Tamoxifen-ebeve 10

Package Leaflet: Information for the Patient

Tamoxifen-Ebewe 10, 10 mg, tablets

Tamoxifen-Ebewe 20, 20 mg, tablets

Tamoxifen

Read the package leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor or pharmacist. See section 4.

Package Leaflet Contents:

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

Tamoxifen-Ebewe is used to treat breast cancer. It may be used as monotherapy, but is most often used in combination with other anticancer medicines.

2. Important information before taking Tamoxifen-Ebewe

When not to take Tamoxifen-Ebewe

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

Tamoxifen-Ebewe should not be taken by children.

Warnings and precautions

Before starting treatment with Tamoxifen-Ebewe, discuss with your doctor or pharmacist if:

• you are taking other medicines, especially blood thinning medicines;
• you have eye, liver, kidney, blood clotting, diabetes or other health problems;
• you have unusual vaginal bleeding, irregular periods, discharge, pain or pressure in the pelvic area; Your doctor will order tests to determine the cause of any vaginal bleeding due to the increased risk of endometrial changes (endometrium) associated with treatment.
• you have had hereditary angioedema, as Tamoxifen-Ebewe may cause or exacerbate symptoms of hereditary angioedema. If symptoms such as facial, lip, tongue and/or throat swelling and difficulty swallowing or breathing occur, seek medical attention immediately.

In premenopausal women, tamoxifen treatment may suppress menstruation. Women with an intact uterus should undergo annual gynecological examinations during tamoxifen treatment to monitor the condition of the endometrium.
At the start of tamoxifen treatment, your doctor will order ophthalmological examinations. If vision disturbances occur during Tamoxifen-Ebewe treatment, seek medical attention immediately, as some changes may be reversible after treatment discontinuation.
Tamoxifen treatment is associated with an increased risk of thromboembolic disease, so your doctor will closely monitor patients with existing risk factors for venous thrombosis, such as obesity, advanced age, and concomitant chemotherapy.
Patients treated with Tamoxifen-Ebewe will be ordered regular blood morphology, liver function, calcium levels, and triglyceride levels in serum.
In patients undergoing breast reconstruction using microsurgical techniques, tamoxifen may increase the risk of complications related to microcirculation disorders in the skin flap.
Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported with Tamoxifen-Ebewe. If you notice any symptoms associated with these severe skin reactions, as described in section 4, discontinue Tamoxifen-Ebewe and seek medical attention immediately.

Tamoxifen-Ebewe and other medicines

Tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you plan to take.
Especially tell your doctor if you are taking:
oral anticoagulants (blood thinning medicines);
Tamoxifen-Ebewe may enhance the effect of concomitantly administered anticoagulant (e.g., coumarin derivatives), prolonging bleeding. Your doctor will order close monitoring of coagulation parameters.
anticancer medicines;
rifampicin (an antibiotic used to treat tuberculosis);
paroxetine, fluoxetine, bupropion (medicines used to treat depression and certain mental illnesses);
quinidine (a medicine used to treat heart rhythm disorders);
cinacalcet (a medicine used to treat parathyroid disorders);
bromocriptine (a medicine used to treat prolactin-related disorders and Parkinson's disease).
Concomitant use of bromocriptine-containing medicines may enhance the effect of Tamoxifen-Ebewe.
Concomitant use of Tamoxifen-Ebewe and estrogen-containing medicines may reduce the efficacy of both medicines (e.g., reduced effectiveness of hormonal oral contraceptives).
Increased incidence of thromboembolic events has been reported when tamoxifen is administered concomitantly with cytotoxic medicines.

Tamoxifen-Ebewe with food and drink

Take the medicine with food. Swallow the tablets whole with a sufficient amount of liquid.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
Tamoxifen-Ebewe should not be taken during pregnancy. There have been reports of spontaneous abortions, birth defects, and fetal death after tamoxifen administration in pregnant women, although a causal relationship has not been established.
Before starting treatment, your doctor will ensure that you are not pregnant. During Tamoxifen-Ebewe treatment and for at least 9 months after treatment discontinuation, effective contraceptive methods should be used. Do not use oral contraceptives.
Breastfeeding
Tamoxifen-Ebewe is not recommended during breastfeeding. Discuss with your doctor whether to stop breastfeeding before taking the medicine or to avoid tamoxifen treatment until breastfeeding is discontinued.

Driving and using machines

Be cautious, as Tamoxifen-Ebewe may cause vision disturbances, fatigue, and dizziness, which may impair your ability to drive or operate machinery.

