Summary of Product Characteristics
last updated on the eMC:
21/12/2011
When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.
Updated on 21/12/2011 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.2 - Posology and method of administration
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 12-Jul-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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In section 4.2 the following paragraph has been changed.
Medikinet XL should not be taken too late in the morning as it may cause disturbances in sleep. However, if the effect of the medicinal product wears off too early in the evening, disturbed behaviour may recur.
A small dose of an immediate-release methylphenidate hydrochloride tablet late in the day may help to solve this problem. In that case, it could be considered that adequate symptom control might be achieved with a twice daily immediate release methylphenidate regimen.
The pros and cons of a small evening dose of immediate-release methylphenidate versus disturbances in falling asleep should be considered.
Treatment should not continue with Medikinet XL if an additional late dose of immediate-release methylphenidate is required, unless it is known that the same extra dose was also required for a conventional immediate-release regimen at equivalent breakfast/lunchtime dose.
The regimen that achieves satisfactory symptom control with the lowest total daily dose should be employed.
For doses not realisable/practicable with this strength, other strengths of this medicinal product and other methylphenidate containing products are available.
In section 4.4 "aggressive or hostile behaviour" the following wording has been changed:
...bearing in mind that upward or downwards titration may be appropriate. Treatment interruption can be considered.
In section 10 the date has been changed to 12th july 2011
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Updated on 11/01/2011 and displayed until 21/12/2011
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Reasons for adding or updating:
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Change to section 3 - Pharmaceutical form
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| Date of revision of text on the SPC: 06-Dec-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Change in pharmaceutical form from prolonged release capsule to modified release capsule
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Updated on 24/06/2010 and displayed until 11/01/2011
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Reasons for adding or updating:
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Change to section 1 -Name of the Medicinal product
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Change to section 2 - Qualitative and quantitative composition
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Change to section 3 - Pharmaceutical form
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Change to section 4.1 - Therapeutic indications
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Change to section 4.2 - Posology and method of administration
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Change to section 4.3 - Contraindications
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 4.7 - Effects on Ability to Drive and Use Machines
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Change to section 4.8 - Undesirable Effects
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Change to section 4.9 - Overdose
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Change to section 5.3 - Preclinical Safety Data
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Change to section 6.1 - List of Excipients
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Change to section 6.2 - Incompatibilities
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 03-Feb-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Updating SmPC
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Updated on 26/02/2007 and displayed until 24/06/2010
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Reasons for adding or updating:
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New SPC for new product
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SPC Retired pending re-submission
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