Tears Naturale

  • Name:

    Tears Naturale

  • Company:
    info
  • Active Ingredients:

    Dextran 70, Hypromellose

  • Legal Category:

    Supply through pharmacy only

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 25/10/18

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Summary of Product Characteristics last updated on medicines.ie: 25/10/2018

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Alcon Laboratories Ireland Limited

Alcon_1543581641

Company Products

Medicine NameActive Ingredients
Medicine Name Tears Naturale Active Ingredients Dextran 70, Hypromellose
1 - 0 of 1 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 25 October 2018 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 25 October 2018 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)

Legal category: Supply through pharmacy only

Updated on 20 August 2018 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

MAT transfer to Novartis  Ireland

Updated on 30 May 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through pharmacy only

Updated on 30 May 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

- Sections 7,8 and 10 updated following approval of change of marketing authorisation holder from Alcon to Novartis.

Updated on 17 May 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 17 May 2017 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - date of revision

Updated on 17 December 2014 SmPC

Reasons for updating

  • 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

- sectiong 4.8 updated with adr reporting information and IMB to HPRA name change.

Updated on 16 December 2014 PIL

Reasons for updating

  • Change to further information section
  • Change to date of revision

Updated on 8 October 2013 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 9 - Date of renewal of authorisation

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Updated MAH address and date of revision.

Updated on 7 October 2013 PIL

Reasons for updating

  • Change to date of revision
  • Change to MA holder contact details

Updated on 29 November 2011 PIL

Reasons for updating

  • Change due to harmonisation of PIL

Updated on 18 February 2011 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • 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 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 9 - Date of renewal of authorisation
  • 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

In Section 1, Name of the medicinal product, ‘(Dextran 70 0.1% w/v, Hypromellose 0.3% w/v)’ is added next to the name of the product.

 

In Section 2, Qualitative and quantitative composition, ‘Also contains Benzalkonium Chloride Solution 0.01% w/v.’ has been added.

 

In Section 4.3, Contraindications, ‘This product contains benzalkonium chloride and should not be used when soft contact lenses are being worn.’ has been replaced with ‘Hypersensitivity to dextran 70, hypromellose or to any of the excipients.’

 

In Section 4.4, Special warnings and precautions for use, special warnings about ocular use, presence of benzalkonium chloride and any undesired reactions are listed.

 

In Section 4.5, Interaction with other medicinal products and other forms of interaction, ‘If more than one topical ophthalmic medicinal product is being used, the medicines must be administered at least 5 minutes apart. Eye ointments should be administered last.’ is added.

 

In Section 4.6, Pregnancy and lactation, further information about the use of Tears Naturale during pregnancy and breast-feeding is added.

 

In Section 4.7, Effects on ability to drive and use machines, ‘Tears Naturale has no or negligible influence on the ability to drive or use machines. As with any eye drops, temporary blurred vision or other visual disturbances may affect the ability to drive or use machines. If blurred vision occurs at instillation, the patient must wait until the vision clears before driving or using machines.’ is added.

 

In Section 4.8, Undesirable effects, a summary of the safety profile of the product and a tabulated list of adverse reactions is added.

 

In Section 4.9, Overdose, ‘No case of overdose has been reported. An overdose of Tears Naturale can easily be washed out of the eye with lukewarm tap water.’ is added.

 

In Section 6.1, List of excipients, solution is added against benzalkonium chloride, concentrated and ‘for PH adjustment’ is added against Sodium hydroxide and/or Hydrochloric acid.

 

In Section 6.3, Shelf life, ‘1 month’ has been replaced with ‘4 weeks’

 

In Section 6.4, Special precautions for storage, ‘Discard one month after opening’ is replaced with ‘Discard 4 weeks after opening’

 

In Section 9, Date of first authorisation/Renewal of authorisation, Date of last renewal is revised to 13th March 2010.

 

In Section 10, Date of revision of the text, the date of revision has been updated to January 2011.

 

Updated on 29 October 2010 PIL

Reasons for updating

  • Change to date of revision
  • Change due to harmonisation of PIL

Updated on 28 October 2010 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • 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 6.1 - List of excipients
  • Change to section 6.3 - Shelf life
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 7 - Marketing authorisation holder
  • Change to section 9 - Date of renewal of authorisation
  • 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

In Section 1, the header is amended in lines with the QRD template, and '(Dextran 70 0.1% w/v, Hypromellose 0.3% w/v)' is added against the product name.

In Section 2, ‘For excipients, see - 6.1.’ is replaced with ‘For a full list of excipients, see section 6.1.’ and ‘Also contains Benzalkonium Chloride Solution 0.01% w/v.’ is added.

In Section 4.4, the header is amended in lines with the QRD template.

In Section 4.5, the header is amended in lines with the QRD template.

In Section 6.1, (for pH adjustment) is added against ‘Sodium hydroxide and/or Hydrochloric acid

In Section 6.3, ‘1 month’ is replaced with ‘4 weeks’

In Section 6.5, ‘polystyrene or polypropylene cap’ is replaced with ‘polypropylene cap’

In Section 6.6, the header is amended in lines with the QRD template

In Section 7, the header is amended in lines with the QRD template

In Section 9, date of last renewal has been updated

In Section 10, date of revision of text has been updated

Updated on 13 August 2010 SmPC

Reasons for updating

  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.5 - Nature and contents of container
  • Change to section 9 - Date of renewal of authorisation
  • 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 6.1 - The Excipient 'Sodium hydroxide and/or Hydrochloric acid' is changed to 'Sodium hydroxide and/or Hydrochloric acid, concentrated'.

Section 6.2 - 'Not applicable' is replaced with 'None known'.

Section 6.5 - 'polystyrene or polypropylene cap' replaced with 'polypropylene cap'.

Section 9 - Date of last renewal updated.

Section 10 - Date of revision updated.

Updated on 16 August 2005 SmPC

Reasons for updating

  • Improved electronic presentation

Legal category: Supply through pharmacy only

Updated on 18 May 2005 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 28 October 2004 PIL

Reasons for updating

  • New PIL for new product

Updated on 27 August 2003 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product

Legal category: Supply through pharmacy only

Updated on 20 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Supply through pharmacy only