Testovis - Package Leaflet

Indications Contraindications Precautions for use Interactions Warnings Dosage and method of use Overdose Undesirable Effects Shelf Life and Storage

Active ingredients: Testosterone (testosterone propionate)

Testovis 100 mg / 2 ml solution for injection for intramuscular use

Indications Why is Testovis used? What is it for?

Testovis is used to replace testosterone in adult men, to treat 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.

Testovis contains testosterone propionate, a sex hormone naturally present in the male body and, to a lesser extent, also in the female body.

This medicine is used to treat:

  • in man:

- conditions of testosterone deficiency (castration, eunucoidism) or reduced development of the sexual organs (hypogenitalism);

- enlargement of the prostate (senile prostatic hypertrophy);

- sperm deficiency (oligospermia);

- depression;

  • in women:

- some diseases of the uterus (metropathies, haemorrhages caused by uterine fibromyomatosis);

- breast cancer, together with other therapies;

  • in man and woman:

- some kidney diseases (mainly glomerular nephropathies);

- difficulty in healing of bone fractures (bone fractures with delayed callus formation);

- difficulty in sexual performance (disturbances of sexual potency).

Contraindications When Testovis should not be used

Do not use Testovis

  • if you are allergic to testosterone propionate or any of the other ingredients of this medicine
  • if you are pregnant or breast-feeding (see section "Pregnancy and breast-feeding");
  • if you are a man and have prostate or breast cancer;
  • if you have an enlarged prostate that obstructs urine output (cysto-urethral obstruction);
  • if you have severe inflammation of the kidney (nephrosis or nephritis in the nephrotic stage);
  • if you have severe liver problems (severe liver dysfunction);
  • in newborns and premature babies.

Precautions for use What you need to know before taking Testovis

Talk to your doctor before using Testovis and tell him if:

  • have blood circulation problems (circulatory failure);
  • have kidney problems (kidney failure);
  • have mild or moderate liver problems;
  • have heart problems (heart failure or coronary heart disease) or have had a heart attack (myocardium);
  • have lung problems (chronic lung disease);
  • suffer from epilepsy;
  • suffer from headache;
  • have high blood pressure or are being treated for high blood pressure, as testosterone can cause your blood pressure to rise;
  • you have diabetes, as this medicine may interfere with your diabetic therapy (see section "Other medicines and Testovis");
  • he is heavily wasted;
  • is elderly, as it must be carefully observed that the treatment does not cause undesirable nervous, mental or physical stimulation;
  • you are overweight;
  • you must undergo tests for the health of your thyroid as this medicine can alter the results (see section "Testovis can alter the results of some diagnostic tests");
  • you must undergo diagnostic tests, because this medicine interferes with the results of some tests (see section "Testovis may alter the results of some diagnostic tests");
  • you are a woman, during your menstrual period;
  • there is an increase in the calcium content in the blood (symptomatic hypercalcemia).

If you have severe heart, liver or kidney disease, treatment with Testovis can cause serious complications in the form of water accumulation in the body, sometimes accompanied by (congestive) heart failure.

While you are being treated with this medicine, your doctor will check you regularly to rule out:

  • abnormal growth of the prostate both benign (benign prostatic hyperplasia) and malignant (prostate cancer) (exams: rectal examination and determination of the PSA value);
  • an increase in red blood cells (blood test to measure hematocrit and hemoglobin).

Before and during treatment, the doctor must carry out the following blood tests:

  • blood testosterone levels, complete blood count.

Testovis can alter the results of some diagnostic tests

This medicine can change the results of laboratory tests used for:

  • evaluate the health of the adrenal glands (metyrapone test);
  • measure the amount of glucose in the blood (glycaemia) in fasting and after loading. Test generally prescribed for people with diabetes;
  • evaluate the state of health of the thyroid gland (thyroid function test). The altered test results typically persist for 2 to 3 weeks after discontinuation of Testovis therapy;
  • measure blood salts (electrolytes);
  • measure the blood's ability to clot (blood coagulation test);
  • evaluate the functioning of your kidneys (creatinine and creatine excretion test). The abnormal test results usually persist for up to 2 weeks after stopping Testovis therapy;
  • measure 17-ketosteroids in urine. Values ​​used to diagnose some diseases;
  • evaluate liver function;
  • measure blood lipid levels;
  • measure PSA levels in the blood (test to assess prostate health).

Children and adolescents

This medicine should not be used in newborns and premature babies.

In young children Testovis should only be used if your doctor considers it absolutely necessary because it can cause serious disturbances in growth and sexual development.

