Testosterone Undecanoate 40mg Capsules Taj Pharma.

1.Name of the medicinal product

Testosterone Undecanoate capsule 40mg Taj Pharma.

2.Qualitative and quantitative composition
Each capsule contains
Testosterone Undecanoate             40.0mg
equivalent to 25.3 mg testosterone.
Excipients                                        q.s.
For the full list of excipients, see section 6.1.

3.Pharmaceutical form
Capsule
Soft oval, glossy capsules, transparent, orange in colour, with a yellow oily fill.

4.Clinical particulars

4.1 Therapeutic indications

Clinical Indications

Testosterone replacement therapy for male hypogonadism, when testosterone deficiency has been confirmed by clinical features and biochemical tests.

Examples of hypogonadal disorder are:

after castration;

eunuchoidism;

hypopituitarism;

endocrine impotence;

male climacteric symptoms like decreased libido and decreased mental and physical activity;

certain types of infertility due to disorders of spermatogenesis

Testosterone therapy may also be indicated in osteoporosis due to androgenic deficiency.

4.2 Posology and method of administration

Posology

In general, the dose should be adjusted according to the response of the individual patient.

Adults

The initial dosage required will usually be 120-160 mg daily for 2-3 weeks. Subsequent dosage (40-120 mg daily) should be based on the clinical effect obtained during the first weeks of therapy.

Elderly Patients

It should be noted that smaller and less frequent doses may achieve the same response.

Paediatric population

The safety and efficacy of Testosterone Undecanoate in children and adolescents has not been established. Pre-pubertal children treated with Testosterone Undecanoate should be treated with caution (see section 4.4).

Method of Administration

Oral.

To ensure absorption, Testosterone Undecanoate must be taken with a normal meal, if necessary with a little fluid, and be swallowed whole without chewing. It is preferable that half of the daily dose be taken in the morning and the other half in the evening. If an uneven number of capsules is taken daily, the greater part should be taken in the morning.

4.3 Contraindications

Known or suspected carcinoma of the prostate or breast (see section 4.4)

History of liver tumours

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 (see section 4.4).

4.4 Special warnings and precautions for use

Medical examination:

Testosterone level should be monitored at baseline and at regular intervals during treatment. Clinicians should adjust the dosage individually to ensure maintenance of eugonadal testosterone levels.

Physicians should consider monitoring patients receiving Testosterone Undecanoate before the start of treatment, at quarterly intervals for the first 12 months and yearly thereafter for the following parameters:

  • digital rectal examination (DRE) of the prostate and PSA in men over the age of 45 years, to exclude benign prostate hyperplasia or a subclinical prostate cancer (see section 4.3),
  • hematocrit and hemoglobin to exclude polycythemia. In case of severe polycythemia, treatment with Testosterone Undecanoate should be stopped or the dosage should be lowered.

In patients receiving long-term androgen therapy, the following laboratory parameters should also be monitored regularly: haemoglobin and haematocrit, liver function tests and lipid profile.

Conditions that need supervision:

Patients, especially the elderly, with the following conditions should be monitored for:

  • Tumours– Mammary carcinoma, hypernephroma, bronchial carcinoma and skeletal metastases. In these patients hypercalcaemia or hypercalciuria may develop spontaneously, also during androgen therapy. The latter can be indicative of a positive tumour response to the hormonal treatment. Nevertheless, the hypercalcaemia should first be treated appropriately and after restoration of normal calcium levels, hormone therapy can be resumed.

Tumours and other histological abnormalities and disturbances of liver function have been reported in patients subjected to prolonged treatment with some testosterone derivatives. Most of these compounds were 17-alpha alkyl derivatives but a smaller number of cases have occurred with certain 17-beta esters of testosterone. The possibility that such changes result from the use of Testosterone Undecanoate has not been excluded.

  • Pre-existing conditions– In patients suffering from severe cardiac, hepatic or renal insufficiency or ischaemic heart disease, treatment with testosterone may cause severe complications characterised by oedema with or without congestive cardiac failure. In such case, treatment must be stopped immediately.

Patients who experienced myocardial infarction, cardiac, hepatic or renal insufficiency, hypertension, epilepsy, or migraine should be monitored due to the risk of deterioration or reoccurrence of disease. In such cases, treatment must be stopped immediately. In addition to discontinuation of the drug, diuretic therapy may be required.

