Neupro 1mg/24hr and 3 mg/24 hTransdermal Patch

  • Name:

    Neupro 1mg/24hr and 3 mg/24 hTransdermal Patch

  • Company:
    info
  • Active Ingredients:

    Rotigotine

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 02/08/18

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Summary of Product Characteristics last updated on medicines.ie: 2/8/2018

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UCB (Pharma) Ireland Limited

UCB (Pharma) Ireland Limited

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Medicine Name Keppra 250 mg film-coated tablets Active Ingredients Levetiracetam
Medicine Name Keppra 500 mg film-coated tablets Active Ingredients Levetiracetam
Medicine Name Keppra 750 mg film-coated tablets Active Ingredients Levetiracetam
Medicine Name Neupro 1mg/24hr and 3 mg/24 hTransdermal Patch Active Ingredients Rotigotine
Medicine Name Neupro 2mg/24hr Transdermal Patch Active Ingredients Rotigotine
Medicine Name Neupro 4 mg/24hr, 6 mg/24hr, 8 mg/24hr Transdermal Patch Active Ingredients Rotigotine
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Medicine Name Vimpat 10 mg/ml syrup Active Ingredients lacosamide
Medicine Name Vimpat 50 mg, 100 mg, 150 mg, 200 mg film-coated tablets Active Ingredients lacosamide
Medicine Name Xyrem 500mg/ml oral solution Active Ingredients Sodium oxybate
Medicine Name Xyzal 0.5mg/ml oral solution Active Ingredients Levocetirizine dihydrochloride
Medicine Name Xyzal 5mg Tablets Active Ingredients Levocetirizine dihydrochloride
Medicine Name Xyzal 5mg/ml Oral Drops, Solution Active Ingredients Levocetirizine dihydrochloride
Medicine Name Zirtek Allergy Relief 10 mg film-coated tablets (OTC) Active Ingredients Cetirizine Dihydrochloride
Medicine Name Zirtek Oral Solution Active Ingredients Cetirizine Dihydrochloride
Medicine Name Zirtek Plus Decongestant 5mg/120mg Prolonged Release Tablets Active Ingredients Cetirizine Dihydrochloride, Pseudoephedrine Hydrochloride
1 - 0 of 26 items.Total: Infinity pages

When a pharmaceutical company changes any document, 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.

Updated on 2 August 2018 PIL

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 2 August 2018 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Changes concerning the following review: Dropped Head Syndrome and additional changes
Section 4.8 Undesirable effect- Tabulated list of adverse reactions; Section 10 Date of revision of the text

Updated on 17 January 2018 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 17 January 2018 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 6.5 - Nature and contents of container

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

 

Changes were made to the following sections:

Section 4.2: Changes to duration of pressing during the application of the patch.

 Section 6.5: amendment to reflect the change of design from cardboard to plastic and to change an existing pack-size.

Updated on 1 December 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 1 December 2017 PIL

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - use in children and adolescents
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - driving and using machines
  • Change to section 2 - excipient warnings
  • Change to section 3 - dose and frequency
  • Change to section 3 - use in children/adolescents
  • Change to section 3 - how to take/use
  • Change to section 3 - duration of treatment
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Individual PILs superseded by joint PIL

Updated on 16 October 2017 PIL

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 16 October 2017 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

In the section 7.0 (Marketing Authorisation Holder) address is updated

Updated on 26 June 2017 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

To include the 14 pack size in the section 6. 5.

Updated on 23 June 2017 PIL

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 6 - what the product looks like and pack contents

Updated on 13 December 2016 PIL

Reasons for updating

  • Change to other sources of information section

Updated on 15 November 2016 PIL

Reasons for updating

  • Change to other sources of information section

Updated on 15 March 2016 SmPC

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

5.1 Pharmacodynamic properties

 

Reference to a skin adhesion study has been included.

 

6.3 Shelf life

 

The shelf life has increased to 30 months (from 2 years).

 

6.4 Special precautions for storage

 

The storage conditions have been updated to “Do not store above 30°C” (previously 25°C).

