Ország: Új-Zéland
Nyelv: angol
Forrás: Medsafe (Medicines Safety Authority)
Atomoxetine hydrochloride 114mg equivalent to atomoxetine 100 mg
Arrotex Pharmaceuticals (NZ) Limited
Atomoxetine hydrochloride 114 mg (equivalent to atomoxetine 100 mg)
100 mg
Capsule
Active: Atomoxetine hydrochloride 114mg equivalent to atomoxetine 100 mg Excipient: Gelatin Iron oxide red Iron oxide yellow Starch TekPrint black SW-9008 TekPrint black SW-9009 Titanium dioxide Water
Prescription
Apotex Pharmachem Inc
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.
Package - Contents - Shelf Life: Blister pack, PVC/PVdC clear film 10ML 250/60, with aluminium foil - 28 capsules - 24 months from date of manufacture stored at or below 25°C - Bottle, plastic, 1500cc HDPE round, white, opaque bottle. White polypropylene screw cap 89mm-400mm with liner seal - 1000 capsules - 24 months from date of manufacture stored at or below 25°C
2013-12-12
APO-Atomoxetine Capsules - Consumer Medicine Information 1 NEW ZEALAND CONSUMER MEDICINE INFORMATION APO-ATOMOXETINE CAPSULES _Contains the active ingredient atomoxetine (as hydrochloride) _ 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: • YOU HAVE OR HAV Olvassa el a teljes dokumentumot
NEW ZEALAND DATA SHEET APO-ATOMOXETINE 1. PRODUCT NAME Atomoxetine (as 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. 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. APO-ATOMOXETINE 10mg is hard gelatin capsule with white opaque body and white opaque cap. Imprinted “APO AM10” in black ink. APO-ATOMOXETINE 18mg is hard gelatin capsule with white opaque body and gold opaque cap. Imprinted “APO AM18” in black ink. APO-ATOMOXETINE 25mg is hard gelatin capsule with white opaque body and blue opaque cap. Imprinted “APO AM25” in black ink. APO-ATOMOXETINE 40mg is hard gelatin capsule with blue opaque body and blue opaque cap. Imprinted “APO AM40” in black ink. APO-ATOMOXETINE 60mg is hard gelatin capsule with gold opaque body and blue opaque cap. Imprinted “APO AM60” in black ink APO-ATOMOXETINE 80mg is hard gelatin capsule with white opaque body and orange opaque cap. Imprinted “APO AM80” in black ink. APO-ATOMOXETINE 100mg is hard gelatin capsule with orange opaque body and orange opaque cap. Imprinted “APO AM100” in black ink. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS APO-ATOMOXETINE 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. 4.2 DOSE AND METHOD OF ADMINISTRATION INSTRUCTIONS FOR USE/HANDLING APO-ATOMOXETINE capsules are not intended to be opened. Atomoxetine hydrochloride is an ocular irritant. In the event of capsule content coming in contact with the eye, the affected eye should be flushed immediately with water, and medical advice obtained. Hands and any potentially contaminated surfaces should be washed as soon as possible. NEW ZEALAND D Olvassa el a teljes dokumentumot