Šalis: Airija
kalba: anglų
Šaltinis: HPRA (Health Products Regulatory Authority)
Methylphenidate hydrochloride
Imbat Limited
N06BA; N06BA04
Methylphenidate hydrochloride
18 milligram(s)
Prolonged-release tablet
Oral use
30 prolonged-release tablets
Product subject to prescription which may not be renewed (A)
JANSSEN PHARMACEUTICA N.V
Centrally acting sympathomimetics
Centrally acting sympathomimetics; methylphenidate
It is indicated as part of a comprehensive treatment programme for Attention Deficit Hyperactivity Disorder in children aged 6 years and over
Authorised
2015-04-02
Page 1 of 2 PACKAGE LEAFLET: INFORMATION FOR THE USER CONCERTA ® XL 18MG PROLONGED-RELEASE TABLETS (methylphenidate hydrochloride) The name of your medicine is Concerta XL, it contains the active substance ‘methylphenidate hydrochloride’. The name ‘methylphenidate’ will also be used in this leaflet. IMPORTANT THINGS YOU NEED TO KNOW ABOUT YOUR MEDICINE THIS MEDICINE IS USED TO TREAT ADHD The full name for ADHD is ‘Attention Deficit Hyperactivity Disorder’. The medicine helps with your brain activity. It can help improve your attention, help you concentrate, and make you less impulsive. You need to have other treatments for ADHD as well as this medicine. Read Section 1 for more information. BEFORE YOU TAKE THIS MEDICINE, TALK TO YOUR DOCTOR IF: You have heart, circulation, or mental health problems - you may not be able to take this medicine. You are taking any other medicines - this is because methylphenidate can affect how other medicines work. Read Section 2 for more information. WHILE TAKING THIS MEDICINE: See your doctor regularly. This is because your doctor will want to check how the medicine is working. Do not stop taking the medicine without first talking to your doctor. Your doctor may stop your medicine to see if it is still needed, if you take it for more than a year. The most common side effects are feeling nervous, not being able to sleep or having a headache. Read Sections 3 and 4 for more information. TALK TO YOUR DOCTOR STRAIGHT AWAY IF ANY OF THE FOLLOWING HAPPEN: Your mood and how you feel changes. You feel any problems with your heart. Read Section 4 for more information. THE REST OF THIS LEAFLET INCLUDES MORE DETAIL AND OTHER IMPORTANT INFORMATION ON THE SAFE AND EFFECTIVE USE OF THIS MEDICINE. Keep this leaflet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of i Perskaitykite visą dokumentą
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Concerta XL 18 mg prolonged-release tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One prolonged-release tablet contains 18 mg of methylphenidate hydrochloride. Excipients with known effect: contains lactose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged-release tablet. _Product imported from Germany_ Capsule-shaped, yellow tablets with “alza 18” printed on one side in black ink. 4 CLINICAL PARTICULARS As per PA0748/049/001 5 PHARMACOLOGICAL PROPERTIES As per PA0748/049/001 6 PHARMACEUTICAL PARTICULARS 6.1 LIST OF EXCIPIENTS Butylhydroxytoluene (E321) Cellulose acetate Hypromellose (E464) Phosphoric acid 85% Poloxamer 188 Macrogol 200 000 and 7000 000 Povidone K29-32 Sodium chloride Stearic acid Succinic acid Iron oxide black (E172) Iron oxide yellow (E172) FILM COAT: Iron oxide yellow (E172) Hypromellose (E464) Lactose monohydrate Stearic acid Titanium dioxide (E171) Triacetin H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ _D_ _a_ _t_ _e_ _ _ _P_ _r_ _i_ _n_ _t_ _e_ _d_ _ _ _0_ _2_ _/_ _0_ _4_ _/_ _2_ _0_ _1_ _5_ _C_ _R_ _N_ _ _ _2_ _1_ _5_ _0_ _5_ _6_ _6_ _p_ _a_ _g_ _e_ _ _ _n_ _u_ _m_ _b_ _e_ _r_ _:_ _ _ _1_ CLEAR COAT: Carnauba wax Hypromellose (E464) Macrogol 400 PRINTING INK: Iron oxide black (E172) Hypromellose (E464) Isopropyl alcohol Propylene glycol Purified water 6.2 INCOMPATIBILITIES Not applicable. 6.3 SHELF LIFE The shelf life expiry date of this product is the date shown on the inner packaging and outer car Perskaitykite visą dokumentą