 

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

 

The date of last renewal has been added: 22 January 2016

 

10. DATE OF REVISION OF THE TEXT

 

The date of revision has been added: 02/2016

Updated on 10 March 2016 PIL

Reasons for updating

  • Change to storage instructions
  • Change to date of revision
  • Change to dosage and administration

Updated on 16 February 2016 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

 

Changes were made to the following sections:

 

Section 1, 2, 3: Changes to reflect the combination of different strengths in one SmPC.

Section 4.1: Editorial changes

Section 4.2: Editorial changes and removal of a sentence about the case a patch fall off.

Section 4.4:Changes to the syncope and augmentation sub-sections.

Section 4.8: addition of  new side effects, and changing in the frequency for already registered side effects. The section 'Description of selected adverse reactions' has also been edited.

 

Section 5.1: Addition of an 'augmentation sub-section'.

Section 6.1: Editorial changes

Section 6.5: Deletion of registered pack-sizes

Section 6.6: Editorial changes

 

Updated on 11 February 2016 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Deletion of a pack size

Updated on 30 June 2015 PIL

Reasons for updating

  • Change to side-effects

Updated on 26 June 2015 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

In section 4.2 (Posology and method of administration): Update on the Paediatric population sub-section

In section 4.8 (undesirable effects), Addition of the Dopamine dysregulation syndrome side effect, Frequency: Not known.

In section 5.2 (Pharmacokinetics properties) Addition of data on the Paediatric population.

Updated on 17 December 2014 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.8: undesirable effects is updated with inclusion of delirium and delusion as rare psychiatric disorders and investigations has been added as the new system organ class with increased CPK as the common undesirable effect.

Updated on 5 February 2014 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

 
Section 4.2 & 4.4 : No changes - only rewording


Section 4.8     
 

Restless Legs Syndrome

Immune system disorders

Common: Hypersensitivity, which may include angioedema, tongue oedema and lip oedema

 

Psychiatric disorders

Common: Sleep attacks/sudden onset of sleep, sexual desire disordersa (incl. hypersexuality, libido increased), insomnia, sleep disorder, abnormal dreams, impulse-control disordersa (incl. pathological gambling, stereotypy/punding, compulsive shoppingc)

Uncommon: Obsessive-compulsive disorder, disorientation, agitation

Rare: Aggressive behaviour/
aggressionb, binge eating/eating disorderb

 

General disorders and administration site conditions

Very Common: Application and instillation site reactionsa (incl. erythema, pruritus, irritation, rash, dermatitis, vesicles, pain, eczema, inflammation, swelling, discolouration, papules, exfoliation, urticaria, hypersensitivity), asthenic conditionsa (incl. fatigue, asthenia, malaise)

Common: Irritability, oedema peripheral

 

Parkinson’s disease

Immune system disorders

Common: Hypersensitivity, which may include angioedema, tongue oedema and lip oedema

 

Psychiatric disorders

Common: Perception disturbancesa
(incl. hallucination, hallucination visual, hallucination auditory, illusion), insomnia, sleep disorder, nightmare, abnormal dreams, impulse-control disordersa (incl. pathological gambling, stereotypy/
punding, compulsive shoppingc)

Uncommon: Sleep attacks/sudden onset of sleep, paranoia, sexual desire disordersa (incl. hypersexuality, libido increased), confusional state, disorientation, agitation

Rare: Psychotic disorder, obsessive-compulsive disorder, aggressive behaviour/
aggressionb, binge eating/eating disorderb

 

Eye disorders

Uncommon: Vision blurred, visual impairment, photopsia

 

General disorders and administration site conditions

Very common: Application and instillation site reactionsa  (incl. erythema, pruritus, irritation, rash, dermatitis, vesicles, pain, eczema, inflammation, swelling, discolouration, papules, exfoliation, urticaria, hypersensitivity)

 

a High Level Term

b Observed in open-label studies

c Observed during post-marketing

 

 

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via

 

Ireland Pharmacovigilance Section, Irish Medicines Board…. etc.

