Cernos Testosterone Gel Patient Information Leaflet

Composition :
Each gram contains:

Testosterone USP - 10mg

Gel Base - q.s.

Also contains Ethanol - 68.9%

Cernos Gel is a clear, colorless hydro alcoholic gel containing 1% testosterone. Cernos Gel provides continuous transdermal delivery of testosterone, the primary circulating endogenous androgen, for 24 hours following a single application to intact, clean, dry skin of the shoulders, upper arms and\or abdomen.

Cernos Gel is a formulation that delivers testosterone on topical application to skin and increases the testosterone levels to normal. The testosterone delivered by Cernos Gel is same as the testosterone produced in your body.
Testosterone supplement is indicated when there is deficiency of testosterone i/e/ Hypothyroidism. Testosterone help the body to produce sperms and for development secondary sexual characteristics. Also, it helps to maintain bone strength and muscle mass and is necessary for normal sexual function & sex drive.

How should one apply Cernos Gel?

1. Apply Cernos gel (1 or 2 pouches as per instruction of your doctor) at the same time each day (preferably morning), apply Cernos Gel after your bath.
2. Ensure your skin is clean and completely dry.
3. Squeeze the entire content onto the palm of your hand or squeeze one portion at a time, and continue until the pouch is empty.
4. Apply Gel to the upper arm\shoulder areas or abdomen ONLY, so as to ensure that your body absorbs the right amount of Testosterone.
5. Please do not apply Cernos Gel to your genitals (Penis & Scrotum) or to skin that is not completely normal (open sores, woulds of irritations).
6. Use circular motions to rub the gel for several seconds until the gel is well rubbed and the area feel dry.
7. Wash your hand thoroughly with soap and water immediately after application.
8. Allow Cernos Gel to dry for a few minutes before you dress, to prevent your clothing from wiping the gel off your skin.
9. Wait for at least 5-6 hours, incase you plan to take shower or swim after the application of gel, to ensure the greatest amount to gel absorbed.
10. Maintain normal activities, once your hand are washed and the application site covered with clothing.

who should not use Cernos Gel?

• Hypersensitivity to any of the component of the formulation.
• Must no be used by women and children. 
• Pregnant and breast feeding women are especially at risk and should avoid skin contact with Cernos Gel applied sites in men, Testosterone may cause harm to fetus. While children, who normally, have low level of testosterone, could be harmed by higher levels of the same.
• Not to be used in patients having prostate cancer or breast cancer (rare condition in males).

What to do of other person come in contact with Cernos Gel?

Wash his or her area of contact thoroughly with soap and water as soon as possible. The longer the gel is in contact with the skin before washing. The greater is the chance that the other person will adsorb some testosterone.

What are the possible side effects of Cernos Gel?

Please tell your doctor, if develop any of the following side effects:

Adverse effects possibly or definitively related to the use of testosterone gel include acne, alopecia, application site reaction, erythema, dry skin, asthenia, depression, emotion lability gynecomastia, headache, hypertension, decreased libido, nervousness, brest pain, prostate disoder, testis discoder and abnormal laboratory test (which may include one or more of the following events: elevated hemoglibin or hematocri, hyperlipidemia, elevated glucose, elevated creatinine or elevated total bilirubin).

Other repoted adverse effects are amnesia, anxiety, discolored hair, dizziness, dry skin hirsutism, hostility, impaired urination, paresthesia, penis discoder, peripheral edema, sweating and vasodilation.

• Penis erection that are too frequent and continue too long.
• Nausea, vomiting, yellow or darker skin (jaundice) or ankle swelling.
• Difficulty in urination.
• Any side effects that concern you

Tell your doctor if you female partner develops changes in hair distribution, increases in acne or other signs of masculinity. Older patients may be at the risk of developing enlarged prostate or prostate cancer. This also may be monitored by periodic blood test and prostate examinations.

Overdosage:

Only one case of acute overdose following an injection has been reported in the literature. This was a case of a cerebrovascular accident in a patient with a high plasma testosterone concentration of 114 ng/ml (395 nmol/l). It would be most unlikely that such plasma testosterone concentrations be achieved using the transfermal route.