Cipandrol 200 mg

Package leaflet: information for the user / patient
Cipandrol 200 mg / ml solution for injection
Testosterone cipionate

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 Cipandrol is and what it is used for
2. What you need to know before you use Cipandrol
3. How to use Cipandrol
4. Possible side effects
5. How to keep Cipandrol
6. Packaging content and other information

1. What Cipandrol is and what it is used for
Cipandrol contains as active substance testosterone cipionate, a male hormone.
Cipandrol is injected into a muscle.
Testosterone cipionate 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 Cipandrol
Do not use Cipandrol:
• 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 androgen-related cancer of the prostate or mammary gland;
• if you have or have liver tumors;
• if you have had a high level of calcium in the blood along with malignant tumors;
• if you have or have had a previous heart attack or have other serious 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.
Cipandrol is not intended for use in children and adolescents. There are no data available on the use of Cipandrol 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.
Cipandrol 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; treatment with testosterone cipionate may 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 have ever had problems with blood clotting; thrombophilia (an abnormality of blood clotting that increases the risk of thrombosis – blood clots in blood vessels);
• you have epilepsy, migraine, diabetes or a cancer of the bone.
Like all oily solutions, Cipandrol 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 cypionate should not be used in women because they may show signs of virilization, such as acne, hair growth on the face or body, and voice change.

Medical examination/consultation
Male hormones can help increase prostate and glandular cancer prostatic hyperplasia (benign prostatic hypertrophy). Before your doctor to inject testosterone cipionate, it will examine you to make sure that you do not have prostate cancer. If you are older, you may have one increased risk of developing prostate enlargement when using cypionate testosterone. Although there is no clear evidence that sex hormones such as cypion of testosterone, actually generates prostate cancer, can increase the growth of any existing cancers of the prostate.
As a precautionary measure, regular examinations are recommended for men prostate, 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
Cipandrol is not intended for use in children and adolescents. There are no data available on the use of Cipandrol in children and adolescents under 18 years of age (see “Do not use Cipandrol”).
Elderly patients (over 65 years)
No dose adjustment is required if you are over 65 years of age (see “Medical examination / consultation”).
Patients with liver disease
No studies have been performed in patients with hepatic impairment. Administration of Cipandrol is contraindicated in men with liver tumors or a history of liver tumors (see “Do not use Cipandrol”).
Patients with kidney problems
No studies have been performed in patients with renal impairment.
Cipandrol is not recommended for muscle building in healthy people or for increasing physical strength. Cipandrol could yield positive results in anti-doping tests.

Cipandrol 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 related problems 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 mellitus, for example metformin;
• hormonal drugs in the corticosteroid group.
If you are diabetic, your doctor may adjust your insulin dose.
Cipandrol can also affect the results of laboratory tests (for example thyroid gland). Tell your doctor or laboratory staff that you are using Cipandrol.
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.
Drug-food interactions
Interactions with drinking and food have not been established.
Pregnancy, breast-feeding and fertility
Testosterone cypionate is exclusively for men. It is not indicated in pregnant or breast-feeding women. Testosterone Cipionate 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
Cipandrol does not affect the ability to drive and use machines.

3. How to use Cipandrol
Injection will 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 condition you are being treated, your doctor will administer the appropriate dose by injection into a muscle.
Dosage
To stimulate the development of underdeveloped androgen-dependent organs and for the initial treatment of endogenous testosterone deficiency symptoms, intramuscular testosterone cypionate 50 mg – 200 mg every 2 to 4 weeks is administered.
It is not recommended to exceed the 400 mg dose per month. The duration of treatment is determined individually.
The dosage is adjusted according to the patient’s response to treatment and the occurrence of adverse reactions
Serum testosterone levels should be measured before treatment and occasionally during treatment and at the end of the injection period. Serum levels below the normal range would indicate the need for a shorter injection interval. In case of elevated serum concentrations, an extension of the injection interval may be considered.
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 Cipandrol injection, your doctor will perform regular prostate screening.
Cipandrol is only used for intramuscular injection. Special care should be taken to avoid injecting into a blood vessel.
Cipandrol solution for injection in vials 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.
Keep the level of Cipandrol 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 Cipandrol is too strong or too weak, talk to your doctor.
If you use more Cipandrol 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, with the exception of stopping treatment or reducing the number of injections.
Symptoms of using more Cipandrol 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 Cipandrol
Please observe the terms of the injection times agreed with your physician for optimal treatment efficacy.
If you are stop using Cipandrol
When you are stop using Cipandrol, symptoms of testosterone deficiency may occur.

4. Possible side effects
Like all medicines, Cipandrol 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 in prostate specific antigen (increase of a biochemical index in the blood);
• increased prostate size and associated problems;
• various injection site reactions (eg 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 (eg 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 (eg 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;
• 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 Cipandrol being administered incorrectly (intravenously) can reach the lungs (lung microemulsion of oil solutions) which, in rare cases, can 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 of yellow skin and eye coloration (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 keep Cipandrol
Keep out of the reach and sight of children.
Keep protected from light and temperatures below 25 °C.
Do not use Cipandrol 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 Cipandrol contains 200 mg / ml solution for injection
The active substance is testosterone cipionate.
Each 1 ml of solution for injection contains 200 mg of testosterone.
Each ampoules of 1 ml contains 200 mg of testosterone.
Each vial of 10 ml contains testosterone cipionate 2000 mg.
The other ingredients are: benzyl alcohol, benzylbenzoate, peach oil.
What Cipandrol 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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