Active ingredients: Testosterone
TESTOGEL 50 mg, gel in sachet
Testogel package inserts are available for pack sizes:- TESTOGEL 50 mg, gel in sachet
- TESTOGEL 25 mg, gel in sachet
Why is Testogel used? What is it for?
This medicine contains testosterone, a male hormone produced naturally by the body.
TESTOGEL is used to replace testosterone in adult men, for the treatment of various health problems due to testosterone deficiency (male hypogonadism). This condition must be confirmed with two separate blood testosterone measurements and must include clinical symptoms such as:
- Impotence
- Infertility
- Poor sexual desire
- Tiredness
- Depressed mood
- Bone loss due to low hormone levels
- Regression of male sexual characteristics
- Reduction in lean body mass
- Inability to get / maintain an erection.
Contraindications When Testogel should not be used
Do not use TESTOGEL
- If you are allergic to testosterone or any of the other ingredients of this medicine (listed in section 6),
- In case of prostate cancer,
- In case of breast cancer.
Precautions for use What you need to know before taking Testogel
Take special care with TESTOGEL
Before starting any treatment with TESTOGEL, testosterone deficiency must be clearly demonstrated by clinical signs (regression of male sexual characteristics, decreased lean body mass, weakness or fatigue, decreased libido, inability to obtain / maintain an erection. , etc.) and confirmed by laboratory tests carried out in the same laboratory.
TESTOGEL is not indicated for:
- The treatment of male infertility or impotence,
- For children, as no information is available for children under 18,
- For women, as masculine characteristics could develop.
Androgens can increase the risk of prostate enlargement (benign prostatic hypertrophy) or prostate cancer. Therefore, regular examinations of the prostate should be carried out, before and during therapy, in accordance with the doctor's prescriptions.
If you have severe heart, liver or kidney disease, treatment with TESTOGEL can cause serious complications in the form of water accumulation in the body, sometimes accompanied by (congestive) heart failure.
Before and during treatment, the doctor must carry out the following blood tests: testosterone levels in the blood, complete blood count.
Tell your doctor if you have high blood pressure or are being treated for high blood pressure, as testosterone can cause your blood pressure to rise.
In predisposed subjects, particularly in cases of obesity or respiratory diseases, a worsening of respiratory disorders during sleep was observed during the testosterone-based treatment.
Patients with cancers affecting the bones may have an increase in the concentration of calcium in their blood and urine. TESTOGEL could affect these calcium concentrations. During treatment with TESTOGEL, your doctor will decide whether to check your calcium levels by blood tests.
Patients on long-term testosterone replacement therapy may develop an abnormal increase in the number of red blood cells (polyglobulia). It will therefore be necessary to carry out regular blood tests to monitor the concentration of red blood cells.
TESTOGEL should be used with caution in patients suffering from epilepsy and / or migraine, as it may worsen these conditions.
In case of severe skin reactions, the treatment should be reconsidered and possibly suspended.
Excessive use of the product can cause the following effects: irritability, nervousness, weight gain, frequent or prolonged erections. In this case, inform the doctor who will redefine the daily dose of TESTOGEL.
Before starting the treatment it will be necessary to carry out a medical check-up. Your doctor will take blood samples at 2 different visits to measure your testosterone levels before prescribing the medicine. During treatment, a periodic medical check-up should be carried out (at least once a year and twice a year in the elderly and in patients at risk).
Potential testosterone transfer
There is the possibility of testosterone transfer to another person in case of relatively prolonged close skin contact with the area of application of the gel. This can cause the partner to develop signs of increased testosterone such as hair on the face and body or a deeper voice. In women it can cause changes in the menstrual cycle. You can prevent this by wearing clothes that cover the application area or by showering before making contact.
The following precautions are recommended:
- wash your hands with soap and water after applying the gel,
- allow the gel to dry and cover the application area with clothes,
- take a shower before intimate contact.
If it is believed that testosterone has been transferred to another person (woman or child):
- immediately wash the skin surface on which testosterone transfer may have taken place with soap and water,
- the appearance of signs such as acne or changes in the hair system must be reported to the attending physician.
To ensure that the safety of another person is not unintentionally endangered, it is advisable to observe a long interval between the application of TESTOGEL and contact. It is also recommended to wear a T-shirt that covers the TESTOGEL application site during close contact or to take a shower before contact.
