SAFLUTAN 15 micrograms/ml eye drops, solution in single-dose container *

  • Company:

    Santen UK Limited
  • Status:

    No Recent Update
  • 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 06 April 2021

File name

pil-taflotan-sd-en-ie-APPR-20210401_1617700969.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

6. Contents of the pack and other information

 

What SAFLUTAN contains

- The active substance is tafluprost. 1 ml of solution contains 15 micrograms of tafluprost. One single-dose container (0.3 ml) contains 4.5 micrograms of tafluprost. One drop (about 30 microlmicrolitre) 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

SAFLUTAN is a clear, colourless liquid (solution) supplied in single-dose plastic containers, each containing 0.3 ml of solution. Ten single-dose containers are provided in one pouch. SAFLUTAN is supplied in packs containing 30 or 90 single-dose containers. Not all pack sizes may be marketed.

Marketing Authorisation Holder (UK/Ireland/Malta): Santen Oy, Niittyhaankatu 20, 33720 Tampere, Finland

Manufacturer: Laboratoire Unither, ZI La Guérie, 50211 Coutances Cedex, France

Santen Oy, Kelloportinkatu 1, 33100 Tampere, Finland

This medicinal product is authorised in the Member States of the EEA under the following names:

Bulgaria, Czech Republic, Denmark, Estonia, Finland, Hungary, Iceland, Latvia, Lithuania, Norway, Poland, Slovakia, Sweden

Taflotan

Germany

Taflotan sine

Austria, Belgium, Cyprus, France, Greece, Ireland, Italy, Luxembourg, Malta, The Netherlands, Portugal, Romania, Slovenia, Spain, United Kingdom

Saflutan

This leaflet was last revised in December 2020March 2021

Updated on 14 December 2020

File name

pil-saflutan-sd-en-ie-APPR 20201210a_1607961250.pdf

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

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.

Section 4

Effects on the respiratory system:

  • worsening of asthma, shortness of breath

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.

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 at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Ireland: HPRA Pharmacovigilance, Website: www.hpra.ie Earlsfort Terrace, IRL - Dublin 2, Tel: +353 1 6764971; Fax: +353 1 6762517, Website: www.hpra.ie; e-mail: medsafety@hpra.ie

Malta: ADR Reporting, Website: www.medicinesauthority.gov.mt/adrportal

The Medicines Authority, Post-Licensing Directorate, 203 Level 3, Rue D'Argens, GŻR-1368 Gżira Website: www.medicinesauthority.gov.mt, e-mail: postlicensing.medicinesauthority@gov.mt

section 6

This leaflet was last revised March 2020 December 2020

Updated on 14 December 2020

File name

spc-saflutan-sd-en-ie-APPR 20201210a_1607960230.pdf

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

Free text change information supplied by the pharmaceutical company

Section 2

One ml of eye drops, solution, contains 15 micrograms of tafluprost.

One single-dose container (0.3 ml) of eye drops, solution, contains 4.5 micrograms of tafluprost.

One drop (about 30 µmicrol) 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.

Section 4.8

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via HPRA Pharmacovigilance, website: www.hpra.ie.Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

Section 10.    

November 2017 10 December 2020

Updated on 24 March 2020

File name

pil-saflutan-sd-en-uk-ie-mt 20200316 rev IE_1585055838.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

Section 6 - Contents of the pack and other information

....

Manufacturer

   Santen Oy

Niittyhaankatu 20 FI-33720,

Kelloportinkatu 1, 33100

Tampere

Finland

This leaflet was last revised March 2020

 

 

Updated on 11 December 2017

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • 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

4.4       Special warnings and precautions for use

There is a potential for hair growth to occur in areas where tafluprost solution comes repeatedly in contact with the skin surface.

 

4.8 Undesirable effects

Eye disorders

Not known (cannot be estimated from the available data): iritis/uveitis, lid sulcus deepened, macular oedema/cystoid macular oedema.

10 DATE OF REVISION OF THE TEXT

July 2015

November 2017

Updated on 11 December 2017

Reasons for updating

  • New SPC for new product

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

Updated on 07 December 2017

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 07 December 2017

File name

PIL_16588_820.pdf

Reasons for updating

  • New PIL for new product

Updated on 04 January 2016

Reasons for updating

  • New PIL for new product

Updated on 04 January 2016

Reasons for updating

  • New SPC for new product

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

Free text change information supplied by the pharmaceutical company

None provided