Omnitrope

Before taking this medicine

Do not use Omnitrope if you: • Are critically ill because of complications after open-heart surgery, abdominal surgery or multiple accidental injuries, or have acute respiratory failure. • Have active cancer, or a brain tumour that is progressing or has returned. Any previous cancer must be inactive and its treatment completed before starting Omnitrope. • Are allergic to somatropin or any of its other ingredients. • Have active proliferative or severe non-proliferative diabetic retinopathy, forms of diabetes-related eye disease. Omnitrope must not be used in children with Prader-Willi syndrome who are severely obese, have a history of upper airway blockage or sleep apnoea, or have severe breathing impairment. Sudden deaths have been reported in these patients. It must not be used to promote growth in children whose growth plates have closed. Special caution and monitoring are needed in people with a history of tumours, diabetes or impaired blood sugar control, low adrenal hormone levels, an underactive thyroid or scoliosis. Childhood cancer survivors treated with somatropin have an increased risk of a second tumour, particularly meningioma after radiation to the head. Blood glucose should be monitored periodically, and diabetes or adrenal hormone treatment may need adjustment by the prescriber. Children with Prader-Willi syndrome need assessment for upper airway blockage and sleep apnoea before treatment; treatment should be stopped if these signs occur. An eye examination is needed to rule out swelling of the optic disc before treatment because increased pressure inside the skull may develop. Fluid retention, joint pain and carpal tunnel syndrome can occur, especially in adults. A new limp or hip or knee pain in a child needs medical assessment. Persistent severe abdominal pain should be assessed for pancreatitis. Seek prompt medical attention for an allergic reaction. If critical illness develops during treatment, the prescriber must weigh the potential benefits of continuing treatment against the risks.