In prepubertal adolescents Testovis should only be used if your doctor deems it absolutely necessary because it can block bone growth and lead to early sexual development.

Interactions Which drugs or foods may change the effect of Testovis

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular, tell your doctor if you are taking:

  • drugs called corticosteroids or adrenocorticotropic hormone therapies (used against inflammation or in specific conditions). Combining these medicines with Testovis may increase the risk of swelling (edema), especially in people with heart, liver or kidney disease;
  • anticoagulant drugs, used to thin the blood and prevent blood clots. Testovis may increase the effects of anticoagulants;
  • drugs that lower blood glucose levels (hypoglycemic agents used in diabetes treatment);
  • imipramine, used against depression, because paranoid syndromes can arise.

Warnings It is important to know that:

Pregnancy and breastfeeding

Do not use Testovis if you are pregnant or breastfeeding.

Driving and using machines

This medicine does not affect the ability to drive or use machines.

Testovis contains sesame oil:

it can rarely cause severe allergic reactions.

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 Testovis: Posology

Always use this medicine exactly as your doctor or pharmacist has told you. If in doubt, consult your doctor or pharmacist.

Generally recommended doses

In the "man and woman:


Kidney problems (both acute and chronic glomerular nephropathies) The recommended dose is half a vial (1 ml) every other day for 10 - 12 days. Bone fractures (with delayed callus formation) The recommended dose is half a vial (1 ml) every 4 - 5 days.

In the "man


Testosterone deficiency and reduced development of the sexual organs (castration, eunuchoidism, hypogenitalism) The recommended dose is half a vial (1 ml) twice a week for at least 2 months. Difficulty in sexual performance and oligospermia Your doctor will assess the dose based on your condition. Prolonged care is generally required for these conditions depression A quarter of a vial (0.5 ml) 2 times a week for at least 3 - 6 weeks. Warning: the cycles will be interspersed with prolonged periods of rest. Enlargement of the prostate (prostatic hypertrophy) From a quarter of a vial (0.5 ml) to half a vial (1 ml), according to the severity of the disease, 3 times a week. Therapy will continue with lower doses. Follow your doctor's instructions.

In the woman


Difficulty in sexual performance, decreased desire The recommended dose is one vial every 3 days, repeatable after a few months. Fibromyoma hemorrhages The recommended dose is half a vial (1 ml) twice a week. Follow 3-week cycles interspersed with a week of rest. Congestive painful sinus syndromes (mastodynia and mastopathy) The recommended dose is half a vial (1 ml) once a week.

Instructions for Use:

Inject deeply into the muscle. In case of partial intake of the contents of the vial, the residue must be eliminated.

Overdose What to do if you have taken too much Testovis

If you have accidentally taken too much Testovis, tell your doctor immediately or go to the nearest hospital.

An overdose of this medicine can cause:

  • in men, prolonged and painful erections (priapism). If this happens, stop the treatment and contact your doctor;
  • in men suffering from reduced testosterone production (hypogonadism), there may be a further inhibition of testosterone production in the testicles and a decrease in ejaculate volume;
  • an increase in the number of red blood cells in the blood (polycythemia). If this happens your doctor will stop the treatment.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Side Effects What are the side effects of Testovis

Like all medicines, this medicine can cause side effects, although not everybody gets them.

With the use of this medicine you can experience:

in adults:

  • excessive sexual, nervous and mental (psychic) ​​stimulation, depression, mood disorders;
  • severe hypersensitivity or allergic reactions (anaphylactoids);
  • swelling caused by fluid retention (edema);
  • pain in the muscles;
  • high blood pressure;
  • nausea;
  • itch;
  • abnormal liver function tests, abnormal blood lipid levels
  • increase in the number of red blood cells, 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 with common frequency.

in males:

  • inhibition of testosterone production by the testes, atrophy of the testicles, reduction in the number of spermatozoa in the ejaculate, impotence, prolonged and painful erections (chronic priapism), enlargement of the breasts (gynecomastia), inflammation of the epididymis (a part of the male genital system), the need to urinate excessively and urgently with possible loss of urine (bladder irritability), enlarged prostate, increased PSA levels in the blood (test to evaluate the health of the prostate);
  • increase or decrease in libido, swollen and red skin due to excessive blood flow (skin hyperemia), acne, habituation, excitement, sleepiness, chills, change in the number of some cells (white blood cells) in the blood (leukopenia), appearance of spots itchy skin (hives), infiltration at the injection site, the appearance of boils, increased number of red blood cells in the blood (polycythemia);
  • progression of prostate cancer.

in women:

  • absence of menstruation, appearance of male characters such as increased hair or appearance of hair in areas where they were not present (virilism), lower and deeper voice that takes on the tone of the male one, abnormal development of the clitoris, abnormalities of sexual desire, atrophy of the breasts and uterus. This medicine also interferes with the results of some tests (see section "Testovis may alter the results of some diagnostic tests").

