FORTESTA- testosterone gel, metered 
Endo Pharmaceuticals Inc.

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MEDICATION GUIDE

FORTESTA® (FOR-tes-ta) CIII

(testosterone) Gel

Read this Medication Guide before you start using FORTESTA and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.

What is the most important information I should know about FORTESTA?

1.      Early signs and symptoms of puberty have happened in young children who were accidentally exposed to testosterone through contact with men using topical testosterone products like FORTESTA.

Signs and symptoms of early puberty in a child may include:

2.      FORTESTA can transfer from your body to others.  Women and children should avoid contact with the unwashed or unclothed area where FORTESTA has been applied to your skin.

Stop using FORTESTA and call your healthcare provider right away if you see any signs and symptoms in a child or a woman that may have occurred through accidental exposure to FORTESTA.

Signs and symptoms of exposure to FORTESTA in a child may include:

Signs and symptoms of exposure to FORTESTA in women may include:

To lower the risk of transfer of FORTESTA from your body to others, you should follow these important instructions:

What is FORTESTA?

FORTESTA is a prescription medicine that contains testosterone. FORTESTA is used to treat adult males who have low or no testosterone.

Your healthcare provider will test your blood before you start taking and while you are taking FORTESTA.

It is not known if FORTESTA is safe or effective in children younger than 18 years old. Improper use of FORTESTA may affect bone growth in children.

FORTESTA is a controlled substance (CIII) because it contains testosterone that can be a target for people who abuse prescription medicines. Keep your FORTESTA in a safe place to protect it. Never give FORTESTA to anyone else, even if they have the same symptoms you have. Selling or giving away this medicine may harm others and is against the law.

FORTESTA is not meant for use in women.

Who should not use FORTESTA?

Do not use FORTESTA if you:

Women who are pregnant or who may become pregnant should avoid contact with the area of skin where FORTESTA has been applied.

Talk to your healthcare provider before taking this medicine if you have any of the above conditions.

What should I tell my healthcare provider before using FORTESTA?

Before you use FORTESTA, tell your healthcare provider if you:

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Using FORTESTA with certain other medicines can affect each other.  Especially, tell your healthcare provider if you take:

Know the medicines you take. Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.

How should I use FORTESTA?

Applying FORTESTA:

                                             application site

What are the possible side effects of FORTESTA?

See “What is the most important information I should know about FORTESTA?”

FORTESTA can cause serious side effects including:

Call your healthcare provider right away if you have any of the serious side effects listed above.

The most common side effects of FORTESTA include:

Other side effects include more erections than are normal for you or erections that last a long time.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of FORTESTA. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store FORTESTA?

Keep FORTESTA and all medicines out of the reach of children.

General information about FORTESTA

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use FORTESTA for a condition for which it was not prescribed. Do not give FORTESTA to other people, even if they have the same symptoms you have. It may harm them.

This Medication Guide summarizes the most important information about FORTESTA. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about FORTESTA that is written for health professionals.

For more information, go to www.fortestagel.com or call 1-800-462-3636.

What are the ingredients in FORTESTA?

Active ingredient: testosterone

Inactive ingredients: propylene glycol, purified water, ethanol, 2-propanol, oleic acid, carbomer 1382, triethanolamine and butylated hydroxytoluene.

This Medication Guide has been approved by the U.S. Food and Drug Administration

Manufactured by:
Pharbil Waltrop GmbH, Im Wirrigen 25, 45731
Waltrop, Germany

Manufactured for:
Endo Pharmaceuticals Inc.
Malvern, PA 19355

© 2014 Endo Pharmaceuticals Inc.  All rights reserved.

Revised:  6/2014

LFT-TOS-US-001

Revised: 06/2014
 
Endo Pharmaceuticals Inc.