When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
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
New SPC for new product
New Strength of Concerta XL
8.
MARKETING AUTHORISATION NUMBER(S)
PA 748/49/4
9.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
01 August 08
August 08
7.
Update address to 50-100 Holmers Farm Way
Changed to August 2008
Change to section 4.4 – Special Warnings and Precautions for Use
Addition of mania/aggression sub-headings & text
Change to section 4.8 – Undesirable effects
Major revision to update to 2005 SPC guidance
Change to section 10 – Date of revision of the text
Changed to September 2007
Change to separate SPCs covering individual presentations
Change to section 4.2 – Posology and Method of Administration
Change in position of ‘Children (under 6 years of age) section to beginning of section 4.2.
Change in position of ‘Use in patients with renal hepatic impairment’ from this section into section 4.2
Under section heading ‘Galactose intolreance’ additional statement adding ‘This medicinal product contains lactose’
Change to section 4.5 –Interaction with other medicinal products and other forms of interaction
Addition of cross-references to sections 4.3 and 4.4
Change to section 4.6 – Pregnancy and Lactation
Addition of section headings: ‘Women of childbearing potential/Contraception ; Pregnancy ; Lactation
Change to section 6.1 – List of Excipients
Excipients capitalised and listed sequentially
Change to section 6.6 – Instructions for use, handling and disposal
Section heading updated
Change to section 9 – Date of Renewal of Authorisation
Updated to add ‘6 June 2007’ ; sub-section headings added
Updated to add ‘6 June 2007’
Change to joint SPC covering all presentations
Updated: warning in patients with cardiac structural abnormalities
Updated INN names for Phenobarbital and amfetamine