Valsts: Malaizija
Valoda: angļu
Klimata pārmaiņas: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Methylphenidate
HYPHENS PHARMA SDN. BHD.
Methylphenidate
30 capsule Capsules
MEDICE Arzneimittel PÃ?Â?tter GmbH
MEDIKINET MR ® HARD CAPSULES Methylphenidate Hydrochloride 5mg, 10mg, 20mg, 30mg & 40mg _Consumer Medication Information Leaflet (RiMUP)_ 1 WHAT IS IN THIS LEAFLET 1. What Medikinet MR is used for 2. How Medikinet MR works 3. Before you use Medikinet MR 4. How to use Medikinet MR 5. While you are using Medikinet MR 6. Side effects 7. Storage and disposal of Medikinet MR 8. Product description 9. Manufacturer and product registration holder 10. Date of revision 1. WHAT MEDIKINET MR IS USED FOR Medikinet MR contains active substance _methlyphenidate_ _ _ _hydrochloride._ It is a mild stimulant acting on central nervous system(CNS). Medikinet MR is used to treat _attention_ _ _ _deficit hyperactivity disorder_ (ADHD). - It is used in children and young people between the ages of 6 to 18 and in adults from the age of 18 years on. - It is used only after trying treatments which do not involve medicines. Such as counselling and behavioural therapy. Medikinet MR is not for in treatment for ADHD in children under 6 years of age as safety and benefits is unknown. 2. HOW MEDIKINET MR WORKS Medikinet MR improves the activity of certain parts of the brain which are under- active. The medicine can help improve attention (attention span), concentration and reduce impulsive behaviour. The medicine is given as part of a treatment programme, which usually includes: _-_ _ _ Psychological _-_ _ _ Educational and _-_ _ _ Social therapy Medikinet MR treatment must only be initiated by, and used under the supervision of, a specialist in behavioural disorders. A very thorough assessment of the ailments is necessary. The accompanying treatment programmes can contribute to an improved management of the disorder. 3. BEFORE YOU USE MEDIKINET MR When you must not use it Do not take Medikinet MR if you or your child has the followings: - Allergic (hypersensitive) to _methylphenidate_ or any of the other ingredients of Medikinet MR (refer to section ‘ Other information’). - Thyroid problem - Increased pressure in the eye (glaucoma) - Tum Izlasiet visu dokumentu
1 PACKAGE INSERT 1. NAME OF THE MEDICINAL PRODUCT MEDIKINET MR 5 MG hard capsules MEDIKINET MR 10 MG hard capsules MEDIKINET MR 20 MG hard capsules MEDIKINET MR 30 MG hard capsules MEDIKINET MR 40 MG hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION MEDIKINET MR 5 MG hard capsules Each hard capsule contains 5 mg methylphenidate hydrochloride, corresponding to 4.325 mg methylphenidate. Excipient with known effect: 63.57 mg – 72.71 mg sucrose/hard capsule MEDIKINET MR 10 MG hard capsules, Each hard capsule contains 10 mg methylphenidate hydrochloride, corresponding to 8.65 mg methylphenidate. Excipient with known effect: 127.14 mg – 145.42 mg sucrose/ hard capsule MEDIKINET MR 20 MG hard capsules Each hard capsule contains 20 mg methylphenidate hydrochloride, corresponding to 17.30 mg methylphenidate. Excipient with known effect: 114.65 mg – 131.13 mg sucrose/ hard capsule MEDIKINET MR 30 MG hard capsules Each hard capsule contains 30 mg methylphenidate hydrochloride, corresponding to 25.95 mg methylphenidate. Excipient with known effect: 69.60 mg – 79.61 mg sucrose/ hard capsule MEDIKINET MR 40 MG hard capsules Each hard capsule contains 40 mg methylphenidate hydrochloride, corresponding to 34.60 mg methylphenidate. Excipient with known effect: 92.80 mg – 106.14 mg sucrose/ hard capsule For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsules FOR SPECIALIST’S USE ONLY 2 MEDIKINET MR 5 MG hard capsules White opaque capsules size 3 with a black imprint containing white and blue pellets. MEDIKINET MR 10 MG hard capsules Amethyst-white opaque capsules size 3 with a black imprint containing white and blue pellets. MEDIKINET MR 20 MG hard capsules Amethyst opaque capsules size 3 with a black imprint containing white and blue pellets. MEDIKINET MR 30 MG hard capsules Hard capsules size 3 with a dark violet opaque cap with a white imprint and a light grey opaque body with a black imprint containing white and blue pellets. MEDIKINET MR 40 MG hard capsules Hard capsules size Izlasiet visu dokumentu