País: Suecia
Idioma: sueco
Fuente: Läkemedelsverket (Medical Products Agency)
metylfenidathydroklorid
Orion Corporation
N06BA04
methylphenidate hydrochloride
18 mg
Depottablett
laktosmonohydrat Hjälpämne; metylfenidathydroklorid 3,24 mg Aktiv substans; metylfenidathydroklorid 14,76 mg Aktiv substans
Receptbelagt
Förpacknings: Burk, 30 tabletter
Godkänd
2020-05-18
1 PACKAGE LEAFLET: INFORMATION FOR THE USER METHYLPHENIDATE ORION 18 MG PROLONGED-RELEASE TABLETS METHYLPHENIDATE ORION 27 MG PROLONGED-RELEASE TABLETS METHYLPHENIDATE ORION 36 MG PROLONGED-RELEASE TABLETS METHYLPHENIDATE ORION 54 MG PROLONGED-RELEASE TABLETS methylphenidate hydrochloride READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD STARTS TAKING 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 or 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. What Methylphenidate Orion is and what it is used for 2. What you need to know before you or your child takes Methylphenidate Orion 3. How to take Methylphenidate Orion 4. Possible side effects 5. How to store Methylphenidate Orion 6. Contents of the pack and other information 1. WHAT METHYLPHENIDATE ORION IS AND WHAT IT IS USED FOR WHAT IT IS USED FOR Methylphenidate Orion is used to treat ‘attention deficit hyperactivity disorder’ (ADHD) - in children aged 6 years and over and in adults - only after trying treatments which do not involve medicines, such as counselling and behavioural therapy. Methylphenidate Orion is not for use as a treatment for ADHD in children under 6 years of age. HOW IT WORKS Methylphenidate Orion 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 Leer el documento completo
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Methylphenidate Orion 18 mg prolonged-release tablets Methylphenidate Orion 27 mg prolonged-release tablets Methylphenidate Orion 36 mg prolonged-release tablets Methylphenidate Orion 54 mg prolonged-release tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Methylphenidate Orion 18 mg: Each prolonged-release tablet contains 18 mg of methylphenidate hydrochloride. Excipient with known effect: each tablet contains 4 mg lactose monohydrate. Methylphenidate Orion 27 mg: Each prolonged-release tablet contains 27 mg of methylphenidate hydrochloride. Excipient with known effect: each tablet contains 3 mg lactose monohydrate. Methylphenidate Orion 36 mg: Each prolonged-release tablet contains 36 mg of methylphenidate hydrochloride. Excipient with known effect: each tablet contains 7 mg lactose monohydrate. Methylphenidate Orion 54 mg: Each prolonged-release tablet contains 54 mg of methylphenidate hydrochloride. Excipient with known effect: each tablet contains 7 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Prolonged-release tablet (tablet). Methylphenidate Orion 18 mg: round, biconvex, yellow film-coated tablets of approximately 8.5 mm of diameter with a hole on one side of the tablet. Methylphenidate Orion 27 mg: round, biconvex, grey film-coated tablets of approximately 8.5 mm of diameter with a hole on one side of the tablet. Methylphenidate Orion 36 mg: round, biconvex, white film-coated tablets of approximately 10 mm of diameter with a hole on one side of the tablet. Methylphenidate Orion 54 mg: round, biconvex, pink film-coated tablets of approximately 10 mm of diameter with a hole on one side of the tablet. 2 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Attention-deficit/hyperactivity disorder (ADHD) Methylphenidate Orion 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 w Leer el documento completo