Enandrol 250 mg

Package leaflet: information for the user/patient
Enandrol 250 mg / ml solution for injection
Testosterone enantate
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 experience 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 Enandrol is and what it is used for
2. What you need to know before you use Enandrol
3. How to use Enandrol
4. Possible side effects
5. How to store Enandrol
6. Packaging content and other information

1. What Enandrol is and what it is used for
Enandrol contains as active substance enanthate testosterone, a male hormone.
Enandrol is injected into a muscle. Enzyme testosterone is a manufactured form of the male sex hormone, testosterone, which is naturally secreted.
It is used in men to replace testosterone for treating various health problems caused by lack of testosterone (male hypogonadism). This must be confirmed by two separate testosterone measurements in the blood and also include clinical symptoms such as impotence, infertility, low sexual desire, fatigue, depressive states, bone loss caused by low levels of testosterone hormone.

2. What you need to know before you use Enandrol
Do not use Enandrol
• if you are allergic to testosterone enanthate or any of the other ingredients of this medicine (See section 6.);
• if you have or have been suspected of androgen-related cancer of the prostate or mammary gland;
• if you have or have been liver tumors;
• if you have had a high level of calcium in the blood along with malignant tumors;
• if you have or have been suffered before a heart attack or other severe heart disease;
• if you have atherosclerosis (pathology in which blood fats are deposited on the vascular wall);
• if you suffer from diabetes;
• administration during pregnancy and lactation is contraindicated.
Enandrol is not intended for use in children and adolescents. There are no data available on the use of Enandrol in children and adolescents under 18 years of age. In children, besides being able due to the early development of male secondary sexual characteristics (masculinization), testosterone can cause accelerated bone growth and stopping growth, thus altering the final height. The appearance of common acne forms is expected.
Enandrol is not recommended for muscle building in healthy individuals or for increasing physical strength.
Warnings and precautions
Tell your doctor if you have or ever had:
• liver problems, including severe upper abdominal pain complaints;
• you suffer from sleep apnea (breathing disruption during sleep), as this may worsen;
• you suffer from severe heart, liver or kidney disease; Enantate testosterone treatment can cause severe complications in the form of water retention in the body, sometimes accompanied by congestive heart failure;
• high blood pressure or if you are being treated for high blood pressure, because testosterone may cause an increase in blood pressure;
• have or ever had problems with blood clotting; thrombophilia (an abnormality of blood clotting that increases the risk of thrombosis – blood clots in blood vessels);
• have epilepsy, migraine, diabetes or a cancer of the bone.
Like all oily solutions, Enandrol should be injected strictly intramuscularly and very slowly. In rare cases, lung microemulsion of oily solutions may cause symptoms such as cough, dyspnea, indigestion, sweating, chest pain, dizziness or syncope.
These reactions may occur during or immediately after the injection and are reversible. Testosterone enanthate should not be used in women because they may show signs of virilization, such of them are acne, hair growth on the face or body and voice change.

Medical examination/consultation
Male hormones can contribute to the growth of prostate cancer and prostatic gland (benign prostatic hypertrophy). Before your doctor injects testosterone enanthate, he will examine you to make sure you have no prostate cancer. If you are older, you may have an increased risk of developing prostate enlargement when using testosterone enanthate. Although there is no evidence clear sex hormones, such as testosterone enanthate, actually generate prostate cancer, can increase the growth of any existing cancers of the prostate.
As a precautionary measure, regular prostate examinations are recommended for men, especially if you are elderly.
If you are treated in the long term, androgen treatment should be performed periodically (See section 4. “Possible side effects”).
The following blood tests should be performed by your doctor before and during treatment:
• testosterone levels in the blood;
• general blood analysis.
Following the use of hormonal substances, such as androgenic compounds, rare cases of benign (non-cancerous) and malignant (cancerous) liver tumors have been observed. Although it is unlikely that a tumor will appear, they would present a health concern. In isolated cases, internal bleeding may develop from these tumors, which could endanger life.
You should therefore consult a doctor when you suffer from severe abdominal pain. Not all the unusual sensations you can feel in the upper abdomen may be considered as a possible sign of tumor or bleeding. Pain that does not disappear in a short time should, however, be better consulted with your doctor.
Children and adolescents
Enandrol is not intended for use in children and adolescents. There are no data available on the use of Enandrol in children and adolescents under 18 years of age (See “Do not use Enandrol”).
Elderly patients (over 65 years)
No dose adjustment is required, if you are over 65 years of age (See “Examination / Medical Consultation”).
Patients with liver disease
No studies have been performed in patients with hepatic impairment. Enandrol is contraindicated in men with liver tumors or a history of liver tumors (See “Do not use Enandrol”).
Patients with kidney problems
No studies have been performed in patients with renal impairment.
Enandrol is not recommended for muscle building for healthy people or for the recovery physical force. Enandrol could yield positive results in anti-doping tests.
Enandrol with other medicines:
Tell your doctor or pharmacist, if you have recently used any other medicines, including medicines without a prescription. Your doctor may adjust your dose if you use any of the following:
• medicines used to treat problems related to nervousness and sleep (barbiturates or other enzyme inducers);
• medicines used to treat pain or inflammation (oxyfenbutazone);
• blood thinning tablets (anticoagulants);
• medicines for the treatment of diabetes, for example metformin.
If you are diabetic, your doctor may adjust your insulin dose.
Enandrol can also affect the results of some laboratory tests (eg thyroid gland). Tell your doctor or laboratory staff that you are using Enandrol.
Please be sure to tell your doctor, if you have an inherited or acquired blood clotting disorder, as it is important for your doctor to know before you decide to give your intramuscular injection.
Pregnancy, breast-feeding and fertility
Testosterone enanthate is exclusively for men. It is not indicated for pregnant or breast-feeding women. Testosterone enantate should not be used during pregnancy due to the possibility of virilization (development of male sexual characteristics) of the fetus.
Fertility
High dose treatment of testosterone preparations may reverse the production of sperm (See “Possible side effects”).
Driving and using machines
Enandrol does not affect the ability to drive and use machines.

