Држава: Ирска
Језик: Енглески
Извор: HPRA (Health Products Regulatory Authority)
ATOMOXETINE HYDROCHLORIDE
Eli Lilly and Company Limited
N06BA09
ATOMOXETINE HYDROCHLORIDE
100 Milligram
Capsules Hard
Product subject to prescription which may not be renewed (A)
Centrally acting sympathomimetics
Transfer Pending
2008-07-04
IMPORTANT THINGS YOU NEED TO KNOW ABOUT YOUR MEDICINE THIS MEDICINE IS USED TO TREAT ADHD • The full name for ADHD is ‘Attention Deficit Hyperactivity Disorder’. • The medicine helps with your brain activity. It can help improve your attention, help you concentrate, and make you less impulsive. • You need to have other help for ADHD as well as this medicine. READ SECTION 1 FOR MORE INFORMATION. BEFORE YOU TAKE THIS MEDICINE, TALK TO YOUR DOCTOR IF YOU: • have mental health problems • have a problem with your heart or blood circulation • have serious problems with the blood vessels in your brain such as a stroke READ SECTION 2 FOR MORE INFORMATION. WHILE TAKING THIS MEDICINE: • See your doctor regularly. This is because your doctor will want to check how the medicine is working. • Do not stop taking the medicine without first talking to your doctor. • Your doctor may stop your medicine to see if it is still needed, if you take it for more than a year. • The most common side effects in children and young people are: headache, stomach ache, not feeling hungry, feeling or being sick, feeling sleepy, increased blood pressure, increased heart rate (pulse). • The most common side effects in adults are: feeling sick, dry mouth, headache, not feeling hungry, not being able to sleep, increased blood pressure, increased heart rate (pulse). READ SECTIONS 3 AND 4 FOR MORE INFORMATION. TALK TO YOUR DOCTOR STRAIGHT AWAY IF ANY OF THE FOLLOWING HAPPEN: • your mood and how you feel changes • you feel any problems with your heart e.g. a fast or unusual heartbeat rhythm READ SECTION 2 AND 4 FOR MORE INFORMATION. THE REST OF THIS LEAFLET INCLUDES MORE DETAIL AND OTHER IMPORTANT INFORMATION ON THE SAFE AND EFFECTIVE USE OF THIS MEDICINE. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacis Прочитајте комплетан документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Strattera 100 mg hard capsules 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains atomoxetine hydrochloride equivalent to 100 mg of atomoxetine. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard STRATTERA 100 mg capsules: hard capsule, opaque brown, imprinted with “Lilly 3251” and “100 mg” in black ink, approximately 19.2-19.8 mm length 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Strattera is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children of 6 years and older, in adolescents and in adults as part of a comprehensive treatment programme. Treatment must be initiated by a specialist in the treatment of ADHD, such as a paediatrician, child/adolescent psychiatrist, or psychiatrist. Diagnosis should be made according to current DSM criteria or the guidelines in ICD. In adults, the presence of symptoms of ADHD that were pre-existing in childhood should be confirmed. Third-party corroboration is desirable and Strattera should not be initiated when the verification of childhood ADHD symptoms is uncertain. Diagnosis cannot be made solely on the presence of one or more symptoms of ADHD. Based on clinical judgment, patients should have ADHD of at least moderate severity as indicated by at least moderate functional impairment in 2 or more settings (for example, social, academic, and/or occupational functioning), affecting several aspects of an individual’s life. Additional information for the safe use of this product: A comprehensive treatment programme typically includes psychological, educational and social measures and is aimed at stabilising patients with a behavioural syndrome characterised by symptoms which may include chronic history of short attention span, distractibility, emotional lability, impulsivity, moderate to severe hyperactivity, minor neurological signs and abnormal EEG. Learning may or may not be impaired. Pharmacological treat Прочитајте комплетан документ