Kraj: Australia
Język: angielski
Źródło: Department of Health (Therapeutic Goods Administration)
atomoxetine hydrochloride, Quantity: 28.57 mg (Equivalent: atomoxetine, Qty 25 mg)
Eli Lilly Australia Pty Ltd
Capsule, hard
Excipient Ingredients: titanium dioxide; pregelatinised maize starch; dimeticone 350; Gelatin; indigo carmine; sodium lauryl sulfate; propylene glycol; ethanol; butan-1-ol; purified water; isopropyl alcohol; Shellac; iron oxide black; simethicone; strong ammonia solution; potassium hydroxide
Oral
56 capsules, 28 capsules, 7 capsules, 14 capsules
(S4) Prescription Only Medicine
STRATTERA is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as defined by DSM-IV criteria in children 6 years of age and older, adolescents and adults.
Visual Identification: Blue and white capsules marked with "Lilly 3228" and "25 mg".; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2004-01-27
STRATTERA ® _atomoxetine hydrochloride_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about STRATTERA. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. The information in this leaflet was last updated on the date shown on the final page. More recent information on this medicine may be available. Make sure you speak to your pharmacist or doctor to obtain the most up to date information on this medicine. You can also download the most up to date leaflet from www.lilly.com.au. The updated leaflet may contain important information about STRATTERA and its use that you should be aware of. All medicines have risks and benefits. Your doctor has weighed the risks of you taking STRATTERA against the benefits it may have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. WHAT STRATTERA IS USED FOR STRATTERA is used to treat Attention Deficit Hyperactivity Disorder (ADHD) in children 6 years and older, adolescents and adults. ADHD is a behavioural disorder that causes lack of focus and/or hyperactivity that is much more frequent or severe than others who are close in age or development. STRATTERA works by acting on brain chemicals called amines which are involved in controlling behaviour. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. YOUR DOCTOR MAY HAVE PRESCRIBED IT FOR ANOTHER REASON. Available evidence suggests that STRATTERA does not have a significant potential for abuse. This medicine is available only with a doctor's prescription. BEFORE YOU TAKE STRATTERA _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE STRATTERA IF YOU HAVE AN ALLERGY TO: • any medicine containing atomoxetine hydrochloride (the active ingredient in STRATTERA) • any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include shortness of breath, wheezing or d Przeczytaj cały dokument
vA15_06May2020 SUPERSEDES: vA14_03Jan2020 Page 1 of 29 AUSTRALIAN PRODUCT INFORMATION STRATTERA (ATOMOXETINE HYDROCHLORIDE) WARNINGS SHORT-TERM PLACEBO CONTROLLED STUDIES EVALUATED OVER 2200 CHILDREN AND ADOLESCENTS WITH ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD). AMONG THE 1357 PATIENTS ON STRATTERA, THERE WAS A POSITIVE SIGNAL FOR SUICIDAL THOUGHTS (5 PATIENTS) AND BEHAVIOURS (1 PATIENT) IN CHILDREN 12 YEARS OF AGE AND YOUNGER COMPARED TO PLACEBO (0/851). NO SUICIDES OCCURRED IN THESE TRIALS. ANYONE CONSIDERING THE USE OF STRATTERA IN CHILDREN MUST BALANCE THE RISK OF SUICIDALITY (SUICIDAL THOUGHTS OR BEHAVIOURS) AGAINST THE CLINICAL NEED. PATIENTS WHO ARE STARTED ON STRATTERA SHOULD BE CLOSELY MONITORED FOR SUICIDALITY (SEE SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE). 1. NAME OF THE MEDICINE STRATTERA ® (atomoxetine hydrochloride) tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Capsules containing 5, 10, 18, 25, 40, 60, 80 and 100 mg of atomoxetine hydrochloride. For the full list of excipients, see section 6.1 LIST OF EXCIPIENTS. 3. PHARMACEUTICAL FORM STRATTERA is available as capsules for oral administration. Each capsule contains 10, 18, 25, 40, 60, 80 or 100 mg of atomoxetine (as the hydrochloride). The capsule colours and markings are as follows: *5 mg capsules: gold and marked with “Lilly 3226” and 5 mg” 10 mg capsules: opaque white and marked with “Lilly 3227” and “10 mg” 18 mg capsules: gold and opaque white and marked with “Lilly 3238” and “18 mg” 25 mg capsules: opaque blue and opaque white and marked with “Lilly 3228” and “25 mg” 40 mg capsules: opaque blue and marked with “Lilly 3229” and “40 mg” 60 mg capsules: opaque blue and gold and marked with “Lilly 3239” and “60 mg 80 mg capsules: opaque brown and opaque white and marked with “Lilly 3250” and “80 mg” vA15_06May2020 SUPERSEDES: vA14_03Jan2020 Page 2 of 29 100 mg capsules: opaque brown and marked with “Lilly 3251” and “100 mg”. * _Not currently available_ 4. CLINI Przeczytaj cały dokument