METHYLPHENIDATE-TEVA XR methylphenidate hydrochloride 18 mg modified release tablet bottle

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

methylphenidate hydrochloride, Quantity: 18 mg

Tilgjengelig fra:

Teva Pharma Australia Pty Ltd

Legemiddelform:

Tablet, modified release

Sammensetning:

Excipient Ingredients: colloidal anhydrous silica; magnesium stearate; fumaric acid; lactose monohydrate; triethyl citrate; purified talc; methacrylic acid copolymer; hypromellose; 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

Administreringsrute:

Oral

Enheter i pakken:

30 tablets

Resept typen:

(S8) Controlled Drug

Indikasjoner:

METHYLPHENIDATE-TEVA XR 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-TEVA XR 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-TEVA XR for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

Produkt oppsummering:

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

Autorisasjon status:

Registered

Autorisasjon dato:

2021-10-13

Informasjon til brukeren

METHYLPHENIDATE-TEVA XR
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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-TEVA XR?
METHYLPHENIDATE-TEVA XR 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-TEVA XR? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE METHYLPHENIDATE-TEVA XR?
Do not use if you have ever had an allergic reaction to
METHYLPHENIDATE-TEVA XR 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-TEVA XR? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with METHYLPHENIDATE-TEVA XR 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-TEVA XR?
•
Your doctor will tell you how much METHYLPHENIDATE-TEVA XR to take and
how long you will need to take it.
More instructions can be found in Section 4. How do I use
METHYLPHENIDATE-TEVA XR? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING METHYLPHENIDATE-TEVA XR?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
METHYLPHENIDATE-TEVA XR.
•
Take METHYLPHENIDATE-TEVA XR exactly as your doctor has prescribed.
Like all stimulants,
METHYLPHENIDATE-TEVA XR 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 medic

Preparatomtale

METHYLPHENIDATE-TEVA XR
Version 2.0
Page 1 of 20
AUSTRALIAN PRODUCT INFORMATION – METHYLPHENIDATE-TEVA XR
(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-TEVA XR 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-TEVA XR 18 mg are yellow film coated, capsule-shaped,
biconvex tablets
with “2392” printed in black ink on one side.
METHYLPHENIDATE-TEVA XR 27 mg are grey film coated, capsule-shaped,
biconvex tablets
with “2393” printed in black ink on one side.
METHYLPHENIDATE-TEVA XR 36 mg are white film coated capsule-shaped,
biconvex tablets
with “2394” printed in black ink on one side.
METHYLPHENIDATE-TEVA XR 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-TEVA XR 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
hype