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TEVA-TAMOXIFEN is a brand name for Tamoxifen, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: TEVA-TAMOXIFEN (tamoxifen citrate) is indicated for: • the adjuvant treatment of early breast cancer in women with estrogen receptor positive tumours. • the treatment of women with hormone responsive locally advanced / metastatic breast cancer. 1.1 Pediatrics Pediatrics (< 18 years of age): The use of TEVA-TAMOXIFEN…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations The duration of treatment with TEVA-TAMOXIFEN will depend on the patient's response. The drug should be continued as long as there is a favourable response. With obvious disease progression, the drug should be discontinued.
However, because an occasional patient will have a local disease flare or an increase in bone pain shortly after starting tamoxifen citrate, it is sometimes difficult during the first few weeks of treatment to determine whether the patient's disease is progressing or whether it will stabilize or respond to continued treatment (see 8 ADVERSE REACTIONS).
There are data to suggest that, if possible, treatment should not be discontinued before a minimum of three to four weeks. In clinical studies, the median duration of treatment before the onset of a definite objective response has been two months.
However, approximately one -quarter of patients who eventually responded were treated for four or more months before a definite obje ctive response was recorded. 2 Recommended Dose and Dosage Adjustment The recommended daily dose of TEVA-TAMOXIFEN is 20 to 40 mg in a single or two divided doses.
The lowest effective dose should be used. In early disease, the recommended duration of therapy is 5 years. The optimal duration of therapy remains to be determined.
Pediatric Use:
Health Canada has not authorized an indication for pediatric use. Serious Warnings and Precautions Tamoxifen citrate therapy was associated with serious and life-threatening events including uterine malignancies, stroke, pulmonary embolism, and deep vein thrombosis in the NSABP P-1 trial for the prevention of breast cancer.
The use of TEVA-TAMOXIFEN for breast cancer prevention is not an approved indication in Canada. 6 for deep vein thrombosis. These events were fatal in some patients. Health care providers should be aware of the possible risks associated with TEVA-TAMOXIFEN therapy and should discuss them with their patients.
THE BENEFITS OF TEVA-TAMOXIFEN THERAPY OUTWEIGH THE RISKS IN THE MAJORITY OF WOMEN BEING TREATED ACCORDING TO THE APPROVED CANADIAN INDICATION FOR THE TREATMENT OF BREAST CANCER. 4 Administration TEVA-TAMOXIFEN is for oral use only.
5 Missed Dose If a patient misses a dose, they should take the next usual dose as soon as they remember. Do not take two doses at the same time.
). There are data to suggest that, if possible, treatment should not be discontinued before a minimum of three to four weeks. In clinical studies, the median duration of treatment before the onset of a definite objective response has been two months.
However, approximately one -quarter of patients who eventually responded were treated for four or more months before a definite obje ctive response was recorded. 2 Recommended Dose and Dosage Adjustment The recommended daily dose of TEVA-TAMOXIFEN is 20 to 40 mg in a single or two divided doses.
The lowest effective dose should be used. In early disease, the recommended duration of therapy is 5 years. The optimal duration of therapy remains to be determined.
Pediatric Use:
Health Canada has not authorized an indication for pediatric use. Serious Warnings and Precautions Tamoxifen citrate therapy was associated with serious and life-threatening events including uterine malignancies, stroke, pulmonary embolism, and deep vein thrombosis in the NSABP P-1 trial for the prevention of breast cancer.
The use of TEVA-TAMOXIFEN for breast cancer prevention is not an approved indication in Canada. 6 for deep vein thrombosis. These events were fatal in some patients. Health care providers should be aware of the possible risks associated with TEVA-TAMOXIFEN therapy and should discuss them with their patients.
THE BENEFITS OF TEVA-TAMOXIFEN THERAPY OUTWEIGH THE RISKS IN THE MAJORITY OF WOMEN BEING TREATED ACCORDING TO THE APPROVED CANADIAN INDICATION FOR THE TREATMENT OF BREAST CANCER. 4 Administration TEVA-TAMOXIFEN is for oral use only.
5 Missed Dose If a patient misses a dose, they should take the next usual dose as soon as they remember. Do not take two doses at the same time. 5 OVERDOSAGE Acute overdosage in humans has not been reported. Possible overdosage effects might include hot flushes, nausea, vomiting, and vaginal bleeding.
, Cardiovascular 04/2025 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. 1 Special Populations ...............................................................................................
1 Pregnant Women .................................................................................................. 2 Breast-feeding.......................................................................................................
3 Pediatrics .............................................................................................................. 11 8 ADVERSE REACTIONS.....................................................................................................
1 Adverse Reaction Overview ................................................................................... 2 Clinical Trial Adverse Reactions.............................................................................. 3 Less Common Clinical Trial Adverse Reactions........................................................
