Saflutan 15 micrograms/ml eye drops, solution

3.      PHARMACEUTICAL form

Eye drops, solution (eye drops).

A clear, colourless solution, practically free from visible particles with a pH between 5.5 and 6.7, and an osmolality of 260 - 31000 mOsmol/kg.

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9.        DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 15^th February 2019

Date of last renewal: 21^st February 2023

10.      DATE OF REVISION OF THE TEXT

03 February 2022 June 2023

This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

 TAFLOTAN sine: Germany

Taflotan sine: Denmark, Finland, Iceland, Norway, Sweden

Taflotan: Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, Greece, Hungary, Iceland, Latvia, Lithuania, Norway, Portugal, Slovak Republic, Spain, Sweden

 Taflotan Multi: Poland

 Saflutan: Austria, Belgium, Croatia, Ireland, Luxembourg, The Netherlands, Romania, Slovenia, United Kingdom (Northern Ireland)

Safluround: Italy

 This leaflet was last revised in 07/202212/2021

5. How to store Saflutan

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You must throw away the bottle 28 days3 months after you first opened it, to prevent infections, and use a new bottle. The bottle with 3 ml fill volume is intended for 1 month in-use period, 5 ml fill volume bottle for 2 months and 7 ml fill volume bottle for 3 months.

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6. Contents of the pack and other information

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What Saflutan looks like and contents of the pack

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, 5 ml or 7 ml, or 3 transparent plastic bottles with 3 ml solution each. The plastic bottles are closed with caps. Not all pack sizes may be marketed.

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This medicinal product is authorised in the Member States of the European Economic area and in the United  Kingdom (Northern Ireland) EEA under the following names:

...

Austria, Belgium, Croatia, