Država: Malezija
Jezik: angleščina
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ATOMOXETINE HYDROCHLORIDE
ZUELLIG PHARMA SDN BHD
ATOMOXETINE HYDROCHLORIDE
28Capsule Capsules; 28 Capsule Capsules
Lilly del Caribe Inc.,
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ STRATTERA CAPSULE ® Atomoxetine HCl (10 mg, 18 mg, 25 mg, 40 mg, 60 mg) ________________________________________________________________________________________________________________________ 1 WHAT IS IN THIS LEAFLET 1. What Strattera is used for 2. How Strattera works 3. Before you use Strattera 4. How to use Strattera 5. While you are using it 6. Side effects 7. Storage and Disposal of Strattera 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT STRATTERA IS USED FOR Strattera contains atomoxetine and is used to treat attention-deficit and hyperactivity disorder (ADHD). 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. Strattera is used in: • children over six years of age • young people • adults It is used only as a part of the total treatment of the disease which also requires treatments which do not involve medicines, such as counselling and behavioural therapy. It is not for use as a treatment for ADHD in children under 6 years of age as it is not known if the drug works or is safe in these people. In adults, Strattera is used to treat ADHD when the symptoms are very troublesome and affect your work or social life and when you have had symptoms of the disease as a child. HOW STRATTERA WORKS Strattera increases the amount of noradrenaline in the brain. This is a chemical in the brain that is produced naturally, which increases attention and decreases impulsiveness and hyperactivity in patients with ADHD. This medicine has been prescribed to help control the symptoms of ADHD. This medicine is not a stimulant and is therefore not addictive. It may take a few weeks after you start the medicine for your symptoms to fully improve. BEFORE YOU USE STRATTERA _- When you must not use it _ • if you are allergic (hypersensitive) to atomoxetine or any of the other ingredients of Strattera. • if you t Preberite celoten dokument
STRATTERA ® 10 MG, 18 MG, 25 MG, 40 MG, OR 60 MG HARD CAPSULES (ATOMOXETINE HCL) 1. NAME OF THE MEDICINAL PRODUCT STRATTERA 10 mg, 18 mg, 25 mg, 40 mg, or 60 mg hard capsules. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION The active substance is atomoxetine hydrochloride. Each STRATTERA 10 mg, 18 mg, 25 mg, 40 mg, or 60 mg capsule contains atomoxetine hydrochloride equivalent to 10 mg, 18 mg, 25 mg, 40 mg, or 60 mg of atomoxetine. For excipients, see 6.1. 3. PHARMACEUTICAL FORM Hard capsules. STRATTERA 10 mg capsules are opaque white, are imprinted with “Lilly 3227” on the cap and “10 mg” on the body in black ink STRATTERA 18 mg capsules are gold (cap) and opaque white (body), imprinted with “Lilly 3238” on the cap and “18 mg” on the body in black ink STRATTERA 25 mg capsules are opaque blue (cap) and opaque white (body), imprinted with “Lilly 3228” on the cap and “25 mg” on the body in black ink STRATTERA 40 mg capsules are opaque blue, imprinted with “Lilly 3229” on the cap and “40mg” on the body in black ink STRATTERA 60 mg capsules are opaque blue (cap) and gold (body), imprinted with “Lilly 3239” on the cap and “60 mg” on the body in black ink 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS STRATTERA is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children 6 years of age and older, adolescents and adults (see 5.1.). Diagnosis should be made according to DSM-IV criteria or the guidelines in ICD-10. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION For oral use. STRATTERA can be administered as a single daily dose in the morning. Patients who experience unwanted effects when taking STRATTERA as a single daily dose may benefit from taking it as twice daily evenly divided doses in the morning and late afternoon or early evening. Dosing of Children and Adolescents up to 70 kg Body Weight STRATTERA should be initiated at a total daily dose of approximately 0.5 mg/kg. The initial dose should be maintained for a minimum of 7 days prior to upwa Preberite celoten dokument