Testosterone may cause a rise in blood pressure and Testosterone Undecanoate should be used with caution in men with hypertension

  • Diabetes mellitus – Androgens in general and Testosterone Undecanoate can improve glucose tolerance in diabetic patients (see section 4.5).
  • Anti-coagulant therapy– Androgens in general and Testosterone Undecanoate can enhance the anti-coagulant action of coumarin-type agents (see section 4.5).
  • Clotting disorders– Testosterone should be used with caution in patients with thrombophilia or risk factors for venous thromboembolism (VTE), as there have been post-marketing studies and reports of thrombotic events (e.g., deep-vein thrombosis, pulmonary embolism, ocular thrombosis) in these patients during testosterone therapy. In thrombophilic patients, VTE cases have been reported even under anticoagulation treatment, therefore continuing testosterone treatment after first thrombotic event should be carefully evaluated. In case of treatment continuation, further measures should be taken to minimize the individual VTE risk.
  • Sleep Apnea – There is insufficient evidence for a recommendation regarding the safety of treatment with testosterone esters in men with sleep apnea. Good clinical judgment and caution should be employed in patients with risk factors such as adiposity or chronic lung diseases.

Androgen therapy should only be used in male hypogonadism in which testosterone levels have been demonstrated to be low.

In treating males, stimulation to the point of increasing nervous, mental and physical activities beyond the patient’s cardiovascular capacity should be avoided.

Adverse events:

If androgen-associated adverse reactions occur (see section 4.8), treatment with Testosterone Undecanoate should be discontinued and upon resolution of complaints resumed with a lower dose.

(Mis)use in sports:

Patients who participate in competitions governed by the World Anti-Doping Agency (WADA) should consult the WADA-code before using this product as Testosterone Undecanoate can interfere with anti-doping testing. The misuse of androgens to enhance ability in sports carries serious health risks and is to be discouraged.

Drug abuse and dependence

Testosterone has been subject to abuse, typically at doses higher than recommended for the approved indication(s) and in combination with other anabolic androgenic steroids. Abuse of testosterone and other anabolic androgenic steroids can lead to serious adverse reactions including: cardiovascular (with fatal outcomes in some cases), hepatic and/or psychiatric events. Testosterone abuse may result in dependence and withdrawal symptoms upon significant dose reduction or abrupt discontinuation of use. The abuse of testosterone and other anabolic androgenic steroids carries serious health risks and is to be discouraged.

Excipients:

Testosterone Undecanoate contains Sunset Yellow) which may cause allergic reactions.

Paediatric Population

In pre-pubertal children statural growth and sexual development should be monitored since androgens in general and Testosterone Undecanoate in high dosages may accelerate epiphyseal closure and sexual maturation.

Older People:

There is limited experience on the safety and efficacy of the use of Testosterone Undecanoate in patients over 65 years of age. Currently, there is no consensus about age specific testosterone reference values. However, it should be taken into account that physiological testosterone serum levels are lower with increasing age.

4.5 Interaction with other medicinal products and other forms of interaction

Concurrent administration of liver enzyme inducing drugs such as rifampicin, barbiturates, carbamazepine, dichloralphenazone, phenylbutazone, phenytoin or primidone may decrease the effect of Testosterone Undecanoate.

Insulin and other anti-diabetic medicines:

Androgens may improve glucose tolerance and decrease the need for insulin or other anti-diabetic medicines in diabetic patients (see section 4.4). Patients with diabetes mellitus should therefore be monitored especially at the beginning or end of treatment and at periodic intervals during Testosterone Undecanoate treatment.

Anti-coagulant therapy:

High doses of androgens may enhance the anti-coagulant action of coumarin-type agents (see section 4.4). Therefore close monitoring of the prothrombin time, and if necessary a dose reduction of the anti-coagulant is required during therapy.

ACTH or corticosteroids:

The concurrent administration of testosterone with ACTH or corticosteroids may enhance oedema formation: thus these active substances should be administered cautiously, particularly in patients with cardiac or hepatic disease or in patients predisposed to oedema (see section 4.4).

Laboratory test interactions:

Androgens may decrease levels of thyroxine-binding globulin resulting in decreased total T4 serum levels and increased resin uptake of T3 and T4. Free thyroid hormone levels remain unchanged, however, and there is no clinical evidence of thyroid dysfunction.

Testosterone Undecanoate must be taken with a normal meal to ensure absorption (see section 4.2).

4.6 Fertility, pregnancy and lactation

Pregnancy and lactation:

Testosterone Undecanoate are not indicated for treatment in women and therefore must not be used by pregnant or breast-feeding women. If used during pregnancy Testosterone Undecanoate pose a risk of virilisation of the fetus.

