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Cephalon (UK) Limited
Teva UK Limited, Field House, Station Approach, Harlow, Essex, CM20 2FB
Telephone: +44 (0) 207 5407117
Fax: +44 (0) 207 4507349
WWW: http://www.tevauk.com
Medical Information Direct Line: +44 (0) 207 5407117
Medical Information e-mail: medinfo@tevauk.com

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 05/07/2011
SPC Provigil 100 mg Tablets, Provigil 200 mg Tablets

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 05/07/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Jun-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
In Section 1, the black triangle has been removed

In Section 10, the date of revision of text has been updated to June 2011
Updated on 07/02/2011 and displayed until 05/07/2011
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 6. 5 - Nature and Contents of Container
Date of revision of text on the SPC:   01-Jan-2011
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company


Substantial amendments to significant portions of the SmPC following review by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).  Below is a summary of the key changes to the SPC.

  • Change to section 4.2 to restrict indication. 

Modafinil is now indicated only for the treatment of  adults with excessive sleepiness in patients with narcolepsy, with and without cataplexy.  Therefore, the indications to be deleted in the United Kingdom, according to the previous licensed indications, are the treatment of excessive sleepiness associated with obstructive sleep apnoea/hypopnoea syndrome (OSAHS) and moderate to severe chronic shift work sleep disorder (SWSD).

 

  • Extensive changes to section 4.4. 

 

  • Changes to section 4.8 – amendment to the frequencies of some psychiatric disorders.
Updated on 15/09/2010 and displayed until 07/02/2011
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   26-Aug-2010
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 4.8 of the SmPC has been updated to add the adverse event "Anaphylaxis" to the end of the Immune system disorder section.
Updated on 24/11/2009 and displayed until 15/09/2010
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
Date of revision of text on the SPC:   05-Nov-2009
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 3 has been updated ONLY for the 200mg strength.

 

  • The scoreline has been deleted from the tablet.

 

 

Section 3 of the 200 mg strength now reads: 

 

Tablet

 White to off-white, capsule-shaped tablets, debossed with “200” on one side.

 

 

 

 
Updated on 09/11/2009 and displayed until 24/11/2009
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
Date of revision of text on the SPC:   29-May-2009
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 3 of the SmPC has been updated as follows:

The word “Provigil” has been removed from the tablet markings so the description of the tablet now reads as follows:

White to off-white, capsule-shaped tablets, debossed with “100” on one side.

White to off-white, scored, capsule-shaped tablets, debossed with “200” on one side.
Updated on 27/10/2009 and displayed until 09/11/2009
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
Date of revision of text on the SPC:   01-May-2009
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company


The word “Provigil” has been removed from the tablet markings so the description of the tablet now reads as follows:

 White to off-white, capsule-shaped tablets, debossed with “100” on one side. White to off-white, scored, capsule-shaped tablets, debossed with “200” on one side.
Updated on 03/02/2009 and displayed until 27/10/2009
Reasons for adding or updating:
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
  • Improved Electronic Presentation
Date of revision of text on the SPC:   23-Jan-2009
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 9 (first authorisation/renewal) now reads 23 Jan 2009

Section 10 (date of revision) also now reads 23 Jan 2009

 
Updated on 15/02/2008 and displayed until 03/02/2009
Reasons for adding or 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
Date of revision of text on the SPC:   02/2008
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 4.2 Addition of a reference to section 4.4 regarding the use in children.
 
Section 4.4 Additional warnings about serious rash and psychiatric events.
 
Section 4.8 Addition of Toxic Epidermal Necrolysis, and Drug Rash with Eosinophilia and Systemic Symptoms (DRESS), Hypersensitivity reactions (characterised by features such as fever, rash, lymphadenopathy and evidence of other concurrent organ involvement), aggression, delusions, hallucinations and suicidal ideation as adverse events.
Updated on 22/01/2008 and displayed until 15/02/2008
Reasons for adding or updating:
  • Change to MA holder contact details
Date of revision of text on the SPC:   12/2007
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 7 the Marketing Authorisation Holder's contact address has changed from 11/13 Fredrick Sanger Road, Surrey Research Park, Guildford, Surrey GU2 7YD, UK to 1 Albany Place, Hyde Way, Welwyn GardenCity, Hertfordshire, AL7 3BT, UK
Updated on 26/07/2007 and displayed until 22/01/2008
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   07/2007
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 4.8 - (undesirable effects) - updated to include post-marketing data
Updated on 30/05/2006 and displayed until 26/07/2007
Reasons for adding or updating:
  • 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 4.5 - Interactions with other Medicaments and other forms of Interaction
  • 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 10 (date of (partial) revision of the text
Date of revision of text on the SPC:   31/03/06
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
 

 

Justification of changes:

Section 4.1

The indication statement is now better defined

Add statement to define excessive sleepiness (ES)

Add statement defining how the diagnosis of Shift Work Sleep Disorder (SWSD) should be made (ICSD guideline and pivotal SWSD clinical trial inclusion criteria)

Section 4.2  

Add statement that in SWSD Provigil should be taken intermittently

Add statement saying treatment should be initiated by or under the supervision of a physician with appropriate knowledge of relevant sleep disorders

Add statement addressing need to treat the underlying condition of ES prior to initiating treatment with Provigil

Add statement ensuring the need for appropriate steps to ensure adequate sleep in patients with ES due to SWSD prior to determining the requirement for Provigil

Section 4.4

Wording amended to refer to possible effect of Provigil on steroidal contraceptives in general

Addition of statement about reviewing caffeine intake as part of good sleep hygiene

Section 4.5

Wording amended to refer to possible effect of Provigil on steroidal contraceptives in general

Section 5.1

Addition of text defining ES, moderate and severe ES, SWSD and pivotal SWSD clinical trial inclusion criteria

Section 6.1

The formulations of the 100mg and 200mg tablets are now the same

Section 6.5

The packaging of the 100mg and 200mg tablets is now the same

 
Updated on 26/05/2005 and displayed until 30/05/2006
Reasons for adding or updating:
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 (date of (partial) revision of the text
Updated on 08/04/2004 and displayed until 26/05/2005
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic Indications
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.3 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Addition of Black Triangle
Updated on 04/12/2002 and displayed until 08/04/2004
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
  modafinil