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The most well known male hormone is testosterone which has an important function in the body. A testosterone deficiency can cause to various complaints in affected men often initially not clear can be associated. Especially after 40 years, the testosterone level in numerous men decreases so that after effects occur. Among other things, the lack of results to listlessness, a decline in libido or erectile dysfunction. At least against this lack of erection ability affected men however can do something, for example, with the drug Testogel. The drug is available in a gel form and may cause that the desired erection occurs again.
How does Testogel?
If you want to buy Testogel, it is certainly important, to understand the mechanism of action of the product you. Advantage is not only the simple use of the product, but also the fact that the mechanism of action is easy to understand. Simplified represented Testogel leads to testosterone your body, so that the hormone increases. This is the whole secret of the effect, because it is simply the lack of testosterone, which leads to sexual function problems.
How to use Testogel?
Who should not use Testogel?
Although Testogel is a harmless drug in this respect, in that only the male sex hormone testosterone is administered to the body. However, also this medicine with regard to possible contra-indications to check before you buy Testogel. If you: suffer from a prostate cancer, do not use the product. The same definitely applies under the condition that you would are allergic against an increased amount of testosterone. Please also note that Testogel exclusively for adult men is intended, while children and women should not even have contact with the gel.
What side effects does Testogel?
After you have ordered Testogel, you should first consult the if you encounter side effects. It may be, for example, you suffer from headaches or mood changes after the application. More complaints, which also cannot be ruled out, are nervousness, prostate problems, muscle spasm or increased sleep disturbances. There may be something more serious side effects also, but they occur very rarely. To name a few, prostate abnormalities are here, jaundice. These side effects occur but actually very very rarely.
Read all of this leaflet carefully before you start using the medication. Contains important information about your treatment.
- If you have more questions, please consult your doctor or pharmacist.
- This medicine has been prescribed for your personal use and should not pass it on to other people. Could harm them, even if their symptoms are similar to yours.
- Keep this leaflet. It is possible that you may need to read it again.
ANDROGEL 50 mg, gel in sachets
- The active ingredient is testosterone. Each 5g contains 0,050 g of testosterone.
- The other ingredients are: Carbomer 980, isopropyl myristate, ethanol 96%, sodium hydroxide, purified water.
1. WHAT IS ANDROGEL 50 mg, gel in sachets AND WHAT it IS USED FOR
ANDROGEL 50 mg gel clear or slightly opalescent and colourless, which is presented in sachets of 5 g. Contains testosterone, a male hormone that occurs naturally in the body.
This medication is a hormone treatment. It is indicated in disorders associated with a deficit of testosterone.
Prior to starting the treatment with ANDROGEL, it must be shown clearly the lack of testosterone by clinical signs (regression of secondary sexual characteristics, modification of the body constitution, asthenia, decreased libido, erectile dysfunction, etc) and confirmed with laboratory testing.
2. BEFORE USING ANDROGEL 50 mg, gel in sachets
Do NOT USE ANDROGEL 50 mg, gel in sachets:
- If you are allergic to testosterone or any of the other components.
- If you have a prostate cancer
- If you have a breast cancer.
Take special care with ANDROGEL 50 mg, gel in sachets:
ANDROGEL is not indicated in the treatment of male sterility or impotence.
ANDROGEL is not indicated in children and should not be used by women.
ANDROGEL can increase the risk of benign hypertrophy of prostate (benign growth of the prostate gland) or prostate cancer so it is recommended to perform periodic reviews of the prostate, according to the recommendations of your doctor.
In people with a severe illness pre-existing heart, liver or kidneys, treatment with ANDROGEL may cause severe complications that is characterized by the appearance of edema (water retention in the body), with or without congestive cardiac failure (alteration of the functioning of the heart due to the overload of body fluid).
In certain predisposed individuals, especially in obese patients or with respiratory diseases, it has been observed a worsening of breathing disorders during sleep while undergoing treatment with testosterone.
