RITALIN LA methylphenidate hydrochloride 60mg modified release capsule bottle

Pajjiż: Awstralja

Lingwa: Ingliż

Sors: Department of Health (Therapeutic Goods Administration)

Ingredjent attiv:

methylphenidate hydrochloride, Quantity: 60 mg

Disponibbli minn:

Novartis Pharmaceuticals Australia Pty Ltd

INN (Isem Internazzjonali):

methylphenidate hydrochloride

Għamla farmaċewtika:

Capsule, modified release

Kompożizzjoni:

Excipient Ingredients: purified talc; methacrylic acid copolymer; ammonio methacrylate copolymer; triethyl citrate; iron oxide yellow; Gelatin; macrogol 6000; titanium dioxide; iron oxide black; iron oxide red; propylene glycol; butan-1-ol; isopropyl alcohol; purified water; Shellac; strong ammonia solution; ethanol absolute; potassium hydroxide; maize starch; sucrose

Rotta amministrattiva:

Oral

Unitajiet fil-pakkett:

30 capsules, 100 capsules

Tip ta 'preskrizzjoni:

(S8) Controlled Drug

Indikazzjonijiet terapewtiċi:

Ritalin 10 tablets and Ritalin LA capsules are indicated for the treatment of ADHD. Ritalin 10 tablets are also indicated for the treatment of narcolepsy. Attention-Deficit Hyperactivity Disorder (ADHD) ADHD was previously known as attention-deficit disorder. Other terms used to describe this behavioural syndrome include: minimal brain dysfunction in children, hyperkinetic child syndrome, minimal brain damage, minimal cerebral dysfunction, minor cerebral dysfunction and psycho-organic syndrome of children. Ritalin 10 / Ritalin LA are 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. Special diagnostic considerations for ADHD in children: The aetiology of this syndrome is unknown and there is no single diagnostic test. Adequate diagnosis requires the use, not only of medical, but also of psychological, educational and social resources. Characteristics commonly reported include: chronic history of short attention span, distractibility, emotional lability, impulsivity, moderate to severe hyperactivity, minor neurological signs and an abnormal EEG. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the child and not solely on the presence of one or more of these characteristics. Drug treatment is not indicated for all children with this syndrome. Stimulants are not intended for use in children who exhibit symptoms secondary to environmental factors (e.g. child abuse in particular) or primary psychiatric disorders. Appropriate educational placement is essential and psychosocial intervention is generally necessary. When remedial measures alone are insufficient, the decision to prescribe stimulant medicine will depend upon the physician's assessment of the chronicity and severity of the child's symptoms. Continuation of treatment in adolescent and special diagnostic considerations for ADHD in adults: There is limited information to guide clinicians about how long older adolescents should continue to receive treatment with drugs for attention deficit hyperactivity disorder (ADHD). The decision should be based on the extent to which symptoms of ADHD and social functioning have improved to a point that medication is no longer needed. If older adolescents have been largely symptom-free for a year and are functioning well, a trial without medication is warranted. This should be undertaken at times of low stress such as during holidays or in a period when a school routine is well established. ADHD needs to be considered in adults who present with longstanding symptoms suggestive of ADHD (inattention, impulsivity, disorganisation) that appear to have started in childhood and are persisting into adult life. Further, people with personality disorder and/or problems with drug use accompanied by a significant level of impulsivity and inattention should be referred for evaluation by a psychiatrist with the training and skills required to assess and treat ADHD. This expertise is necessary due to the overlap of ADHD symptoms with anxiety, mood and personality disorders. Narcolepsy The symptoms include daytime sleepiness, inappropriate sleep episodes and rapidly occurring loss of voluntary muscle tone. Ritalin 10 is effective for symptoms of sleepiness but not for loss of voluntary muscle tone.

Sommarju tal-prodott:

Visual Identification: Size 00, light brown opaque gelatin cap and a yellow opaque body, imprinted with NVR on the cap and R60 on the body in tan-coloured ink, containing white to off-white beads that are roughly spherical in shape; Container Type: Bottle; Container Material: HDPE; Container Life Time: 18 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

L-istatus ta 'awtorizzazzjoni:

Licence status A

Data ta 'l-awtorizzazzjoni:

2016-03-11

Fuljett ta 'informazzjoni

RITALIN
® LA
_methylphenidate hydrochloride_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Ritalin LA (long-
acting) capsules.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
final page. More recent information
on the medicine may be available.
YOU SHOULD ENSURE THAT YOU SPEAK
TO YOUR PHARMACIST OR DOCTOR TO
OBTAIN THE MOST UP TO DATE
INFORMATION ON THE MEDICINE. YOU
CAN ALSO DOWNLOAD THE MOST UP TO
DATE LEAFLET FROM
WWW.NOVARTIS.COM.AU.
Those updates may contain important
information about the medicine and
its use of which you should be aware.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you or your child taking
this medicine against the benefits
they expect it will provide.
IF YOU HAVE ANY CONCERNS ABOUT THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT RITALIN LA IS
USED FOR
Ritalin LA contain the active
ingredient methylphenidate
hydrochloride. Methylphenidate
hydrochloride is a central nervous
system stimulant.
Ritalin LA (long-acting) capsules are
used to treat Attention Deficit
Hyperactivity Disorder (ADHD).
Ritalin LA is a stimulant that
increases attention and decreases
impulsiveness and hyperactivity in
patients with ADHD. Ritalin LA is
thought to work by regulating
specific chemicals in the brain that
affect behaviour. It helps to focus
attention, shut out distraction and
allows impulsive people to think
before they act. If successful, it will
enhance an inattentive person's
natural ability.
Ritalin LA should be given as part of
a total treatment program for ADHD
that may include other measures
(psychological, educational and
social). It is not intended for use in
patients who have symptoms due to
environmental factors and/or other
primary psychiatric disorders,
including psychosis.
ASK YOUR DOCTOR IF YO

Karatteristiċi tal-prodott

1
_ _
AUSTRALIAN
PRODUCT
INFORMATION
RITALIN
®
10/RITALIN
®
LA
(METHYLPHENIDATE)
_DRUG DEPENDENCE: Ritalin 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
Ritalin 10 contain methylphenidate hydrochloride 10 mg.
Ritalin LA modified release capsules contain 10 mg, 20 mg, 30 mg, 40
mg or 60 mg of
methylphenidate hydrochloride.
Ritalin 10 contains lactose, sugars, milk products, lactitol, gluten
and sulfur dioxide.
Ritalin LA contains sucrose.
For the full list of the excipients, see Section 6.1.
3
PHARMACEUTICAL FORM
Ritalin 10 tablets are immediate release white tablets that are scored
and marked AB and
CG on the reverse.
Ritalin LA are modified release capsules that presented as follows:
10 mg cotaining white to off-white beads in a light brown opaque hard
gelatin capsule
with the imprint of NVR on the cap and R10 on a white opaque body in
tan-coloured ink.
20 mg containing white to off-white beads in a white opaque hard
gelatin capsule with
imprint NVR on the cap and R20 on body in tan-coloured ink.
30 mg containing white to off-white beads in a yellow opaque hard
gelatin capsule with
the imprint NVR on cap and R30 on body in tan-coloured ink.
40 mg containing white to off-white beads in a light brown opaque hard
gelatin capsule
with the imprint NVR on cap and R40 on body in tan-coloured ink.
60 mg containing white to off-white beads in a light brown opaque cap
and a yellow
opaque body hard gelatin capsule with imprint NVR on cap and R60 on
body in