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  • Dutasteride Teva
    / Abic


    Active Ingredient
    Dutasteride 0.5 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Soft Capsules

    30 X 0.5 mg

    not in the basket chart 20083

    Dosage

    The usual dose is generally one capsule (0.5 mg) taken once a day.


    Indications

    Treatment of moderate to severe symptoms of benign prostatic hyperplasia (BPH).
    Reduction in the risk of acute urinary retention (AUR) and surgery in patients with moderate to severe symptoms of BPH.


    Contra-Indications

    Hypersensitivity to other 5-alpha-reductase inhibitors or to any of drug’s excipients.
    Patients with severe hepatic disease.
    Female patients, children or adolescents.


    Special Precautions

    If the patient had any ailment that affected the liver, he may need to undergo additional tests when taking Dutasteride Teva.
    Women, children and adolescents must avoid contact with leaking capsules of Dutasteride Teva, since the active ingredient can be absorbed through the skin.
    Patients should use a condom during sexual contact. Dutasteride has been found in sperm of men taking Dutasteride Teva. Dutasteride may affect the normal development of a male fetus.
    Dutasteride has been found to lower sperm counts, semen fluid volume and
    sperm motility. This may reduce fertility.
    Dutasteride Teva affects the PSA (prostate-specific antigen) blood test, which is sometimes used to detect prostate cancer. Men taking Dutasteride Teva need to check their PSA regularly.
    In a clinical study in men with increased risk of prostate cancer, men who took
    Dutasteride Teva developed a severe degree of prostate cancer more frequently than men who did not take Dutasteride Teva. The effect of Dutasteride Teva on the severity of prostate cancer is unclear.
    Dutasteride Teva may cause breast enlargement or tenderness. These may be signs of a severe medical problem, such as breast cancer.


    Side Effects

    Common (1/10): Inability to achieve or maintain an erection (impotence);
    Reduced sexual drive (libido); Ejaculation disturbances such as reduced seminal discharge during sexual intercourse; Breast enlargement or tenderness in the
    breast (gynecomastia); Dizziness when taken with tamsulosin.
    See prescribing information for full details.


    Drug interactions

    Verapamil or diltiazem (for high blood pressure); Ritonavir or indinavir (for HIV – Human Immunodeficiency Virus); Itraconazole or ketoconazole (for fungal infection); Nefazodone (for depression); Alpha blockers (to treat an enlarged prostate gland or high blood pressure).


    Pregnancy and Lactation

    Pregnancy: Women who are pregnant (or who may be pregnant) must avoid contact with leaking capsules. Dutasteride is absorbed through the skin and may affect the normal development of a male fetus. This risk is increased during the first 16 weeks of pregnancy. Patients should use a condom during sexual contact.
    Dutasteride has been found in the seminal fluid of men taking Dutasteride Teva. If the patient partner is pregnant or may be pregnant, he must avoid exposing her to his sperm.
    Fertility: Dutasteride Teva has been found to lower sperm counts, semen fluid volume and sperm motility. Therefore, male fertility may be reduced.


    Manufacturer
    Teva Pharmaceutical Industries Ltd, Israel
    Licence holder
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