Patients with a cancer that affects the bones, may present an increase in the levels of calcium in the blood or in the urine. In these people it is recommended to perform a regular control of the calcium levels.
Individuals following a substitute treatment to long-term with testosterone may develop polycythemia (abnormal increase in the number of red blood cells in the blood), so you must perform a regular monitoring of the number of red blood cells in the blood.
In people taking oral anticoagulants (used to make more fluid the blood), insulin or corticosteroids, may be necessary to adjust the dose of the medication.
Special precautions for use:
Before you start the treatment it is necessary to perform a medical examination, and throughout the treatment you will get a regular medical monitoring (at least once a year and twice yearly in elderly patients and at risk).
Possible transfer of testosterone
If precautions are not taken, it can produce a transfer of testosterone from one person to another by skin contact, the narrow and relatively long with the area of application of the gel. This transfer can be avoided by covering the application area with clothing or showering before contact.
Therefore, it is recommended to take the following precautions:
- Wash hands with soap and water after applying the gel.
- Cover the application area with clothing once the gel has dried. * Take a shower before intimate contact.
For people not treated with ANDROGEL 50 mg:
- In case of contact with the area of application is not washed or covered with clothing, wash immediately with water and soap the skin surface on which it has been able to produce a transfer of testosterone.
- Check with your doctor if you develop signs such as acne or modification of body hair.
It is preferable to respect an interval of at least 6 hours between applying the gel and showering or bathing.However, a bath or a shower casual between 1 hour and 6 hours after application of the gel should not have a major impact on the development of the treatment
To ensure the safety of the female partner, it is advised to the patient, for example, leaving a long interval between the application and the period of contact, wear a shirt that covers the places of application at the time of contact or taking a shower before sex
Pregnancy and breast-feeding:
ANDROGEL is not indicated for women who are pregnant or breast-feeding.
Pregnant women should avoid any contact with the areas of application of
ANDROGEL.This product may have adverse virilizing effects on the fetus. In case of contact, as recommended above, wash as soon as possible with soap and water the area to which you may have transferred the testosterone.
In the case that your partner is pregnant the patient should pay greater attention to the recommendations for use listed above.
Consult your doctor or pharmacist before taking a medication.
Driving and using machines:
ANDROGEL, does not influence the ability to drive and/or operate machinery.
Sportsmen and women:
We warn sportsmen and women that this specialty contains an active ingredient (testosterone) that may produce a positive result at a doping control.
List of excipients with marked effect:
Taking or using other medicines:
Report to your doctor or pharmacist if you are taking or have recently taken any other medicines, especially oral anticoagulants, including medicines obtained without a prescription.
3. HOW to USE ANDROGEL 50 mg, gel in sachets
MEDICATION RESERVED FOR ADULT MALE
The recommended dose is 5 g of gel (i.e. 50 mg of testosterone) applied once daily, at about the same time and preferably in the morning.
The doctor will adjust the daily dose according to each patient, without exceeding 10 g of gel per day.
The product simply must be spread gently on the skin clean, dry, and healthy, forming a thin layer on both shoulders, both arms or the abdomen.
After opening the envelope, must be removed all of its contents and be applied immediately on the skin. Let it dry at least 3-5 minutes before dressing. Wash hands with soap and water after application.
Should not be applied on the genital area (penis and testicles) because of the high alcohol content may cause local irritation.
FOLLOW EXACTLY THE INSTRUCTIONS OF YOUR DOCTOR TO APPLY ANDROGEL 50 mg.
If You use more ANDROGEL 50 mg, gel in sachets than you should:
Talk to your doctor.
If you forgot to use ANDROGEL 50 mg, gel in sachets:
Do not use a double dose to compensate the missed dose.
4. POSSIBLE ADVERSE EFFECTS WITH ANDROGEL 50 mg, gel in sachets
Like all medicines, ANDROGEL 50 mg, gel in sachets, can have adverse effects:
Sometimes can be observed in the area of application reactions skin type irritation, acne, and dry skin.
