Testosterone Combo 250 mg/ml

Testosterone Combo is an oily liquid for injection. It contains testosterone, the male sex hormone that men's bodies normally make, in four different forms. Each form has a chemical chain of a different length attached to it: one short, two medium and one long. The short one starts working within a day or two, and the long one keeps working for well over a week, so a single injection releases testosterone in overlapping waves rather than all at once. All four forms are the same hormone once your body has released them. Your doctor has prescribed this medicine to keep your testosterone level steady with fewer injections.

Read this section before you are given the injection, and tell your doctor about anything that applies to you.

Warnings and precautions

• +Talk to your doctor before using it if you have heart failure, high blood pressure or swollen legs, because testosterone makes the body hold water and salt.
• +Talk to your doctor before using it if you have diabetes, epilepsy, migraine, or liver or kidney problems.
• +Talk to your doctor before using it if you stop breathing briefly during sleep, or snore heavily and wake unrefreshed.
• +Talk to your doctor before using it if you are older, have an enlarged prostate, or have difficulty passing urine.
• +Because this medicine contains a long-lasting form as well as short ones, it stays in your body for some time after the last injection. If a side effect appears, it may take a few weeks to fade even once treatment stops.
• +You will need regular blood tests during treatment: testosterone level, red blood cell count, cholesterol, liver function and prostate checks. Please keep these appointments.
• +This medicine contains a substance banned in sport and will show up on a doping test, even when prescribed.

Other medicines and Testosterone Combo

Tell your doctor or pharmacist about any other medicines you are taking, have recently taken, or might take, including medicines bought without a prescription. Blood thinners such as warfarin need special attention, because testosterone can make them work more strongly and increase the chance of bleeding. Medicines for diabetes, including insulin, may need adjusting, as your blood sugar can drop. Steroid tablets such as prednisolone taken alongside this medicine can make swelling of the ankles and feet worse.

Pregnancy, breastfeeding and fertility

This medicine must not be used by women. If a pregnant woman is exposed to testosterone it can affect the development of the baby, especially a baby girl. It must not be used while breastfeeding. In men, testosterone injections reduce sperm production and can make you temporarily infertile, so tell your doctor before starting if you want to father a child.

Driving and using machines

Testosterone Combo is not expected to affect your ability to drive or use machines. If you feel dizzy, sleepy or unusually irritable, wait until you feel normal again before driving.

Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if anything is unclear. It is given as a slow, deep injection into a muscle, normally the upper outer part of the buttock, by a doctor or a nurse. It must never be injected into a vein. The oil is thick, so the injection is given slowly and may sting for a short time. If you inject yourself, follow the training you were given and change the site each time. Your doctor decides how many weeks to leave between injections. If you miss an appointment, arrange another as soon as possible; do not have a double injection to make up for it. If you think you have been given too much, tell your doctor.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Other possible side effects

• +Acne and oily skin
• +Pain, stinging or a lump at the injection site
• +Fluid retention, with puffy ankles, feet or face
• +Difficulty sleeping
• +Mood changes, irritability or feeling on edge
• +Headache
• +Increased sex drive and more frequent erections
• +Smaller testicles and fewer sperm
• +Tender or enlarged breast tissue
• +Thinning scalp hair or more body and facial hair
• +Higher blood pressure and weight gain
• +Blood test changes, including thicker blood and unfavourable cholesterol

Keep this medicine out of the sight and reach of children. Store below 25 °C and keep the ampoules in the outer carton so they are protected from light. Do not freeze. Do not use after the expiry date printed on the carton and ampoule; the expiry date is the last day of that month. The solution is thick, and in a cold room it may look slightly hazy; warming the ampoule gently in your hand should clear it. Do not use it if it stays cloudy, has visible particles, or if the glass is chipped. Do not throw medicines away in wastewater or household rubbish. Take unused medicine and used ampoules and needles back to your pharmacy.

The active ingredients are four forms of testosterone. Each 1 ml ampoule contains testosterone propionate 30 mg, testosterone phenylpropionate 60 mg, testosterone isocaproate 60 mg and testosterone decanoate 100 mg, making 250 mg of testosterone forms in total per millilitre. The other ingredients are a sterile oil carrier and benzyl benzoate, which helps keep all four dissolved. The medicine is a clear, pale yellow oily solution. It is supplied in single-use 1 ml glass ampoules, amber or clear, 10 ampoules and this leaflet to a carton. Each carton is printed with a GS1 DataMatrix barcode and a verification code so you can confirm online that the pack is genuine. Manufactured under GMP conditions by Ergopharm Advanced Research Centre, Tandalja, Vadodara, Gujarat 390012, India. For export only.