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.
Section 4.4 – Special warnings and precautions for use
Previous wording:
In particular, when clonidine is used off-label concomitantly with methylphenidate in children with ADHD, serious adverse reactions, including death, have been observed. Therefore clonidine in this combination is not recommended.
Updated wording:
Serious adverse events, including sudden death have been reported in concomitant use with methylphenidate. The safety of using methylphenidate in combination with clonidine has not been systematically evaluated.
Section 4.9 - Overdose
Previous wording: Treatment: In most cases all that is required are general supportive measures. Where bradycardia is severe atropine will increase the heart rate. Updated wording: Treatment: There is no specific antidote for clonidine overdose. Administration of activated charcoal should be performed where appropriate. Supportive care may include atropine sulphate for symptomatic bradycardia, and intravenous fluids and/or inotropic sympathomimetic agents for hypotension. Severe persistent hypertension may require correction with alpha-adrenoceptor blocking drugs. Naloxone may be a useful adjunct for the management of clonidine-induced respiratory depression Section 10 – Date of revision of the text November 2009
In most cases all that is required are general supportive measures. Where bradycardia is severe atropine will increase the heart rate. Updated wording: Treatment: There is no specific antidote for clonidine overdose. Administration of activated charcoal should be performed where appropriate. Supportive care may include atropine sulphate for symptomatic bradycardia, and intravenous fluids and/or inotropic sympathomimetic agents for hypotension. Severe persistent hypertension may require correction with alpha-adrenoceptor blocking drugs. Naloxone may be a useful adjunct for the management of clonidine-induced respiratory depression Section 10 – Date of revision of the text November 2009
Naloxone may be a useful adjunct for the management of clonidine-induced respiratory depression
Section 10 – Date of revision of the text
November 2009
Section 4.4 - The following information has been added:
Patients who wear contact lenses should be warned that treatment with Catapres may cause decreased lacrimation.
The use and the safety of clonidine in children and adolescents has little supporting evidence in randomized controlled trials and therefore cannot be recommended for use in this population.
Section 4.8 - This section has been completely rewritten and now includes frequencies of adverse events
Section 4.9 - coma and apnoea
now reads 'somnolence including coma and respiratory depression including apnoea'
Reason for update:
Change to Section 1 - Name of medical product
Change to section 4.5 - Interaction with other medical products and other forms of interaction
Change to section 6.3 -Shelf life
Change to section 6.4 - Special precautions for storage
Change to section 6.6 - Instructions for use and handling
Change to section 9 - Date of first authorisation/ renewal of authorisation
Change to section 10 - Date of revision of text.
All changes are minor.