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

This medicinal productmedicine is authorised in the Member States of the EEAEuropean Economic Area and in the United Kingdom (Northern Ireland) 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 (Northern Ireland)	Saflutan

This leaflet was last revised in MarchJuly 2021

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

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

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

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

 

 

4.4       Special warnings and precautions for use

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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

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Eye disorders

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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

None provided