Tamoxifen Sandoz

Package Leaflet: Information for the User

Tamoxifen Sandoz, 20 mg, Film-Coated Tablets

Tamoxifen

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

• Keep this 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 those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the Package Leaflet:

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

1. What is Tamoxifen Sandoz and what is it used for

Tamoxifen Sandoz is a synthetic anti-estrogenic agent used in the treatment of advanced breast cancer with metastases or as adjuvant therapy after primary treatment of breast cancer.
The direct anti-tumor effect of the drug is based on the inhibition of the cell division process in cells with estrogen receptors and blocking the hormonal effect of endogenous estradiol.

2. Important information before taking Tamoxifen Sandoz

When not to take Tamoxifen Sandoz

if you are allergic to tamoxifen or any of the other ingredients of the medicine (listed in section 6);
if you have been diagnosed with:

• significant reduction in platelet count (severe thrombocytopenia),
• significant reduction in white blood cell count (severe leukopenia)
• increased calcium levels in the blood (hypercalcemia); if you are pregnant.

This medicine should not be taken by children.

Warnings and precautions

Before taking Tamoxifen Sandoz, discuss it with your doctor or pharmacist:

• if you have ever had hereditary angioedema, as Tamoxifen Sandoz may cause or exacerbate symptoms of hereditary angioedema. If symptoms such as facial swelling, lip swelling, tongue swelling, and (or) throat swelling, and difficulty swallowing or breathing occur, contact your doctor immediately. All worrying symptoms that occur during treatment with this medicine should be reported to the doctor immediately. In particular, if you experience:
• vaginal bleeding in postmenopausal women;
• irregular bleeding in premenopausal women;
• discharge; feeling of increased pressure in the pelvis or pelvic pain.

Your doctor will order thorough examinations to determine the cause of these symptoms due to the increased risk of tumor changes in the endometrium associated with treatment.
In premenopausal women, tamoxifen treatment may suppress menstruation.
Women with an intact uterus should undergo a gynecological examination every year during tamoxifen treatment to monitor the endometrium.
At the beginning of tamoxifen treatment, your doctor will order ophthalmological examinations. If vision disturbances occur during treatment with Tamoxifen Sandoz, contact your doctor immediately, as some changes detected early may resolve after discontinuation of treatment.
Tamoxifen treatment is associated with an increased risk of thrombotic disease, so your doctor will closely monitor patients with concomitant risk factors for venous thrombosis, such as obesity, advanced age, concurrent chemotherapy.
In patients undergoing breast reconstruction using microsurgical techniques, tamoxifen may increase the risk of complications related to microcirculation disorders in the skin flap.
Patients treated with Tamoxifen Sandoz should have regular blood morphology, liver function, calcium levels, and triglyceride levels in serum monitored by their doctor.
Severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported with the use of Tamoxifen Sandoz. If you notice any symptoms associated with these severe skin reactions, as described in section 4, discontinue Tamoxifen Sandoz and contact your doctor immediately.

Tamoxifen Sandoz 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. This includes medicines that are available without a prescription.
In particular, tell your doctor if you are taking:
oral anticoagulants (blood thinners);
aminoglutethimide (an aromatase inhibitor used in the treatment of breast and ovarian cancer);
anticancer medicines;
rifampicin (an antibiotic used in the treatment of tuberculosis);
paroxetine, fluoxetine, bupropion (medicines used in the treatment of depression and certain mental illnesses);
quinidine (a medicine used in heart rhythm disorders);
cinacalcet (a medicine used in disorders of parathyroid function).
oral hormonal contraceptives. Tamoxifen Sandoz may reduce the effectiveness of oral hormonal contraceptives.

Tamoxifen Sandoz with food and drink

Tamoxifen Sandoz should be taken with meals, swallowing the tablets whole and washing them down with a liquid.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Tamoxifen Sandoz should not be taken during pregnancy. Before starting treatment, your doctor will ensure that you are not pregnant. During treatment with Tamoxifen Sandoz and for 9 months after the end of treatment, effective non-hormonal contraceptive methods should be used. Do not use oral hormonal contraceptives.
Breastfeeding
Tamoxifen Sandoz is not recommended during breastfeeding. You should discuss with your doctor whether to stop breastfeeding or not to start treatment with tamoxifen during breastfeeding.

Driving and using machines

Be cautious, as vision disturbances, fatigue, and dizziness may occur during treatment with Tamoxifen Sandoz, affecting your ability to drive vehicles and operate machines.

Tamoxifen Sandoz contains lactose and sodium

If you have been diagnosed with intolerance to some sugars, contact your doctor before taking the medicine.
The medicine contains less than 1 mmol (23 mg) of sodium per film-coated tablet, which means it is essentially 'sodium-free'.