Fertility:

In men treatment with androgens can lead to fertility disorders by repressing sperm-formation (see section 4.8).

4.7 Effects on ability to drive and use machines

Testosterone Undecanoate has no influence on the ability to drive or use machines.

4.8 Undesirable effects

The following adverse reactions have been associated with androgen therapy in general. The most appropriate MedDRA term to describe a certain adverse event is listed.

All adverse reactions listed by system organ class and frequency; common (≥ 1/100 to < 1/10) and not known (cannot be estimated from the available data).

System Organ Class Common Not known
Neoplasms benign, malignant and unspecified (incl. cysts and polyps) Prostatic cancer1
Blood and lymphatic system disorders Polycythaemia
Metabolism and nutrition disorders Weight increased Fluid retention
Psychiatric disorders Depression

Nervousness

Mood altered

Libido increased

Libido decreased

Vascular disorders Hypertension
Gastrointestinal disorders Nausea
Hepatobiliary disorders Hepatic function abnormal
Skin and subcutaneous tissue disorders Pruritus

Acne

Musculoskeletal and connective tissue disorders Myalgia
Renal and urinary disorders Urinary obstruction
Reproductive system and breast disorders Gynaecomastia

Oligozoospermia

Priapism

Benign prostatic hyperplasia2

Investigations Hematocrit increased

Red blood cell count increased

Haemoglobin increased

Lipids abnormal3

PSA increased

1 Progression of a sub-clinical prostatic cancer

2 Prostatic growth (to normogonadal size)

3 Decrease in serum LDL-C, HDL-C and triglycerides

The terms used to describe the undesirable effects above are also meant to include synonyms and related terms.

With high doses and prolonged treatment electrolyte changes (sodium, potassium, calcium, inorganic phosphate and water retention), hypertension, oligozoospermia, or azospermia, priaprism, changes in lipid metabolism, polycythaemia.

In a few patients diarrhoea and abdominal pain or discomfort have been reported during use of Testosterone Undecanoate.

Paediatric population:

The following undesirable effects have been reported in pre-pubertal children using androgens (see section 4.4): precocious sexual development, an increased frequency of erections, phallic enlargement and premature epiphyseal closure.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions.

4.9 Overdose

The acute toxicity of testosterone is low.

High doses of Testosterone Undecanoate may cause gastrointestinal complaints due to the castor oil present in the capsule. Treatment consists of supportive measures.

5.Pharmacological properties

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Androgens.

Testosterone Undecanoate, after oral administration, delivers physiological amount of testosterone in the circulation. Treatment of hypogonadal men also results in a clinically significant rise of plasma concentrations of dihydrotestosterone and oestradiolas well as a decrease of SHBG (sex hormone binding globulin). Treatment of males with primary (hypergonadotropic) hypogonadism results in a normalization of gonadotropin levels.

Endogenous androgens, principally testosterone, secreted by the testes and its major metabolite DHT, are responsible for the development of the external and internal genital organs and for maintaining the secondary sexual characteristics (stimulating hair growth, deepening of the voice, development of the libido); for a general effect on protein anabolism; for development of skeletal muscle and body fat distribution; for a reduction in urinary nitrogen, sodium, potassium, chloride, phosphate and water excretion.

Androgens are also responsible for the growth spurt of adolescence and for the eventual termination of linear growth and stimulate the production of red blood cells by enhancing erythropoietin production.

The effects of testosterone in some target organs arise after peripheral conversion of testosterone to oestradiol, which then binds to oestrogen receptors in the target cell nucleus e.g. the pituitary, fat, brain, bone and testicular Leydig cells.

Exogenous administration of androgens inhibits endogenous testosterone release. With large doses of exogenous androgens, spermatogenesis may be suppressed.

5.2 Pharmacokinetic properties

Absorption

Testosterone Undecanoate must be taken with a normal meal or breakfast to ensure absorption. Food enhances the absorption of Testosterone Undecanoate: In healthy volunteers the AUC of testosterone was increased more than 12 –fold compared with fasted conditions when Testosterone Undecanoate was taken with a normal meal. No differences were found in the AUC of testosterone when Testosterone Undecanoate was taken with a normal meal (containing 18.8 grams of fat) as compared to a high fat meal (containing 44.1 grams of fat). The absorption is about 7%. Following oral administration of Testosterone Undecanoate, an important part of the active substance testosterone undecanoate is co-absorbed with the lipophilic solvent from the intestine into the lymphatic system, thus circumventing the first pass inactivation by the liver.

