Sustandrol 250 mg

Package leaflet: information for the user / patient
Sustandrol 250 mg / ml injectible solution
Testosterone propionate, Testosterone phenylpropionate,
Testosterone isocaproate, Testosterone decanoate

Read all of this leaflet carefully, before you start using this medicine because it contains important information for you.
– Keep this leaflet. You may need to read it again.
– If you have any further questions, ask your doctor or pharmacist or nurse.
– This medicine has been prescribed for you only. You do not have to give it to others. It can harm them, even if they have the same signs of illness as yours.
– If you have any side effects, talk to your doctor or pharmacist or nurse. These include any possible side effects not mentioned in this leaflet. See section 4.
What you find in this leaflet:
1. What Sustandrol is and what it is used for
2. What you need to know before you use Sustandrol
3. How to use Sustandrol
4. Possible side effects
5. How to store Sustandrol
6. Packaging content and other information

1. What Sustandrol is and what it is used for
Sustandrol contains the active substance testosterone in the form of 4 ester forms (testosterone propionate, testosterone phenylpropionate, testosterone isocaproate, testosterone decanoate). Sustandrol’s active substances are transformed into your body into testosterone. Testosterone is a male hormone that is part of the androgen hormone group.
In men, testosterone is produced by the testicles. It is necessary for the normal growth, development and functioning of male sexual organs and the development of secondary male characteristics. It is necessary for the growth of hair on the body, the development of bones and muscles and stimulates the production of erythrocytes. At the same time, medicine gives the voice an accentuated tone.
Sustandrol is used in adult men in the testosterone replacement therapy to treat various health problems caused by lack of testosterone (male hypogonadism). This has to be confirmed by two separate measurements of testosterone levels in the blood and also includes clinical symptoms such as impotence, infertility, low appetite, fatigue, depressive states and bone loss caused by the low level of hormones.

2. What you need to know before you use Sustandrol
Do not use Sustandrol
– if you are allergic to testosterone or any of the other ingredients of this medicine (see section 6);
– if you have or have been suspected of androgenic cancer – dependent on the prostate or mammary gland;
– using during pregnancy and lactation is contraindicated.
Sustandrol is not for use in children and adolescents. There are no data available on the use of Sustandrol in children and adolescents under 18 years of age. In children, besides the fact that it can lead to the early development of male secondary sexual characteristics (masculinization), testosterone can cause an accelerated bones growth and stop their growth, thus reducing the final height. The appearance of common acne forms is expected.
Warnings and precautions
If you notice any signs of masculinization (for example thickening of the voice or increased body or facial hair), contact your doctor immediately.
Treatment with male hormones such as testosterone can increase the size of the prostate, especially in elderly men. Therefore, your doctor will examine your prostate at regular intervals by rectal retention and prostate specific antigen (PSA) blood testing.
In addition, at regular intervals, blood tests will be performed to check the oxygen-transferring substance (hemoglobin) in the erythrocytes.In very rare cases, the number of erythrocytes in the blood can increase exaggerated, which leads to complications.
The following blood tests should be performed before and during your treatment: blood testosterone levels, blood counts.
Also, medical checks may be required under other conditions. Therefore, before you start using this medicine, you should tell your doctor or pharmacist if you have had, or are, or are suspected of having:
• Breast cancer with bone metastases;
• Renal or lung cancer;
• Cardiac diseases;
• Renal diseases;
• Liver disease;
• Hypertension;
• Diabetes;
• Epilepsy;
• Migraines, headaches;
• Prostate disorders such as urinary problems;
• Blood clotting disorders – thrombophilia (a blood coagulation abnormality that increases the risk of thrombosis – the presence of blood clots in blood vessels).
If you suffer from severe heart, liver or kidney disease, treatment with Sustandrol may cause severe complications in the form of water retention in the body, sometimes accompanied by congestive heart failure.
Tell your doctor if you have hypertension or if you are receiving high blood pressure because testosterone may cause an increase in blood pressure. If you have sleep apnea (temporary stopping of breathing during sleep), it may get worse, if you use testosterone-containing products. Tell your doctor if you are worried about it. If you are overweight or have chronic lung disease, additional supervision by your doctor may be required.
Children and adolescents
The safety and efficacy of this drug in children and adolescents have not been adequately determined.
In the treatment of children and adolescents, additional supervision by the doctor is required, since testosterone administration may in general lead to early sexual development and may limit growth.
Patients with liver disease
No studies have been performed in patients with hepatic impairment. Sustandrol is contraindicated in men with liver tumors or a history of liver tumors.
Patients with kidney problems
No studies have been performed in patients with renal impairment.
Sustandrol is not recommended for muscle building in healthy or for people increasing physical strength. Sustandrol could give positive results to anti-doping tests.
Sustandrol with other medicines
Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. Other medicines may influence the effects of Sustandrol, or Sustandrol may affect other medicines.
Therefore, you should tell your doctor or pharmacist if you are taking or intend to use:
• Insulin and/or other medicines that control blood sugar;
• Medicines that reduce the formation of blood clots (anticoagulants);
• Some medicines that change the amount of enzymes in the liver, such as medicines used to treat epilepsy (phenobarbital).
These medicines can affect testosterone levels in your body and your doctor needs to adjust the dose or frequency of Sustandrol.
The use of androgen such as Sustandrol may lead to a reduction in the doses of these medicines.
Also tell your doctor or pharmacist if you are taking or intend to use ACTH or glucocorticoids (used in the treatment of various conditions such as rheumatism, arthritis, allergic and asthmatic diseases). The use of androgen such as Sustandrol may increase the risk of water retention, especially if the heart and your liver is not working properly.
Androgens can also influence the results of laboratory tests (for example thyroid gland). Therefore, you should tell your doctor you or your laboratory staff these investigations that you are using this medicine.
Using Sustandrol with food and drink
This drug can be injected without taking into consideration meals and beverages.
Pregnancy, breast-feeding and fertility
Sustandrol should not be taken by pregnant women or by nursing women.
In men, treatment with Sustandrol can lead to fertility disorders by inhibiting sperm formation. In women, treatment with this medicine can lead to menstrual cycle disorders or interruption.
If you are pregnant or breast-feeding, think you may be pregnant or planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
As far as it is known, this medicine has no influence on the handling of vehicles and the use of machinery.

