Testovis
Italy
Table of Contents
Patient Information Leaflet
Testovis 100 mg/2 ml intramuscular injection solution
testosterone propionate
Please read all of this leaflet carefully before you use this medicine because 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 give it to others, even if their symptoms are the same as yours, as it may be harmful.
- If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What Testovis is and what it is used for
- What you need to know before using Testovis
- How to use Testovis
- Possible side effects
- How to store Testovis
- 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 caused by testosterone deficiency (male hypogonadism). This condition must be confirmed by two separate blood testosterone measurements and must include clinical symptoms such as:
- impotence;
- infertility;
- low 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 medicinal product is used to treat:
- in men:
- conditions of testosterone deficiency (castration, eunuchoidism) or underdeveloped sexual organs (hypogenitalism);
- enlarged prostate (senile prostatic hypertrophy);
- low sperm count (oligospermia);
- depression;
- in women:
- certain uterine disorders (metropathies, bleeding caused by uterine fibromyomatosis);
- breast cancer, in combination with other therapies;
- in both men and women:
- certain kidney diseases (nephropathies predominantly of glomerular type);
- delayed healing of bone fractures (bone fractures with delayed callus formation);
- difficulties in 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 to 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 causing obstruction to the outflow of urine (vesicourethral obstruction);
- if you have severe kidney inflammation (nephrosis or nephritis in the 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 inform him if:
- you have circulatory problems (circulatory insufficiency);
- you have or have ever had blood clotting disorders:
- thrombophilia (a blood clotting disorder 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 pulmonary diseases);
- you suffer from epilepsy;
- you suffer from headaches;
- you have high blood pressure or are being treated for high blood pressure, as testosterone may increase blood pressure;
- you have diabetes, because this medicine may interfere with your diabetes treatment (see section 2 “Other medicines and Testovis”);
- you are severely undernourished;
- you are elderly, as careful monitoring is required to ensure that the treatment does not cause undesirable nervous, mental, or physical stimulation;
- you are overweight;
- you need to undergo tests for your thyroid health, as this medicine may alter their results (see section 2 “Testovis may alter the results of certain diagnostic tests”);
- you need to undergo diagnostic tests, as this medicine may interfere with the results of certain tests (see section 2 “Testovis may alter the results of certain diagnostic tests”);
- you are a woman during your menstrual period;
- you develop 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 (congestive).
During treatment with this medicine, your doctor will regularly perform control tests to rule out:
- abnormal prostate growth, either benign (benign prostatic hyperplasia) or malignant (prostate carcinoma) (tests: digital rectal examination and PSA level measurement);
- 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 may alter the results of certain diagnostic tests This medicine may alter the results of laboratory tests used to:
- assess adrenal gland health (metyrapone test);
- measure glucose levels in the blood (blood glucose) fasting and after glucose load. This test is usually prescribed for diabetic patients;
- evaluate thyroid health (thyroid function tests). Altered test results generally persist for 2–3 weeks after discontinuation of Testovis therapy;
- measure electrolyte levels in the blood;
- measure the blood's ability to clot (coagulation tests);
- evaluate kidney function (creatinine and creatine excretion tests). Altered test results generally persist up to 2 weeks after discontinuation of Testovis therapy;
- measure 17-ketosteroids in urine. These values are used to diagnose certain diseases;
- evaluate liver function;
- measure lipid levels in the blood;
- measure PSA levels in the blood (test to evaluate prostate health).
Children and adolescents
This medicine must not be used in newborns and premature infants.
In young children, Testovis should be used only if the doctor considers it absolutely necessary, as it may cause serious disturbances in growth and sexual development.
In adolescents of prepubertal age, Testovis should be used only if the doctor considers it absolutely necessary, as it may block bone growth and lead to premature sexual development.
Other medicines and Testovis
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking:
- medicines called corticosteroids or therapies with adrenocorticotropic hormone (used against inflammation or in specific diseases). The combination of these medicines with Testovis may increase the risk of swelling (edema), especially in people with heart, liver, or kidney diseases;
- anticoagulant medicines, used to thin the blood and prevent clot formation. Testovis may enhance the effects of anticoagulants;
- medicines that lower blood glucose levels (hypoglycemics used in diabetes therapy);
- imipramine, used for depression, as paranoid syndromes may occur.
Pregnancy and breastfeeding
Do not use Testovis during pregnancy or breastfeeding.
Driving and using machines
This medicine does not affect the ability to drive vehicles or operate machinery.
Testovis contains sesame oil:
rarely it may cause severe allergic reactions.