It is preferable that patients observe a period of at least 6 hours after applying the gel before bathing or showering. However, an occasional bath or shower taken between one and 6 hours after applying the gel will not they should significantly influence the course of treatment.
Interactions Which drugs or foods can modify the effect of Testogel
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, even non-prescription medicines, especially oral anticoagulants (used to thin the blood), insulin or corticosteroids. These particular medicines may require a change in the dosage of TESTOGEL.
Warnings It is important to know that:
Pregnancy and breastfeeding
TESTOGEL should not be used during pregnancy or breastfeeding.
Pregnant women must avoid any contact with the areas of application of TESTOGEL. The product may have harmful virilizing effects on the fetus. In case of contact, as previously recommended, wash the area to which a testosterone transfer may have taken place with soap and water as soon as possible. In case of pregnancy of the partner, the patient must carefully observe the precautions for use indicated above to avoid transfer of the testosterone-based gel.
Driving and using machines
TESTOGEL does not affect the ability to drive or use machines.
Warnings for those who play sports
For those who carry out sporting activities: the use of the drug without therapeutic necessity constitutes doping and can in any case determine positive anti-doping tests.
Dose, Method and Time of Administration How to use Testogel: Posology
Medicinal product reserved for adult men.
Always use this medicine exactly as your doctor has told you. If in doubt, consult your doctor.
The recommended dose is 5 g of gel (50 mg of testosterone) applied once a day, around the same time, preferably in the morning.
The daily dose will eventually be adjusted by the doctor according to the individual patient, without exceeding 10 g of gel per day.
The gel is simply distributed gently on clean, dry and healthy skin to form a thin layer on both shoulders, arms or abdomen.
Once the sachet is opened, all the contents must be extracted and applied immediately to the skin. Leave to dry for at least 3-5 minutes before dressing. Wash your hands with soap and water after application.
Do not apply to the genitals (penis and testicles), as the high alcohol content can cause local irritation.
If you forget to use TESTOGEL
Do not use a double dose to make up for a forgotten dose.
If you stop using TESTOGEL
It is not recommended to discontinue TESTOGEL therapy unless your doctor prescribes it.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Overdose What to do if you have taken too much Testogel
If you use more TESTOGEL than you should
Seek the advice of your doctor.
Side Effects What are the side effects of Testogel
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common side effects, which may affect up to 10 in 100 people
Frequent applications on the skin can cause irritation and dryness of the skin due to the presence of alcohol. Also one can notice the onset of acne.
Common side effects (affects 1 to 10 in 100 people)
TESTOGEL can cause headaches, hair loss, painful development or tension of the breasts, prostate disorders, diarrhea, dizziness, high blood pressure, mood disturbances, increased red blood cell counts, hematocrit (percentage of red blood cells in the blood) and hemoglobin (the component of red blood cells that carries oxygen), evidenced by periodic blood tests, altered lipid levels, skin hypersensitivity, itching and memory loss.
Other side effects have been observed during oral or injection testosterone treatments: weight gain, change in blood salt content, muscle pain, nervousness, depression, hostility, difficulty breathing during sleep, yellowing of the skin ( jaundice), changes in liver function test results, seborrhea, changes in sexual desire, decreased sperm count, frequent and prolonged erections, urinary obstruction, fluid retention, hypersensitivity reactions.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
This medicine does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton.
Deadline "> Other information
What TESTOGEL contains
- The active ingredient is testosterone. Each 5g sachet contains 50mg of testosterone.
- The other ingredients are Carbomer 980, isopropyl myristate, 96% ethanol, sodium hydroxide, purified water.
Description of the appearance of TESTOGEL and contents of the pack
TESTOGEL 50 mg is a colorless gel presented in 5 g sachets.
TESTOGEL is available in cartons of 1, 2, 7, 10, 14, 28, 30, 50, 60, 90 or 100 sachets (not all pack sizes may be marketed).
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT -
TESTOGEL 50 MG, GEL
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION -
One 5g sachet contains 50mg of testosterone.
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM -
Gel in sachet
Colorless transparent or slightly opalescent gel in sachet.
04.0 CLINICAL INFORMATION -
04.1 Therapeutic indications -
Testosterone replacement therapy in male hypogonadism due to testosterone deficiency diagnosed through clinical signs and biochemical tests (see 4.4 Special warnings and appropriate precautions for use).
04.2 Posology and method of administration -
Skin application.