UK: The Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard

Updated on 25 September 2013 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to improve clarity and readability

Updated on 3 July 2013 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.5 - Nature and contents of container

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

 

4.2     Posology and method of administration

 

Patients with hepatic impairment: Adjustment of the dose is not necessary in patients with mild to moderate hepatic impairment. Caution is advised when treating patients with severe hepatic impairment, which may result in lower rotigotine clearance. Rotigotine has not been investigated in this patient group. A dose reduction might be needed in case of worsening of the hepatic impairment. Patients with renal impairment: Adjustment of the dose is not necessary in patients with mild to severe renal impairment, including those requiring dialysis. Unexpected accumulation of rotigotine levels may also occur at acute worsening of renal function (see sections 4.2 and 5.2).

 

4.6     Fertility, Pregnancy and lactation

Women of childbearing potential, contraception in females

Women of childbearing potential should use effective contraception to prevent pregnancy during treatment with rotigotine.

 

4.8     Undesirable effects

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

 

6.5     Nature and contents of container

The carton contains 7, 20, 28, 30, 56, 60, 84 (multipack containing 2 packs of 42), 90 or 100 (multipack containing 2 packs of 50) transdermal patches, individually sealed in sachets.

Other minor changes are editorial, including new headings, bold text etc.

Updated on 12 June 2013 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

4.2     Posology and method of administration

Abnormal thinking and behaviour

Abnormal thinking and behaviour have been reported and can consist of a variety of manifestations including paranoid ideation, delusions, hallucinations, confusion, psychotic-like behaviour, disorientation, aggressive behaviour, agitation, and delirium.

 

4.8     Undesirable effects

Immune system disorders

Not known: Angioedema, tongue oedema and lip oedema

Psychiatric disorders

Uncommon: disorientation

Updated on 4 June 2013 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.2: Use and handling: Protective liner replaced with release liner
Section 6.1: Release liner: Transparent fluoropolymer coated polyester film.
Section 6.3: 2 years
Section 6.4: Do not store above 25°C.

Updated on 28 January 2013 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 9 - Date of renewal of authorisation

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

4.4     Special warnings and precautions for use

Impulse control disorders

Patients should be regularly monitored for the development of impulse control disorders. Patients and carers should be made aware that behavioural symptoms of impulse control disorders including pathologic gambling, increased libido,hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur  in patients treated with dopamine agonists, for Parkisons disease, including rotigotine.  Dose reduction/tapered discontinuation should be considered if such symptoms develop.

 

4.8     Undesirable effects

Restless Legs Syndrome

Rare

Psychiatric disorders

Aggressive behaviour/ aggressionb, binge eating and compulsive eatingb

 

Parkinson’s disease

Rare

Psychiatric disorders

Psychotic disorder, obsessive-compulsive disorder, aggressive behaviour/
aggression
b, binge eating and compulsive eatingb

 

b Observed in open-label studies

 

Impulse control disorders

Pathological gambling, increased libido,hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists including rotigotine  (see section 4.4 ‘Special warnings and precautions for use’).

 

 

5.1     Pharmacodynamic properties

 

Clinical studies in Parkinson’s disease

In further studies the effects of rotigotine on specific aspects of Parkinson’s disease were evaluated.

 

This study failed to demonstrate non-inferiority of rotigotine to ropinirole.

 

In a subsequent open-label, multicenter, multinational study, the tolerability of overnight switching from ropinirole, pramipexole or cabergoline to rotigotine transdermal patch and its effect on symptoms in subjects with idiopathic Parkinson’s disease have been studied. 116 patients were switched from previous oral therapy to receive up to 8 mg/24 h of rotigotine, among these were 47 who had been treated with ropinirole up to 9 mg/day, 47 who had been treated with pramipexole up to 2 mg/day and 22 who had been treated with cabergoline up to 3 mg/day. Switching to rotigotine was feasible, with minor dose adjustment (median 2 mg/24 h) being necessary in only 2 patients switching from ropinirole, 5 patients from pramipexole and 4 patients from cabergoline. Improvements were seen in UPDRS Parts I - IV scores. The safety profile was unchanged from that observed in previous studies.

