País: Sudáfrica
Idioma: inglés
Fuente: South African Health Products Regulatory Authority (SAHPRA)
Eli Lilly (S.A.) (Pty) Ltd
See ingredients
CAPSULES
EACH CAPSULE CONTAINS ATOMOXETINE HYDROCHLORIDE EQUIVALENT TO ATOMOXETINE 60,0 mg
Registered
2005-03-06
_ _ _Page 1 of 13 _ _ _ PATIENT INFORMATION LEAFLET SCHEDULING STATUS S5 PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM STRATTERA 10 mg (capsules) STRATTERA 18 mg (capsules) STRATTERA 25 mg (capsules) STRATTERA 40 mg (capsules) STRATTERA 60 mg (capsules) STRATTERA 80 mg (capsules) WARNING: SUICIDAL IDEATION IN CHILDREN AND ADOLESCENTS STRATTERA (ATOMOXETINE) INCREASED THE RISK OF SUICIDAL IDEATION IN CHILDREN OR ADOLESCENTS. PATIENTS STARTED ON THERAPY SHOULD BE CLOSELY MONITORED. _ _ Each capsule contains ATOMOXETINE hydrochloride equal to 10 mg, 18 mg, 25 mg, 40 mg, 60 mg or 80 mg atomoxetine. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR A CHILD IN YOUR CARE START TAKING STRATTERA (STRA-TAIR-A) Keep this leaflet. You may need to read it again. If you have further questions, please ask your doctor or your pharmacist. _ _ _Page 2 of 13 _ _ _ STRATTERA has been prescribed for you personally or a child in your care and you should not share this medicine with other people. It may harm them, even if their symptoms are the same as yours or a child in your care. _ _ WHAT STRATTERA CONTAINS The active substance is atomoxetine. The other ingredients are black ink, dimethicone, FD&C blue 2 (25 mg, 40 mg and 60 mg only), gelatin, pregelatinised starch, red iron oxide (80 mg only), sodium laurilsulfate, titanium dioxide, yellow iron oxide (18 mg, 60 mg and 80 mg only). LACTOSE FREE. WHAT STRATTERA IS USED FOR STRATTERA is used to treat Attention-Deficit/ Hyperactivity Disorder (ADHD) in children 6 years of age or older, adolescents and adults. BEFORE YOU TAKE STRATTERA OR GIVE STRATTERA TO A CHILD IN YOUR CARE DO NOT TAKE OR GIVE STRATTERA TO A CHILD IN YOUR CARE IF YOU OR A CHILD IN YOUR CARE: are allergic to atomoxetine or any of the other ingredients of STRATTERA; took a medicine known as a monoamine oxidase inhibitor (MAOI), for example phenelzine, in the last two weeks. An MAOI is sometimes used for depression and other mental-health problems; taking STRATTERA with an MAOI could cause seriou Leer el documento completo
_ _ _Page 1 of 21 _ _ _ _ _ SCHEDULING STATUS S5 PROPRIETARY NAME AND DOSAGE FORM STRATTERA 10 mg (Capsules) STRATTERA 18 mg (Capsules) STRATTERA 25 mg (Capsules) STRATTERA 40 mg (Capsules) STRATTERA 60 mg (Capsules) STRATTERA 80 mg (Capsules) WARNING: SUICIDAL IDEATION IN CHILDREN AND ADOLESCENTS STRATTERA (ATOMOXETINE) INCREASED THE RISK OF SUICIDAL IDEATION IN SHORT-TERM STUDIES IN CHILDREN OR ADOLESCENTS WITH ATTENTION-DEFICIT/HYPERACTIVITY DISORDER (AHDH). ANYONE CONSIDERING THE USE OF STRATTERA IN A CHILD OR ADOLESCENT MUST BALANCE THIS RISK WITH THE CLINICAL NEED. CO-MORBIDITIES OCCURRING WITH ADHD MAY BE ASSOCIATED WITH AN INCREASE IN THE RISK OF SUICIDAL IDEATION AND/OR BEHAVIOUR. PATIENTS WHO ARE STARTED ON THERAPY SHOULD BE MONITORED CLOSELY FOR SUICIDALITY (SUICIDAL THINKING AND BEHAVIOUR), CLINICAL WORSENING, OR UNUSUAL CHANGES IN BEHAVIOUR. FAMILIES AND CAREGIVERS SHOULD BE ADVISED OF THE NEED FOR CLOSE OBSERVATION AND COMMUNICATION WITH THE PRESCRIBER. STRATTERA IS APPROVED FOR ADHD IN PAEDIATRIC AND ADULT PATIENTS. STRATTERA IS NOT APPROVED FOR MAJOR DEPRESSIVE DISORDER. COMPOSITION _ _ _ _ _Page 2 of 21 _ _ _ _ _ Each capsule contains atomoxetine hydrochloride equal to 10 mg, 18 mg, 25 mg, 40 mg, 60 mg or 80 mg atomoxetine. STRATTERA capsules contain the following inactive ingredients: black ink, dimethicone, FD&C blue 2 (25 mg, 40 mg and 60 mg only), gelatin, pregelatinised starch, red iron oxide (80 mg only), sodium laurilsulfate, titanium dioxide, yellow iron oxide (18 mg, 60 mg and 80 mg only). Lactose Free. PHARMACOLOGICAL CLASSIFICATION A1.2 Psychoanaleptics PHARMACOLOGICAL ACTION PHARMACODYNAMIC PROPERTIES Atomoxetine is a selective inhibitor of the presynaptic norepinephrine transporter, without directly affecting the serotonin or dopamine transporters. Atomoxetine has minimal affinity for other noradrenergic receptors or for other neurotransmitter transporters or receptors. PHARMACOKINETIC PROPERTIES The pharmacokinetics of atomoxetine in children and adolescents are similar to those in Leer el documento completo