RUBIFEN LA methylphenidate hydrochloride 10 mg modified release capsules blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

methylphenidate hydrochloride, Quantity: 10 mg

Available from:

AFT Pharmaceuticals Pty Ltd

Pharmaceutical form:

Capsule, hard

Composition:

Excipient Ingredients: strong ammonia solution; Shellac; Gelatin; purified talc; propylene glycol; iron oxide yellow; ammonio methacrylate copolymer; triethyl citrate; titanium dioxide; povidone; iron oxide red; methacrylic acid copolymer; potassium hydroxide; sucrose; maize starch

Administration route:

Oral

Units in package:

30 capsules

Prescription type:

(S8) Controlled Drug

Therapeutic indications:

Rubifen LA modified release capsules are indicated for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD).,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.,Rubifen LA modified release capsules 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.

Product summary:

Visual Identification: Whitish pellets in hard gelatin capsule size 2; dark yellow opaque cap with "RUB" print in red ink; white opaque body with "M10" print in red ink; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 48 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Registered

Authorization date:

2022-05-26

Patient Information leaflet

Rubifen LA
1
RUBIFEN LA
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.
WARNING: Important safety information is provided in a boxed warning
in the full CMI. Read before using this medicine.
1.
WHY AM I USING RUBIFEN LA?
Rubifen LA contains the active ingredient methylphenidate
hydrochloride. Rubifen LA is used to treat Attention Deficit
Hyperactivity Disorder (ADHD).
For more information, see Section 1. Why am I using Rubifen LA?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE RUBIFEN LA?
Do not use if you have ever had an allergic reaction to Rubifen LA 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
Rubifen LA?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Rubifen LA 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 RUBIFEN LA?
•
Your doctor will decide on the most suitable dosage according to the
individual patient’s medical need and response.
•
Rubifen LA should be taken orally once daily in the morning with a
full glass of water.
More instructions can be found in Section 4. How do I use Rubifen LA?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING RUBIFEN LA?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Rubifen LA.
•
Be sure to keep all of your doctor’s appointments so that your or
your child’s progress can be checked.
THINGS YOU
SHOULD NOT DO
•
Do not stop using this medicine suddenly. You will need medical
supervision after having interrupted
the treatment.
•
Do not change the dose without talking to the doctor.
DRIVING OR USING
MACHINES
•
Rubifen LA may

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION – RUBIFEN LA
(METHYLPHENIDATE HYDROCHLORIDE)
_DRUG DEPENDENCE: Rubifen LA 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
Rubifen LA modified release capsules contain 10 mg, 20 mg, 30 mg, 40
mg or 60 mg methylphenidate
hydrochloride.
Excipient(s) with known effect: sugar (sucrose)
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Rubifen modified release capsules are presented as follows:
Rubifen LA 10 mg modified release capsules:
Hard gelatin capsule size 2, with a dark yellow opaque cap and a white
opaque body, imprinted with
“RUB” in red ink on the cap and “M10” in red ink on the body,
containing 10 mg white and whitish
pellets.
Rubifen LA 20 mg modified release capsules:
Hard gelatin capsule size 2, white opaque capsule, imprinted with
“RUB” in red ink on the cap and
“M20” in red ink on the body, containing 20 mg white and whitish
pellets.
Rubifen LA 30 mg modified release capsules:
Hard gelatin capsule size 2, ivory opaque capsule, imprinted with
“RUB” in red ink on the cap and
“M30” in red ink on the body, containing 30 mg white and whitish
pellets.
Rubifen LA 40 mg modified release capsules:
Hard gelatin capsule size 1, dark yellow opaque, imprinted with
“RUB” in red ink on the cap and “M40”
in red ink on the body, containing 40 mg white and whitish pellets.
Rubifen LA 60 mg modified release capsules:
Hard gelatin capsule size 0, with a dark yel