 

In a randomized, open-label study in patients with early-stage Parkinson’s disease, 25 patients were randomized to rotigotine treatment and 26 to ropinirole. In both arms treatment was titrated to optimal or maximum dose of 8 mg/24 h or 9 mg/day, respectively. Both treatments showed improvements in early morning motor function and sleep. Motor symptoms (UPDRS Part III) improved by 6.3 ± 1.3 points in rotigotine-treated patients, and by 5.9 ± 1.3 points in the ropinirole-group after 4 weeks of maintenance. Sleep (PDSS) improved by 4.1 ± 13.8 points for rotigotine-treated patients, and by 2.5 ± 13.5 points for ropinirole-treated patients. The safety profile was comparable, with the exception of application site reactions.

 

In these studies conducted since the initial comparative trial, rotigotine and ropinirole at equivalent doses were shown to have comparable efficacy.

 

Two additional pivotal trials were conducted in patients who were receiving concomitant levodopa therapy.

 

9.       DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

 

Date of first authorisation: 15 February 2006

Date of last renewal: 17 February 2011

Updated on 17 February 2012 PIL

Reasons for updating

  • Change to instructions about overdose

Updated on 4 October 2011 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

.4       Special warnings and precautions for use

 

Fibrotic complications

Fibrotic complications: Cases of retroperitoneal fibrosis, pulmonary infiltrates, pleural effusion, pleural thickening, pericarditis and cardiac valvulopathy have been reported in some patients treated with ergot-derived dopaminergic agents. While these complications may resolve when treatment is discontinued, complete resolution does not always occur.

Although these adverse reactions are believed to be related to the ergoline structure of these compounds, whether other, nonergot derived dopamine agonists can cause them is unknown.

 

4.8     Undesirable effects

 

The following table covers adverse drug reactions from the pooled studies mentioned above in patients with Parkinson’s disease. Within the system organ classes, adverse reactions are listed under headings of frequency (number of patients expected to experience the reaction), using the following categories: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Post-marketing experience: The post-marketing experience to date is consistent with the adverse effects profile observed in the clinical trials.

 

 

4.9     Overdose

 

The most likely adverse reactions would be those related to the pharmacodynamic profile of a dopamine agonist, including nausea, vomiting, hypotension, involuntary movements, hallucinations, confusion, convulsions and other signs of central dopaminergic stimulation.

There is no known antidote for overdose of dopamine agonists. In case of suspected overdose, removal of the patch(es) should be considered because after removal of the patch(es) the drug input is stopped and the plasma concentration of rotigotine decreases rapidly. The patient should be monitored closely, including heart rate, heart rhythm and blood pressure.

Treatment of overdose may require general supportive measures to maintain the vital signs. Dialysis would not be expected to be beneficial as rotigotine is not eliminated by dialysis.

If it is necessary to discontinue rotigotine, this should be done gradually to prevent neuroleptic malignant syndromeThere is no known antidote for overdose of dopamine agonists. In case of suspected overdose, the patch(es) should immediately be removed from the patient. Levels of rotigotine decrease after patch removal. Before stopping use of rotigotine completely see section 4.2.

The patient should be monitored closely, including heart rate, heart rhythm and blood pressure. Because rotigotine is over 90% protein bound, dialysis would not be expected to be beneficial.

Treatment of overdose may require general supportive measures to maintain the vital signs.

 

 

5.       PHARMACOLOGICAL PROPERTIES

 

5.1     Pharmacodynamic properties

 

Pharmacotherapeutic group: Anti-parkinsons drugs, dopamine agonists; ATC code: N04BC09

 

Rotigotine is a non-ergolinic dopamine agonist for the treatment of signs and symptoms of Parkinson’s disease and Restless Legs Syndrome.

Regarding the functional activity at the various receptor subtypes and their distribution in the brain, rotigotine is a D2 and D3 receptor agonist acting also on D1, D4 and D5 receptors. With non-dopaminergic receptors, rotigotine showed antagonism at alpha2B and agonism at 5HT1A receptors, but no activity on the 5HT2B receptor.

Rotigotine is believed to elicit its beneficial effect on Parkinson’s disease by activation of the D3, D2 and D1 receptors of the caudate-putamen in the brain.

