Страна: Малайзия
Язык: английский
Источник: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
METHYLPHENIDATE HYDROCHLORIDE
NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.
METHYLPHENIDATE HYDROCHLORIDE
100Tablet Tablets; 30Tablet Tablets; 200Tablet Tablets; 30 Tablet Tablets
Siegfried Barbera, S.L.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ _ _ RITALIN ® TABLET Methylphenidate Hydrochloride (10mg) RITALIN ® LA CAPSULE Methylphenidate Hydrochloride (20 mg, 30 mg) 1 WHAT IS IN THIS LEAFLET 1. What Ritalin is used for 2. How Ritalin works 3. Before you use Ritalin 4. How to use Ritalin 5. While you are using Ritalin 6. Side effects 7. Storage and Disposal of Ritalin 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision 11. Serial Number WHAT RITALIN IS USED FOR Ritalin is used for the treatment of attention-deficit/hyperactivity disorder (ADHD). About 3% of children suffer from this disorder, which makes them unable to sit still and/or concentrate on tasks for any length of time. Children with this disorder may have difficulty in learning and doing schoolwork. They may frequently become difficult to manage both in school and at home. Adults with ADHD often find it hard to concentrate. Ritalin is part of an ADHD treatment program which will usually also include psychological, educational and social therapy. Ritalin is also used for the treatment of narcolepsy (Ritalin tablets only). Narcolepsy is a sleep-attack disorder. People with narcolepsy experience recurring attacks of irresistible day-time sleepiness despite adequate night-time sleep. Ritalin LA capsules are not used to treat narcolepsy. HOW RITALIN WORKS ADHD Ritalin works by improving the activity of certain parts of the brain which are underactive. Ritalin improves attention and concentration, and reduces impulsive behavior. Narcolepsy Ritalin relieves excessive day-time sleepiness in people suffering from narcolepsy. BEFORE YOU USE RITALIN_ _ Ritalin will only be prescribed by a doctor. Follow all the doctor’s instructions carefully, even if they differ from the general information contained in this leaflet. _- When you must not use it _ are allergic (hypersensitive) to methylphenidate or to any of the other ingredients of Ritalin listed at the end of this leaflet. If you think you may be allergic, Прочитать полный документ
Novartis Page 2 Malaysian Package Leaflet 13-Dec-2021 Ritalin, Ritalin LA RITALIN RITALIN LA Psychostimulants. DESCRIPTION AND COMPOSITION PHARMACEUTICAL FORMS Ritalin: Immediate-release tablet, divisible. Ritalin LA: Modified-release capsule, hard. ACTIVE SUBSTANCE The active substance is methylphenidate hydrochloride. One Ritalin tablet contains 10 mg methylphenidate hydrochloride. One Ritalin LA capsule contains 20 mg and 30 mg methylphenidate hydrochloride. ACTIVE MOIETY Methylphenidate (INN for alpha-phenyl-2-piperidine acetic acid methyl ester). DESCRIPTION RITALIN 10MG TABLETS White, round, flat, with beveled edges. One side bears the imprint “CG”, the other “A/B” and score. May contain dark specks. RITALIN LA 20MG MODIFIED RELEASE CAPSULE White to off-white beads in a white opaque hard gelatin capsule with imprint ‘NVR’ on the cap and ‘R20’ on the body in tan-coloured ink. RITALIN LA 30MG MODIFIED RELEASE CAPSULE White to off-white beads in a yellow opaque hard gelatin capsule with imprint ‘NVR’ on the cap and ‘R30’ on the body in tan-coloured ink. EXCIPIENTS RITALIN TABLET [10 MG]: calcium phosphate, lactose, wheat starch, gelatin, magnesium stearate, talc. RITALIN LA CAPSULE [20 MG AND 30 MG]: ammonio methacrylate copolymer, gelatin, methacrylic acid copolymer, macrogol, sugar spheres, talc, titanium dioxide (E 171), triethyl citrate, yellow iron oxide (E 172) 30 capsules only). Novartis Page 3 Malaysian Package Leaflet 13-Dec-2021 Ritalin, Ritalin LA INDICATIONS 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. Ritali Прочитать полный документ