Ergotropin 10 IU (3.3 mg)

Ergotropin is a powder for injection. It contains somatropin, a copy of human growth hormone made by recombinant DNA methods, with the same 191 amino acids as the hormone the pituitary gland produces. After the powder is mixed with the water supplied in the kit, it is injected under the skin. Your doctor has prescribed it because your body is not making enough growth hormone, or for another reason they have explained to you. It is prescription-only and must not be used by anyone else.

Read this section before the first injection, and tell your doctor about anything here that applies to you. This medicine is kept in the refrigerator and must never be frozen.

Warnings and precautions

• +Talk to your doctor before using it if you have diabetes or have been told your blood sugar is high. Growth hormone can raise blood sugar, and your diabetes treatment may need to change.
• +Talk to your doctor before using it if you have a thyroid problem, or if you take steroid tablets such as hydrocortisone or prednisolone. Doses of those medicines sometimes need adjusting.
• +Talk to your doctor before using it if you have ever had a brain tumour, raised pressure inside the skull, or trouble with your hips or spine.
• +If you get a bad headache, feel sick, or your sight changes, stop and contact your doctor. These can be signs of raised pressure around the brain, which is uncommon but needs checking.
• +In a child, a limp or pain in the hip or knee needs a prompt check. It can be a slip of the growing hip bone.
• +This medicine contains a substance banned in sport. It will show up on a doping test even when a doctor has prescribed it.

Other medicines and Ergotropin

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including ones bought without a prescription. It is especially important to mention insulin and other diabetes medicines, because this medicine can make them work less well; steroid tablets, which can work against the effect on growth; thyroid hormone tablets; the oral contraceptive pill or oestrogen tablets, which can mean you need a different dose of growth hormone; and medicines for epilepsy or medicines that suppress the immune system, whose levels can change.

Pregnancy, breastfeeding and fertility

Tell your doctor if you are pregnant, think you may be pregnant, or are planning to become pregnant. Ergotropin is not usually used in pregnancy unless your doctor has specifically decided that you should continue it. Tell your doctor if you are breastfeeding. Ask your doctor or pharmacist for advice before using any medicine.

Driving and using machines

This medicine is not expected to affect your ability to drive or use tools and machines. If you feel dizzy or get a severe headache, do not drive until it has settled and you have spoken to your doctor.

Always use this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure. The powder in each vial is mixed with the bacteriostatic water in the kit, using the method your doctor or nurse has shown you. Do not shake the vial hard; swirl it gently until the powder has dissolved. The liquid should be clear. Do not inject it if it is cloudy or has bits in it. It is injected under the skin, not into a vein, and you should use a different spot each time — abdomen, thigh or buttock, as you were shown. Your doctor decides the amount and how often. If you miss a dose, ask your doctor what to do. Do not inject a double amount to make up for a missed dose. If you think you have injected too much, contact your doctor.

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

Other possible side effects

• +Pain, redness or itching where you injected
• +Puffy hands, ankles or face from fluid
• +Aching joints or muscles, or stiff hands
• +Headache
• +Feeling sick
• +Higher blood sugar
• +Tingling in the fingers
• +In children, temporary pain in the hip or knee

Keep this medicine out of the sight and reach of children. Store the unopened kit in a refrigerator at 2–8 °C. Do not freeze it. Keep the vials in the outer carton to protect them from light. After you have mixed a vial, put it straight back in the refrigerator, do not freeze it, and use it within the time your doctor or the carton tells you. Do not use this medicine after the expiry date printed on the carton and the vial; the expiry date refers to the last day of that month. Do not use the powder or the mixed liquid if the seal is broken or the liquid is cloudy. Do not throw needles or leftover medicine into household rubbish. Take them back to your pharmacy. This helps protect the environment.

The active substance is somatropin. Each vial contains 10 IU (3.3 mg) of somatropin as a powder. The kit contains 10 vials, which is 100 IU (33.3 mg) in total, and one 10 ml vial of bacteriostatic water for mixing the powder. The other ingredients of the powder and of the water are printed on the carton. Ergotropin is a white powder in a glass vial. After mixing it becomes a clear liquid for injection under the skin. Every carton carries a printed square barcode (a GS1 DataMatrix) and a verification code you can check online to confirm the pack is genuine. Lot ERG2800A expires 06 / 2029. Manufactured under GMP conditions by Ergopharm Advanced Research Centre, Tandalja, Vadodara, Gujarat 390012, India. For export only.