Страна: Швеция
Язык: шведский
Источник: Läkemedelsverket (Medical Products Agency)
metylfenidathydroklorid
Generis Farmacêutica, SA
N06BA04
methylphenidate hydrochloride
54 mg
Depottablett
metylfenidathydroklorid 44,28 mg Aktiv substans; metylfenidathydroklorid 9,72 mg Aktiv substans; laktosmonohydrat Hjälpämne
Receptbelagt
Förpacknings: Burk, 30 tabletter; Burk, 60 (2 x 30) tabletter; Burk, 90 (3 x 30) tabletter
Godkänd
2022-02-10
PACKAGE LEAFLET: INFORMATION FOR THE USER METHYLPHENIDATE GENERIS 18 MG PROLONGED RELEASE TABLETS METHYLPHENIDATE GENERIS 27 MG PROLONGED RELEASE TABLETS METHYLPHENIDATE GENERIS 36 MG PROLONGED RELEASE TABLETS METHYLPHENIDATE GENERIS 54 MG PROLONGED RELEASE TABLETS methylphenidate hydrochloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD START THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - 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 or your child only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours/your child’s. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. Whatis and what it is used for 2. What you need to know before you or your child take Прочитать полный документ3. How to take 4. Possible side effects 5. How to store 6. Contents of the pack and other information 1. WHAT < INVENTED NAME> IS AND WHAT IT IS USED FOR WHAT IT IS USED FOR < invented name> is used to treat ‘attention deficit hyperactivity disorder’ (ADHD). • It is used in children aged 6 years and over and in adults. • It is used only after trying treatments which do not involve medicines, such as counselling and behavioural therapy. < invented name> is not for use as a treatment for ADHD in children under 6 years of age. HOW IT WORKS < invented name> 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. It is prescribed only by doctors who have experience in children, adolescents or adults with behaviour probl
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Methylphenidate Generis 18 mg prolonged release tablets Methylphenidate Generis 27 mg prolonged release tablets Methylphenidate Generis 36 mg prolonged release tablets Methylphenidate Generis 54 mg prolonged release tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One prolonged-release tablet contains 18 mg; 27 mg; 36 mg; 54 mg of methylphenidate hydrochloride. Excipients with known effect: - For the strenght of 18 mg, one prolonged release tablet contains 4 mg of lactose monohydrate - For the strenght of 27 mg, one prolonged release tablet contains 3.4 mg of lactose monohydrate - For the strenght of 36 mg, one prolonged release tablet contains 6.6 mg of lactose monohydrate - For the strenght of 54 mg, one prolonged release tablet contains 6.8 mg of lactose monohydrate For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Prolonged-release tablet. 18 mg Round, biconvex, yellow film-coated tablets of approximately 9 mm of diameter with a hole in one side of the tablet. 27 mg Round, biconvex, grey film-coated tablets of approximately 9 mm of diameter with a hole in one side of the tablet. 36 mg Round, biconvex, white film-coated tablets of approximately 10 mm of diameter with a hole in one side of the tablet. 54 mg Round, biconvex, pink film-coated tablets of approximately 10 mm of diameter with a hole in one side of the tablet. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Attention-Deficit/Hyperactivity Disorder (ADHD)is indicated as part of a comprehensive treatment programme for Attention Deficit Hyperactivity Disorder (ADHD) in children aged 6 years of age and over and adults when remedial measures alone prove insufficient. TREATMENT MUST BE INITIATED AND SUPERVISED BY A PHYSICIAN SPECIALISED IN THE TREATMENT OF ADHD SUCH AS AN EXPERT PAEDIATRICIAN, A CHILD AND ADOLESCENT PSYCHIATRIST OR AN ADULT PSYCHIATRIST . Special Diagnostic Considerations for ADHD in children Diagnosis should be made according Прочитать полный документ