ANDROGEL can cause headache, hair loss, appearance of breast tenderness with or without pain, alterations of the prostate, diarrhea, dizziness, high blood pressure, mood alterations, alterations of the numbers of laboratory (increased number of red blood cells,lipids), hypersensitivity skin and itching.
There have been other adverse reactions during treatment with testosterone by mouth or injection, prostatic hypertrophy (benign increase of the prostate gland) and progression of prostate cancer are subclinical, pruritus (itching) all over the body, redness in face and neck, nausea, jaundice(yellowing of the skin and mucous membranes), increased libido (sexual desire), depression, nervousness, muscular pain, disturbances of electrolyte balance (content of salts in the blood) oligospermia (decreased sperm count) and erections, frequent or prolonged.
Certain clinical signs of type irritability, nervousness, weight gain, erections are too frequent or persistent they may indicate an effect too powerful of product: tell your doctor, who will adjust the daily dose of ANDROGEL
Due to the presence of alcohol, the common applications on the skin can cause irritation and dryness of the skin.
If you have or are adverse reactions not mentioned in this leaflet, tell your doctor or pharmacist.
5. CONSERVATION OF ANDROGEL 50 mg, gel in sachets
Does not require any special storage conditions.
Keep out of the reach and sight of children.
Do not use after the expiry date which is stated on the packaging.
Do not use ANDROGEL 50 mg if you notice visible signs of deterioration of the product.
AndroGel is the blockbuster gel used to treat low testosterone (“Low T”), but it is linked to an increased risk of cardiovascular problems. Many men filed lawsuits against Abbott and AbbVie.
One of the most-used medical products to treat Low T is AndroGel. Made and heavily marketed in the United States by AbbVie Inc., AndroGel is prescribed as a testosterone-replacement drug, mostly to men whose bodies fail to produce sufficient amounts of the male hormone.
The drug was developed by Brussells-based pharmaceutical company Solvay Pharmaceuticals, and the U.S. Food and Drug Administration (FDA) approved it in 2011 for use by men diagnosed with Low T.
Abbott Laboratories, AbbVie’s parent company, bought the drug from Solvay in 2010 and soon began pumping millions into the drug’s marketing. Within two years, doctors sounded alerts about the drug’s dangerous side effects for older users after many men gained prescriptions as a way to regain their youth or simply boost energy and sex drive.
One of the biggest risks with AndroGel and other testosterone products is an increase in cardiovascular events like heart attacks and strokes. The makers of AndroGel now face a growing number of lawsuits filed by men who suffered strokes, heart attacks and blood clots after using the drug. The lawsuits state Abbott and AbbVie failed to warn consumers about these risks.
According to a study published in JAMA, by 2011 nearly one in 25 men in their 60s took testosterone. Doctors blame the rampant advertising.
“The market for testosterone gels evolved because there is an appetite among men and because there is advertising. The problem is that no one has proved that it works, and we don’t know the risks,” Dr. Joel Finkelstein, an associate professor at Harvard Medical School, told The New York Times.
AbbVie spent $80 million on aggressive marketing campaigns in 2012, and the gel generated over $1 billion in sales that year. AndroGel is the top-selling testosterone product in the U.S. AbbVie markets it in the U.S., while Abbott markets it overseas.
What is AndroGel and How Does it Work?
AndroGel is synthetic testosterone mixed into a gel with alcohol that is applied to the skin once daily. The testosterone is absorbed into the skin for continuous 24-hour delivery into the body. The medication can cost as much as $500 a month, but some insurance companies will cover it.
The drug is available in two strengths: 1 percent and 1.62 percent. Patients dispense the gel through a multi-dose pump or use single-dose packets. It is quick-drying, clear and odorless when dry.
The two dose strengths have different application sites. Patients can apply the 1 percent gel to the upper arms and shoulders, as well as on both sides of the abdomen. For the 1.62 gel, the gel should only be applied to the upper arms and shoulders.