3. How to use Enandrol
Injection must be given very slowly in a muscle by a doctor or a nurse. The number of injections given per day or per week is called “dose”. Depending on the state in which you are being treated, your doctor will administer the appropriate dose by injection into a muscle.
To stimulate the development of underdeveloped androgen-dependent organs and for the initial treatment of deficiency symptoms, 250 mg testosterone enanthate intramuscularly is administered every 2-3 weeks.
For maintenance treatment: 250 mg testosterone enanthate intramuscularly every three to six weeks, according to individual requirements.
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 Enandrol injection, your doctor will perform regular prostate screening.
Enandrol is used for intramuscular injection only. Special care should be taken to avoid injecting into a blood vessel.
Enandrol solution for injection in vials may be used several times after the first injection provided that the vial cap has not been removed and the remaining contents hermetically sealed.
Start treatment
Your doctor will measure your blood testosterone concentration before starting treatment and during the first stages of treatment.
Keep the Enandrol 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 Enandrol is too strong or too weak, talk to your doctor.
If you use more Enandrol 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 Enandrol include:
• irritability;
• nervousness;
• weight gain;
• long or frequent erections.
Tell your doctor if any of the above applies to you. Doctor will inject you fewer times or stop the treatment.
If you forget to use Enandrol
Please observe the terms of the injection times agreed with your physician for optimal treatment efficacy.
If you stop using Enandrol
When Enandrol is stopped, symptoms of testosterone deficiency may occur.

4. Possible side effects
Like all medicines, Enandrol 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 counts;
• weight gain;
• hot flashes;
• acne;
• increase of prostate specific antigen (increase of biochemical index in blood);
• increased prostate size and associated problems;
• various injection site reactions (for example pain, discomfort, itching, redness, bruising or irritation);
• increased red blood cell counts, hematocrit (red blood cells) and hemoglobin (the red blood cells that carry oxygen) detected by periodic blood tests;
• increased erections.
Uncommon side effects (may affect up to 1 in 100 people):
• alergic reactions;
• increased appetite;
• changes in blood test result (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, cough, difficulty in breathing, snoring, voice problems;
• diarrhea, nausea;
• abnormal liver function tests, for example aspartate aminotransferase;
• hair loss, skin reactions redness, skin 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;
• increased prostate cell counts (prostatic intraepithelial neoplasia), prostate tissue 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 oestradiol, elevation of testosterone levels in the blood, abnormal sperm production;
• fatigue, general weakness, hyperspectration, 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, maculopapular erythematous rash;
• urinary tract disorders, nocturia;
• prostatic intraepithelial neoplasia (tumor).
The liquid and oily substance of Enandrol, which is given inappropriately (intravenously), can reach the lungs (lung microemulsion of oily solutions), which in rare cases can lead to signs and symptoms such as cough, dyspnea, 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 Enandrol
Keep out of the reach and sight of children.
Keep protected from light and temperatures below 25 °C.
Do not use Enandrol 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 be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines you no longer need. These measures will help to protect the environment.

6. Packaging content and other information
What Enandrol contains
The active substance is testosterone enanthate.
Each 1 ml of solution for injection contains 250 mg of testosterone enanthate.
Each 1 amploules of 1 ml contains 250 mg of testosterone enanthate.
Each 1 vial of 10 ml contains 2500 mg of testosterone enanthate.
The other ingredients are: benzyl alcohol, benzylbenzoate, peach oil.
What Enandrol looks like and contents of the pack
Clear, transparent, colorless or light yellow solution.
Cardboard box with 1 ml ampoules of 2 PVC holders each containing 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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