Maa: Australia
Kieli: englanti
Lähde: Department of Health (Therapeutic Goods Administration)
atomoxetine hydrochloride, Quantity: 45.72 mg (Equivalent: atomoxetine, Qty 40 mg)
Sandoz Pty Ltd
Atomoxetine hydrochloride
Capsule, hard
Excipient Ingredients: dimeticone 350; sodium starch glycollate type A; maize starch; pregelatinised maize starch; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide; titanium dioxide; indigo carmine; sorbitan monolaurate; Gelatin; sodium lauryl sulfate
Oral
28, 7
(S4) Prescription Only Medicine
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 opaque cap and body, with A940 printed on cap and body in black ink; Container Type: Blister Pack; Container Material: Other plastic laminate/Al; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2015-11-10
1 ATOMOXETINE SANDOZ ATOMOXETINE SANDOZ ATOMOXETINE (AS HYDROCHLORIDE) CAPSULES CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET? This leaflet answers some common questions about ATOMOXETINE SANDOZ. 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 ATOMOXETINE SANDOZ and its use that you should be aware of. All medicines have risks and benefits. Your doctor has weighed the risks of you taking ATOMOXETINE SANDOZ 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 IS ATOMOXETINE SANDOZ USED FOR ATOMOXETINE SANDOZ 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. ATOMOXETINE SANDOZ 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 ATOMOXETINE SANDOZ does not have a significant potential for abuse. This medicine is available only with a doctor's prescription. BEFORE YOU TAKE IT _ _ _WHEN YOU MUST NOT TAKE IT _ _ _ DO NOT TAKE ATOMOXETINE SANDOZ IF YOU HAVE AN ALLERGY TO: • any medicine containing atomoxetine hydrochloride (the active ingredient in ATOMOXETINE SANDOZ) • any of the ingredi Lue koko asiakirja
190605-atomoxetine-sandoz-pi Page 1 of 27 AUSTRALIAN PRODUCT INFORMATION ATOMOXETINE SANDOZ ® (ATOMOXETINE HYDROCHLORIDE) 1 NAME OF THE MEDICINE Atomoxetine hydrochloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each Atomoxetine Sandoz 10 mg capsule contains 11.43 mg of atomoxetine hydrochloride equivalent to 10 mg of atomoxetine. Each Atomoxetine Sandoz 18 mg capsule contains 20.57 mg of atomoxetine hydrochloride equivalent to 18 mg of atomoxetine. Each Atomoxetine Sandoz 25 mg capsule contains 28.58 mg of atomoxetine hydrochloride equivalent to 25 mg of atomoxetine. Each Atomoxetine Sandoz 40 mg capsule contains 45.72 mg of atomoxetine hydrochloride equivalent to 40 mg of atomoxetine. Each Atomoxetine Sandoz 60 mg capsule contains 68.58 mg of atomoxetine hydrochloride equivalent to 60 mg of atomoxetine. Each Atomoxetine Sandoz 80 mg capsule contains 91.44 mg of atomoxetine hydrochloride equivalent to 80 mg of atomoxetine. Each Atomoxetine Sandoz 100 mg capsule contains 114.3 mg of atomoxetine hydrochloride equivalent to 100 mg of atomoxetine. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Atomoxetine Sandoz 10 mg capsules are white opaque cap and body and marked with “A910” on cap and body in black ink. Atomoxetine Sandoz 18 mg capsules are gold opaque cap and white opaque body and marked with “A918” on cap and body in black ink. Atomoxetine Sandoz 25 mg capsules are blue opaque cap and white opaque body and marked with “A925” on cap and body in black ink. WARNINGS SHORT-TERM PLACEBO CONTROLLED STUDIES EVALUATED OVER 2200 CHILDREN AND ADOLESCENTS WITH ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD). AMONG THE 1357 PATIENTS ON ATOMOXETINE, 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 ATOMOXETINE IN CHILDREN MUST BALANCE THE RISK OF SUICIDALITY (SUICIDAL THOUGHTS OR BEHAVIOURS Lue koko asiakirja