5 Post-Market Adverse Reactions ............................................................................. 16 9 DRUG INTERACTIONS ....................................................................................................
2 Drug Interactions Overview ................................................................................... 4 Drug-Drug Interactions .......................................................................................... 16 TEVA-TAMOXIFEN Page 3 of 35 Unclassified / Non classifié 10 CLINICAL PHARMACOLOGY............................................................................................
1 Mechanism of Action............................................................................................. 2 Pharmacodynamics ............................................................................................... 3 Pharmacokinetics ..................................................................................................
TEVA-TAMOXIFEN is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
TEVA-TAMOXIFEN must not be given during pregnancy. There have been a small number of reports of spontaneous abortions, birth defects and fetal deaths after women have taken tamoxifen citrate, although no causal relationship has been established.
Women should be advised not to become pregnant while taking TEVA-TAMOXIFEN and for nine months following the cessation of therapy and should use a barrier or other non-hormonal contraceptive methods if sexually active. Pre-menopausal patients must be carefully examined before treatment to exclude the possibility of pregnancy.
Women should be informed of the potential risks to the fetus, should they become pregnant while taking TEVA-TAMOXIFEN or within nine months of cessation of therapy. When used in the prevention setting (an indication not approved in Canada), TEVA-TAMOXIFEN is contraindicated in patients with a history of stroke, deep ve nous thrombosis or pulmonary embolism, and in patients who are at an increased risk of developing endometrial cancer.
TEVA-TAMOXIFEN Page 5 of 35 Unclassified / Non classifié
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Tamoxifen in Canada.
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No specific treatment for overdosage is known and treatment must be symptomatic. In the case of accidental ingestion by a child, gastric emptying is suggested. There have been reports in the literature that tamoxifen citrate given at several times the standard dose may be associated with prolongation of the QT interval of the ECG.
For management of a suspected drug overdose, contact your regional poison control centre. 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 1 – Dosage Forms, Strengths and Composition Route of Administration Dosage Form / Strength / Composition Non-medicinal Ingredients Oral Film coated tablets 10 mg, 20 mg Colloidal silicon dioxide, hydroxypropyl methylcellulose, mannitol, magnesium stearate, povidone, polyethylene glycol, sodium starch glycolate and titanium dioxide.
AVAILABILITY Film Coated Tablets 10 mg:
White to off-white, round, bi-convex, film coated tablets, engraved stylized "N" over 10 on one side and plain on the other side, containing tamoxifen citrate equivalent to 10 mg of tamoxifen. These tablets are available in bottles of 60, 100 and 250 and in blister packages of 6 strips of 10 tablets.
TEVA-TAMOXIFEN Page 7 of 35 Unclassified / Non classifié 20 mg:
White to off-white, round, bi-convex, film coated tablets, engraved on one side stylized "N" over scoreline, 20 under it, and plain on the other, containing tamoxifen citrate equivalent to 20 mg of tamoxifen. These tablets are available in bottles of 60 and 100 and in blister packages of 3 strips of 10 tablets.
7 WARNINGS AND PRECAUTIONS Please see the 3 SERIOUS WARNINGS AND PRECAUTIONS BOX at the beginning of Part I: Health Professional Information. General TEVA-TAMOXIFEN should be used only for the conditions listed under the 1 INDICATIONS section.
g. paroxetine, a known CYP2D6 inhibitor) (see
18 11 STORAGE, STABILITY AND DISPOSAL.............................................................................. 18 12 SPECIAL HANDLING INSTRUCTIONS ............................................................................... 18 PART II: SCIENTIFIC INFORMATION.......................................................................................
19 13 PHARMACEUTICAL INFORMATION ................................................................................ 19 14 CLINICAL TRIALS ............................................................................................................
1 Clinical Trials by Indication..................................................................................... 2 Comparative Bioavailability Studies ....................................................................... 19 15 MICROBIOLOGY.............................................................................................................
21 16 NON-CLINICAL TOXICOLOGY .......................................................................................... 21 PATIENT MEDICATION INFORMATION..................................................................................
26 TEVA-TAMOXIFEN Page 4 of 35 Unclassified / Non classifié PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS TEVA-TAMOXIFEN (tamoxifen citrate) is indicated for: • the adjuvant treatment of early breast cancer in women with estrogen receptor positive tumours.
• the treatment of women with hormone responsive locally advanced / metastatic breast cancer. 1 Pediatrics Pediatrics (< 18 years of age): The use of TEVA-TAMOXIFEN is not recommended in children, as safety and efficacy have not been established.
2 CONTRAINDICATIONS TEVA-TAMOXIFEN is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
TEVA-TAMOXIFEN must not be given during pregnancy. There have been a small number of […]