Tamoxifen-Ebewe contains lactose

If you have been diagnosed with intolerance to some sugars, contact your doctor before taking the medicine.

3. How to take Tamoxifen-Ebewe

Always take this medicine exactly as your doctor has told you. If you are not sure, ask 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.
Response to treatment is usually seen within 4 to 10 weeks of treatment, but in patients with bone metastases, it may occur only after several months.
Swallow the tablets whole with a sufficient amount of liquid.
Take the medicine with food.
If it is necessary to take more than one tablet, the dose of Tamoxifen-Ebewe can be taken once or twice daily.
Treatment duration is determined by your doctor individually for each patient, depending on the severity and course of the disease. Treatment is usually long-term.

Use in children

Tamoxifen-Ebewe should not be taken by children.

Overdose of Tamoxifen-Ebewe

If you have taken more than the prescribed dose, seek medical attention immediately. No cases of severe overdose have been reported in humans.

Missed dose of Tamoxifen-Ebewe

If you forget to take a dose, take it as soon as you remember, then continue with the prescribed dosing schedule.
Do not take a double dose to make up for the missed dose.

Discontinuation of Tamoxifen-Ebewe

Do not stop taking the medicine without consulting your doctor first.
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.
If you experience any of the following symptoms, stop taking Tamoxifen-Ebewe and seek medical attention immediately:
Red, flat, target-like or circular patches on the torso, often with central blisters, skin peeling, oral, throat, nose, genital, and eye ulcers. Such symptoms of severe skin rash may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis) - these side effects are rare.
Stop taking Tamoxifen-Ebewe and seek medical attention immediately if you experience any of the following side effects - you may need urgent medical attention:
Facial, lip, tongue, or throat swelling, difficulty swallowing or breathing (angioedema). Tamoxifen-Ebewe may cause or exacerbate symptoms of hereditary angioedema.
Very common(may affect more than 1 in 10 people):
fluid retention, hot flashes, nausea, unusual vaginal bleeding, menstrual disorders, amenorrhea, discharge, skin rash (including rare reactions such as erythema multiforme or pemphigus), fatigue.
Common(may affect up to 1 in 10 people):
transient anemia, hypercalcemia in patients with bone metastases, increased triglyceride levels in serum, dizziness, headache, sensory disturbances (including paresthesia and taste disturbances), vision disturbances (due to changes in the cornea, cataracts, and retinopathy), transient ischemic attacks, leg cramps, thromboembolic events (including deep vein thrombosis, thrombosis in small vessels, and pulmonary embolism), vomiting, diarrhea, constipation, changes in liver enzyme activity, liver steatosis, alopecia, hypersensitivity reactions (including rare cases of angioedema), muscle pain, vulvar itching, uterine fibroids, changes in the endometrium.
Uncommon(may affect up to 1 in 100 people):
leukopenia, transient thrombocytopenia, stroke, interstitial pneumonia, liver cirrhosis, endometrial cancer, confusion, tumor flare, reversible ovarian cysts in premenopausal women treated with tamoxifen, endometrial cancer.
Rare(may affect up to 1 in 1,000 people):
agranulocytosis, neutropenia, optic neuropathy (optic neuritis), skin vasculitis, ovarian cysts, uterine sarcomas, endometrial polyps, bone pain, depression, loss of libido in men, tremor, hirsutism in men, impotence, severe liver dysfunction, changes in lipid profiles in serum.
Very rare(may affect up to 1 in 10,000 people):
bile duct obstruction, hepatitis, jaundice, liver failure (sometimes life-threatening), severe neutropenia, pancytopenia, severe hypertriglyceridemia, sometimes with pancreatitis, cutaneous lupus erythematosus, porphyria cutanea tarda, recurrence of radiation-induced symptoms.

Reporting of side effects

If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, 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
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this 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 month.
Store in a temperature below 25°C.
Store in the original packaging to protect from light and moisture.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will 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: lactose monohydrate, microcrystalline cellulose, corn starch, colloidal anhydrous silica, magnesium stearate.

What Tamoxifen-Ebewe looks like and contents of the pack

Tamoxifen-Ebewe tablets are packaged in polypropylene containers with a polyethylene cap or in blisters of aluminum/PVC/PVDC film, in a cardboard box.
The packs contain 30 tablets.

Marketing authorization 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 further information, please contact:

Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00

Date of last revision of the leaflet:

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