Adults and elderly subjects
The recommended dosage is 5 g of gel (50 mg of testosterone) applied once a day, at approximately the same time, preferably in the morning. The daily dose will be adjusted on the advice of the doctor according to the clinical response or laboratory analyzes of the individual patient, without exceeding 10 g of gel per day. Dosage adjustment should be achieved with 2.5 g of gel at a time
The application must be carried out by the patient himself, on clean, dry and healthy skin, on both shoulders or arms or on the abdomen.
Once the sachet is opened, all the contents must be extracted and applied immediately to the skin. The gel is simply distributed gently on the skin to form a thin layer. It is not necessary to rub. Allow the product to dry for at least 3-5 minutes before dressing. After application, wash your hands with soap and water.
Do not apply on the genitals because the high alcohol content can cause local irritation.
The equilibrium stage of plasma testosterone concentrations is reached approximately on the 2nd day of treatment with Testogel. In order to be able to adjust the testosterone dose, it is necessary to measure the testosteronemia in the morning before the application starting from the 3rd day after the start of the treatment (one week seems reasonable). If the plasma testosterone concentration exceeds the desired level, the dosage can be reduced. In case of low concentration, the dosage can be increased, without exceeding 10 g of gel per day.
Children
Testogel is not indicated for children and has not undergone clinical studies in children under the age of 18.
04.3 Contraindications -
Testogel is contraindicated:
in case of suspected or confirmed prostate cancer, or breast cancer
in case of known hypersensitivity to testosterone or to any other component of the gel.
04.4 Special warnings and appropriate precautions for use -
Do not administer Testogel if a condition of hypogonadism (hyper- and hypogonadotrophic) has not been demonstrated and if other aetiologies that could be at the origin of the symptoms have not been excluded before starting the treatment. clear from clinical signs (regression of secondary sexual characteristics, change in body image, asthenia, decreased libido, erectile dysfunction, etc.) and confirmed by two separate dosages of testosteronemia. At the moment the values of age-specific testosterone reference. However, it must be taken into account that, due to physiological factors, plasma testosterone levels decrease with increasing age.
Due to the variability of laboratory test values, all testosterone level measurements must be made within the same laboratory.
Testogel is not indicated for the treatment of male infertility or impotence.
Before using a testosterone-based treatment, all patients must undergo a thorough examination in order to eliminate any risk of existing prostate cancer.In patients undergoing testosterone treatment, careful and regular monitoring of the prostate gland and chest should be performed at least once a year and twice a year in elderly subjects and in patients at risk (those with clinical or familial factors). recommended methods (digital rectal examination and evaluation of PSA in serum).
Androgens can accelerate the evolution of subclinical prostate cancer and benign prostatic hyperplasia.
Testogel should be used with caution in patients with cancer and at risk of hypercalcemia (and associated hypercalciuria) due to bone metastases. Regular monitoring of calcium is recommended in such patients.
In patients with severe cardiac, hepatic or renal insufficiency, treatment with Testogel may lead to severe complications characterized by edema, accompanied or not by congestive heart failure. In this case the treatment must be stopped immediately. Diuretic therapy may also be required.
Testogel should be used with caution in patients with ischemic heart disease.
Testosterone can cause an increase in blood pressure. Therefore Testogel should be used with caution in hypertensive patients.
In patients undergoing long-term androgenic treatment, in addition to laboratory analyzes on testosterone concentrations, the following laboratory parameters must be periodically checked: hemoglobin, hematocrit (to detect a "possible polycythemia), and analysis of liver function, and lipid profile .
Testogel should be used with caution in patients with epilepsy and migraine problems as it can aggravate these conditions.
In the literature there are reported cases of increased risk of sleep apnea in hypogonadal subjects undergoing treatment with testosterone esters, in particular in subjects at risk with evident obesity and chronic respiratory disease.
In patients treated with androgens and who reach normal plasma testosterone levels following replacement therapy, an improvement in insulin sensitivity may be observed.
Certain clinical signs such as irritability, nervousness, weight gain, prolonged or frequent erections may be symptomatic of excessive androgen exposure and require dosage adjustment.
If the patient experiences severe reactions at the application site, the treatment should be investigated and, if necessary, discontinued.
Athletes must be informed that this specialty contains an active ingredient (testosterone) which could induce a positive reaction to the tests performed during doping controls.
