-free'.

For individuals engaged in sports: using the drug without therapeutic need constitutes doping and may lead to a positive result in anti-doping tests.

3. How to take TAMOXIFENE EG

Take this medicine exactly as directed by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist.
The recommended dose for the treatment of breast cancer is 20 to 40 mg, taken in one or two daily doses. Your doctor will determine the most appropriate dose for you and advise you how many tablets to take.
The recommended dose for the prevention and treatment of breast enlargement and breast pain caused by antiandrogen medicines used in the treatment of prostate cancer is 20 mg once daily.
Always follow your doctor's instructions regarding the dose and frequency of tablet administration.
Do not chew the tablets; swallow them whole with a little water during meals, preferably at the same time each day.

If you take more TAMOXIFENE EG than you should
If you accidentally take or ingest too much TAMOXIFENE EG, contact your doctor immediately or go to the nearest hospital.

If you forget to take TAMOXIFENE EG
Take the missed dose as soon as you remember, unless it is almost time for your next dose. In this case, continue taking TAMOXIFENE EG at your usual time and dose as 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 using this medicine, consult your doctor or pharmacist.
Treatment with tamoxifene must not be stopped, even if your health condition improves, unless instructed by your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The experience with TAMOXIFENE EG in women is extensive. Although experience in men is much more limited, the overall profile of side effects appears similar, except for events specific to the female sex.
Stop treatment with TAMOXIFENE EG and contact your doctor immediately if you notice
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 symptoms of hereditary angioedema;
  • swelling of the hands, feet or ankles;
  • flat, reddish spots on the trunk shaped like targets or rings, often with central blisters, skin peeling, mouth, throat, nose, genital or eye ulcers. These severe skin rashes may be preceded by fever and flu-like symptoms [Stevens-Johnson syndrome, toxic epidermal necrolysis] – these side effects occur rarely;
  • hives.

Contact your doctor immediately if you experience any of the following symptoms:

  • facial numbness or weakness in arms or legs, and speech or vision disturbances which could indicate reduced blood flow to the brain (stroke);
  • chest pain or shortness of breath (dyspnea), which could be symptoms of a blood clot in the pulmonary artery (pulmonary embolism);
  • abdominal pain or abnormal vaginal bleeding, which could indicate a possible uterine tumour;
  • cough and shortness of breath, which could be symptoms of lung inflammation (interstitial pneumonia), characterized by fever, cough, dyspnea, increased white blood cells, a type of blood cell (neutrophilia).

During treatment with tamoxifene, as with any other medicine, side effects may occur with the following frequencies:
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;
  • changes or absence of menstrual periods.

Common (may affect up to 1 in 10 people)

  • temporary decrease in the number of red blood cells in the blood (anaemia);
  • clouding of the lens, the eye's focusing structure (cataract);
  • disease of the retina, the innermost layer of the eye (retinopathy);
  • drowsiness, headache;
  • allergic reactions;
  • hair loss (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 arms or legs, sudden difficulty speaking, walking, holding objects, or thinking, which may be due to reduced blood flow to the brain (e.g. stroke);
  • dizziness;
  • sensory disturbances (including numbness and altered taste);
  • itching of external genitalia;
  • changes in the endometrium, the lining of the uterus (including hyperplasia and polyps);
  • vomiting;
  • diarrhoea;
  • constipation;
  • changes in liver enzyme levels;
  • fatty liver (steatosis);
  • 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 platelet count (thrombocytopenia);
  • decrease in white blood cell count (leucopenia);
  • increased calcium in the blood (hypercalcaemia) in patients with tumours spread to the bones;
  • tumour of the endometrium, the lining of the uterus (endometrial cancer);
  • visual disturbances;
  • inflammation of the pancreas, a gland in 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 1,000 people)

  • disorders and inflammation of the optic nerve (rarely leading to loss of vision);
  • jaundice, causing yellowing of the skin and eyes;
  • enlargement of ovarian cysts;
  • uterine cancer;
  • decrease in a type of white blood cells (neutropenia);
  • severe decrease in white blood cells (agranulocytosis);
  • changes in the transparent membrane covering the eye (cornea);
  • disease of the optic nerve, the nerve transmitting images from the eye to the brain (optic neuropathy);
  • uterine cancer;
  • growths (polyps) in the vagina;
  • worsening of a tumour (tumour flare);
  • endometriosis (when cells normally found only in the uterine lining are present in other parts of the body, usually in nearby organs);
  • severe inflammation of the optic nerve, the nerve transmitting images from the eye to the brain (optic neuritis);
  • liver inflammation (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 causing skin swellings and spots (cutaneous vasculitis);
  • autoimmune disease causing subcutaneous swellings (bullous pemphigoid);
  • allergic reaction characterized by skin rash (erythema multiforme).

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

  • autoimmune disease affecting the skin with formation of erythemas, lesions, hair loss (cutaneous lupus erythematosus);
  • disease caused by accumulation in the blood of certain liver proteins, porphyrins, leading to blisters, lesions turning into crusts and cysts on the skin (porphyria cutanea tarda);
  • skin eruption characterized by redness, swelling and/or blistering after radiotherapy (radiation recall reaction).

Other side effects reported in the literature include: dizziness, depression, confusion and tiredness.
Results from a large 5-year study involving approximately 13,000 women at high risk of developing breast cancer showed an increased incidence of the following adverse reactions in women treated with tamoxifene compared to untreated women: uterine cancer (endometrial adenocarcinoma and uterine sarcoma), pulmonary embolism, deep vein thrombosis, stroke, cataract formation and cataract surgery. Some cases of malignant uterine tumours, cerebral stroke and pulmonary embolism were fatal.
Uterine fibroids, endometriosis and other endometrial changes including hyperplasia and polyps have been reported.
Interstitial pneumonia may occur, which can present with the same symptoms as pneumonia, such as dyspnea and cough.
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 TAMOXIFENE EG

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after Exp. The expiry date refers to the last day of that month.
Store below 30°C and protect from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer used. This will help protect the environment.

6. Package contents and other information

What TAMOXIFENE EG contains

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

Description of the appearance of TAMOXIFENE EG and package contents
Film-coated white tablets.
TAMOXIFENE EG is available in packs of 30 tablets for the 10 mg dosage strength and in packs of 20 tablets for the 20 mg dosage strength.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
EG S.p.A., Via Pavia, 6 – 20136 Milan, Italy
Manufacturer
Doppel Farmaceutici S.r.l., Via Martiri delle Foibe, 1 – 29016 Cortemaggiore (PC), Italy