Saflutan 15 micrograms/ml eye drops, solution

  • Name:

    Saflutan 15 micrograms/ml eye drops, solution

  • Company:
    info
  • Active Ingredients:

    Tafluprost

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 13/01/20

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XPIL

Summary of Product Characteristics last updated on medicines.ie: 10/1/2020

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Santen UK Limited

Santen UK Limited

Company Products

Medicine NameActive Ingredients
Medicine Name COSOPT 20 mg/ml + 5 mg/ml, eye drops, solution Active Ingredients Dorzolamide Hydrochloride, Timolol Maleate
Medicine Name COSOPT Preservative-Free 20 mg/ml + 5 mg/ml, eye drops, solution in single-dose container Active Ingredients Dorzolamide Hydrochloride, Timolol Maleate
Medicine Name IKERVIS 1 mg/mL eye drops, emulsion Active Ingredients Ciclosporin
Medicine Name Saflutan 15 micrograms/ml eye drops, solution Active Ingredients Tafluprost
Medicine Name SAFLUTAN 15 micrograms/ml eye drops, solution in single-dose container Active Ingredients Tafluprost
Medicine Name Taptiqom 15 micrograms/ml + 5 mg/ml eye drops, solution in single-dose container Active Ingredients Tafluprost, Timolol Maleate
Medicine Name Timoptol 0.25% and 0.5% w/v Eye Drops Solution Active Ingredients Timolol Maleate
Medicine Name TRUSOPT 20 mg/ml eye drops, solution Active Ingredients Dorzolamide Hydrochloride
Medicine Name TRUSOPT Preservative-Free 20 mg/ml eye drops, solution Active Ingredients Dorzolamide Hydrochloride
1 - 0 of 9 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 13 January 2020 PIL

Reasons for updating

  • XPIL Updated

Free text change information supplied by the pharmaceutical company

XPIL updated (revision date and documnet refernce number) to align with recently published PIL

Updated on 10 January 2020 PIL

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 5 - how to store or dispose
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Section 3

  1. Put the cap back on and close the bottle tightly.

There will be a residual volume of approximately 1 ml after the amount required for 28 days is used, which cannot be dosed. Do not try to empty the bottle.

Section 5

Store in the refrigerator (2°C – 8°C). Do not freeze.

After opening, store below 25°C.

Store in the original carton in order to protect from light.

Section 6

Add manufacturer:

Vianex S.A

Tatoiou Street

14671Nea Erithrea

Greece

 

Change date of revision from 8/19 to 12/19

Updated on 10 January 2020 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

section 4.2

....

There will be a residual volume of approximately 1 ml after the amount required for 28 days is used., which cannot be dosed. The patient should not try to empty the bottle.

......

section 6.4

Store in a refrigerator (2°C -8°C). Do not freeze.

After opening: Store below 25°C.

Store in the original carton in order to protect from light.

section 6.5

Transparent low-density polyethylene (LDPE) bottles with white Aptar OSD (polyethylene, polypropylene, thermoplastic elastomercyclic olefin copolymer) with blue polyethylene cap packed in a PET coated aluminium/polyethylene foil pouch. Each bottle has a fill volume of 3 ml.

The following pack sizes are available: cartons containing 1 or 3 bottles of 3 ml each packed in pouch.

Not all pack sizes may be marketed.

section 10

15.2.2019 January 2020

Updated on 17 September 2019 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 17 September 2019 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 16 September 2019 PIL

Reasons for updating

  • New PIL for medicines.ie

Free text change information supplied by the pharmaceutical company

new leaflet for new product

Updated on 16 September 2019 PIL

Reasons for updating

  • New PIL for medicines.ie

Free text change information supplied by the pharmaceutical company

New leaflet for new product.

Updated on 16 September 2019 PIL

Reasons for updating

  • New PIL for new product

Updated on 16 September 2019 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)