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SANOFI

Citywest Business Campus, Dublin 24, Ireland
Telephone: +353 1 4035600
Fax: +353 1 4035687
Medical Information e-mail: iemedinfo@sanofi.com
Summary of Product Characteristics last updated on medicines.ie: 15/12/2017
SPC Pharmaton Capsules

When a pharmaceutical company changes an SPC or PIL, 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 15/12/2017 and displayed until Current
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-Dec-2017
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company

Section 6.3 - Shelf-Life
The details for bottles have been amended from 36 to 24 months.

Section 10 - Date of Revision of the Text
The date has been amended from August 2017 to December 2017.
Updated on 15/08/2017 and displayed until 15/12/2017
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-Aug-2017
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company

Section 7 (Marketing Authorisation Holder) has been amended.  Boehringer Ingelheim Limited details have been replaced by sanofi-aventis Ireland Ltd details.

Section 8 (Marketing Authorisation Number) has been amended.  PA 7/66/1 has been replaced by PA 540/188/1.

Section 10 (Date of Revision of the Text) has been amended from March 2017 to August 2017.
Updated on 09/03/2017 and displayed until 15/08/2017
Reasons for adding or updating:
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   03-Mar-2017
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company

Section 4.9 has been revised to incorporate current Company Core Data Sheet information.  The updates include the addition of symptoms of chronic toxicity, information on acute and toxic doses of Vitamin A and D and information on the total daily intake of zinc.

Section 10 has been updated from November 2014 to March 2017.
Updated on 10/12/2014 and displayed until 09/03/2017
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-Nov-2014
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company



Section 2 Qualitative and Quantitative Composition

The text Each capsule contains: has been added to the beginning of this section.

 

Section 4.8 Undesirable Effects

The details regarding the reporting of suspected adverse reactions (final paragraph of this section) have been updated following the change in name from the IMB to the HPRA.

 

Section 10 Date of Revision of the Text

The date has been updated from August 2013 to November 2014.

Updated on 13/08/2013 and displayed until 10/12/2014
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • 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 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-Aug-2013
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company



Section 4.3 Contraindications

The word metabolism has been added to the first sentence of the first paragraph of this section, after the word calcium.

 

The text …, pregnancy and lactation (see section 4.6) has been added to the first sentence of the first paragraph of this section.

 

What was previously the final paragraph of this section has been deleted, i.e. the text In case of intolerance to lactose, an excipient of the product, the use of the product is contraindicated.  (See section 4.4).

 

Section 4.5 Interaction with Other Medicinal Products and Other Forms of Interaction

New text has been added to the Interactions (third) paragraph of this section regarding interactions of iron.  New text has been added as a final sentence to this third paragraph (regarding patients on any of the medications listed).

 

What was previously the final paragraph of this section has been deleted, i.e. If you are taking warfarin (or other coumarin anticoagulants), consult a doctor before starting or stopping treatment with Pharmaton Capsules.

 

A new final paragraph regarding the concomitant intake of ginseng preparations and anticoagulants has been added to this section.

 

Section 4.6 Fertility, Pregnancy and Lactation

A new sub-heading (Pregnancy) has been added before the first paragraph of this section. 

 

The text … (see section 4.3) has been added to the first sentence of the first Pregnancy sub-heading paragraph.

 

The text As with many other medicines an assessment of benefits versus risks should be made before this product is administered during this period has been deleted from the end of what is now the second paragraph of the Pregnancy sub-heading text.

 

A new sub-heading (Fertility) and corresponding text has been added to this section.

 

Section 4.7 Effects on Ability to Drive and Use Machines

The previous text of None stated has been deleted and replaced with the following text: No studies on the effects on the ability to drive and use machines have been performed.

 

Section 4.8 Undesirable Effects

The previous text of Cases of headache, dizziness, gastrointestinal reactions (such as nausea, stomach pain, vomiting and diarrhoea) and hypersensitivity reactions (such as rash and pruritus) have been observed has been deleted and replaced with completely new text (including details regarding the ranking of adverse events under headings of frequency and addition of the reporting of suspected adverse reactions information).

 

Section 10 Date of Revision of the Text

The date has been updated from November 2012 to August 2013.

Updated on 01/02/2013 and displayed until 13/08/2013
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text
  • Change to marketing authorisation holder
  • Change to MA holder contact details
Date of revision of text on the SPC:   01-Nov-2012
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company



Section 7 Marketing Authorisation Holder

The details have been amended from:

 

United Pharmacist Co-Op Ltd.,

Belgard Road,

Tallaght,

Dublin 24.

to:

Boehringer Ingelheim Limited

Ellesfield Avenue

Bracknell

Berkshire

RG12 8YS

United Kingdom

 

Section 8 Marketing Authorisation Number

The details have been amended from:

 

PA 337/5/1

 

to:

 

PA 7/66/1

 

Section 10 Date of Revision of the Text

The date has been amended from April 2009 to November 2012. 

Updated on 17/07/2009 and displayed until 01/02/2013
Reasons for adding or updating:
  • New SPC for new product
Date of revision of text on the SPC:  
Legal Category:   Supply through pharmacy only

Free-text change information supplied by the pharmaceutical company

None provided

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