3. How to use Sustandrol
Injection will be given very slowly in a muscle by a doctor or a nurse. Depending on the condition you are being treated, your doctor will administer the appropriate dose by injection into a muscle.
Typically, the dose is one ml per injection every three weeks.
The correct dose will be decided by your doctor. If you are not sure ask your doctor. Elderly male patients may be prescribed lower doses. During treatment with Sustandrol, your doctor will perform regular prostate screening.
Sustandrol is only used for intramuscular injection. Special care should be taken to avoid injecting into a blood vessel.
Sustandrol vial solution for injection may be used several times after the first injection provided that the vial cap was not removed and the remaining contents remained hermetically sealed.
Start treatment
Your doctor will measure your blood testosterone concentration before starting treatment and during the first stages of treatment.
Keeping Sustandrol level during treatment
Your doctor will periodically measure your testosterone plasma concentration at the end of an injection interval. If the level is too low, your doctor may decide to give you injections more frequently. Plasma concentrations below the normal range indicate the need to shorten the interval between injections. In the event of elevated plasma concentrations, your doctor may consider an increase in the interval between injections. Do not miss the injections schedule because it will not keep your optimal testosterone level.
If you have the impression that the effect of Sustandrol is too strong or too weak, talk to your doctor.
If you use more Sustandrol than you should
Your doctor will determine the optimal injection interval to avoid excessive increase in testosterone levels in the blood.In the event of accidental overdose, no special therapeutic measures are required, except stopping treatment or reducing the number of injections.
Symptoms of using more Sustandrol include:
– irritability;
– nervousness;
– weight gain;
– long or frequent erections.
Tell your doctor if any of the above applies to you. Your doctor will inject you less often or stop the treatment.
If you forget to use Sustandrol
Your doctor or nurse will inject you this medicine. If you miss a scheduled injection, talk to your doctor or nurse as soon as possible. Do not inject a double dose to make up for the forgotten individual doses.
If you stop using Sustandrol
The effects of this medicine do not stop immediately after stopping treatment, but gradually disappear.
When discontinuing treatment with this medicine, within a few weeks, similar symptoms may be reappearing before treatment.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, Sustandrol can cause side effects, although not everybody gets them. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist. The most common side effects are acne and pain at the site of administration.
Common side effects (may affect up to 1 in 10 people)
– abnormally high abnormal red blood cell count;
– weight gain;
– hot flashes;
– acne;
– increased prostate-specific antigen (increase of a biochemical index in the blood);
– increased prostate size and associated problems;
– various reactions at the injection site (for example pain, discomfort, itching, redness, bruising or irritation);
– increased blood red blood cells, hematocrit (red blood cells) and hemoglobin (the red blood cells that carry the oxygen) detected by periodic blood tests;
– increased erections.
Uncommon side effects (may affect up to 1 in 100 people)
– alergic reactions;
– increasing appetite;
– changes in the blood test results (for example increases in blood sugar and fat levels);
– depression, emotional disturbances, insomnia, nervousness, agitation, aggression or irritability;
– headaches, migraines or tremors, numbness of parts of the body;
– cardiovascular disorders, increased blood pressure, hypertension or dizziness;
– bronchitis, sinusitis, coughing, difficulty in breathing, snoring, voice problems;
– diarrhea, nausea;
– abnormal liver function tests, for example, aspartate aminotransferase increase;
– hair loss, skin reactions (such as redness, rash, blistering of the skin (red spots), itching or dry skin;
– joint pain, pain in the hands and feet, muscle spasms, pain or muscle stretch, increased creatine phosphokinase levels in the blood;
– low urinary flow, urinary retention, need for urination during the night, urinary tract disorders or pain in urination;
– increase in prostate cell counts (prostate intraepithelial neoplasia), prostate strengthening or inflammation, prostate disorders, increased appetite, decreased interest in sex, testicular pain, tissue tightening or breast enlargement, breast pain, elevations in hormone levels female blood estradiol, elevation of testosterone levels in the blood, abnormal sperm production;
– fatigue, general weakness, night sweats.
Very rare side effects (may affect <1 / 10,000)
– benign or malignant tumors of the liver;
– enlargement of the liver;
– transient erythematous rash, maculo-papular erythematous rash;
– urinary tract disorders, icterus;
– prostatic intraepithelial neoplasia (tumor).
The liquid and oily substance of Sustandrol being administered incorrectly (intravenously) may reach the lungs (lung microemulsion of oily solutions) which in rare cases may lead to signs and symptoms such as cough, dyspnoea, general malaise, excessive sweating, chest pain, dizziness, feeling prickly or faint. These reactions may occur during or immediately after injections and are reversible.
In addition to the side effects listed above, the following events have been reported after treatment with testosterone-containing preparations: nervousness, hostility, shortness of breath during sleep, various skin reactions including dandruff and oily skin, more frequent erections and very rare cases yellowing of the skin and eyes (jaundice).
Treatment with preparations containing high doses of testosterone stops or reduces sperm production, although this returns to normal after cessation of treatment.
Testosterone replacement therapy in case of testicular disorders (hypogonadism) can cause, in rare cases, persistent painful erections (priapism).
High doses or long-term administration of testosterone sometimes increase the incidence of water retention and edema (inflammation caused by fluid retention).
Reporting adverse reactions
If you experience any side effects, talk to your doctor or pharmacist. These include any possible side effects not mentioned in this leaflet. By reporting side effects, you can help provide additional information on the safety of this medicine.