Additional side effects in children and adolescents

This medicine in children and adolescents can cause:

  • stunting;
  • early sexual development in males;

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 https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide more information on safety. of this medicine.

Expiry and Retention

Store in the original package to protect the medicine from light.

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 after "Expiry". The expiry date refers to the last day of that month.

Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.

What Testovis contains

  • The active ingredient is testosterone propionate. Each 2 ml ampoule of intramuscular solution for injection contains 100 mg of testosterone propionate.
  • The other component is sesame oil.

Description of what Testovis looks like and contents of the pack

Testovis 100 mg / 2 ml solution for injection for intramuscular use is available in cartons containing 2 ampoules each.

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.

Further information on Testovis can be found in the "Summary of Characteristics" tab. 01.0 NAME OF THE MEDICINAL PRODUCT 02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION 03.0 PHARMACEUTICAL FORM 04.0 CLINICAL PARTICULARS 04.1 Therapeutic indications 04.2 Posology and method of administration 04.3 Contraindications 04.4 Special warnings and appropriate precautions for use 04.5 Interactions with other medicinal products and other forms of interaction04.6 Pregnancy and lactation04.7 Effects on ability to drive and use machines04.8 Undesirable effects04.9 Overdose05.0 PHARMACOLOGICAL PROPERTIES05.1 Pharmacodynamic properties05.2 Pharmacokinetic properties05.3 Preclinical safety data06.0 INFORMATION PHARMACEUTICALS 06.1 Excipients 06.2 Incompatibilities 06.3 Shelf life 06.4 Special precautions for storage 06.5 Nature of the immediate packaging and contents of the package 06.6 Instructions for use and handling 07.0 MARKETING AUTHORIZATION HOLDER08 .0 MARKETING AUTHORIZATION NUMBER 09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION 10.0 DATE OF REVISION OF THE TEXT 11.0 FOR RADIOPharmaceuticals, FULL DATA ON INTERNAL RADIATION DOSIMETRY 12.0 FOR RADIO DRUGS, ADDITIONAL DETAILED INSTRUCTIONS ON ESTEMPORANEA PREPARATION AND CONTROL

01.0 NAME OF THE MEDICINAL PRODUCT

TEXT VIS

02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION

Testovis tablets - One tablet contains:

Active ingredient: methyltestosterone 10.00 mg.

Excipients: sucrose; lactose; talc; magnesium stearate.


Testovis 50 and 100 mg vials - Each vial contains: Active principle '50' '100' testosterone propionate 50 mg 100 mg

Excipient: sesame oil.

03.0 PHARMACEUTICAL FORM

Ampoules and tablets for sublingual use.

04.0 CLINICAL INFORMATION

04.1 Therapeutic indications

In both sexes

Nephropathies mainly of the glomerular type. Bone fractures with delayed callus formation. Senile involution. Torpid ulcers of atrophic type.

In the "man

Pre-pubertal hypogenitalism (cryptorchidism, adipose-genital syndrome, delayed puberty).

Hypogenitalism of the adult (infantilism, enucoidism, gynecomastia). Impotence and hyposexuality.

Disorders of the virile climacteric, depressive states. Prostatic hypertrophy.

Dermatosis of endocrine origin.

In the woman

Frigidity. Menometrorrhagia. Fibromyoma hemorrhages. Mastodinias and mastopathies. Postpartum breast engorgement.

04.2 Posology and method of administration

Nephropathies (acute and chronic, mainly glomerular type): 50 mg every other day for 10-12 days;

Atrophic type numb ulcers: 10 mg tablets 2-3 times a week.

Bone fractures of old people (with delayed callus formation): 50 mg every 4-5 days.

Senile involution (cachexia, hearing loss): 2-3 tablets of 10 mg twice a week.

- In the man

Pre-pubertal hypogenitalism (adipose-genital syndrome, cryptorchidism, delayed puberty): one tablet per day sublingually until normalization. Treatment is generally started at 9-11 years of age. If the treatment should give rise to a too rapid sexual development, the dosage will be proportionally reduced.

Hypogenitalism in adults (infantilism, eunucoidism, gynecomastia): 50 mg twice a week for at least 2 months or sublingually 1-3 tablets a day.

