TESTOVIS 100 mg /2 Ml Injectable Solution

Зміст інструкції

1. Testovis 100 mg/2 ml injectable solution for intramuscular use
   1. What Testovis is and what it is used for
   2. What you need to know before using Testovis
   3. How to use Testovis
   4. Possible side effects
   5. How to store Testovis
   6. Contents of the pack and other information

Testovis 100 mg/2 ml injectable solution for intramuscular use

testosterone propionate

Read this leaflet carefully before using this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What Testovis is and what it is used for
• 2. What you need to know before you use Testovis
• 3. How to use Testovis
• 4. Possible side effects
• 5. How to store Testovis
• 6. Contents of the pack and other information

1. What Testovis is and what it is used for

Testovis 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 distinct measurements of testosterone in the blood and must include clinical symptoms such as:

• impotence;
• infertility;
• decreased sexual desire;
• fatigue;
• depressed mood;
• loss of bone tissue due to low hormone levels.

Testovis contains testosterone propionate, a sex hormone naturally present in the male body and, in smaller amounts, also in the female body. This medicine is used to treat:

• in men:
• conditions of testosterone deficiency (castration, eunuchoidism) or reduced development of the sex organs (hypogenitalism);
• enlargement of the prostate (senile prostatic hypertrophy);
• sperm deficiency (oligospermia);
• depression;
• in women:
• certain diseases of the uterus (metropathies, bleeding caused by uterine fibromyomatosis);
• breast cancer, together with other therapies;
• in men and women:
• certain kidney diseases (nephropathies predominantly of the glomerular type);
• difficulty healing bone fractures (bone fractures with delayed callus formation);
• difficulty with sexual performance (sexual potency disorders).

2. What you need to know before using Testovis

Do not use Testovis

• if you are allergic to testosterone propionate or any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant or breastfeeding (see section “Pregnancy and breastfeeding”);
• if you are a man and have prostate or breast cancer;
• if you have an enlarged prostate that obstructs the flow of urine (cysto-urethral obstruction);
• if you have a severe kidney inflammation (nephrosis or nephritis in a nephrotic phase);
• if you have severe liver problems (severe hepatic dysfunction);
• in newborns and premature infants.

Warnings and precautions
Talk to your doctor before using Testovis and tell them if:

• you have problems with blood circulation (circulatory insufficiency);
• you have or have ever had blood clotting problems:
• thrombophilia (an abnormality of blood coagulation that increases the risk of thrombosis - blood clots in blood vessels);
• you have kidney problems (renal insufficiency);
• you have mild or moderate liver problems;
• you have heart problems (heart failure or coronary artery disease) or have had a heart attack (myocardial infarction);
• you have lung problems (chronic lung diseases);
• you suffer from epilepsy;
• you suffer from headaches;
• you suffer from high blood pressure or are being treated for high blood pressure, because testosterone can cause an increase in blood pressure;
• you suffer from diabetes, because this medicine may interfere with your diabetic therapy (see section 2 “Other medicines and Testovis”);
• you are severely debilitated;
• you are elderly, as treatment should be carefully monitored to ensure it does not cause undesirable nervous, mental or physical stimulation;
• you are overweight;
• you need to undergo tests for your thyroid health because this medicine can alter the results (see section 2 “Testovis can alter the results of some diagnostic tests”);
• you need to undergo diagnostic tests, because this medicine interferes with the results of some tests (see section 2 “Testovis can alter the results of some diagnostic tests”);
• you are a woman, during your menstrual period;
• you experience an increase in calcium levels in the blood (symptomatic hypercalcemia).

If you suffer from a severe heart, liver or kidney disease, treatment with Testovis may cause
serious complications in the form of fluid accumulation in the body, sometimes accompanied by
heart failure (congestion).
During treatment with this medicine, your doctor will regularly perform check-up examinations to rule out:

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

Before and during treatment, your doctor must perform the following blood tests:

• testosterone levels in the blood, complete blood count. Testovis can alter the results of some diagnostic testsThis medicine can change the results of laboratory tests used for:
• evaluating the health of the adrenal glands (metirapone test);
• measuring the amount of glucose in the blood (fasting and postprandial blood glucose). Test generally prescribed to people with diabetes;
• assessing the health of the thyroid (thyroid function test). Alterations in test results usually persist for 2-3 weeks after stopping therapy with Testovis;
• measuring salts in the blood (electrolytes);
• measuring the blood's ability to clot (coagulation tests);
• assessing the function of your kidneys (creatinine and creatinine clearance test). Alterations in test results usually persist for up to 2 weeks after stopping therapy with Testovis;
• measuring 17-ketosteroids in the urine. Values used to diagnose certain diseases;
• assessing liver function;
• measuring lipid levels in the blood;
• measuring PSA levels in the blood (test to assess prostate health).

