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

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.

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.