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AndroGel Gel is used for:

Treating symptoms of low testosterone in adult men when the body does not make any testosterone or not enough testosterone (hypogonadism). It may also be used for other conditions as determined by your doctor.

AndroGel Gel is a hormone. It works by replacing or supplementing the testosterone that is naturally made in the body.

Do NOT use AndroGel Gel if:

• you are allergic to any ingredient in AndroGel Gel
• you are female
• you are pregnant or breast-feeding
• you have known or suspected breast or prostate cancer

Contact your doctor or health care provider right away if any of these apply to you.

Before using AndroGel Gel:

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

• if you are pregnant, planning to become pregnant, or 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 (especially soy products)
• if you have heart disease, heart failure, coronary artery disease, angina (chest pain), high cholesterol levels, swelling (edema), lung disease, or sleep apnea (long pauses in breathing while you sleep)
• if you have diabetes, an enlarged prostate, kidney or liver disease, high blood calcium levels, or obesity

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

• Carbamazepine, corticosteroids (eg, prednisone), macrolide immunosuppressants (eg, tacrolimus), or oxyphenbutazone because their actions and the risk of their side effects may be increased by AndroGel Gel
• Anticoagulants (eg, warfarin), insulin, or oral hypoglycemics (eg, glyburide) because the risk of side effects, including risk of bleeding, may be increased by AndroGel Gel
• Propranolol because its effectiveness may be decreased by AndroGel Gel

This may not be a complete list of all interactions that may occur. Ask your health care provider if AndroGel Gel 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.

How to use AndroGel Gel:

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

• AndroGel Gel comes with an additional patient leaflet. Read it carefully. Reread it each time you get AndroGel Gel refilled.
• Apply AndroGel Gel to clean, dry skin on the shoulders, upper arms, or stomach.
• Do not apply AndroGel Gel to the scrotum or genitals.
• Wash your hands immediately after using AndroGel Gel.
• For best results, wait 5 to 6 hours after applying AndroGel Gel before showering or swimming. Showering or swimming just 1 hour after applying AndroGel Gel may be permitted if done very infrequently.
• If you miss a dose of AndroGel Gel, 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 AndroGel Gel.

Important safety information:

• Tell your doctor or dentist that you take AndroGel Gel before you receive any medical or dental care, emergency care, or surgery.
• Diabetes patients - AndroGel Gel may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
• AndroGel Gel is flammable. Do not store or use near an open flame or while smoking.
• AndroGel Gel may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using AndroGel Gel.
• Lab tests, including liver function, blood cell counts, blood cholesterol, prostatic specific antigen, and blood testosterone, may be performed while you use AndroGel Gel. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use AndroGel Gel with caution in the ELDERLY; they may be more sensitive to its effects, especially an enlarged prostate or prostate cancer.
• AndroGel Gel should not be used in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Using AndroGel Gel while pregnant may cause harm to the fetus. It is not known if AndroGel Gel is found in breast milk. AndroGel Gel should not be used by women.

Possible side effects of AndroGel Gel:

All 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:

Acne; bitter or strange taste in mouth; change in sex drive; dry skin; fatigue; gum or mouth irritation; gum pain; gum tenderness or swelling; hair loss; headache; skin irritation at the application site.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); breast growth or pain; change in the size or shape of the testicles; dark urine or light-colored bowel movements; decreased urination; depression or mood changes; dizziness; gingivitis; interrupted breathing while sleeping; loss of appetite; nausea; painful or prolonged erection; stomach pain; swelling of the ankles or legs; unusual tiredness or weakness; urination problems; weight gain; yellowing of the skin or eyes.

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. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include confusion; one-sided weakness; vision problems.

Store AndroGel Gel at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep AndroGel Gel out of the reach of children and away from pets.

General information:

• If you have any questions about AndroGel Gel, please talk with your doctor, pharmacist, or other health care provider.
• AndroGel Gel is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about AndroGel Gel. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.