Distribution

From the lymphatic system testosterone undecanoate is released into the plasma. Single administration of 20-80 mg Testosterone Undecanoate to postmenopausal women leads to peak-levels of total plasma testosterone of approximately 1.5-2.0, 2.5-5.5 and 5.2-10.3ng/ml after a dose of 20, 40 and 80 mg Testosterone Undecanoate, respectivelyThese levels are reached approximately 5-6 h (tmax) after administration. Plasma testosterone levels remain elevated for at least 8 hours. In Japanese women the testosterone levels are about two fold higher.

During steady state after 28 days of administration plasma levels of total testosterone in hypogonadal men were increased after administration of 40 mg t.i.d, 40 b.i.d+80 mg, 80 mg b.i.d and 80 mg t.i.d. The dose of 80 mg b.i.d or 80 mg t.i.d. resulted in levels in the male physiological range for a considerable proportion of the time during the day. Testosterone and testosterone undecanoate display a high (over 97%) non-specific binding to plasma proteins and sex hormone binding globulin in in vitro tests.

Biotransformation

In plasma and tissues testosterone undecanoate is hydrolyzed to yield the natural male androgen testosterone. Testosterone is further metabolized to dihydrotestosterone and oestradiol, which are further metabolized via the normal pathways.

Elimination

Excretion mainly takes place via the urine as conjugates of etiocholanolone and androsterone.

Linearity

Dose-linearity has been demonstrated for 20-240 mg/day.

5.3 Preclinical safety data

Preclinical data with androgens in general reveal no special hazards for humans. Experimental data in rodents have shown testosterone can promote the development of certain tumours in hormone responsive tissues. In reproductive studies the use of androgens in different species has been demonstrated to result in virilisation of the external genitals of female fetuses.

6.Pharmaceutical particulars

6.1 List of excipients

Capsule contents

Each capsule contains

Castor oil

Propylene glycol laurate

Capsule shell

Glycerin

Sunset Yellow

Gelatin

Auxiliary substances

Medium-chain triglycerides

Lecithin

6.2 Incompatibilities

Not applicable

6.3 Shelf life

3 years

6.4 Special precautions for storage

Store below 30 °C; do not refrigerate or freeze; store in the original package and keep the blister in the outer carton.

6.5 Nature and contents of container

A box of Testosterone Undecanoate contains either 3 or 6 sachets, each containing a blister with 10 capsules

6.6 Special precautions for disposal and other handling

Any unused product or waste material should be disposed of in accordance with local requirements

See also “Special precautions for storage” (section 6.4) and “Posology and method of administration” (section 4.2)

7. Manufactured in India by:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com

TESTOSTERONE UNDECANOATE CAPSULES  40mg TAJ PHARMA

(testosterone undecanoate)

Read all of this leaflet carefully before you start taking 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 your pharmacist.

This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

This medicine is available using the above name but will be referred to as Testosterone Undecanoate capsules throughout the leaflet.

What is in this leaflet:

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

 

1.WHAT TESTOSTERONE UNDECANOATE CAPSULES IS AND WHAT IT IS USED FOR
Testosterone Undecanoate capsules are soft oval glossy capsules which contain 40 mg of testosterone undecanoate. The active substance, testosterone undecanoate is turned into testosterone by your body. Testosterone is a natural male hormone known as an androgen. It is produced in the body by both men and women.

Testosterone Undecanoate capsules is used in adult men for testosterone replacement to treat various health problems caused by a lack of testosterone (male hypogonadism). This should be confirmed by two separate blood testosterone measurements and also include clinical symptoms such as impotence, infertility, low sex drive, tiredness, depressive moods, bone loss caused by low hormone levels.

Testosterone Undecanoate capsules are used if your body does not make enough testosterone of its own, for example:

  • impotence caused by hormonal disorders
  • after castration or a similar problem called eunuchoidism
  • decreased sex drive and decreased mental and physical activity
  • certain types of infertility because you don’t make enough sperm

It may also be used to treat a type of bone disease (osteoporosis) caused by having too little testosterone.

2.WHAT YOU NEED TO KNOW BEFORE YOU TAKE TESTOSTERONE UNDECANOATE CAPSULES

  • Do not take Testosterone Undecanoate capsules: If you are allergic (hypersensitive) to testosterone undecanoate or any of the ingredients of this medicine (listed in section 6 “What Testosterone Undecanoate capsules contain”).
  • If you have or have had a tumour of your prostate or breast or are suspected to have one of these tumours.
  • If you have ever had liver cancer

Take special care with Testosterone Undecanoate capsules:

Treatment with male hormones like testosterone may increase the size of the prostate gland, especially in elderly men. Therefore your doctor will examine your prostate gland at regular intervals. In men over the age of 45, the prostate gland will be investigated by digital rectal examination (DRE) and blood tests for prostate-specific antigen (PSA).

