Tamoxifen-ebewe 10

Package leaflet: Information for the patient

Tamoxifen-Ebewe 10, 10 mg, tablets
Tamoxifen-Ebewe 20, 20 mg, tablets
Tamoxifenum
Please read carefully the entire leaflet before use, as it contains important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm other people, even if their symptoms are the same.
• If you experience any adverse effects, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents:

1. What Tamoxifen-Ebewe is and what it is used for
2. Important information before taking Tamoxifen-Ebewe
3. How to take Tamoxifen-Ebewe
4. Possible side effects
5. How to store Tamoxifen-Ebewe
6. Contents of the pack and other information

1. What Tamoxifen-Ebewe is and what it is used for

Tamoxifen-Ebewe is used for the treatment of breast cancer. It may be used as monotherapy,
but is most commonly used together with other anticancer drugs.

2. Important information before using Tamoxifen-Ebewe

When not to use Tamoxifen-Ebewe

• if the patient is allergic to tamoxifen or any of the other ingredients of this medicine (listed in section 6);
• if the patient has severe blood disorders such as thrombocytopenia or leukopenia;
• if the patient has high calcium levels in the blood (hypercalcemia);
• if the patient is pregnant.

Tamoxifen-Ebewe must not be used in children.
Warnings and precautions
Before starting to take Tamoxifen-Ebewe, discuss with your doctor or
pharmacist if:

• the patient is currently taking other medicines, especially medicines preventing blood clotting;
• the patient has a history of eye, liver, or kidney disease, thromboembolic disorders, diabetes, or other health problems;
• the patient has abnormal vaginal bleeding, irregular menstruation, vaginal discharge, or pelvic pain or pressure; Your doctor will order examinations to determine the cause of any vaginal bleeding, due to an increased risk of endometrial changes (in the lining of the uterus) associated with treatment.
• the patient has previously experienced hereditary angioedema, as Tamoxifen-Ebewe may cause or worsen symptoms of hereditary angioedema. If symptoms such as swelling of the face, lips, tongue and/or throat, or difficulty swallowing or breathing occur, contact your doctor immediately.

In premenopausal women, treatment with tamoxifen may suppress menstruation.
Women who still have their uterus should undergo annual gynecological examinations during tamoxifen treatment to monitor the condition of the endometrium.
At the beginning of tamoxifen treatment, your doctor will order ophthalmological examinations. If vision disturbances occur during treatment with Tamoxifen-Ebewe, seek medical advice promptly, as some early changes may resolve after discontinuation of treatment.
Tamoxifen treatment is associated with an increased risk of thromboembolic disease; therefore, your doctor will closely monitor patients with coexisting risk factors for venous thrombosis, such as obesity, advanced age, or concomitant chemotherapy.
Patients treated with Tamoxifen-Ebewe will require regular monitoring of blood counts, liver function, serum calcium, and serum triglyceride levels.
In patients undergoing breast reconstruction using microsurgical techniques, tamoxifen may increase the risk of complications related to microcirculatory disturbances in the skin flap.
Serious skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported with the use of Tamoxifen-Ebewe. If the patient notices any of the symptoms related to these serious skin reactions described in section 4, treatment with Tamoxifen-Ebewe must be discontinued and medical advice sought immediately.
Tamoxifen-Ebewe and other medicines
Inform your doctor about all medicines currently used, recently taken, or planned for use.
In particular, inform about the use of the following medicines:
oral anticoagulants (blood-thinning medicines);
Tamoxifen-Ebewe may enhance the effect of concomitantly administered anticoagulant drugs (e.g. coumarin derivatives), leading to prolonged bleeding. Your doctor will recommend close monitoring of coagulation parameters.
anticancer medicines;
rifampicin (an antibiotic used, among others, in the treatment of tuberculosis);
paroxetine, fluoxetine, bupropion (medicines used in the treatment of depression and certain psychiatric disorders);
quinidine (a medicine used for cardiac arrhythmias);
cinacalcet (a medicine used in disorders of parathyroid function);
bromocriptine (a medicine used, among others, in the treatment of disorders related to prolactin secretion and in Parkinson's disease).
Concomitant use of medicines containing bromocriptine may enhance the effect of Tamoxifen-Ebewe.
Simultaneous use of Tamoxifen-Ebewe and estrogen-containing hormonal medicines may reduce the effectiveness of both drugs (e.g. reduced efficacy of oral hormonal contraceptives).
Increased incidence of thromboembolic complications has been more frequently reported when tamoxifen is administered together with cytotoxic drugs.
Tamoxifen-Ebewe with food and drink
Take the medicine during meals. Swallow the tablets whole with sufficient liquid.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or plans to become pregnant, she should consult her doctor or pharmacist before using this medicine.
Pregnancy
Tamoxifen-Ebewe must not be used during pregnancy. There are few reports of spontaneous abortions, congenital malformations, and fetal death following tamoxifen use in pregnant women, although a causal relationship has not been established.
Before starting treatment, the doctor will confirm that the patient is not pregnant. During treatment with Tamoxifen-Ebewe and for at least 9 months after completion of treatment, effective contraceptive methods must be used. Do not use oral contraceptives.
Breastfeeding
Use of this medicine during breastfeeding is not recommended. Discuss with your doctor whether breastfeeding should be discontinued before starting the medicine or whether treatment with tamoxifen should be delayed until breastfeeding has ended.
Driving and operating machinery
Exercise caution, as vision disturbances, fatigue, and dizziness may occur during treatment with Tamoxifen-Ebewe, which may impair the ability to drive or operate machinery.
Tamoxifen-Ebewe contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult their doctor before taking this medicine.