Impotence and hyposexuality (prolonged treatments with Testovis, even without exercising direct aphrodisiac action, bring substantial benefits).

Disorders of the virile climacteric (premature senility).

Neurosuppressive disorders (mental exhaustion, headache, memory impairment): 25 mg twice a week. Treatment periods of at least 3-6 weeks are required. The cycles of treatment must be interspersed with prolonged periods of rest. Sublingually: 2-3 tablets per day.

Prostatic hypertrophy (urinary disorders of old age): 25-50 mg according to the severity, 3 times a week, for 2-3 weeks, continuing with lower doses or with prolonged oral care at a convenient dosage.

Endocrine origin dermatosis: one 10 mg tablet twice a week.

- In women (as a general rule, the administration of Testovis during the menstrual period should be avoided).

Frigidity: 100 mg injections of Testovis spaced 3 days, repeatable after a few months.

Minor metrorrhagia: 1-3 tablets of 10 mg per day until symptoms disappear.

Fibromyoma haemorrhages: injections of 50 mg twice a week in 3-week cycles, interspersed with one week.

Mastodinias and mastopathies in congestive pain syndromes: one 10 mg tablet per day (5 mg in young girls) in the 3 days preceding the presumed onset of pain; in the fibrocystic forms 50 mg weekly of Testovis ampoules.

Post partum breast engorgement: 3 tablets per day for 2-3 days.

04.3 Contraindications

Hypersensitivity to the individual components. Known or suspected prostate cancer, male breast cancer and lung cancer.

Testovis Tablets are contraindicated in patients with hepatic insufficiency.

04.4 Special warnings and appropriate precautions for use

To be administered with caution in patients suffering from circulatory and renal insufficiency, epilepsy and migraine and in defected subjects.

In prepubertal age, Testovis should only be administered in cases of real need.

In elderly subjects it must be carefully observed that the treatment does not cause undesirable nervous, mental or physical stimulation.

Testovis tablets for sublingual use: allow to dissolve slowly under the tongue or between cheek and molars.

Warnings

Testovis tablets should not be swallowed, but let them slowly dissolve under the tongue.

Discontinue treatment in case of hypercalcemia; carry out periodic checks of calcium levels, especially in patients with breast cancer.

Discontinue administration in case of liver test abnormalities; it is advisable to periodically check liver function.

X-rays should be performed in prepubertal patients to assess the rate of bone maturation and the effects on epiphyses.

It is advisable to monitor hemoglobin and hematocrit values ​​in patients receiving high doses due to the risk of polycythemia.

Keep this medicine out of the reach of children.

04.5 Interactions with other medicinal products and other forms of interaction

Testosterone can increase the incidence of bleeding in patients receiving oral anticoagulants: it inhibits the formation and increases the catabolism of coagulation factors; increases the affinity of the anticoagulant for the receptor site; it possesses fibrinolytic activity.

It can decrease blood glucose in diabetic patients and inhibit the metabolism of oral hypoglycemic agents. It may decrease the binding of thyroxine to plasma proteins.

In combination with imipramine it can cause the onset of paranoid syndromes.

04.6 Pregnancy and breastfeeding

Given the possible virilizing effect on the fetus or newborn, Testovis should not be administered to pregnant and breastfeeding women.

04.7 Effects on ability to drive and use machines

Not provided.

04.8 Undesirable effects

Testovis at high and repeated doses can cause the typical side effects of androgens: weight gain, water and sodium retention with consequent edema, hypercalcemia, the appearance of acne.

In women, moreover, inhibition of ovarian function with suppression of the menstrual cycle, virilism, modification of the voice, atrophy of the breast and endometrial tissue, hypertrophy of the clitoris, abnormality of the libido can be observed.

In infancy there may be a premature sealing of the epiphyses with arrest of growth, early sexual development in the male and virilization in the female; in adults excessive sexual, nervous and psychic stimulation. Rarely anaphylactoid and hypersensitivity reactions.

04.9 Overdose

The symptom of overdose in humans is the onset of priapism.

05.0 PHARMACOLOGICAL PROPERTIES

Property

Free testosterone injected in oily solution is so rapidly absorbed, metabolized and excreted that its androgenic effect is very low; by mouth it is rapidly absorbed but is even less active because the hormone is metabolized and inactivated by the liver before reaching the circulatory system.

Testovis ampoules contain the propionic ester of testosterone in an oily solution. Testosterone propionate is less polar than the free steroid, therefore it is absorbed more slowly and is considerably more effective.