For individuals engaged in sports: using this medicine without therapeutic need constitutes doping and may result in a positive anti-doping test.
3. How to use Testovis
Use this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
| Generally recommended doses | |
| In men and women: | |
| Kidney problems (glomerular-type nephropathies, both acute and chronic) | The recommended dose is half an ampoule (1 ml) on alternate days for 10–12 days. |
| Bone fractures (with delayed callus formation) | The recommended dose is half an ampoule (1 ml) every 4–5 days. |
| In men: | |
| Testosterone deficiency and underdevelopment of sexual organs (castration, eunuchism, hypogenitalism) | The recommended dose is half an ampoule (1 ml) twice a week for at least 2 months. |
| Sexual performance difficulties and oligospermia | The physician will determine the dose according to your condition. For these conditions, prolonged treatment is generally required. |
| Depression | A quarter of an ampoule (0.5 ml) twice a week for at least 3–6 weeks. Attention: cycles should be followed by prolonged rest periods. |
| Enlargement of the prostate gland (prostatic hypertrophy) | From a quarter of an ampoule (0.5 ml) to half an ampoule (1 ml), depending on the severity of the disease, three times a week. Treatment will continue with lower doses. Follow your doctor's instructions. |
| In women: | |
| Sexual performance difficulties, decreased libido | The recommended dose is one ampoule every 3 days, repeatable after a few months. |
| Bleeding due to fibroids | The recommended dose is half an ampoule (1 ml) twice a week. Follow cycles of 3 weeks alternating with 1 week of rest. |
| Painful congestive breast syndromes (mastodynia and mastopathy) | The recommended dose is half an ampoule (1 ml) once a week. |
Instructions for use:
Inject deeply into the muscle.
In case of partial use of the contents of the vial, any remaining 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 may cause:
- in men, prolonged and painful erections (priapism). If this occurs, stop treatment and consult your doctor;
- in men suffering from reduced testosterone production (hypogonadism), further suppression of testosterone production in the testes and a decrease in ejaculate volume;
- an increase in the number of red blood cells in the blood (polycythaemia). If this occurs, your doctor will instruct you to stop treatment.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur with the use of this medicine:
In adults:
- excessive sexual, nervous, and mental (psychic) stimulation, depression, mood disorders;
- severe hypersensitivity or allergic reactions (anaphylactoid reactions);
- swelling due to fluid retention (oedema);
- muscle pain;
- high blood pressure;
- nausea;
- itching;
- changes in liver function tests, changes in blood lipid levels;
- increase in red blood cell count, haematocrit (percentage of red blood cells in the blood), and haemoglobin (the component of red blood cells that carries oxygen), detected through periodic blood tests with common frequency.
In males:
- inhibition of testosterone production by the testes, testicular atrophy, reduced sperm count in ejaculate, impotence, prolonged and painful erections (chronic priapism), breast enlargement (gynaecomastia), inflammation of the epididymis (a part of the male genital system), need to urinate too frequently and urgently, possibly with urinary incontinence (vesical irritability), prostate enlargement, increased PSA levels in blood (a test to assess prostate health);
- increased or decreased libido, skin swelling and redness due to excessive blood flow (cutaneous hyperaemia), acne, drug dependence, excitement, drowsiness, chills, changes in the number of certain blood cells (white blood cells) (leucopenia), appearance of itchy skin rashes (urticaria), injection site infiltration, development of boils, increased number of red blood cells in blood (polycythaemia);
- progression of prostate cancer.
In females:
- absence of menstruation, development of male characteristics such as increased body hair or appearance of hair in areas where it was previously absent (virilisation), lowering and deepening of the voice to a male tone, abnormal clitoral enlargement, sexual desire disorders, breast and uterine atrophy.
Additionally, this medicine may interfere with the results of certain laboratory tests (see section 2 "Testovis may alter the results of certain diagnostic tests").
Additional side effects in children and adolescents
This medicine may cause the following side effects in children and adolescents:
- growth arrest;
- premature sexual development in males;
- development of male characteristics in females.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly via 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
Keep in the original packaging 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 stated on the carton after "Expiry".
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.
6. Package contents and other information
What Testovis contains
- The active substance is testosterone propionate. Each 2 ml vial of injectable intramuscular 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 solution for intramuscular injection is available in cardboard packs containing 2 vials each.
Marketing Authorization Holder
Laboratorio Farmaceutico SIT S.r.l. - Via Cavour, 70 - 27035 Mede (PV)
Manufacturer
EVER Pharma Jena GmbH - Otto Schott-Str., 15 – Jena (Germany).