Land: Australien
Sprog: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
atomoxetine hydrochloride, Quantity: 20.5 mg (Equivalent: atomoxetine, Qty 18 mg)
Arrotex Pharmaceuticals Pty Ltd
Atomoxetine hydrochloride
Capsule, hard
Excipient Ingredients: iron oxide yellow; pregelatinised maize starch; Gelatin; titanium dioxide; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; Shellac; strong ammonia solution; iron oxide black; potassium hydroxide
Oral
28 capsules
(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: Hard gelatin capsule, white opaque body and gold opaque cap, printed in black APO AM18, containing white to off white powder; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2017-09-29
APO-ATOMOXETINE Capsules 1 APO-ATOMOXETINE CAPSULES _Contains the active ingredient atomoxetine (as hydrochloride) _ CONSUMER MEDICINE INFORMATION _FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about atomoxetine. 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 listed on the last page. More recent information on this medicine may be available. ASK YOUR DOCTOR OR PHARMACIST: • if there is anything you do not understand in this leaflet, • if you are worried about taking your medicine, or • to obtain the most up-to-date information. You can also download the most up to date leaflet from www.apotex.com.au. All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you. Pharmaceutical companies cannot give you medical advice or an individual diagnosis. Keep this leaflet. You may want to read it again. WHAT THIS MEDICINE IS USED FOR The name of your medicine is APO- Atomoxetine capsules. It contains the active ingredient atomoxetine (as hydrochloride). It 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 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 CHOSEN FOR YOU. YOUR DOCTOR MAY HAVE GIVEN YOU THIS MEDICINE FOR ANOTHER REASON. There is no evidence that this medicine is addictive. This medicine is available only with a doctor's prescription. BEFORE YOU ARE GIVEN THIS MEDICINE _WHEN YOU MUST NOT BE GIVEN _ _IT _ YOU MUST NOT BE GIVEN THIS MEDICINE IF: • YO Læs hele dokumentet
1 AUSTRALIAN PRODUCT INFORMATION APO- ATOMOXETINE (ATOMOXETINE HYDROCHLORIDE) CAPSULES 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) AGAINST THE CLINICAL NEED. PATIENTS WHO ARE STARTED ON ATOMOXETINE SHOULD BE CLOSELY MONITORED FOR SUICIDALITY (SEE SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE). 1 NAME OF THE MEDICINE Atomoxetine hydrochloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg or 100 mg of atomoxetine (as hydrochloride), as the active ingredient. EXCIPIENTS WITH KNOWN EFFECT Gelatin (may contain trace amounts of sulfites) For the full list of excipients see section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Atomoxetine hydrochloride is available as capsules for oral administration. The capsules contain a white to off-white powder. 10 MG CAPSULES: Hard gelatin capsule, white opaque body and white opaque cap, printed in black APO AM10, containing white to off-white powder. 18 MG CAPSULES: Hard gelatin capsule, white opaque body and gold opaque cap, printed in black APO AM18, containing white to off-white powder. 25 MG CAPSULES: Hard gelatin capsule, white opaque body and blue opaque cap, printed in black APO AM25, containing white to off-white powder. 40 MG CAPSULES: Hard gelatin capsule, blue opaque body and blue opaque cap, printed in black APO AM40, containing white to off-white powder. 2 60 MG CAPSULES: Hard gelatin capsule, gold opaque body and blue opaque cap, printed in black APO AM60, containing white to off-white powder. 80 MG CAPSULES: Hard gelatin capsule, white opaque b Læs hele dokumentet