Saflutan 15 micrograms/ml eye drops, solution *

  • Company:

    Santen UK Limited
  • Status:

    Updated
  • Legal Category:

    Product subject to medical prescription which may be renewed (B)
  • Active Ingredient(s):

    *Additional information is available within the SPC or upon request to the company

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 21 September 2021

File name

pil-saflutan-pfmd-en-ie-APPR 20210917_1632235926.pdf

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Section 3

When you start a new bottle:

Do not use the bottle if the pouch is broken or if the plastic ring around the bottle neck is missing or broken. Open the pouch along the dashed line. Write down the date you opened the bottle in the space reserved for the date on the outer carton.

Section 6

What Saflutan contains

- The active substance is tafluprost. 1 ml of solution contains 15 micrograms of tafluprost. One drop contains about 0.45 micrograms of tafluprost.

- The other ingredients are glycerol, sodium dihydrogen phosphate dihydrate, disodium edetate, polysorbate 80, and water for injections. Hydrochloric acid and/or sodium hydroxide are added to adjust the pH.

What Saflutan looks like and contents of the pack

[Tradename] Saflutan is a clear, colourless liquid (solution), practically free from visible particles. It is supplied in a pack containing either 1 or 3 transparent plastic bottles with 3 ml solution each. The plastic bottles are closed with caps. Each bottle is packed in a pouch. Not all pack sizes may be marketed.

 

This leaflet was last revised in 09/2020 08/2021

Updated on 21 September 2021

File name

spc-saflutan-pfmd-en-ie-APPR 20210917_1632233522.pdf

Reasons for updating

  • 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 6.5

Transparent low-density polyethylene (LDPE) bottles with white Aptar OSD (polyethylene, polypropylene, cyclic 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

17 December 2020 17 September 2021

Updated on 18 December 2020

File name

spc-saflutan-pfmd-en-ie-APPR 20201217_1608292269.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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

2        QUALITATIVE AND QUANTITATIVE COMPOSITION

One ml of solution contains 15 micrograms of tafluprost

One drop contains about 0.45 micrograms of tafluprost.

Excipient with known effect: One ml of eye drops solution contains 1.2 mg phosphates and one drop contains approximately 0.04 mg phosphates.

For the full list of excipients, see section 6.1.

10      DATE OF REVISION OF THE TEXT

January 2020 17/12/2020

Updated on 18 December 2020

File name

pl-saflutan-pfmd-en-ie-APPR 20201217_1608291631.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

ADDED to section 2:

Saflutan contains phosphates

This medicine contains approximately 0.04 mg phosphates in each drop which is equivalent to 1.2 mg/ml. If you suffer from severe damage to the clear layer at the front of the eye (the cornea), phosphates may cause in very rare cases cloudy patches on the cornea due to calcium build-up during treatment.

DELETED from section 4

In very rare cases, some patients with severe damage to the clear layer at the front of the eye (the cornea) have developed cloudy patches on the cornea due to calcium build-up during treatment.

This leaflet was last revised in 03/2020 09/2020

 

Updated on 24 March 2020

File name

pil-saflutan-pfmd-en-uk-ie 20200316_1585064612.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Section 4

...

Reporting of side effects 
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.

United Kingdom: Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Ireland: HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2, Tel: +353 1 6764971, Fax: +353 1 6762517, Website: www.hpra.ie; e-mail: medsafety@hpra.ie.
Ireland: HPRA Pharmacovigilance, Website: www.hpra.ie.

.................

Section 6

.......

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder

Santen Oy

Niittyhaankatu 20
33720 Tampere
FINLAND

Vianex S.A
Tatoiou Street
14671Nea Erithrea
Greece

Manufacturer
Santen Oy
Niittyhaankatu 20
33720

Kelloportinkatu 1

33100 Tampere
FINLAND

This leaflet was last revised in 12/2019 03/2020

Updated on 13 January 2020

File name

pil-taflotan-pfmd-en-ie-APPR-20200103_1578676915.pdf

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

File name

pil-taflotan-pfmd-en-ie-APPR-20200103_1578676915.pdf

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

File name

spc-taflotan-pfmd-en-ie-APPR-20200103_1578675111.pdf

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

File name

pil-taflotan-pfmd-en-ie-APPR-20190802_1568646530.pdf

Reasons for updating

  • New PIL for medicines.ie

Updated on 17 September 2019

File name

pil-taflotan-pfmd-en-ie-APPR-20190802_1568646530.pdf

Reasons for updating

  • New PIL for medicines.ie

Updated on 16 September 2019

File name

pil-taflotan-pfmd-en-ie-APPR-20190802_1568646530.pdf

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

File name

pil-taflotan-pfmd-en-ie-APPR-20190802_1568646530.pdf

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

File name

pil-taflotan-pfmd-en-ie-APPR-20190802_1568646530.pdf

Reasons for updating

  • New PIL for new product

Updated on 16 September 2019

File name

spc-taflotan-pfmd-en-ie-APPR-20190215_1568646441.pdf

Reasons for updating

  • New SPC for new product

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