Testogel is not suitable for women due to possible virilizing effects.
Potential testosterone transfer
If proper precautions are not taken, testosterone gel can be passed on to other people in case of close skin contact, resulting in increased plasma testosterone levels and potential side effects (e.g. growth of facial and / or facial hair. body, alteration of the timbre of the voice, irregularity of the menstrual cycle) in the case of repeated contact (involuntary androgenisation).
The physician should inform the patient of the risk of testosterone transfer and the safety precautions to be taken (see below). Testogel should not be prescribed in patients who may not follow safety instructions (e.g. severe alcoholism, drug use, severe psychiatric disorders).
Testosterone transfer is avoided by wearing clothing that covers the application area or by taking a shower before contact.
Therefore, the following precautions are recommended:
* for the patient:
- wash your hands with soap and water after applying the gel,
- allow the gel to dry and cover the application area with clothes,
- take a shower before any situation in which the possibility of contact is foreseen.
* for people not treated with Testogel:
- in case of contact with the application area that is not washed or not covered with clothing, wash the skin surface on which the testosterone transfer could take place as soon as possible with soap and water,
- report the occurrence of signs of excessive exposure to androgens, such as the onset of acne or modification of the hair system.
Following the studies in vitro absorption of testosterone carried out with Testogel, it is preferable that patients respect a period of at least 6 hours after applying the gel before taking a bath or shower. However, an occasional bath or shower taken between 1 and 6 hours after application of the gel should not significantly affect the course of treatment.
In order to ensure the safety of the partner, the patient should be recommended, for example, to observe a long interval between the application of Testogel and sexual intercourse, to wear a t-shirt that covers the area of application during the period of contact or take a shower before intercourse.
In addition, it is recommended to wear a T-shirt, covering the application site, when in contact with children, to avoid contaminating children's skin.
Pregnant women should avoid any contact with Testogel application areas. If the partner becomes pregnant, the patient must carefully observe the precautions for use (see section 4.6).
04.5 Interactions with other medicinal products and other forms of interaction -
Oral anticoagulants
Change in the anticoagulant effect (increase in the effect of the oral anticoagulant by modifying the hepatic synthesis of coagulation factors and competitive inhibition at the level of plasma protein binding).
More frequent testing of prothrombin time and INR monitoring is recommended. Patients taking oral anticoagulants require careful monitoring, especially when starting or stopping androgen treatment.
Concomitant administration of testosterone and ATCH or corticosteroids may increase the risk of edematous manifestations. Consequently, these medicinal products should be administered with caution, particularly in patients with heart, kidney or liver disease.
Interaction with laboratory tests: androgens can reduce the levels of thyroxine-binding globulin and, consequently, decrease the plasma concentrations of T4 and increase the uptake of T3 and T4 on resin. However, the values of free thyroid hormones remain unchanged and show no clinical signs of thyroid insufficiency.
04.6 Pregnancy and breastfeeding -
Testogel is intended for male use only.
Testogel is contraindicated during pregnancy or breastfeeding. No clinical studies have been performed on this type of treatment in women.
Pregnant women should avoid any contact with Testogel application areas (see section 4.4). The product may have harmful virilizing effects on the fetus. In case of contact, wash with soap and water as soon as possible.
04.7 Effects on ability to drive and use machines -
No studies on the ability to drive and use machines have been performed.
04.8 Undesirable effects -
At the recommended dosage of 5 g of gel per day, the most frequently observed side effects are skin reactions (10%): application site reactions, erythema, acne, dry skin.
Side effects observed in 1 -
In patients treated for hypogonadism, frequent, sometimes persistent, gynecomastia phenomena are observed.
Other known undesirable effects of oral or injection testosterone treatments have been reported in the literature and are listed in the following table:
* The data relating to the risk of prostate cancer associated with testosteronic therapy do not allow us to draw firm conclusions
Other rare known side effects associated with excessive testosterone dosages include liver malignancies.
Frequent applications on the skin can cause irritation and dryness of the skin due to the presence of alcohol.
04.9 Overdose -
Only one case of acute testosterone overdose following injection is described in the literature. This was a case of a cerebrovascular accident in a patient who had an "elevated plasma testosterone concentration of 114 ng / ml (395 nmol / l). It is highly unlikely that transdermal treatment would lead to such concentrations. plasma testosterone.