In men with Low T, the medication increases the total amount of circulating testosterone in the body to a normal range found in healthy men – according to the drug insert, this measurement is somewhere between 298 – 1043 ng/dl. If men use lotion or sunscreen, the amount of testosterone absorbed increases.
After applying AndroGel, men should wash their hands thoroughly with soap and water. It is also important to know that the drug is flammable until dry, and patients should avoid flames, smoking or fire.
Black-Box Warning for Secondary Exposure
AndroGel has a black-box warning for secondary exposure to women and children, and patients should take precautions and follow application instructions carefully to avoid accidental exposure.
Women and children should avoid contact with unwashed application sites or unwashed clothing of men using the drug. Men using the medication must cover all application sites with clothing. Patients should wash any application sites before any skin-to-skin contact.
Women and children may show symptoms of secondary exposure, including:
- Enlargement of the genitals
- Early development of pubic hair in children
- Increased erections
- Increased libido
- Aggressive behavior
- Advanced bone age in children
- Increase in acne and body hair in women
Contact a doctor if symptoms of secondary exposure develop, and discontinue use of the gel until advised by the doctor.
Heart Attacks and Other Side Effects
One of the most dangerous side effects of AndroGel is its link to cardiovascular problems like heart attacks and strokes. Recently, a number of studies revealed that men using testosterone drugs are at increased risk of heart attack and stroke.
For some doctors, like Sidney Wolfe of the watchdog group Public Citizen, the evidence is enough to merit a black-box warning on AndroGel and other drugs like it. The nonprofit group petitioned the FDA to require warnings for cardiovascular risks on the drugs’ packaging.
Wolfe told Drugwatch that there are about 27 studies available on the safety of testosterone drugs; 13 of these are funded by drug companies and show no heart risk, while 14 independent studies revealed a risk.
In addition to serious cardiovascular risks, AndroGel may also cause a number of other side effects, including:
- Prostate Cancer. Patients treated with androgen (hormone) therapy are at increased risk for enlargement of the prostate as well as developing prostate cancer.
- Larger Red Blood Cells. The gel may cause red blood cells to grow. Because the cells can become too large, patients who take this medication are at increased risk for blood clots, which can lead to stroke.
- Reduced Sperm Count. When the hormones in a man’s body increase, it affects sperm production. In some cases, this is irreversible.
- Edema. The gel is known to cause water and sodium retention. In men with pre-existing liver, kidney or heart disease, this can cause swelling and congestive heart failure.
- Gynecomastia. Men using this drug may develop enlarged breasts.
- Sleep Apnea. Using AndroGel may worsen or cause men to develop sleep apnea.
- High cholesterol. The drug increases the levels of cholesterol in the body, and doctors may recommend discontinuing treatment.
In February 2014, five men sued Abbott Laboratories and its spinoff, AbbVie, Inc., alleging injuries caused by AndroGel. The plaintiffs’ ages range from 50 to 63. Three of the men suffered heart attacks, and two suffered strokes. The lawsuit was filed in the U.S. District Court for the Northern District of Illinois.
The plaintiffs include 54-year-old Michael Gallagher of Virginia, who suffered myocardial infarction, congestive heart failure and other injuries after being prescribed the gel. He had no history of cardiac problems before taking the prescription drug, Mr. Gallagher claims he started AndroGel therapy after the defendants’ advertisements led him to attribute symptoms to low testosterone.
According to the complaints, Abbott and AbbVie “deceived potential users by relaying positive information through the press, including testimonials from retired professional athletes” and statistics suggesting a widespread need for the drugs, “while downplaying known adverse and serious health risks,” Bloomberg reported.
In March 2014, the multidistrict litigation panel received a motion to consolidate all federal testosterone lawsuits, including the AndroGel lawsuits, in federal court in Illinois.
If you took AndroGel or any other testosterone drug and suffered a heart attack, stroke or blood clot, you may be entitled to compensation. Drugwatch can help you find a qualified attorney.
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