Pharmaton Capsules

Summary of Product Characteristics last updated on medicines.ie: 8/7/2019

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SANOFI

SANOFI

Company Products

Medicine NameActive Ingredients
Medicine Name Adenocor Active Ingredients Adenosine
Medicine Name Amaryl 1mg Tablets Active Ingredients Glimepiride
Medicine Name Amaryl 3mg Tablets Active Ingredients Glimepiride
Medicine Name Anthisan Cream Active Ingredients Mepyramine Maleate
Medicine Name Apidra 100 units/ml solution for injection in a cartridge Active Ingredients Insulin Glulisine
Medicine Name Apidra 100 Units/ml solution for injection in a vial Active Ingredients Insulin Glulisine
Medicine Name Apidra SoloStar 100 units/ml solution for injection in a pre-filled pen Active Ingredients Insulin Glulisine
Medicine Name Aprovel 150mg film-coated tablets Active Ingredients Irbesartan
Medicine Name Aprovel 300mg film-coated tablets Active Ingredients Irbesartan
Medicine Name Aprovel 75mg film-coated tablets Active Ingredients Irbesartan
Medicine Name Arava 10 mg film-coated tablets Active Ingredients Leflunomide
Medicine Name Arava 20 mg film-coated tablets Active Ingredients Leflunomide
Medicine Name Arelix Tablets 6mg Active Ingredients Piretanide
Medicine Name Bisolvon Oral Solution Active Ingredients Bromhexine hydrochloride
Medicine Name Brolene 0.1%w/v Eye Drops Solution Active Ingredients Propamidine Isethionate
Medicine Name Brolene 0.15% w/w Eye Ointment Active Ingredients Dibromopropamidine Isethionate
Medicine Name Buscopan 10 mg Coated Tablets Active Ingredients hyoscine butylbromide
Medicine Name Buscopan Ampoules Active Ingredients hyoscine butylbromide
Medicine Name Buscopan Rx 10mg Coated Tablets Active Ingredients hyoscine butylbromide
Medicine Name Calcium Resonium Active Ingredients Calcium polystyrene sulfonate
Medicine Name Cerubidin 20mg Powder for Solution for Injection Active Ingredients daunorubicin hydrochloride
Medicine Name Cidomycin Paediatric 20mg/2ml Solution For Injection Active Ingredients Gentamicin sulfate
Medicine Name Claforan Powder for Solution for Injection 1g Active Ingredients Cefotaxime sodium
Medicine Name Claforan Powder for Solution for Injection 500mg Active Ingredients Cefotaxime sodium
Medicine Name Clexane 10,000 IU (100mg)/1ml Solution for Injection Active Ingredients Enoxaparin sodium
1 - 0 of 176 items.Total: Infinity pages

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

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 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 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 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 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 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

Free text change information supplied by the pharmaceutical company

None provided