Uses

This medicated patch contains testosterone. It is used for hormone replacement in men who are not able to produce enough testosterone (for example, due to hypogonadism). This medication is absorbed through the skin, enters your bloodstream, and helps your body reach normal testosterone levels.

Testosterone helps the body to develop and maintain the male sexual characteristics (masculinity), such as a deep voice and body hair. It also helps to maintain muscle and prevent bone loss, and is necessary for natural sexual ability/desire.

This drug should not be used by women.

How To Use

Read the Patient Information Leaflet provided by your pharmacist before you start using testosterone and each time you get a refill. If you have any questions regarding the information, consult your doctor or pharmacist.

There are many testosterone products available for use on the skin. They may have different amounts of testosterone and may not have the same effects. Read the dosing instructions carefully for each product. Do not change products without asking your doctor or pharmacist.

Apply to a dry, clean area of skin on the back, abdomen, upper arms, or thighs. Do not apply the patch to skin that has been treated with a topical ointment because doing so may decrease the amount of testosterone that your body will absorb.

The patch site must not be oily or irritated. Do not place on the scrotum or on bony areas such as the shoulders or hips.

To use the patch, remove the protective backing to expose the sticky surface. Immediately place the patch with the sticky side down on clean, dry skin, usually once nightly or as directed by your doctor. Wear the patch for 24 hours, then replace it with a new patch. Be sure to apply the patches to a different area each day. Wait 7 days before applying a patch to the same area of skin.

The patch may be worn during sex. Wait at least 3 hours after application before showering, swimming, or other contact with water. Heavy exercise or sweating may loosen the patch or make it fall off. If the patch comes loose, press around the edges of the patch to secure it in place. If the patch falls off, see Missed Dose section.

To discard a patch, fold it so the adhesive side is on the inside. Place the folded patch in the pouch from which the new patch is taken and discard it in the trash.

Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same time each night.

Misuse or abuse of testosterone can cause serious side effects such as heart disease (including heart attack), stroke, liver disease, mental/mood problems, abnormal drug-seeking behavior, or improper bone growth (in adolescents). Do not increase your dose or use this drug more often or for longer than prescribed. When testosterone is misused or abused, you may have withdrawal symptoms (such as depression, irritability, tiredness) when you suddenly stop using the drug. These symptoms may last from weeks to months.

Inform your doctor if your condition persists or worsens.

Side Effects

Itching, irritation, and discomfort at the application site may occur during the first few days as your body adjusts to the patch. Other side effects may include acne, headache, hair loss, anxiety, and a change in sexual desire. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• breast pain/enlargement
• swelling of the feet/ankles (edema)
• weight gain
• very slow/shallow/difficult breathing (possibly while sleeping)
• unusual weakness
• trouble urinating
• increased urination (especially at night)
• mental/mood changes (such as depression, agitation, hostility)
• change in size/shape of the testicles
• testicle pain/tenderness
• stomach/abdominal pain
• dark urine
• yellowing of eyes/skin
• fast/irregular heartbeat

Get medical help right away if you have any very serious side effects, including:

• shortness of breath/rapid breathing
• chest/jaw/left arm pain
• unusual sweating
• confusion
• sudden dizziness/fainting
• pain/swelling/warmth in the groin/calf
• sudden/severe headaches
• trouble speaking
• weakness on one side of the body
• sudden vision changes

Rarely, males may have a painful or prolonged erection lasting 4 or more hours. If this occurs, stop using this drug and get medical help right away, or permanent problems could occur.

Rarely, burn-like reactions under the patch may occur. This is most likely to happen if the patch is placed on bony areas of the body (see How to Use section for proper application sites). Permanent scarring may occur, so tell your doctor right away if this type of reaction occurs while you are using this patch.

If you have diabetes, especially if you are using insulin, testosterone may decrease your blood sugar. Be prepared to treat low blood sugar while you are using this medication. Symptoms of low blood sugar include shakiness, nervousness, rapid pulse, and sweating. If you are experiencing these symptoms, consult your doctor. Your doctor may need to adjust your diabetes medications.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before using testosterone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as soy), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• male breast cancer
• prostate cancer
• blood clots (such as in the leg, lungs)
• liver problems
• prostate problems (such as enlarged prostate or BPH)
• heart problems (such as heart failure, heart attack)
• stroke
• kidney problems
• diabetes
• high cholesterol level
• difficulty breathing during sleep (apnea)
• high blood pressure
• bone cancer

If you are going to have an MRI test, tell testing personnel that you are using this patch. Some patches may contain metals that can cause serious burns during an MRI. Ask your doctor whether you will need to remove your patch before the test and apply a new patch afterward, and how to do so properly.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Extreme caution is advised if using this drug in children because it might stunt the growth of the child. Monitor the child's growth rate carefully.

Elderly men may be at greater risk for developing an enlarged prostate or prostate cancer while using this drug. Consult your doctor or pharmacist for more details.

This medication can affect fertility in males. Ask your doctor for more details.

This medication should not be used by women. Women accidentally exposed to this medication may have side effects due to testosterone. If you notice symptoms in a woman such as changes in body hair or a large increase in acne, talk to her doctor and your doctor right away. Women who are pregnant or breast-feeding must avoid contact with this medication. This medication may harm an unborn or breast-feeding baby. Consult your doctor for more details.

Drug Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include:

• "blood thinners" (such as warfarin)

This medication may interfere with certain laboratory tests (including thyroid function tests), possibly causing false test results. Make sure laboratory personnel and your doctors know you use this drug.

Overdose

This medication patch may be harmful if chewed or swallowed. If someone has overdosed, remove the patch if possible. For serious symptoms such as passing out or trouble breathing, call 9-1-1. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: weakness on one side of the body, trouble speaking, vision problems, or confusion.

Notes

Do not share this medication with others. Sharing it is against the law.

Laboratory and/or medical tests (such as PSA, cholesterol, hemoglobin, hematocrit, testosterone blood levels, prostate exams) should be performed from time to time to monitor your progress or check for side effects. Consult your doctor for more details.

This medication has been prescribed for your current condition only. Do not use it later for another problem unless told to do so by your doctor. A different medication may be necessary in those cases.

Inform all your doctors that you are using or have used this medication.

Missed Dose

If the patch falls off, or if you miss a dose, apply a new patch right away. If it is after noon the next day and you remember that you missed a dose, or if your patch fell off, do not apply a new patch, but instead go back to your usual dosing schedule. Do not double the dose to catch up.

Storage

Store patches in their protective pouches at room temperature away from heat, light and moisture. Do not store in the bathroom. Properly discard used patches to protect others from exposure to this drug. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed (See How to Use section).