05.0 PHARMACOLOGICAL PROPERTIES -
05.1 "Pharmacodynamic properties -
Pharmacotherapeutic group: ANDROGENS, ATC code: G03BA03
Endogenous androgens, especially testosterone and its main metabolite DHT, secreted by the testicles, are responsible for the development of the external and internal genital organs and for the maintenance of secondary sexual characteristics (development of hair, alteration of the tone of the voice, appearance of libido) ; the general action on the metabolism of proteins; the development of skeletal muscles and the distribution of body fat; the reduction in the elimination of nitrogen, sodium, potassium, chlorine, phosphorus and water through the urine.
Testosterone does not induce testicular development: it reduces the pituitary secretion of gonadotropins.
The effects of testosterone in some organs occur after the peripheral conversion of testosterone to estradiol which then binds to estrogen receptors in the target cell nucleus, e.g. Leydig's pituitary, fat, brain, bone and testicular cells.
05.2 "Pharmacokinetic properties -
Percutaneous absorption of testosterone ranges from approximately 9% to 14% of the applied dose.
Following percutaneous absorption, testosterone diffuses into the systemic circulation with relatively constant concentrations over twenty-four hours.
The serum concentration of testosterone increases from the first hour after the application to reach a situation of equilibrium starting from the second day. The daily variations of the testosterone concentration therefore have a similar magnitude to those observed in the course of the circadian rhythm of endogenous testosterone. . The percutaneous route of administration thus avoids the blood diffusion peaks induced by the injections and, unlike oral androgen therapy, does not induce hepatic concentrations of the steroid higher than the physiological ones.
Administration of 5 g of Testogel corresponds to an average increase in the level of testosterone of approximately 2.5 ng / ml (8.7 nmol / l) in plasma
Following discontinuation of treatment, the decrease in testosterone concentrations begins approximately 24 hours after the last application. Baseline concentrations are restored within 72-96 hours after the last administration.
The main active metabolites of testosterone are dihydrotestosterone and estradiol.
Testosterone is mostly excreted in the urine and faeces in the form of conjugated testosterone metabolites.
05.3 Preclinical safety data -
Testosterone was found to be non-mutagenic in vitro according to the model of inverse mutations (Ames test) or hamster ovary cells. Studies in laboratory animals have shown a relationship between androgen treatment and certain types of tumors. Data from experiments in mice showed an increase in prostate cancer incidences after testosterone treatment.
Sex hormones are known to facilitate the development of certain cancers induced by known carcinogens. No correlation has been established between these data and the actual risk to humans.
06.0 PHARMACEUTICAL INFORMATION -
06.1 Excipients -
Carbomer 980
isopropyl myristate
ethanol 96%
sodium hydroxide
purified water.
06.2 Incompatibility "-
Not relevant.
06.3 Period of validity "-
3 years.
06.4 Special precautions for storage -
This medicinal product does not require any special storage conditions.
06.5 Nature of the immediate packaging and contents of the package -
2.5 g in sachet (PET / Aluminum / LDPE).
Carton containing 1, 2, 7, 10, 14, 28, 30, 50, 60, 90 or 100 sachets.
Not all pack sizes may be marketed.
06.6 Instructions for use and handling -
No special instructions.
07.0 HOLDER OF THE "MARKETING AUTHORIZATION" -
Laboratoires BESINS INTERNATIONAL
3, rue du Bourg l "Abbé
75003 PARIS / France
Local representative:
Bayer S.p.A. Viale Certosa, 130 - Milan
08.0 MARKETING AUTHORIZATION NUMBER -
Box containing 1 single-dose sachet AIC N ° 035864127 / M
Box containing 2 single-dose sachets AIC N ° 035864139 / M
Box containing 7 single-dose sachets AIC N ° 035864141 / M
Box containing 10 single-dose sachets AIC N ° 035864154 / M
Box containing 14 single-dose sachets AIC N ° 035864166 / M
Box containing 28 single-dose sachets AIC N ° 035864178 / M
Box containing 30 single-dose sachets AIC N ° 035864180 / M
Box containing 50 single-dose sachets AIC N ° 035864192 / M
Box containing 60 single-dose sachets AIC N ° 035864204 / M
Box containing 90 single-dose sachets AIC N ° 035864216 / M
Box containing 100 single-dose sachets AIC N ° 035864228 / M
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION -
March 2004
10.0 DATE OF REVISION OF THE TEXT -
July 2008
