STRATTERA Capsule, hard (2021)
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Περιεχόμενα
Name of the medicinal product
STRATTERA 10mg, 18mg, 25mg, 40mg, 60mg, 80mg or 100mg hard capsules.
Qualitative and quantitative composition
Each hard capsule contains atomoxetine hydrochloride equivalent to 10mg, 18mg, 25mg, 40mg, 60mg, 80mg or 100mg of atomoxetine. For the full list of excipients, see Section 6.1.
Pharmaceutical form
Capsule, hard. <u>STRATTERA 10 mg capsules:</u> hard capsule, opaque white, imprinted with Lilly 3227 and 10 mg in black ink, approximately 15.5-16.1 mm length. <u>STRATTERA 18 mg capsules:</u> hard capsule, ...
Therapeutic indications
STRATTERA is indicated for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children of 6 years and older, in adolescents and in adults as part of a comprehensive treatment programme. ...
Posology and method of administration
Posology STRATTERA can be administered as a single daily dose in the morning. Patients who do not achieve a satisfactory clinical response (tolerability [e.g. nausea or somnolence] or efficacy) when taking ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Atomoxetine should not be used in combination with monoamine oxidase inhibitors (MAOI). Atomoxetine should not ...
Special warnings and precautions for use
Suicide-related behaviour Suicide-related behaviour (suicide attempts and suicidal ideation) has been reported in patients treated with atomoxetine. In double-blind clinical trials, suicide-related behaviours ...
Interaction with other medicinal products and other forms of interaction
Effects of Other Drugs on Atomoxetine MAOIs Atomoxetine should not be used with MAOIs (see section 4.3). CYP2D6 inhibitors (SSRIs (e.g. fluoxetine, paroxetine), quinidine, terbinafine) In patients receiving ...
Pregnancy and lactation
Pregnancy Animal studies in general do not indicate direct harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3). For atomoxetine ...
Effects on ability to drive and use machines
Data on the effects on the ability to drive and use machines are limited. Strattera has a minor influence on the ability to drive and use machines. Atomoxetine has been associated with increased rates ...
Undesirable effects
Paediatric population Summary of the safety profile In paediatric placebo-controlled trials, headache, abdominal pain<sup>1</sup> and decreased appetite are the adverse events most commonly associated ...
Overdose
Signs and symptoms During postmarketing, there have been reports of non-fatal acute and chronic overdoses of atomoxetine alone. The most commonly reported symptoms accompanying acute and chronic overdoses ...
Pharmacodynamic properties
Pharmacotherapeutic group: Psychoanaleptics, centrally acting sympathomimetics ATC code: N06BA09 Mechanism of action and Pharmacodynamic effects Atomoxetine is a highly selective and potent inhibitor of ...
Pharmacokinetic properties
The pharmacokinetics of atomoxetine in children and adolescents are similar to those in adults. The pharmacokinetics of atomoxetine have not been evaluated in children under six years of age. Pharmacokinetic ...
Preclinical safety data
Preclinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenicity, or reproduction and development. Due ...
List of excipients
Starch, pregelatinised (Maize) Dimeticone <u>Capsule shell:</u> Sodium laurilsulfate Gelatin <u>Capsule shell cap colourants:</u> 10 mg: Titanium dioxide E171 18 mg: Yellow iron oxide E172 25 mg, 40 mg, ...
Incompatibilities
Not applicable.
Shelf life
3 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
Polyvinyl chloride (PVC)/polyethylene (PE)/ Polychlorotrifluoroethylene, PCTFE blister sealed with aluminium foil lid. Available in pack sizes of 7, 14, 28 and 56 capsules. Not all pack sizes may be marketed. ...
Special precautions for disposal and other handling
The capsules are not intended to be opened. Atomoxetine is an ocular irritant. In the event of capsules content coming in contact with the eye, the affected eye should be flushed immediately with water, ...
Marketing authorization holder
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands
Marketing authorization number(s)
STRATTERA 10 mg hard capsules: PL 14895/0303 STRATTERA 18 mg hard capsules: PL 14895/0304 STRATTERA 25 mg hard capsules: PL 14895/0305 STRATTERA 40 mg hard capsules: PL 14895/0306 STRATTERA 60 mg hard ...
Date of first authorization / renewal of the authorization
Date of first authorisation: 27 May 2004 Date of latest renewal: 27 May 2014
Date of revision of the text
26 January 2021
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