Pays: Nouvelle-Zélande
Langue: anglais
Source: Medsafe (Medicines Safety Authority)
Methylphenidate hydrochloride 36mg (Drug Layer 1, Drug Layer 2 & Drug Coat)
Janssen-Cilag (New Zealand) Ltd
Methylphenidate hydrochloride 36 mg (Drug Layer 1, Drug Layer 2 & Drug Coat)
36 mg
Modified release tablet
Active: Methylphenidate hydrochloride 36mg (Drug Layer 1, Drug Layer 2 & Drug Coat) Excipient: Butylated hydroxytoluene Carnauba wax Cellulose acetate Hypromellose Ferric oxide, green (Push Layer) Iron oxide yellow Opacode black NS-78-17715 Opadry Clear YS-1-19025-A Opadry white Y-30-18037 Phosphoric acid Poloxamer 188 Polyethylene oxide Povidone Sodium chloride Stearic acid Succinic acid
Bottle, plastic, HDPE, 28s, 28 tablets
Class B2 Controlled Drug
Class B2 Controlled Drug
Janssen Pharmaceuticals Inc
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. Need for comprehensive treatment programme: CONCERTA is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational and social) for patients with this syndrome. 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. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician's assessment of the chronicity and severity of the patient's symptoms. Long term use: The effectiveness of CONCERTA for long-term use has not been systematically evaluated in controlled trials. Therefore the physician who elects to use CONCERTA for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
Package - Contents - Shelf Life: Bottle, plastic, HDPE - 28 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE - 30 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE - 56 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE - 60 tablets - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, HDPE - 100 tablets - 36 months from date of manufacture stored at or below 25°C
2002-05-27
CONCERTA ® (230516) ACMI 1 CONCERTA ® _EXTENDED-RELEASE TABLETS _ _Methylphenidate hydrochloride _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about CONCERTA extended-release tablets. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you or your child taking CONCERTA against the benefits this medicine is expected to have for you or your child. If you have any concerns about taking CONCERTA ask your doctor or pharmacist. Keep this leaflet with your medicine. You may need to read it again. WHAT IS CONCERTA USED FOR CONCERTA is used to treat Attention Deficit Hyperactivity Disorder (ADHD). CONCERTA is part of a comprehensive treatment program which usually includes psychological, educational and social therapy. CONCERTA is a stimulant that increases attention and decreases impulsiveness and hyperactivity in patients with ADHD. CONCERTA should be used as part of a total treatment program for ADHD that may include counselling or other therapies. CONCERTA is not recommended for use in children less than 6 years and elderly over 65 years because it has not been studied in these age groups. CONCERTA tablets are made in an extended release form. This means that they release the active ingredient slowly. The outer layer of the CONCERTA tablet dissolves right after it is swallowed in the morning, giving an initial dose of methylphenidate hydrochloride. The tablets have a special shell that allows the rest of the methylphenidate hydrochloride to be released from the tablet at a slow rate throughout the day. The tablet shell does not dissolve completely after all the drug has been released and sometimes the tablet shell may be seen in your stool. This is normal. YOUR DOCTOR MAY HAVE PRESCRIBED CONCERTA FOR ANOTHER REASON. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU/YOUR CHILD. CON Lire le document complet
16.230215 1 CONCERTA(230516)ADS CONCERTA ® DATA SHEET 1. PRODUCT NAME CONCERTA Extended – Release Tablets 18 mg methylphenidate hydrochloride modified release tablet CONCERTA Extended – Release Tablets 27 mg methylphenidate hydrochloride modified release tablet CONCERTA Extended – Release Tablets 36 mg methylphenidate hydrochloride modified release tablet CONCERTA Extended – Release Tablets 54 mg methylphenidate hydrochloride modified release tablet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One extended release tablet contains 18 mg, 27 mg, 36 mg or 54 mg of methylphenidate hydrochloride. Excipient(s) with known effect: Lactose For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS . 3. PHARMACEUTICAL FORM CONCERTA is available as an extended-release tablet for once-a-day oral administration containing 18, 27, 36 or 54 mg methylphenidate hydrochloride. It is designed to have a 12-hour duration of effect. CONCERTA 18 mg are yellow capsule-shaped tablets, with “alza 18” printed in black ink on one side. CONCERTA 36 mg are white capsule-shaped tablets, with “alza 36” printed in black ink on one side. CONCERTA 27 mg are grey capsule-shaped tablets, with “alza 27” printed in black ink on one side. CONCERTA 54 mg are brownish-red capsule-shaped tablets, with “alza 54” printed in black ink on one side. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS 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. NEED FOR COMPREHENSIVE TREATMENT PROGRAMME: CONCERTA is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational and social) for patients with this syndrome. Stimulants are not intended for use in the patient who exhibits symptoms secondary to environmental Lire le document complet