Teva Pharmaceuticals Ltd

Changes to:

Section 7:  Marketing Authorisation Holder

Change of address to:

Teva Pharma GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

Section 10:  DATE OF REVISION OF THE TEXT

December 2011


Minor punctuation and typo corrections. 

The changes to the SmPC are:

Section 4.2 : Amendment to ‘Posology and method of administration’ section.

Posology - Added heading

Change from "In case patients progress ........." to "If patients progress from mild to moderate hepatic impairment rasagiline should be stopped" (see section 4.4).

Section 4.4 :  Special warnings and precautions for use.

Change from "In case patients progress ........." to "If patients progress from mild to moderate hepatic impairment rasagiline should be stopped" (see section 5.2).

Section 4.6 :  Fertility added to heading 

Section 4.8 :  Amendment to ‘Undesirable effects’ section.

Change from "one case" to "rare cases" of hypertensive crisis associated with ingestion of unknown amounts of tyramine-rich foods, have been reported in patients taking rasagiline.

Section 10 :  DATE OF REVISION OF THE TEXT

25/10/10

Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu

Section 4.2 : Posology and method of administration

Minor rewording of elderly and paediatric section.

Patients with hepatic impairment: Change in terminology from mild hepatic ‘insufficiency’ to ‘impairment’.

Section 4.3 : Contraindications.

Concomitant treatment with other monoamine oxidase (MAO) inhibitors (including medicinal and natural products without prescription e.g. St. John’s Wort) or pethidine …..  At least 14 days must elapse ….. ’.

Change in terminology from mild hepatic ‘insufficiency’ to ‘impairment’.

Section 4.4 : Special warnings and precautions for use.

Change in terminology from ‘medications’ and ‘drugs’ to ‘medicinal products’.

Change in terminology from mild hepatic ‘insufficiency’ to ‘impairment’.

Section 4.5 :  Interaction with other medicinal products and other forms of interaction.

Rasagiline must not be administered along with other MAO inhibitors (including medicinal and natural products without prescription e.g. St John’s Wort) ….’

Minor rewording, including change in terminology from ‘medications’ to ‘medicinal products’.

Reference to use of SSRIs and SNRIs in clinical trials, see section 4.8.

Update of results from ‘four’ to ‘five’ tyramine challenge studies … ‘.

Section 4.7 : Effects on ability to drive and use machines.

New text included:

Patients should be cautioned about operating hazardous machines, including motor

vehicles, until they are reasonably certain AZILECT does not affect them adversely.

Section 4.8 : Undesirable effects.

Adverse reactions listed have been converted to MeDRA terms.  This had lead to some changes in the adverse reactions listed, the term used and the incidence presented. 

New text included:

Clinical trial and post-marketing experience with the use of rasagiline and antidepressants.

New text included:

Post-marketing cases of elevated blood pressure with rasagiline and tyramine-rich foods.

New text included:

Post-marketing experience with rasagiline and sympathomimetic medicinal products.

Section 4.9 : Overdose

Update with post-marketing experience.

Section 6.3 : Shelf life

Blisters: Change from 2 years to 3 years

Section 9 : Date of First Authorisation / Renewal of the Authorisation

Date of latest renewal: 21 September 2009

Section 4.8 Incidence of hallucinations has been added to the monotherapy section.  Incidence of hallucinations and confusion has been added to the adjunct therapy section.

Addition of the following statement in section 4.8:

Parkinson’s disease is associated with symptoms of hallucinations and confusion.  In post marketing experience these symptoms have also been observed in Parkinson’s disease patients treated with rasagiline.