البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
METHYLPHENIDATE HYDROCHLORIDE
J-C HEALTH CARE LTD
N06BA04
TABLETS EXTENDED RELEASE
METHYLPHENIDATE HYDROCHLORIDE 18 MG
PER OS
Required
JANSSEN-CILAG MANUFACTURING, L.L.C, USA
METHYLPHENIDATE
METHYLPHENIDATE
Concerta is indicated for the treatment of Attention deficit hyperactivity disorder (ADHD).
2022-11-30
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS )PREPARATIONS( – 1986 The medicine is dispensed with a doctor’s prescription only CONCERTA ® , PROLONGED-RELEASE TABLETS Each CONCERTA 18 MG tablet contains Methylphenidate Hydrochloride 18 mg Each CONCERTA 27 MG tablet contains Methylphenidate Hydrochloride 27 mg Each CONCERTA 36 MG tablet contains Methylphenidate Hydrochloride 36 mg Each CONCERTA 54 MG tablet contains Methylphenidate Hydrochloride 54 mg Inactive and allergenic ingredients in the preparation – see section 6 ”Further Information“. READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. This medicine has been prescribed to treat you. Do not pass it on to others. It may harm them even if it seems to you that their medical condition is similar. 1. WHAT IS THE MEDICINE INTENDED FOR? Concerta is intended for the treatment of Attention Deficit Hyperactivity Disorder )ADHD( in children over the age of 6, adolescents and adults up to the age of 65. Concerta can improve the attention and concentration and reduce impulsiveness and hyperactivity in individuals with ADHD. Concerta is supposed to be given as part of an ADHD treatment program that can include consultation or other therapies. THERAPEUTIC GROUP: Central nervous system stimulant 2. BEFORE USING THE MEDICINE: DO NOT USE THE MEDICINE IF YOU OR YOUR CHILD: • is sensitive )allergic( to the active ingredient )methylphenidate hydrochloride( or to any of the additional ingredients contained in the medicine )see section 6 – ”Further Information“(. • is very anxious, mentally tense, or agitated )suffers from restlessness – agitation( • has an eye problem called glaucoma )increased intraocular pressure( • has tics or Tourette’s syndrome, or a family history of Tourette’s syndrome. Tics are involuntary repeated movements or sounds. • is taking or has taken within اقرأ الوثيقة كاملة
1 CONCERTA ® (METHYLPHENIDATE HCL) EXTENDED-RELEASE ORAL TABLETS 18,27,36,54 MG FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE CONCERTA is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in two or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least six of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least six of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; “on the go;” excessive talking; blurting answers; can’t wait turn; intrusive. The Combined Type requires both inattentive and hyperactive-impulsive criteria to be met. 1.1 SPECIAL DIAGNOSTIC CONSIDERATIONS 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. The diagnosis must be based upon a complete history and evaluation of the patient and not solely on the presence of the required number of DSM-IV characteristics. 1.2 NEED FOR COMPREHENSIVE TREATMENT PROGRAM CONCERTA is indicated as an integral part of a total treatment program for ADHD WARNING: DRUG DEPENDENCE CONCERTA SHOULD BE GIVEN CAUTIOU اقرأ الوثيقة كاملة