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Janssen-Cilag Ltd
50 - 100 Holmers Farm Way, High Wycombe, Bucks, HP12 4EG
Telephone: +44 (0)1494 567 567
Fax: +44 (0)1494 567 568
WWW: http://www.janssen.co.uk
WWW: http://www.janssen-medinfo.co.uk
Medical Information Direct Line: +44 (0)800 731 8450
Medical Information e-mail: medinfo@janssen-cilag.co.uk
Customer Care direct line: +44 (0)800 731 5550

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: 12/05/2011
SPC Topamax 25 mg, 50mg, 100mg, 200mg Tablets and Sprinkle Capsules 15, 25 or 50 mg.

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 12/05/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   05-May-2011
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
The following paragrpah has been added to section 4.6:

Compared with a reference group not taking antiepileptic drugs, registry data for Topamax monotherapy showed a higher prevalence of low birth weight (<2500 grams). A causal relationship has not been established.
Updated on 01/02/2011 and displayed until 12/05/2011
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   24-Nov-2010
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company


Change to section 2 - Qualitative and quantitative composition

Tablets: Lactose amounts added

Capsules: Sucrose amounts added

 

Change to section 3 - Pharmaceutical form

Tablets: Product description revised to add dimensions

Capsules: Product description revised

 

Change to section 6.1 - List of Excipients

Tablets: Minor changes to highlight core tablet and film-coating excipients

Capsules: Minor changes to highlight capsule and printing ink excipients

Change to section 6. 4 - Special Precautions for Storage

Tablets: Addition of: “Store in the original package.” and “... in order to protect from moisture.”

Capsules: Addition of: “… in order to protect from moisture.”

 

Change to section 6. 5 - Nature and Contents of Container

Addition of non marketed presentations

 

Change to section 10 - Date of revision of the text

24 November 2010
Updated on 08/07/2010 and displayed until 01/02/2011
Reasons for adding or updating:
  • Change to section 6.1 - List of Excipients
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   05-Jul-2010
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Change to section 6.1 - Excipients change
Change to section 10 - 05 July 2010
Updated on 25/03/2010 and displayed until 08/07/2010
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • 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 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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 4.9 - Overdose
  • Change to section 5 - Pharmacological Properties
  • 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 10 date of revision of the text
Date of revision of text on the SPC:   12-Mar-2010
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company


Change to section 1 –Name of the medicinal product*

Inclusion of pharmaceutical form

Change to section 4 – Clinical Particulars

Revised as per the EC Commission Decision on Article 30 Referral for Topamax

Change to section 4.1 – Therapeutic Indications

Monotherapy in adults, adolescents and children over 6 years of age with partial seizures with or without secondary generalised seizures, and primary generalised tonic-clonic seizures.

 

Adjunctive therapy in children aged 2 years and above, adolescents and adults with partial onset seizures with or without secondary generalization or primary generalized tonic-clonic seizures and for the treatment of seizures associated with Lennox-Gastaut syndrome.

 

Topiramate is indicated in adults for the prophylaxis of migraine headache after careful evaluation of possible alternative treatment options. Topiramate is not intended for acute treatment.

 

 

 

 

Change to section 4.2 – Posology and |Method of Administration

Revised as per the EC Commission Decision on Article 30 Referral for Topamax

Change to section 4.3 – Contra-indications

Hypersensitivity to the active substance or to any of the excipients.

 

Migraine prophylaxis in pregnancy and in women of childbearing potential if not using effective methods of contraception.

 

Change to section 4.4 – Special Warnings and Precautions for Use

Revised as per the EC Commission Decision on Article 30 Referral for Topamax

Change to section 4.5 –Interaction with other medicinal products and other forms of interaction