Additionally, at regular intervals, blood tests will be done to check the oxygen-carrying substance in your red blood cells (haemoglobin). In very rare cases the number of red blood cells will increase too much leading to complications.

The following blood checks should be carried out by your doctor before and during the treatment: testosterone blood level, full blood count.

Medical check may also be necessary in some other conditions.

Tell your doctor if you have ever had, still have, or are suspected to have: – breast cancer which has spread to the bones – kidney or lung cancer – heart disease – kidney disease – liver disease – high blood pressure – diabetes mellitus – epilepsy – migraine, headaches – prostatic complaints, such as problems passing urine – blood clotting problems – thrombophilia (an abnormality of blood coagulation that increases the risk of thrombosis – blood clots in blood vessels)

If you are suffering from severe heart, liver or kidney disease, treatment with Testosterone Undecanoate capsules may cause severe complications in the form of water retention in your body sometimes accompanied by (congestive) heart failure. Tell your doctor if you have high blood pressure or if you are treated for high blood pressure as testosterone may cause a raise in blood pressure.

If you have sleep apnea (temporarily stopping breathing during your sleep), this may get worse if you are using testosterone-containing products. Let your doctor know if you are worried about this. Extra supervision by your doctor may be necessary in case you are overweight or suffer from chronic lung disease.

Also tell your doctor – if you are taking anticoagulants (drugs to treat blood clots) Your medication may need to be monitored more closely.

Children and adolescents The safety and efficacy of this medicine has not been adequately determined in children and adolescents. Extra supervision by the doctor is necessary in the treatment of children and adolescents since testosterone administration in general may cause early sexual development and limits growth (see section 4 “Children and adolescents”).

Other medicines and Testosterone Undecanoate capsules        Please tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines-even those not prescribed.

Other medicines may affect how Testosterone Undecanoate capsules works or Testosterone Undecanoate capsules may affect how they work. Therefore you must tell your doctor or pharmacist if you are using or are about to use: – insulin and/or other medicines to control your blood sugar levels; – medicines to reduce the clotting of your blood (anti-coagulants);

The following medicines may decrease the effect of Testosterone Undecanoate capsules: – antibiotics such as rifampicin – anti-epileptic drugs such as barbiturates, carbamazepine, dichloralphenazone, phenylbutazone, phenytoin and primidone. The use of androgens like Testosterone Undecanoate capsules may lead to a reduction of the doses of these medicines

Also tell your doctor or pharmacist if you are using or about to use the hormone ACTH or corticosteroids (used to treat various conditions such as rheumatism, arthritis, allergic conditions and asthma). The use of androgens like Testosterone Undecanoate capsules may increase the risk of water retention, especially if your heart and liver are not working properly.

Laboratory tests: Androgens may also affect the results of some laboratory tests (e.g. thyroid gland). Therefore you must tell your doctor or the laboratory staff performing the tests that you are using this medicine.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Using Testosterone Undecanoate capsules with food and drink Food allows testosterone undecanoate, the active substance of this medicine to be absorbed by your body.         Therefore, Testosterone Undecanoate capsules must be taken with a normal meal (see section 3).

Pregnancy, breast-feeding and fertility Testosterone Undecanoate capsules are not for use in women, therefore this medicine must not be taken by women who are pregnant or think that they are pregnant, or by women who are breast-feeding.

In men, treatment with Testosterone Undecanoate capsules can lead to fertility disorders by repressing sperm formation.

If you are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines As far as is known this medicine has no influence on driving or using machines.

Important information about some of the ingredients of Testosterone Undecanoate capsules This medicine contains: Sunset yellow FCF (E110) which can cause allergic type reactions including asthma. Allergy is more common in those people who are allergic to aspirin.   Improper use  If you are a patient who participates in competitions governed by the World Anti-Doping Agency (WADA), then you should consult the WADA-code before using this medicine as Testosterone Undecanoate capsules can interfere with antidoping testing.

The misuse of this medicine to enhance ability in sports carries serious health risks and is to be discouraged.

