Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
METHYLPHENIDATE HYDROCHLORIDE
JOHNSON & JOHNSON SDN BHD
METHYLPHENIDATE HYDROCHLORIDE
30Tablet Tablets
JANSSEN CILAG MANUFACTURING L.L.C
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ CONCERTA ® EXTENDED RELEASE TABLETS Methylphenidate hydrochloride (18mg, 27mg, 36mg) 1 WHAT IS IN THIS LEAFLET 1. What CONCERTA ® is used for 2. How CONCERTA ® works 3. Before you use CONCERTA ® 4. How to use CONCERTA ® 5. While you are using it 6. Side effects 7. Storage and disposal of CONCERTA ® 8. Product description 9. Manufacturer and product registration holder 10. Date of revision WHAT CONCERTA ® IS USED FOR CONCERTA ® is used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents aged 6 to 17 and adults aged 18 to 65 years old. HOW CONCERTA ® WORKS CONCERTA ® improves the activity of certain parts of the brain which are under-active. The medicine can help improve attention (attention span), concentration and reduce impulsive behavior. The medicine is given as part of a treatment program, which usually includes: • psychological • education and • social therapy Although there is no cure for ADHD, it can be managed using treatment programs. BEFORE YOU USE CONCERTA ® - _When you must not use it _ You should not take CONCERTA ® if you: • Are allergic to methylphenidate or any of the other ingredients in CONCERTA® (see _PRODUCT _ _DESCRIPTION_ ). • Have glaucoma, an eye disease. • Are being treated or recently been treated with monoamine oxidase (MAO) inhibitor medicines within 14 days. • Take CONCERTA ® for severe depression and/or for the prevention or treatment of normal fatigue states. • Use in children under 6 years old. _ _ - _Before you start to use it _ Talk to your doctor _before _ or while taking CONCERTA ® if you: • Have a heart defect. • Have medical conditions related to blood pressure and heart rate • Have tics (movements or sounds that you cannot control) or Tourette’s syndrome, or if someone in your family has tics or Tourette’s syndrome. • Have a serious mental health problem. • Have history of seizures. • Have a problem with the blood vessels in your brai Baca dokumen lengkap
1 PRODUCT NAME CONCERTA ® FOR SPECIALIST’S USE ONLY DOSAGE FORMS AND STRENGTHS Extended-release tablets 18 MG TABLET Capsule-shaped yellow tablet with “alza 18” printed on one side in black ink. Each tablet contains 18 mg of methylphenidate hydrochloride. 27 MG TABLET Capsule-shaped gray tablet with "alza 27" printed on one side in black ink. Each tablet contains 27 mg of methylphenidate hydrochloride. 36 MG TABLET Capsule-shaped white tablet with “alza 36” printed on one side in black ink. Each tablet contains 36 mg of methylphenidate hydrochloride. For excipients _, _ see _ List of Excipients _ CLINICAL INFORMATION INDICATIONS CONCERTA is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). The efficacy of CONCERTA in the treatment of ADHD was established in controlled trials of children and adolescents aged 6 to 17 and adults aged 18 to 65 who met DSM- IV criteria for ADHD. CONCERTA should be used as a part of a comprehensive treatment program where remedial measures alone prove insufficient. A comprehensive treatment program for the treatment of ADHD may include other measures (psychological, educational, social) for patients with this disorder. Diagnosis must be made according to the current DSM criteria or ICD guidelines. CONCERTA treatment is not indicated in all patients with ADHD and the decision to use the drug must be based on a very thorough assessment of the severity of the patient’s symptoms. Stimulants are not intended for use in the patient who exhibits symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. Appropriate educational placement is essential, and psychosocial intervention is often helpful. Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use of medical and special psychological, educational, and social resources. Learning may or may not be impaired. 2 DOSAGE AND ADMINISTRATION DOSAGE PATIENTS NEW TO METHYLPHENIDATE The recom Baca dokumen lengkap