Fertigel 1% is a testosterone-based transdermal gel designed to support healthy testosterone levels in men. Applied directly to the skin, it ensures effective absorption into the bloodstream, offering a convenient and non-invasive option for hormone support. Ideal for individuals experiencing symptoms of low testosterone, Fertigel 1% helps enhance energy, mood, libido, and overall well-being.
Marketed by
Fertillmed Pharmaceuticals Private Limited.
(Testosterone transdermal gel) for topical use
(tes-TOS-te-ron)
children and women. Children and women should avoid contact with the unwashed or not covered (unclothed) areas where FERTIGEL 1% has been applied to your skin. Early signs and symptoms of puberty have occurred in young children who have come in direct contact with testosterone by touching areas where men have used FERTIGEL 1%.
Signs and symptoms of early puberty in a child when they come in direct contact with FERTIGEL 1%
may include:
Abnormal sexual changes:
• enlarged penis or clitoris.
• early growth of hair near the vagina or around the penis (pubichair).
• erections or acting out sexual urges (sex drive).
Behavior problems:
acting aggressively, behaving in an angry or violent way.
Signs and symptoms in women when they come in direct contact with FERTIGEL 1%may include:
• changes in body hair.
• an abnormal increase in pimples (acne).
Stop using FERTIGEL 1% and call your healthcare provider right away if you see any signs and symptoms in a child or a woman that may have happened through accidental touching of the area where you have applied FERTIGEL 1%.
• Apply FERTIGEL 1% only to your shoulders and upper arms, which will be covered by a short-sleeved T-shirt.
• Wash your hands immediately with soap and water after applying FERTIGEL 1%.
• After the gel has dried, cover the application area with clothing. Keep the area covered until you have washed the application area well or have showered.
• If you expect to have skin-to-skin contact with another person, first wash the application area well with soap and water.
If a child or woman touches the area where you have applied FERTIGEL 1% that area on the child or woman should be washed well with soap and water right away.
FERTIGEL 1%is a prescription medicine that contains testosterone. FERTIGEL 1% is used to treat adult males who have low or no testosterone due to certain medical conditions.
• Your healthcare provider will test your blood before you start and while you are using FERTIGEL 1%.
• It is not known if FERTIGEL 1% is safe or effective to treat men who have low testosterone due to aging.
• It is not known if FERTIGEL 1% is safe or effective in children younger than 18 years old. Improper use of FERTIGEL 1% may affect bone growth in children.
FERTIGEL 1% is a controlled substancebecause it contains testosterone that can be a target for people who abuse prescription medicines. Keep your FERTIGEL 1% in a safe place to protect it. Never give your FERTIGEL 1% 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.
* Fertigel 1% is for men only and should not be used by women.
Do not use FERTIGEL 1% if you:
• Do not use FERTIGEL 1% have or might have prostate cancer.
• are pregnant FERTIGEL 1% may harm your unbornbaby.
• Women who are pregnant should avoid contact with the area of skin where FERTIGEL 1%has been applied.
Before using FERTIGEL 1%, tell your healthcare provider about all of your medical conditions, including if you:
• have breast cancer.
• have or might have prostatecancer.
• have urinary problems due to an enlarged prostate.
• have heart problems.
• have kidney or liver problems.
• have problems breathing while you sleep (sleep apnea).
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using Fertigel 1% with certain other medicines can affect each other.
Especially, tell your healthcare provider if youtake:
• insulin
• medicines that decrease blood clotting (blood thinners)
corticosteroids
How should I use FERTIGEL 1%?
• See the detailed Instructions for Use about how to use FERTIGEL 1% at the end of this Medication Guide.
• It is important that you apply FERTIGEL 1% exactly as your healthcare provider tells you to.
• Your healthcare provider may change your FERTIGEL 1% dose. Do not change your FERTIGEL 1% dose without talking to your healthcare provider.
Apply FERTIGEL 1% at the same time each morning. FERTIGEL 1% should be applied after showering or bathing.
What are the possible side effects of FERTIGEL 1%?
FERTIGEL 1% can cause serious side effects including:
See “What is the most important information I should know about FERTIGEL 1%?”
• If you already have enlargement of your prostate gland your signs and symptoms can get worse while using FERTIGEL 1%. This can include:
o increased urination at night.
o trouble starting your urine stream.
o having to pass urine many times during the day.
o having an urge to go to the bathroom right away.
o having a urine accident.
o being unable to pass urine or weak urine flow.
• Possible increased risk of prostate cancer. Your healthcare provider should check you for prostate cancer or any other prostate problems before you start and while you use FERTIGEL 1%.
• Blood clots in the legs or lungs. Signs and symptoms of a blood clot in your leg can include leg pain, swelling, or redness. Signs and symptoms of a blood clot in your lungs can include difficulty breathing or chest pain.
• Possible increased risk of heart attack or stroke.
• In large doses FERTIGEL 1%may lower your spermcount.
• Swelling of your ankles, feet, or body, with or without heart failure.
• Enlarged or painful breasts.
• Have problems breathing while you sleep (sleep apnea).
Call your healthcare provider right away if you have any of the serious side effects listed above. The most common side effects of FERTIGEL 1% include:
• increased prostate specific antigen (a test used to screen for prostate cancer)
• mood swings
• hypertension
• increased red blood cell count
• skin irritation where FERTIGEL 1% is applied
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 FERTIGEL 1%. For more information, ask your healthcare provider or pharmacist.
General information about the safe and effective use of FERTIGEL 1%
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use FERTIGEL 1% for a condition for which it was not prescribed. Do not FERTIGEL 1% to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for information
About FERTIGEL 1% that is written for health professionals.
What are the ingredients in FERTIGEL 1%?
Active ingredient: Testosterone Undecanoate (5mg Tube Contains 50 mg of testosterone in gel base)
Inactive ingredients: Gel Base q.s.
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