Country: Malta
Lingwa: Ingliż
Sors: Medicines Authority
ATOMOXETINE
Eli Lilly Nederland B.V Papendorpseweg 83, 3528 BJ, Utrecht, NL-3991, Netherlands
N06BA09
ATOMOXETINE 18 mg
HARD CAPSULE
ATOMOXETINE 18 mg
POM
PSYCHOANALEPTICS
Withdrawn
2007-01-31
Page 1 of 14 PACKAGE LEAFLET: INFORMATION FOR THE USER STRATTERA ® 10, 18, 25, 40, 60, 80 AND 100 MG HARD CAPSULES ATOMOXETINE 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 pharmacist. • This me Aqra d-dokument sħiħ
Page 1 of 20 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT STRATTERA 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg or 100 mg hard capsules. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains atomoxetine hydrochloride equivalent to 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg or 100 mg of atomoxetine. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule, hard STRATTERA 10 mg capsules: hard capsule, opaque white, imprinted with “Lilly 3227” and “10 mg” in black ink, approximately 15.5-16.1 mm length STRATTERA 18 mg capsules: hard capsule, gold (cap) and opaque white (body), imprinted with “Lilly 3238” and “18 mg” in black ink, approximately 15.5-16.1 mm length. STRATTERA 25 mg capsules: hard capsule, opaque blue (cap) and opaque white (body), imprinted with “Lilly 3228” and “25 mg” in black ink, approximately 15.5-16.1 mm length. STRATTERA 40 mg capsules: hard capsule, opaque blue, imprinted with “Lilly 3229” and “40 mg” in black ink, approximately 15.5-16.1 mm length. STRATTERA 60 mg capsules: hard capsule, opaque blue (cap) and gold (body), imprinted with “Lilly 3239” and “60 mg” in black ink, approximately 17.5-18.1 mm length. STRATTERA 80 mg capsules: hard capsule, opaque brown (cap) and opaque white (body), imprinted with “Lilly 3250” and “80 mg” in black ink, approximately 17.5-18.1 mm length. 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 guidelin Aqra d-dokument sħiħ