Pharmaton Capsules
- Name:
Pharmaton Capsules
- Company:
SANOFI
- Active Ingredients:
Ascorbic Acid (Vitamin C), Biotin, Calcium phosphate, anhydrous, dibasic, Colecalciferol (Vitamin D3), Copper sulfate, Cyanocobalamin (Vitamin B12), Ferrous sulfate, Folic Acid, Ginseng extract, Lecithin, Magnesium sulfate, Nicotinamide, pyridoxine hydrochloride (B6), Riboflavine (Vitamin B2), sodium selenite, thiamine mononitrate (B1), Vitamin A, Vitamin E (tocopherol), Zinc sulfate monohydrate
- Legal Category:
Supply through pharmacy only
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 05/07/18
(Click to Download)Click on this link to Download PDF directly
SANOFI
Company Products
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 8 July 2019 SmPC
Reasons for updating
- File format updated to PDF
Legal category: Supply through pharmacy only
Updated on 5 July 2018 SmPC
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category: Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Section 4.8 - Undesirable effects
SOC 'Immune system disorders' updated to add 'anaphylactic reaction'
Section 10 - Date of revison of the text
Date of revision updated to July 2018
Updated on 5 July 2018 PIL
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 12 May 2018 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Supply through pharmacy only
Updated on 15 December 2017 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Supply through pharmacy only
Updated on 15 December 2017 SmPC
Reasons for updating
- Change to section 6.3 - Shelf life
- Change to section 10 - Date of revision of the text
Legal category: Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
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 August 2017 SmPC
Reasons for 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
Legal category: Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
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 11 August 2017 PIL
Reasons for updating
- New PIL for new product
Updated on 11 August 2017 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 9 March 2017 SmPC
Reasons for updating
- Change to section 4.9 - Overdose
- Change to section 10 - Date of revision of the text
Legal category: Supply through pharmacy only
Free text change information supplied by the pharmaceutical company
Section 10 has been updated from November 2014 to March 2017.
Updated on 10 December 2014 SmPC
Reasons for 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
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 1 December 2014 PIL
Reasons for updating
- Change to date of revision
- Addition of information on reporting a side effect.
Updated on 13 August 2013 SmPC
Reasons for 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
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 8 August 2013 PIL
Reasons for updating
- Change to side-effects
- Change to drug interactions
- Change to date of revision
- Addition of information on reporting a side effect.
Updated on 1 February 2013 SmPC
Reasons for 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
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 31 January 2013 PIL
Reasons for updating
- Change to date of revision
- Change to marketing authorisation holder
Updated on 26 September 2011 PIL
Reasons for updating
- Change to further information section
- Change to date of revision
Updated on 27 November 2009 PIL
Reasons for updating
- New PIL for new product
Updated on 17 July 2009 SmPC
Reasons for updating
- New SPC for new product
Legal category: Supply through pharmacy only