Ülke: Avustralya
Dil: İngilizce
Kaynak: Department of Health (Therapeutic Goods Administration)
atomoxetine hydrochloride
Apotex Pty Ltd
Atomoxetine hydrochloride
Registered
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: • YOU HAVE OR HAVE HAD ANY OF THE Belgenin tamamını okuyun
Product Information – Australia APO-Atomoxetine Capsules Page 1 APO-ATOMOXETINE 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 PRECAUTIONS). NAME OF THE MEDICINE Atomoxetine hydrochloride Chemical Name: _R_-(-)-N-Methyl-gamma-(2-methylphenoxy)-benzenepropanamine hydrochloride Structural Formula: Molecular Formula: C 17 H 21 NO.HCl Molecular Weight: 291.82 CAS Registry Number: 82248-59-7 DESCRIPTION Atomoxetine hydrochloride is a white to practically white solid that has a solubility of 27.8 mg/mL in water. Atomoxetine hydrochloride is available as capsules for oral administration. The capsules contain a white to off-white powder. Each capsule contains 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg or 100 mg atomoxetine (as hydrochloride). In addition to atomoxetine hydrochloride, each atomoxetine capsule contains pregelatinised maize starch. The capsule shell consists of gelatin, titanium dioxide, iron oxide yellow (18 mg, 25 mg, 40 mg, 60 mg, 80 mg, 100 mg), iron oxide red (80 mg, 100 mg), indigo carmine (25 mg, 40 mg, 60 mg). The capsules are printed with edible black ink (TekPrint SW-9008/SW-9009). Product Information – Australia APO-Atomoxetine Capsules Page 2 PHARMACOLOGY PHARMACOLOGICAL ACTIONS Atomoxetine is used as a treatment for Attention-Deficit/Hyperactivity Disorder (ADHD). ADHD was formerly known as Attention Deficit Disorder (ADD) with or without hyperactivity. Atomoxetine is a relatively potent inhibitor of the presynaptic n Belgenin tamamını okuyun