Testovis tablets contain methyl-testosterone. The presence of methyl in position 17 slows down the oxidation and inactivation of the molecule in the liver, allowing the product to be effective. The pharmaceutical form in tablets for sublingual use also allows double therapeutic effects of those obtained by simple oral route.

Testovis possesses both androgenic and anabolic properties.

The hormone binds to a plasma receptor protein; the hormone-receptor complex is conveyed through the cytoplasm to the nucleus where it stimulates the activity of RNA polymerase and the consequent synthesis of RNA and proteins.

Testosterone acts as an anabolic by increasing anabolism and inhibiting protein catabolism, resulting in an increase in muscle mass.

It stimulates the formation of erythrocytes by increasing the synthesis of the erythropoiesis stimulating factor.

Toxicology

Acute toxicity studies conducted with methyltestosterone gave LD50 values ​​of 430 mg / kg in mice treated intraperitoneally.

Similar studies conducted with testosterone propionate at a dose of 275 mg / kg, again intraperitoneally in rats, did not show any mortality, while at the dose of 550 mg / kg there was a lethality at 72 hours in 83% of the animals.

Testosterone and its derivatives are potentially hepatotoxic, being able to determine, following prolonged use, hepatic carcinoma. Furthermore, prolonged use can accelerate the growth of prostate cancers.

In humans, an overdose causes the onset of priapism.

High doses of testosterone can cause inhibition of spermatogenesis and degeneration of seminiferous canals in men; hirsutism, lowering of the voice, atrophy of the breasts and endometrial tissue, acne, hypertrophy of the clitoris, increased libido, inhibition of lactation in women.

Repeated and high doses during puberty can cause premature sealing of the epiphyses and inhibition of growth.

The use of the drug during pregnancy has virilizing effects on the female fetus.

Pharmacokinetics

Methyltestosterone is absorbed from the gastrointestinal tract and the oral mucosa.

It is metabolised to a lesser extent by the liver than testosterone and has a longer half-life (2.5 hours).

After oral administration (10 mg) the plasma peak (24-39 ng / ml) is reached within 1-2 hours.

Sublingual administration has greater (approximately double) therapeutic effects than those obtained after oral administration. It is excreted in the urine. It permeates the placental barrier.

Intramuscularly injected testosterone propionate is absorbed and hydrolyzed to free testosterone. About 98% binds to plasma proteins (globulin which also binds estradiol); the percentage of free testosterone (2%) has a half-life of 10-20 minutes.

Testosterone is mainly metabolized in the liver.

The reaction starts with the oxidation of the hydroxyl in 17 and leads to the formation of androsterone (weak and androgen) and ethiocolanone (inactive). The metabolites are excreted in the urine as glucuronides and sulfates.

05.1 Pharmacodynamic properties

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05.2 Pharmacokinetic properties

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05.3 Preclinical safety data

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06.0 PHARMACEUTICAL INFORMATION

06.1 Excipients

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06.2 Incompatibility

Incompatibility with alkalis and oxidizing agents

06.3 Period of validity

Testovis tablets: 60 months.

Testovis vials i.m .: 60 months.

06.4 Special precautions for storage

None.

06.5 Nature of the immediate packaging and contents of the package

Testovis tablets: amber glass pill container closed by screw cap type pilfer-proof: each labeled pill container is packaged with the package leaflet in a cardboard box.

Testovis ampoules 50-100 mg: 2 neutral glass ampoules packed in round cardboard inserted with the package leaflet in a cardboard box.

Testovis 20 tablets of 10 mg

Testovis 2 vials i.m. 50 mg

Testovis 2 vials i.m. 100 mg

06.6 Instructions for use and handling

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07.0 MARKETING AUTHORIZATION HOLDER

S.I.T. PHARMACEUTICAL LABORATORY

Hygienic Therapeutic Specialties S.r.L.

Via Cavour, 70 - Mede (PV)

08.0 MARKETING AUTHORIZATION NUMBER

Testovis 20 tablets of 10 mg AIC n. 003559010

Testovis 2 vials i.m. 50 mg AIC n. 003559046

Testovis 2 vials i.m. 100 mg AIC n. 003559059

Date released: 1946

09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION

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10.0 DATE OF REVISION OF THE TEXT

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11.0 FOR RADIO DRUGS, COMPLETE DATA ON THE INTERNAL RADIATION DOSIMETRY

12.0 FOR RADIO DRUGS, FURTHER DETAILED INSTRUCTIONS ON EXEMPORARY PREPARATION AND QUALITY CONTROL

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