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Section 4.4 Special warningd and precautions Aggressive or hostile behaviour
The emergence or worsening of aggression or hostility can be caused by treatment with stimulants. Patients treated with methylphenidate should be closely monitored for the emergence or worsening of aggressive behaviour or hostility at treatment initiation, at every dose adjustment and then at least every 6 months and every visit. Physicians should evaluate the need for adjustment of the treatment regimen in patients experiencing behaviour changes bearing in mind that upwards or downwards titration may be appropriate. Treatment interruption can be considered.
Section 4.9 Overdose
When treating patients with overdose, allowances must be made for the delayed release of methylphenidate from this formulations with extended durations of action
4.1
Therapeutic Indications
Treatment must be under the supervision of a specialist in childhood behavioural disorder, and emphasis on the need for remedial measures before introducing pharmacotherapy.
4.2
Posology and method of administration
Addition of Phaecochromocytoma
4.3
Contraindications
4.4
Special Warnings and Precautions for Use
More detailed information on long term effects, ongoing monitoring requirements, and withdrawing medication for trial period
4.5
Interaction with other medicinal products and other forms of interaction
Additional caution with dopaminergic drugs, clonidine, halogenated anaesthetics , antihypertensive drugs
4.6
Pregnancy and Lactation
Pregnancy:Addition of reports of neonatal cardioresipiratory toxicity, specifically foetal tachycardia and respiratory distress
Lactation: methylphenidate has been found in breast milk, one case report of weight decrease
4.7
Effects of ability to drive and use machines
Visual disturbances including blurred vision may affect ability to drive or operate machinery
4.8
Undesirable effects
Table has been re-formatted with new system organ classes.In crease in number and type of psychiatric side effects including suicide. Also reports of cerebrovascular accident , neuroleptics malignant syndrome, choreoatheroid movements, hyperhidrosis, muscle cramps, gynaecomastia
4.9
Overdose
No new information section re-written
5.3
Preclinical Safety Data
10.
DATE OF REVISION OF THE TEXT
Changed to Ferbruary 2010