5. How to store Sustandrol
Keep out of the reach and sight of children.
Keep protected from light and temperatures below 25 °C.
Do not use Sustandrol after the expiry date which is stated on the pack after “EXP”.
The expiration date refers to the last day of that month.
No special storage conditions are required. Medicines should not discarded by household water or household waste. Ask pharmacist how to dispose of medicines that you no longer have required. These measures will help to protect the environment.

6. Packaging content and other information
What SUSTANDROL contains
1 ml of solution for injection contains the following active substances:
Testosterone propionate 30 mg,
Testosterone phenylpropionate 60 mg,
Testosterone isocaproate 60 mg,
Testosterone decanoate 100 mg.
All four components are esters of the testosterone natural hormone.
Each ampoule of 1 ml total contains 250 mg of active substance.
Each vial of 10 ml total contains 2500 mg active substances.
The other ingredients are: benzyl alcohol, benzylbenzoate, peach oil.
What SUSTANDROL looks like and contents of the pack
Clear, transparent, colorless or light yellow solution.
Cardboard box with 1 ml ampoules of two (2) PVC holders each containing five (5) ampoules.
Cardboard box with 1 vial of 10 ml.

CERTIFICATE OF REGISTRATION
SC Balkan Pharmaceuticals SRL N. Grădescu str., 4, MD-2002, or. Chisinau, Republic of Moldova.
The manufacturer
SC Balkan Pharmaceuticals SRL Industrial Street, 7 / A, MD-2091, or. Singera, Republic of Moldova.

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