Children and adolescents
This medicine should not be used in newborns and premature infants.
In young children, Testovis should only be used if the doctor deems it absolutely necessary
because it can cause serious disturbances in growth and sexual development.
In adolescents in the prepubertal age, Testovis should only be used if the doctor deems it
absolutely necessary because it can block bone growth and lead to precocious sexual development.

Other medicines and 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:

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

Pregnancy and breastfeeding
Do not use Testovis if you are pregnant or breastfeeding.

Driving and operating machinery
This medicine does not impair the ability to drive vehicles or operate machinery.

Testovis contains sesame oil:
rarely it can cause serious allergic reactions.

For athletes:the use of the drug without a therapeutic need constitutes doping and
can still result in positive doping tests.

3. How to use Testovis

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have
any doubts, consult your doctor or pharmacist.

Instructions for use:
Inject deeply into the muscle.
If only part of the vial's contents is taken, the residue must be discarded.

If you use more Testovis than you should
If you have accidentally taken an excessive dose of Testovis, inform your doctor immediately or
go to the nearest hospital.
An excessive dose of this medicine can cause:

• in men, prolonged and painful erections (priapism). If this happens, stop treatment and see your doctor;
• in men who suffer from reduced testosterone production (hypogonadism), there may be 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 doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
With the use of this medicine, the following may occur:
in adults:

• excessive sexual, nervous and mental (psychic) stimulation, depression, mood disorders;
• severe hypersensitivity or allergic reactions (anaphylactoid);
• swelling caused by fluid retention (edema);
• muscle pain;
• high blood pressure;
• nausea;
• itching;
• alteration of liver function tests, alteration of lipid levels in the blood
• increase in the count of red blood cells, hematocrit (percentage of red blood cells in the blood) and hemoglobin (the component of red blood cells that carries oxygen), highlighted through periodic blood tests with common frequency. in males:
• inhibition of testosterone production by the testicles, testicular atrophy, reduction in the number of spermatozoa in the ejaculate, impotence, prolonged and painful erections (chronic priapism), increased breast volume (gynecomastia), inflammation of the epididymis (a part of the male genital apparatus), need to urinate with excessive frequency and urgency with possible urinary leakage (bladder irritability), enlarged prostate, increased PSA levels in the blood (test to assess prostate health);
• increase or decrease in libido, swollen and reddened skin due to excessive blood flow (skin hyperemia), acne, habituation, excitement, drowsiness, chills, alteration in the number of some blood cells (white blood cells) (leukopenia), appearance of itchy spots (urticaria), infiltration at the injection site, appearance of boils, increase in the number of red blood cells in the blood (polycythemia);
• progression of prostate cancer. in women:
• absence of menstruation, appearance of male characteristics such as increased hair or appearance of hair in areas where it was not present (virilization), lower and deeper voice that takes on the tone of the male voice, abnormal development of the clitoris, abnormalities of sexual desire, atrophy of the breasts and uterus.

Furthermore, this medicine interferes with the results of some tests (see section 2 “Testovis can
alter the results of some diagnostic tests”).

Additional side effects in children and adolescents
This medicine in children and adolescents can cause:

• growth arrest;
• precocious sexual development in males;
• appearance of male characteristics in females.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your
doctor or pharmacist. You can also report side effects directly through the national reporting system at
http://www.agenziafarmaco.gov.it/it/responsabili . By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Testovis

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 pack after “Expiry”. The
expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Testovis contains

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

Description of the appearance of Testovis and contents of the pack
Testovis 100 mg/2 ml injectable solution for intramuscular use is available in packs containing 2
vials each.

Marketing Authorisation Holder
Laboratorio Farmaceutico SIT S.r.l. - Via Cavour, 70 - 27035 Mede (PV)

Manufacturer
EVER Pharma Jena GmbH - Otto Schott-Str., 15 – Jena (Germany).