Summary of Product Characteristics
last updated on the eMC:
14/07/2011
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 14/07/2011 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 5.1 - Pharmacodynamic Properties
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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: 09-Jun-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.2 - clarification on efficacy
Section 5.1 - clarification on efficacy
Section 10 - date of revision
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Updated on 10/12/2010 and displayed until 14/07/2011
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Reasons for adding or updating:
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Change to section 2 - Qualitative and quantitative composition
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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 4.8 - Undesirable Effects
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Change to section 4.9 - Overdose
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Change to section 5.2 - Pharmacokinetic Properties
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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: 18-Nov-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section Summmary of change
2 Updated lactose to lactose monohydrate
4.2 Updated with information on End Stage Renal Disease and on the Elderly
4.3 Updated statement on renal impairment
4.8 Minor change to standard wording on frequencies in line with current QRD template
4.9 Minor change to overdose statement
5.2 Updated information on Elderly, Renal Impairment and Paediatric population
10 Updated with new date of revision of text
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Updated on 20/08/2010 and displayed until 10/12/2010
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Reasons for adding or updating:
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Change to section 3 - Pharmaceutical form
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.8 - Undesirable Effects
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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: 23-Jul-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Sections:
3. Change to tablet description
4.4 Revision of statement on augmentation and ealry morning rebound
4.8 Addition of table on augmentation and early morning rebound
10 Date of Revision 23/07/2010
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Updated on 05/03/2009 and displayed until 20/08/2010
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Reasons for adding or updating:
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Change to section 2 - Qualitative and quantitative composition
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Change to section 4.8 - Undesirable Effects
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Change to section 5.3 - Preclinical Safety Data
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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: 26-Jan-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 2 - The following was added to this section:- Excipient: 45.3 / 45.0 / 44.9 / 44.6 mg lactose
Section 4.8 - The following was added to this section:- Hypersensitivity reactions (including urticaria, angioedema, rash, pruritus)
Section 5.3 - This section is amended as follows:
Absorption
A high fat meal decreases the rate of absorption of ropinirole, as shown by a delay in median Tmax by 2.6 hours and an average 25% decrease in Cmax.
Distribution
Plasma protein binding of ropinirole is low (10 – 40%). Consistent with its high lipophilicity,ropinirole exhibits a large volume of distribution (approx. 7 l/kg)
Metabolism
Ropinirole is primarily cleared by the cytochrome P450 enzyme, CYP1A2, and its metabolites are mainly excreted in the urine. The major metabolite is at least 100 times less potent than ropinirole in animal models of dopaminergic function.
Elimination
Ropinirole is cleared from the systemic circulation with an average elimination half-life of approximately 6 hours. No change in the oral clearance of ropinirole is observed following single and repeated oral administration. Wide inter-individual variability in the pharmacokinetic parameters has been observed.
Section 10 - Date changed to 26 January 2009
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Updated on 23/01/2009 and displayed until 05/03/2009
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Reasons for adding or updating:
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 5.3 - Preclinical Safety Data
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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: 09-Jan-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Section 5.1 - The following paragraph is added to the bottom of the section: Study of the effect of ropinirole on cardiac repolarisation A thorough QT study conducted in male and female healthy volunteers who received doses of 0.5, 1, 2 and 4 mg of ropinirole film-coated (immediate release) tablets once daily showed a maximum increase of the QT interval duration at the 1mg dose of 3.46 milliseconds (point estimate) as compared to placebo. The upper bound of the one sided 95% confidence interval for the largest mean effect was less than 7.5 milliseconds. The effect of ropinirole at higher doses has not been systematically evaluated. The available clinical data from a thorough QT study do no indicate a risk of QT prolongation at doses of ropinirole up to 4 mg/day.
Section 5.3 - This section is amended as follows: Toxicology: The toxicology profile is principally determined by the pharmacological activity of ropinirole: behavioural changes, hypoprolactinaemia, decrease in blood pressure and heart rate, ptosis and salivation. In the albino rat only, retinal degeneration was observed in a long term study at the highest dose (50 mg/kg/day), and was probably associated with an increased exposure to light. Genotoxicity: Genotoxicity was not observed in the usual battery of in vitro and in vivo tests. Carcinogenicity: From two-year studies conducted in the mouse and rat at dosages up to 50 mg/kg/day there was no evidence of any carcinogenic effect in the mouse. In the rat, the only ropinirole-related lesions were Leydig cell hyperplasia and testicular adenoma resulting from the hypoprolactinaemic effect of ropinirole. These lesions are considered to be a species specific phenomenon and do not constitute a hazard with regard to the clinical use of ropinirole. Reproductive Toxicity: Administration of ropinirole to pregnant rats at maternally toxic doses resulted in decreased foetal body weight at 60 mg/kg/day (approximately 15 times the AUC at the maximum dose in humans), increased foetal death at 90 mg/kg/day (approximately 25 times the AUC at the maximum dose in humans) and digit malformations at 150 mg/kg/day (approximately 40 times the AUC at the maximum dose in humans). There were no teratogenic effects in the rat at 120 mg/kg/day (approximately 30 times the AUC at the maximum dose in humans) and no indication of an effect on development in the rabbit.Safety Pharmacology: In vitro studies have shown that ropinirole inhibits hERG-mediated currents. The IC50 is 5-fold higher than the expected maximum plasma concentration in patients treated at the highest recommended dose (4 mg/day), see section 5.1.
Section 10 - Date changed to 9 January 2009
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Updated on 08/05/2008 and displayed until 23/01/2009
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Reasons for adding or updating:
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Change to section 6. 5 - Nature and Contents of Container
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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: 25-Apr-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Section 6.5 Additional blister type: PVC/PCTFE/PVC/Aluminium blister
Section 10 Date of revision updated to 25/04/08
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Updated on 24/08/2007 and displayed until 08/05/2008
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Reasons for adding or updating:
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.8 - Undesirable Effects
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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: 08/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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Section 4.4 New wording added:
Impulse control disorders including pathological gambling and hypersexuality, and increased libido, have been reported in patients treated with dopamine agonists, including ropinirole, principally for Parkinson’s disease. Those disorders were reported especially at high doses and were generally reversible upon reduction of the dose or treatment discontinuation. Risk factors such as a history of compulsive behaviours were present in some cases (see section 4.8).
Section 4.8 New wording added, under the sub-heading 'Post marketing reports':
Psychotic reactions (other than hallucinations) including delirium, delusion, paranoia have been reported.
Impulse control disorders including pathological gambling and hypersexuality, and increased libido, have been reported (see section 4.4).
Section 10: Updated to:
22/08/07
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Updated on 22/05/2006 and displayed until 24/08/2007
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Reasons for adding or updating:
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