3. How to take Tamoxifen Sandoz

This medicine should always be taken exactly as prescribed by your doctor. If you are unsure, consult your doctor or pharmacist.
Tamoxifen is usually taken in a daily dose of 20 to 40 mg. A dose of 20 mg is usually sufficient.
Duration of treatment
Your doctor will determine how long you should take the medicine. Treatment is usually long-term.

Taking more than the recommended dose of Tamoxifen Sandoz

If you take more than the recommended dose, contact your doctor or pharmacist immediately. Treatment of overdose is symptomatic.

Missing a dose of Tamoxifen Sandoz

Do not take a double dose to make up for a missed dose.

Stopping treatment with Tamoxifen Sandoz

Do not stop taking Tamoxifen Sandoz without consulting your doctor.
If you have any further questions about taking this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Tamoxifen Sandoz can cause side effects, although not everybody gets them.
If you notice any of the following symptoms, stop taking Tamoxifen Sandoz and contact your doctor immediately:
Red, flat, target-like or circular patches on the torso, often with central blisters, skin peeling, ulcers of the mouth, throat, nose, genitals, and eyes. 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 Sandoz and inform your doctor immediately if you experience any of the following side effects - you may need urgent medical attention:
Swelling of the face, lips, tongue, or throat, difficulty swallowing or breathing (angioedema). Tamoxifen Sandoz may cause or exacerbate symptoms of hereditary angioedema.
The following side effects may occur during treatment with tamoxifen.
Very common side effects (may affect more than 1 in 10 people):
edema (due to fluid retention in the body), nausea, skin rash (including rare severe reactions such as erythema multiforme or pemphigus), hot flashes, discharge, irregular menstrual cycles (up to complete cessation of menstruation in premenopausal women), vaginal bleeding, feeling of fatigue.
Common side effects (may affect up to 1 in 10 people):
transient reduction in red blood cell count (anemia), increased calcium levels in the blood (hypercalcemia) in patients with bone metastases, increased triglyceride levels in serum, dizziness, headache, sensory disturbances (including paresthesia and taste disturbances), vision disturbances, cerebrovascular incidents, leg cramps, thromboembolic events (including deep vein thrombosis, microvascular thrombosis, and pulmonary embolism), vomiting, diarrhea, constipation, changes in liver enzyme activity, liver steatosis, alopecia, hypersensitivity reactions (including rare angioedema), muscle pain, vulvar pruritus, uterine fibroids, changes in the endometrium.
Uncommon side effects (may affect up to 1 in 100 people):
reduction in white blood cell count (leukopenia), transient reduction in platelet count (thrombocytopenia), stroke, interstitial pneumonia, liver cirrhosis, endometrial cancer.
Rare side effects (may affect up to 1 in 1,000 people):
agranulocytosis, reduction in neutrophil count (neutropenia), optic neuropathy, optic neuritis (in rare cases with vision loss), cutaneous vasculitis, ovarian cysts, uterine sarcomas, endometrial polyps, in the initial treatment period, bone pain, and pain in the area of the affected tissue.
Very rare side effects (may affect less than 1 in 10,000 people):
severe neutropenia (life-threatening granulocytopenia) and pancytopenia (reduction in white blood cell, red blood cell, and platelet count), significantly increased triglyceride levels in serum (severe hypertriglyceridemia), sometimes with pancreatitis, cholestasis, hepatitis, jaundice, liver cell damage, and liver failure (sometimes life-threatening), cutaneous lupus erythematosus, porphyria cutanea tarda, recurrence of radiation symptoms.
Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the 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 Sandoz

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month.
Store the medicine in a dry place, at a temperature below 25°C. Protect from light.
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 Sandoz contains

The active substance is tamoxifen. One film-coated tablet contains 30.4 mg of tamoxifen citrate, equivalent to 20 mg of tamoxifen.
The other ingredients are: lactose monohydrate, sodium carboxymethylcellulose, povidone (Kollidon 25), microcrystalline cellulose, magnesium stearate, titanium dioxide (E 171), hypromellose, polyethylene glycol 4000.

What Tamoxifen Sandoz looks like and contents of the pack

Tamoxifen Sandoz tablets are white, with a smooth surface, round, biconvex, with a score line on one side.
Blister packs in a cardboard box contain 30 or 100 film-coated tablets.

Marketing authorization holder

Sandoz GmbH
Biochemiestrasse 10
A-6250 Kundl, Austria

Manufacturer

Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany
Haupt Pharma Amareg GmbH
Donaustaufer Strasse 378
93055 Regensburg, Germany

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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