País: Nueva Zelanda
Idioma: inglés
Fuente: Medsafe (Medicines Safety Authority)
Methylphenidate hydrochloride 20mg;
AFT Pharmaceuticals Ltd
Methylphenidate hydrochloride 20 mg
20 mg
Tablet
Active: Methylphenidate hydrochloride 20mg Excipient: Calcium hydrogen phosphate dihydrate Magnesium stearate Maize starch Microcrystalline cellulose
Blister pack, PVC/Al 30's, 30 tablets
Class B2 Controlled Drug
Class B2 Controlled Drug
Ipca Laboratories Limited
Package - Contents - Shelf Life: Blister pack, PVC/Al 30's - 30 tablets - 24 months from date of manufacture stored at or below 25°C protect from moisture
2002-08-14
RUBIFEN 1 RUBIFEN _METHYLPHENIDATE HYDROCHLORIDE_ Immediate release tablets Slow-release tablets WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Rubifen. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you or your child taking Rubifen against the benefits they expect it will have. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT RUBIFEN IS USED FOR RUBIFEN IS USED TO TREAT A BEHAVIOURAL DISORDER CALLED ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD). About 3% of children suffer from ADHD. It makes them unable to sit still or concentrate on tasks for any length of time. They may have trouble learning and doing schoolwork. They frequently become difficult to manage, both in school and at home. Rubifen is a central nervous system stimulant. It 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. RUBIFEN 2 Rubifen is part of a treatment program that usually includes psychological, educational, and social therapy. RUBIFEN IS ALSO USED TO TREAT NARCOLEPSY, A SLEEP-ATTACK DISORDER. People with narcolepsy have recurring attacks of irresistible daytime sleepiness in spite of having enough sleep at night. A doctor can diagnose narcolepsy by recording wake-sleep patterns. Narcolepsy is not a normal fatigue state. Rubifen should not be used to prevent or treat normal fatigue. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY RUBIFEN HAS BEEN PRESCRIBED FOR YOU OR YOUR CHILD. Your doctor may have prescribed it for another reason. This medicine is only available with a doctor's prescription and your doctor has special permission to prescribe i Leer el documento completo
Page 1 of 17 NEW ZEALAND DATA SHEET 1. PRODUCT NAME Rubifen: Methylphenidate hydrochloride (USP) 5 mg, 10 mg and 20 mg Rubifen SR : Methylphenidate hydrochloride (USP) 20 mg sustained release tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5mg tablet contains methylphenidate 5mg Each 10mg tablet contains methylphenidate 10mg Each 20mg tablet contains methylphenidate 20mg For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Rubifen immediate release 5, 10 and 20 mg tablets: round white tablet with slightly bevelled edges, marked RU-5, RU-10 or RU-20 containing 5 mg, 10 mg and 20 mg methylphenidate respectively with a score mark on the 10 mg tablets. Rubifen sustained release 20 mg tablets: oblong white or white-cream smooth tablet containing 20 mg methylphenidate in a modified release formulation. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _ATTENTION DEFICIT/HYPERACTIVITY DISORDER (ADHD)_ ADHD was previously known as attention-deficit disorder or minimal brain dysfunction. Other terms used to describe this behavioural syndrome include: hyperkinetic disorder, minimal brain damage, minimal cerebral dysfunction, minor cerebral dysfunction and psycho-organic syndrome of children. Rubifen is indicated as part of a comprehensive treatment program which typically includes psychological, educational and social measures and is aimed at stabilising children with a behavioural syndrome characterised by moderate to severe distractibility, short attention span, hyperactivity, emotional lability and impulsivity. The diagnosis should be made according to DSM-IV criteria or the guidelines in ICD-10. Non-localising (soft) neurological signs, learning disability and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted. _SPECIAL DIAGNOSTIC CONSIDERATIONS FOR ADHD_ The specific etiology of this syndrome is unknown, and there is no single diagnostic test. Proper diagnosis requires medical and neuropsychological, educational and soc Leer el documento completo