Land: Zweden
Taal: Zweeds
Bron: Läkemedelsverket (Medical Products Agency)
dexamfetaminsulfat
Orifarm AB
N06BA02
dexamfetaminsulfat
20 mg
Tablett
isomalt Hjälpämne; dexamfetaminsulfat 20 mg Aktiv substans
Receptbelagt
Avregistrerad
2018-06-27
Page 1 of 9 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ATTENTIN 10 MG/20 MG TABLETS dexamfetamine sulfate READ ALL OF THIS LEAFLET CAREFULLY BEFORE 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 your child only. Do not pass it on to others. It may harm them, even if their signs of illness are the same. • If your child gets 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 Attentin is and what it is used for 2. What you need to know before you use Attentin 3. How to use Attentin 4. Possible side effects 5. How to store Attentin 6. Contents of the pack and other information 1. WHAT ATTENTIN IS AND WHAT IT IS USED FOR WHAT ATTENTIN IS Attentin tablets contain the active substance dexamfetamine sulfate. Attentin is a psychostimulant. It improves activity in parts of the brain. This medicine can help to improve attention span, concentration, and reduce impulsive behaviour. WHAT IT IS USED FOR Attentin is used to treat attention-deficit/hyperactivity disorder (ADHD). • It is used in children and adolescents aged 6-17 years. • It is not indicated in all children with ADHD. • It is used only after when another medicine called methylphenidate was not sufficiently effective. • It should be used as part of a treatment programme which typically includes psychological, educational and social measures. Attentin treatment must only be initiated by, and used under the supervision of a specialist in childhood or adolescent behavioural disorders. You must talk to a doctor if your child does not feel better or if they feel worse after a month. The doctor may decide that a different treatment is needed. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE ATTENTIN DO NOT USE ATTENTIN IF YOUR CHILD: • is allerg Lees het volledige document
Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Attentin10 mg tablets Attentin 20 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Attentin 10 mg Each tablet contains 10 mg dexamfetamine sulfate. Attentin 20 mg Each tablet contains 20 mg dexamfetamine sulfate. Excipient with known effect: Isomalt (E953) 147.7 mg per 10 mg tablet Isomalt (E953) 137.7 mg per 20 mg tablet For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet Attentin 10 mg Yellow, round, cloverleaf-shaped tablets of 8.4 mm diameter with a notched, cross-scored line on the top side and a cross-scored line embossed with ”M” on each quarter on the rear side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. Attentin 20 mg Reddish, round, cloverleaf-shaped tablets of 8.4 mm diameter with a notched, cross-scored line on the top side and a cross-scored line embossed with ”L” on each quarter on the rear side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Dexamfetamine is indicated as part of a comprehensive treatment programme for attention- deficit/hyperactivity disorder (ADHD) in children and adolescents aged 6 to 17 years when response to previous methylphenidate treatment is considered clinically inadequate. A comprehensive treatment programme typically includes psychological, educational and social measures. Diagnosis should be made according to current DSM criteria or the guidelines in ICD-10 and should be based on a comprehensive multidisciplinary evaluation of the patient. Page 2 of 15 Dexamfetamine is not indicated in all children with ADHD and the decision to use dexamfetamine must be based on a very thorough assessment of the severity and chronicity of the child’s symptoms in relation to the child’s age and potential for abuse, misuse or diversion. Treatment should be under the supervision of a specialist i Lees het volledige document