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EUGIA-PROGESTERONE is a brand name for Progesterone, supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE............................................................................ 3 CONTRAINDICATIONS ................................................................................................. 3 WARNINGS AND PRECAUTIONS ............................................................................... 4…
Verbatim from this product's HC label. Tap a section to expand.
Serious Warnings and Precautions The Women’s Health Initiative (WHI) trial examined the health benefits and risks of combined estrogen plus progestin therapy (n=16,608) and estrogen-alone therapy (n=10,739) in postmenopausal women aged 50 to 79 years.
2 years compared to those receiving placebo. 30 The Women’s Health Initiative Memory Study (WHIMS) estrogen plus progestin ancillary study of the WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age or older.
Therefore, the following should be given serious consideration at the time of prescribing: • Estrogens with or without progestins should not be prescribed for primary or secondary prevention of cardiovascular diseases or dementia. • Estrogens with or without progestins should be prescribed at the lowest effective dose for the approved indication.
• Estrogens with or without progestins should be prescribed for the shortest period possible for the approved indication. Some of the information presented in the Warnings and Precautions section is provided in light of the fact that progestin medication is often prescribed concomitantly with an estrogen medication.
Information in this section pertaining to combined estrogen-progestin therapy may therefore not apply to progestin-only therapy. Physician discretion is advised. General Effects on ability to drive and use machines Transient and occasional somnolence or dizziness may occur in some patients 1-4 hours after ingestion of Eugia-Progesterone, particularly if administered with food.
Activities requiring concentration, good attention, good coordination or reflex action should be avoided when the above-mentioned neurological symptoms occur. In most cases, these problems can be avoided by taking the capsules at the recommended times.
The 200 mg dosage should be taken at bedtime. The 300 mg dosage should be divided into two doses, 100 mg 2 hours after breakfast and 200 mg at bedtime. Page 5 of 34 Carcinogenesis and Mutagenesis Breast Cancer Available epidemiological data indicate that the use of combined estrogen plus progestin by postmenopausal women is associated with an increased risk of invasive breast cancer.
1] vs. 04) and were at a more advanced stage compared with those diagnosed in the placebo group. The percentage of women with abnormal mammograms (recommendations for short-interval follow-up, a suspicious abnormality, or highly suggestive of malignancy) was significantly higher in the estrogen plus progestin group versus the placebo group.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Progesterone in Canada.
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30 It is recommended that estrogens with or without progestins not be given to women with existing breast cancer or those with a previous history of the disease. There is a need for caution in prescribing estrogens with or without progestins for women with known risk factors associated with the development of breast cancer, such as strong family history of breast cancer (first degree relative) or who present a breast condition with an increased risk (abnormal mammograms and/ or atypical hyperplasia at breast biopsy).
Other known risk factors for the development of breast cancer such as nulliparity, obesity, early menarche, late age at first full term pregnancy and at menopause should also be evaluated. It is recommended that women undergo mammography prior to the start of HRT treatment and at regular intervals during treatment, as deemed appropriate by the treating physician and according to the perceived risks for each patient.
The overall benefits and possible risks of hormone replacement therapy should be fully considered and discussed with patients. It is important that the modest increased risk of being diagnosed with breast cancer after 4 years of treatment with combined estrogen plus progestin HRT (as reported in the results of the WHI trial) be discussed with the patient and weighed against its known benefits.
Instructions for regular self-examination of the breasts should be included in this counselling. Page 6 of 34 Ovarian cancer Some recent epidemiologic studies have found that the use of hormone replacement therapy (estrogen-alone and estrogen plus progestin therapies), in particular for five or more years, has been associated with an increased risk of ovarian cancer.
8, 11, 31 The results of the WHI trial indicate that the use of […]