Ország: Ausztrália
Nyelv: angol
Forrás: Department of Health (Therapeutic Goods Administration)
Atomoxetine hydrochloride
Amneal Pharma Australia Pty Ltd
Atomoxetine hydrochloride
ATOMOXETINE-AMNEAL CMI v0.3 ATOMOXETINE AMNEAL _ATOMOXETINE (AS HYDROCHLORIDE) 10MG, 18MG, 25MG, 40MG, 60MG, 80MG AND 100MG _ _HARD CAPSULES _ WHAT IS IN THIS LEAFLET? This leaflet answers some common questions about ATOMOXETINE AMNEAL. 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 AMNEAL 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 AMNEAL 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 AMNEAL USED FOR ATOMOXETINE AMNEAL 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 AMNEAL 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 AMNEAL 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 AMNEAL IF YOU HAVE AN ALLERGY TO: • any medicine containing atomoxetine hydrochloride (the active ingredient in ATOMOXETINE AMNEA Olvassa el a teljes dokumentumot
Page 1 of 25 ATOMOXETINE AMNEAL PI v1.0 PRODUCT INFORMATION ATOMOXETINE AMNEAL atomoxetine (as 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 PRECAUTIONS). NAME OF THE MEDICINE ATOMOXETINE AMNEAL atomoxetine (as hydrochloride) capsules The active ingredient in ATOMOXETINE AMNEAL capsules is atomoxetine hydrochloride. Chemically, atomoxetine hydrochloride is (3_R_)-_N_-Methyl-3-(2-methylphenoxy)-3- phenylpropan-1-amine hydrochloride. The empirical formula is C 17 H 21 NO•HCl which corresponds to a molecular weight of 291.82 daltons. The chemical structure is: The CAS number for atomoxetine hydrochloride is 82248-59-7. Page 2 of 25 ATOMOXETINE AMNEAL PI v1.0 DESCRIPTION Atomoxetine hydrochloride is a white to practically white solid which has a solubility of 27.8 mg/mL in water. ATOMOXETINE AMNEAL is available as capsules for oral administration. Each capsule contains 10, 18, 25, 40, 60, 80 or 100 mg of atomoxetine (as hydrochloride). The capsules also contain StarCap 1500 (ARTG No. 12847), dimethicone 350, sodium starch glycollate type A. The following details relate to the capsule shells and lids in which the capsule contents are encapsulated: Empty hard gelatin capsules size 4, 0999 White Opaque ‐ 0999 White Opaque (ARTG No. 109783; 10 mg); Empty hard gelatin capsules size 3, 0999 White Opaque ‐ 2306 Gold Opaque (ARTG No. 109778; 18 mg); Empty hard gelatin capsules size 3 0999 White Op ‐ 1516 Blue Opaque (ARTG No. Olvassa el a teljes dokumentumot