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PROVIRON

mesterone 5 mg/tablet

1 BOX containing 60 tablets

What is mesterone

mesterone is used for treating a deficiency of the male hormone testosterone when the body does not make enough. It is also used to stimulate puberty in males with delayed puberty.Treating advanced breast cancer in women who are 1 to 5 years past menopause.

mesterone is an androgen.It works by stimulating normal growth and development of the male sex organs and maintaining normal secondary sex characteristics.It is unknown exactly how mesterone works to treat breast cancer.

Before taking mesterone

Some medical conditions may interact with mesterone . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

       if you are breast-feeding

       if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

       if you have allergies to medicines, foods, or other substances

       if you have prostate problems, high blood calcium levels, or heart, liver, or kidney disease

Some MEDICINES MAY INTERACT with mesterone . Tell your health care provider if you are taking any other medicines, especially any of the following:

       Anticoagulants (eg, warfarin), carbamazepine, corticosteroids (eg, prednisone), macrolide immunosuppressants (eg, tacrolimus), or oxyphenbutazone because the actions and side effects of these medicines may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if mesterone may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

Taking mesterone

Use mesterone as directed by your doctor. Check the label on the medicine for exact dosing instructions.

       mesterone may be taken with or without food. If stomach upset occurs, take with food to reduce stomach irritation.

       If you miss a dose of mesterone , take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use mesterone .

Side Effects

medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Changes in sexual desire; absence of menstrual flow; acne; breast swelling or tenderness; deepening of voice; growth of facial hair; headache; irregular menstrual flow; mood changes; painful, prolonged erection; swelling of the clitoris.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); ankle swelling; change in skin color; nausea; vomiting; weight gain.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider.

Effects with other drugs

Androgens may increase sensitivity to oral anticoagulants. Dosage of the anticoagulant may require reduction in order to maintain satisfactory therapeutic hypoprothrombinemia.

Concurrent administration of oxyphenbutazone and androgens may result in elevated serum levels of oxyphenbutazone.

In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, insulin requirements

Proper Use

Take this medicine only as directed. Do not take more of it and do not take it more often than your doctor ordered . Doing so may increase the chance of side effects.

There are two types of testosterone skin patches. The matrix-type is applied to skin of the scrotum. The reservoir-type is never applied to the skin of the scrotum. It is applied to other parts of the body. Be sure you know which type you are using so that you will apply it properly. These skin patches come with patient directions. Read them carefully before using the patch.

For patients taking mesterone or methyltestosterone :

       Take this medicine with food to lessen possible stomach upset, unless otherwise directed by your doctor.

Precautions

Women should be observed for signs of virilization which is usual following androgen use at high doses. Discontinuation of drug therapy at the time of evidence of mild virilism is necessary to prevent irreversible virilization. A decision may be made by the patient and the physician that some virilization will be tolerated during treatment for breast carcinoma.

Patients with benign prostatic hypertrophy may develop acute urethral obstruction. Priapism or excessive sexual stimulation may develop. Oligospermia may occur after prolonged administration or excessive dosage. If any of these effects appear, the androgen should be stopped and if restarted, a lower dosage should be utilized.

This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.