 

The precise mechanism of action of rotigotine as a treatment of RLS is unknown. It is thought that rotigotine may exert its activity mainly via dopamine receptors.

Rotigotine is a non-ergolinic D3/D2/D1 dopamine agonist for the treatment of Parkinson’s disease. It is believed to elicit its beneficial effect by activation of the D3, D2 and D1 receptors of the caudate-putamen in the brain.

Rotigotine alleviates signs and symptoms of idiopathic Parkinson’s disease.

 

 

Clinical studies in Parkinson’s disease

 

A further multinational double-blind study was conducted in 287 patients with early or advanced stages of Parkinson’s disease who had unsatisfactory early morning motor symptom control. 81.5% of these patients were on concomitant levodopa therapy. 190 patients received rotigotine, and 97 placebo. The patients were titrated to their optimal dose of rotigotine or placebo in weekly increments of 2 mg/24 h starting at 2 mg/24 h to a maximum dose of 16 mg/24 h over 8 weeks, followed by a maintenance period of 4 weeks. Early morning motor function, assessed by UPDRS part III, and nocturnal sleep disturbances, measured by the modified Parkinson’s Disease Sleep Scale (PDSS-2), were co-primary outcome measures. At the end of maintenance, the mean UPDRS part III score had improved by 7.0 points in rotigotine-treated patients (baseline 29.6), and by 3.9 points in the placebo-group (baseline 32.0). Improvements in the mean PDSS-2 total score were 5.9 (rotigotine, baseline 19.3) and 1.9 points (placebo, baseline 20.5). Treatment differences for the coprimary variables were statistically significant (p=0.0002 and p<0.0001).

 

5.2     Pharmacokinetic properties

 

Elimination

Approximately 71% of the rotigotine dose is excreted in urine and a smaller part of about 23% is excreted in faeces.

The clearance of rotigotine after transdermal administration is approximately 10 l/min and its elimination half-life is 5 to 7 hours. The pharmacokinetic profile shows a biphasic elimination with an initial half-life of about 2 to 3 hours.

Because the patch is administered transdermally, no effect of food and gastrointestinal conditions is expected.

 

Updated on 18 May 2011 SmPC

Reasons for updating

  • Correction of spelling/typing errors

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Include augmentation for RLS only.
Correct pack size for (2x50)

Updated on 13 May 2011 PIL

Reasons for updating

  • Change to further information section

Updated on 11 May 2011 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The following is amended in section 4.4

Augmentation

Augmentation may occur. Augmentation refers to the earlier onset of symptoms in the evening (or even the afternoon), increase in severity of symptoms, and spread of symptoms to involve other body parts. Based on two open-label follow-up studies with one year duration, symptoms reflecting clinically relevant and not relevant augmentation may be as high as 9.4%. However, based on two 6-month, double-blind, placebo-controlled studies, clinically relevant augmentation was observed in 1.5% of rotigotine-treated patients versus 0.5% of placebo treated patients. In two open-label, follow-up studies over a subsequent 12 months, the rate of clinically relevant augmentation was 2.9%. None of these patients discontinued therapy because of augmentation. Analysis of a 5-year open-label treatment study showed that augmentation occurred in 11.9% of patients treated with the approved dosages for RLS (1-3 mg/24 h), and that 5.1% were considered clinically significant. The majority of augmentation episodes occurred in the first and second years of treatment. This study also allowed 4 mg/24 h dosing, which showed higher rates of augmentation. The 4 mg/24 h dosage is not approved for the treatment of RLS (see Section 4.2).

 

 

Updated on 2 March 2011 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of special precautions for disposal

Updated on 13 January 2011 SmPC

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

4.6     Fertility, Pregnancy and lactation

 

Fertility

For information on fertility studies, please see section 5.3.

Updated on 13 September 2010 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life

Legal category: Product subject to medical prescription which may not be renewed (A)

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Shelf life 18 months

Updated on 31 August 2010 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 11 April 2010 SmPC

Reasons for updating

  • Addition of joint SPC covering all presentations

Legal category: Product subject to medical prescription which may not be renewed (A)

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None provided