Revised as per the EC Commission Decision on Article 30 Referral for Topamax

Change to section 4.6 – Pregnancy and Lactation

Revised as per the EC Commission Decision on Article 30 Referral for Topamax

Change to section 4.7 - Effects on Ability to Drive and Use Machines

Revised as per the EC Commission Decision on Article 30 Referral for Topamax

Change to section 4.8 – Undesirable effects

Revised to include the latest data on ADRs in one consolidated table

Change to section 4.9 - Overdose

Revised as per the EC Commission Decision on Article 30 Referral for Topamax

Change to section 5 – Pharmacological Properties

Revised as per the EC Commission Decision on Article 30 Referral for Topamax

Change to section 5.1 - Pharmacodynamic properties

Revised as per the EC Commission Decision on Article 30 Referral for Topamax

Change to section 5.2 - Pharmacokinetic properties

Revised as per the EC Commission Decision on Article 30 Referral for Topamax

Change to section 5.3 - Preclinical Safety Data

Revised as per the EC Commission Decision on Article 30 Referral for Topamax

Change to section 10 – Date of revision of the text

12 March 2010
Updated on 19/12/2008 and displayed until 25/03/2010
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   10-Dec-2008
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company


Change to section 4.4 – Special Warnings and Precautions for Use

Update to implement  warnings on suicidal thoughts and behaviour associated with antiepileptic medicines

Change to section 10 – Date of revision of the text

10 Dec 2008
Updated on 01/09/2008 and displayed until 19/12/2008
Reasons for adding or updating:
  • Change to section 6.1 - List of Excipients
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   14-Aug-2008
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company


6.1

List of excipients

Change the excipient name of polyethylene glycol to Macrogol 400.

 

10.

DATE OF REVISION OF THE TEXT

 

14 August  2008

 

Updated on 10/07/2008 and displayed until 01/09/2008
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   18-Jun-2008
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company


7.

MARKETING AUTHORISATION HOLDER

Change of address

10.

DATE OF REVISION OF THE TEXT

 

June 2008

 

Updated on 14/02/2008 and displayed until 10/07/2008
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.2 - Pharmacokinetic Properties
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

Change to section 4.5 –Interaction with other medicinal products and other forms of interaction

Addition of  – Lithium, glyburide, valproic acid, dilitiazem, venlafaxine

Change to section 5.2 - Pharmacokinetic properties

risperidone.
Updated on 15/11/2006 and displayed until 14/02/2008
Reasons for adding or updating:
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   11/2006
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 4.7 - Updated - visual disturbances/blurred vision
Section 4.8 - Major update - post marketing data
Section 10 - Updated to 12.11.2006
Updated on 13/07/2006 and displayed until 15/11/2006
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 6.1 - List of Excipients
Date of revision of text on the SPC:   06/2006
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Change to section 4.4 -
Special Warnings and Precautions for Use - Providing more information on withdrawing treatment of Topamax to reduce the potential for drug withdrawal convulsions and

Change to section 6.1 -
List of Excipients - Hypromellose (excipient name change)
Updated on 20/04/2006 and displayed until 13/07/2006
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 (date of (partial) revision of the text
Updated on 14/11/2005 and displayed until 20/04/2006
Reasons for adding or updating:
  • Addition of Black Triangle
Updated on 03/08/2005 and displayed until 14/11/2005
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 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
Updated on 03/09/2004 and displayed until 03/08/2005
Reasons for adding or updating:
  • Change to section 10 (date of (partial) revision of the text
Updated on 24/08/2004 and displayed until 03/09/2004
Reasons for adding or updating:
  • 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 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 10 (date of (partial) revision of the text
Updated on 30/07/2004 and displayed until 24/08/2004
Reasons for adding or updating:
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 10 (date of (partial) revision of the text
Updated on 24/02/2004 and displayed until 30/07/2004
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 10 (date of (partial) revision of the text
Updated on 22/01/2004 and displayed until 24/02/2004
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 10/12/2003 and displayed until 22/01/2004
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 (date of (partial) revision of the text
Updated on 24/09/2003 and displayed until 10/12/2003
Reasons for adding or updating:
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 (date of (partial) revision of the text
Updated on 14/05/2003 and displayed until 24/09/2003
Reasons for adding or updating:
  • Change to section 1 - trade name
  • Change to section 2 - qualitative and quantitative composition
  • Change to section 3 - pharmaceutical form
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 10 (date of (partial) revision of the text
Updated on 19/06/2002 and displayed until 14/05/2003
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.8 - Undesirable Effects
Updated on 18/06/2002 and displayed until 19/06/2002
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.8 - Undesirable Effects
Updated on 10/10/2001 and displayed until 18/06/2002
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
Updated on 28/08/2001 and displayed until 10/10/2001
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 23/08/2001 and displayed until 28/08/2001
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Active Ingredients/Generics

 
  topiramate