3. How to use Tamoxifen-Ebewe

This medicine should always be used as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
The recommended daily dose of Tamoxifen-Ebewe is 20 mg.
In patients with advanced disease, doses of 30 or 40 mg have been used.
The maximum daily dose of Tamoxifen-Ebewe is 40 mg.
A response to treatment is usually observed within four to ten weeks of treatment, but in patients with bone metastases, it may occur only after several months.
Tablets should be swallowed whole with liquid.
The medicine should be taken during a meal.
If more than one tablet needs to be taken, the dose of Tamoxifen-Ebewe can be taken once or twice daily.
The duration of treatment is determined individually by the doctor for each patient, depending on the severity and course of the disease. Treatment is usually long-term.
Use in children
Tamoxifen-Ebewe must not be used in children.
Use of a higher than recommended dose of Tamoxifen-Ebewe
If you have taken more medicine than prescribed, seek medical advice immediately. Cases of severe overdose in humans have not been reported.
Missed dose of Tamoxifen-Ebewe
If the patient forgets to take a dose of Tamoxifen-Ebewe, they should take it as soon as they remember, then return to the prescribed dosing schedule.
Do not take a double dose to make up for a missed dose.
Stopping Tamoxifen-Ebewe
Do not stop taking this medicine without first consulting your doctor.
If you have any further doubts concerning the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following symptoms occur, treatment with Tamoxifen-Ebewe must be stopped immediately and a doctor should be consulted:
Reddish, flat, target-like or circular skin lesions on the trunk, often with central blisters, skin peeling, and ulceration of the mouth, throat, nose, genital organs and eyes. Such severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis) – these adverse reactions are rare.

Treatment with Tamoxifen-Ebewe must be stopped and a doctor should be notified immediately if any of the following adverse reactions occur – urgent treatment may be necessary:
Swelling of the face, lips, tongue or throat, difficulty swallowing or breathing (angioedema). Tamoxifen-Ebewe may cause or worsen symptoms of hereditary angioedema.

Very common (may occur in more than 1 in 10 people):
fluid retention, hot flushes, nausea, abnormal genital bleeding, menstrual disorders, amenorrhea, vaginal discharge, skin rash (including rarely such reactions as erythema multiforme or bullous pemphigoid), fatigue.

Common (may occur in less than 1 in 10 people):
transient decrease in red blood cells (anaemia), increased calcium levels in blood (hypercalcaemia) in patients with bone metastases, increased serum triglyceride levels, dizziness, headache, sensory disturbances (including paraesthesia and taste disturbances), visual disturbances (due to corneal changes, cataract and retinopathy), cerebrovascular incidents, leg cramps, thromboembolic events (including deep vein thrombosis of the legs, microvascular thrombosis and pulmonary embolism), vomiting, diarrhoea, constipation, changes in liver enzyme activity, fatty liver, alopecia, hypersensitivity reactions (including rarely angioedema), muscle pain, genital itching, uterine fibroids, changes in the endometrial mucosa.

Uncommon (may occur in less than 1 in 100 people):
decrease in white blood cells (leukopenia), transient decrease in platelets (thrombocytopenia), stroke, interstitial lung disease, liver cirrhosis, endometrial cancer, confusion, redness of the tumour, in premenopausal women treated with tamoxifen, reversible ovarian cyst enlargement, endometrial cancer.

Rare (may occur in less than 1 in 1000 people):
complete or almost complete absence of a certain type of white blood cells, so-called granulocytes (agranulocytosis), decrease in neutrophil granulocytes (neutropenia), optic nerve disease (optic neuropathy), optic neuritis (in rare cases leading to vision loss), cutaneous vasculitis, ovarian cysts, uterine sarcomas, endometrial polyps, bone pain and pain in the area of diseased tissue at the beginning of treatment, depression, in men loss of libido, leg tremor, excessive hair growth, in men impotence, severe liver function disorders, changes in serum lipid profile.

Very rare (may occur in less than 1 in 10,000 people):
cholestasis, hepatitis, jaundice, liver cell damage and necrosis, liver failure (sometimes life-threatening), marked decrease in neutrophil granulocytes, decrease in red blood cells, white blood cells and platelets (pancytopenia), marked increase in serum triglyceride levels, sometimes associated with pancreatitis, cutaneous lupus erythematosus, porphyria cutanea tarda, recurrence of radiation-induced symptoms.

Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw
Tel.: +48 22 49 21 301 / Fax: +48 22 49 21 309 / Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Tamoxifen-Ebewe

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging.
The expiry date refers to the last day of the stated month.
Store below 25ºC.
Store in the original packaging to protect from light and moisture.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures help protect the environment.

6. Contents of the pack and other information

What Tamoxifen-Ebewe contains
The active substance is tamoxifen.
One tablet of Tamoxifen-Ebewe 10 contains 10 mg of tamoxifen.
One tablet of Tamoxifen-Ebewe 20 contains 20 mg of tamoxifen.
The other ingredients are: monohydrate lactose, microcrystalline cellulose, maize starch,
anhydrous colloidal silicon dioxide, magnesium stearate.

What Tamoxifen-Ebewe looks like and contents of the pack
Tamoxifen-Ebewe tablets are packed in polypropylene containers with a polyethylene cap or in blisters made of Aluminium/PVC/PVDC foil, placed in a cardboard box.
The packs contain 30 tablets.

Marketing Authorisation Holder
EBEWE Pharma Ges.m.b.H. Nfg. KG
Mondseestrasse 11
A-4866 Unterach, Austria

Manufacturer
EBEWE Pharma Ges.m.b.H. Nfg. KG
Mondseestrasse 11
A-4866 Unterach, Austria
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany
Lek Pharmaceuticals d.d.
Verovškova 57
1526 Ljubljana, Slovenia

For more detailed information, please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00
Logo Ebewe