Country: Australia
Bahasa: Inggeris
Sumber: Department of Health (Therapeutic Goods Administration)
methylphenidate hydrochloride, Quantity: 36 mg
Teva Pharma Australia Pty Ltd
Tablet, modified release
Excipient Ingredients: colloidal anhydrous silica; lactose monohydrate; magnesium stearate; hypromellose; triethyl citrate; purified talc; fumaric acid; methacrylic acid copolymer; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; Shellac; sulfuric acid; titanium dioxide; polyvinyl alcohol; macrogol 3350
Oral
30 tablets
(S8) Controlled Drug
METHYLPHENIDATE XR ARX is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). Treatment should be commenced by a specialist.,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 METHYLPHENIDATE XR ARX 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 methylphenidate hydrochloride extended release tablets for long-term use has not been systematically evaluated in controlled trials. Therefore the physician who elects to use METHYLPHENIDATE XR ARX for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
Visual Identification: White, film coated, capsule-shaped, biconvex tablet with '2394' printed in black ink on one,side; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure
Registered
2021-06-24
METHYLPHENIDATE XR ARX M E T H Y L Y P H E N I D A T E X R A R X v 3 . 0 CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING METHYLPHENIDATE XR ARX? METHYLPHENIDATE XR ARX contains the active ingredient Methylphenidate hydrochloride and is used to treat Attention Deficit Hyperactivity Disorder (ADHD). For more information, see Section 1. Why am I using METHYLPHENIDATE XR ARX? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE METHYLPHENIDATE XR ARX? Do not use if you have ever had an allergic reaction to METHYLPHENIDATE XR ARX or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use METHYLPHENIDATE XR ARX? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with METHYLPHENIDATE XR ARX and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE METHYLPHENIDATE XR ARX? • Your doctor will tell you how much METHYLPHENIDATE XR ARX to take and how long you will need to take it. More instructions can be found in Section 4. How do I use METHYLPHENIDATE XR ARX? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING METHYLPHENIDATE XR ARX? THINGS YOU SHOULD DO • Remind any doctor, dentist or pharmacist you visit that you are using METHYLPHENIDATE XR ARX. • Take METHYLPHENIDATE XR ARX exactly as your doctor has prescribed. Like all stimulants, METHYLPHENIDATE XR ARX may become habit-forming and can be abused by some people. If you/ your child take it correctly as instructed by your doctor, abuse or dependence should not be a problem, either now or later in life THINGS YOU SHOULD NOT DO • If you/your child suddenly stop taking this medicine, you/your child Baca dokumen lengkap
METHYLPHENIDATE XR ARX Version 2.0 Page 1 of 21 AUSTRALIAN PRODUCT INFORMATION – METHYLPHENIDATE XR ARX (METHYLPHENIDATE HYDROCHLORIDE) EXTENDED RELEASE TABLETS DRUG DEPENDENCE: Methylphenidate hydrochloride extended release tablets should be given cautiously to patients with a history of drug dependence or alcoholism. Chronic abusive use can lead to marked tolerance and psychological dependence with varying degrees of abnormal behaviour. Frank psychotic episodes can occur, especially with parenteral abuse. Careful supervision is required during withdrawal from abusive use since severe depression may occur. Withdrawal following chronic therapeutic use may unmask symptoms of the underlying disorder that may require follow-up. 1 NAME OF THE MEDICINE Methylphenidate hydrochloride 2 QUALITATIVE AND QUANTITATIVE COMPOSITION METHYLPHENIDATE XR ARX 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. Excipient(s) with known effect: sugars (as lactose) For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM METHYLPHENIDATE XR ARX 18 mg are yellow film coated, capsule-shaped, biconvex tablets with “2392” printed in black ink on one side. METHYLPHENIDATE XR ARX 27 mg are grey film coated, capsule-shaped, biconvex tablets with “2393” printed in black ink on one side. METHYLPHENIDATE XR ARX 36 mg are white film coated capsule-shaped, biconvex tablets with “2394” printed in black ink on one side. METHYLPHENIDATE XR ARX 54 mg are brownish-red film coated capsule-shaped biconvex tablets with “2395” printed in black ink on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS METHYLPHENIDATE XR ARX is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). Treatment should be commenced by a specialist. A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV) implies the presence of hyperactive-i Baca dokumen lengkap