3.HOW TO TAKE TESTOSTERONE UNDECANOATE CAPSULES

Always take this medicine exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

Adults The recommended dose is 3–4 capsules daily during the first 2–3 weeks, followed by a gradual decrease to 1–3 capsules daily. Look at the label on the pack to see how many capsules your doctor would like you to take each day.

You must take this medicine with a normal meal. Swallow the capsules whole without chewing, using some water or other fluid. Depending on the dose prescribed for you, take the capsules as shown in the table below.

Prescribed daily dose

Elderly Smaller doses, taken less often, may be given if you are elderly. Your doctor will have chosen the correct dose for you.

Use in children and adolescents The safety and efficacy of this medicine have not been adequately determined in children and adolescents. Pre-pubertal children using this medicine will be monitored by your doctor (see section 2 “Take special care with Testosterone Undecanoate capsules”).

If you take more Testosterone Undecanoate capsules than you should: If you have taken several capsules at once, there is no need for great concern, however you should tell your doctor. The castor oil in the capsule may cause diarrhoea.

If you forgot to take Testosterone Undecanoate capsules: Don’t worry. If you miss the morning dose and it is more than 2 hours after breakfast, wait until lunch-time and then take the dose. If you miss the evening dose, and its more than 2 hours after dinner, don’t take the missed dose. Take the next morning dose as normal.         Remember to always take Testosterone Undecanoate capsules with food.

If you stop taking Testosterone Undecanoate capsules: When treatment with this medicine is stopped, complaints such as those experienced before treatment may re-occur within a few weeks.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.POSSIBLE SIDE EFFECTS
Like all medicines, Testosterone Undecanoate capsules can have side effects, although not everybody gets them.

Common (may affect upto 1 in 10 people) – increase in red blood cell count (the cells which carry the oxygen in your blood); hematocrit (percentage of red blood cells in blood) and haemoglobin (the component of red blood cells that carries oxygen), identified by periodic blood tests.     Not known (cannot be estimated from available data)  – itching (pruritus) – acne – nausea (feeling sick) – problems with your liver including liver tumours, though this is rare – changes in the way your body processes fats – depression – nervousness – mood alterations – muscle pain – fluid retention in the tissues, usually marked by the swelling of ankles or feet – high blood pressure – increased or decreased sex drive – prolonged painful erection – decreased amounts of ejaculation fluid and sperm – enlargement of the breasts – growth of the prostate gland – increased levels of a blood marker which is associated with prostate cancer (PSA) – worsening of the early stage of prostate cancer – yellowing of the skin or eyes – difficulty passing urine – allergy to sunset yellow, a colour used in the capsules. – electrolyte changes (sodium, potassium, calcium, inorganic phosphate and water retention) – no sperm count

In a few patients diarrhoea, stomach pain or discomfort have been reported during the use of this medicine.

Children and adolescents: The following side effects have been reported in pre-pubertal children using androgens: – early sexual development; – penis enlargement; – an increased frequency of erections; – growth limitation (limited body height)

Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

5.HOW TO STORE TESTOSTERONE UNDECANOATE CAPSULES

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the package, sachet and blister. The expiry date refers to the last day of that month. Do not store above 30 °C. Do not refrigerate or freeze. Store in the original package and keep the blister in the outer carton. If the capsules become discoloured or show signs of any other deterioration, you should seek the advice of your pharmacist who will advise you what to do. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6.CONTENTS OF THE PACK AND OTHER INFORMATION 

What Testosterone Undecanoate capsules contains The active substance is: Testosterone undecanoate. Each capsule contains 40 mg testosterone undecanoate equivalent to 25.3 mg testosterone.

The other ingredients are: – Capsule contents: Castor oil and propylene glycol monolaurate (E477)

– Capsule shell ingredients: Glycerin, Sunset Yellow FCF and gelatin

– Auxiliary substances: Medium-chain triglycerides and Lecithin

What Testosterone Undecanoate capsules looks like and contents of the pack Testosterone Undecanoate capsules are soft oval glossy capsules, transparent, orange in colour containing a yellow oily fill and are printed in white ORG and DV3. A box of Testosterone Undecanoate capsules contains either 3 or 6 sachets.

Each sachet contains a blister strip with 10 capsules.

7. MANUFACTURED IN INDIA BY:
TAJ PHARMACEUTICALS LTD.
Mumbai, India
Unit No. 214.Old Bake House,
Maharashtra chambers of  Commerce Lane,
Fort, Mumbai – 400001
at:Gujarat, INDIA.
Customer Service and Product Inquiries:
1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
E-mail: tajgroup@tajpharma.com