METHYLPHENIDATE XR ARX methylphenidate hydrochloride18 mg modified release tablet bottle

দেশ: অস্ট্রেলিয়া

ভাষা: ইংরেজি

সূত্র: Department of Health (Therapeutic Goods Administration)

সক্রিয় উপাদান:

methylphenidate hydrochloride, Quantity: 18 mg

থেকে পাওয়া:

Teva Pharma Australia Pty Ltd

ফার্মাসিউটিকাল ফর্ম:

Tablet, modified release

রচনা:

Excipient Ingredients: fumaric acid; magnesium stearate; lactose monohydrate; triethyl citrate; purified talc; hypromellose; methacrylic acid copolymer; colloidal anhydrous silica; propylene glycol; butan-1-ol; isopropyl alcohol; strong ammonia solution; iron oxide black; ethanol; Shellac; sulfuric acid; titanium dioxide; iron oxide yellow; iron oxide red; polyvinyl alcohol; macrogol 3350

প্রশাসন রুট:

Oral

প্যাকেজ ইউনিট:

30 tablets

প্রেসক্রিপশন টাইপ:

(S8) Controlled Drug

থেরাপিউটিক ইঙ্গিত:

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.

পণ্য সারাংশ:

Visual Identification: Yellow, film coated, capsule-shaped, biconvex tablet with '2392' 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

অনুমোদন অবস্থা:

Registered

অনুমোদন তারিখ:

2021-06-24

তথ্য লিফলেট

METHYLPHENIDATE XR ARX
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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

পণ্য বৈশিষ্ট্য

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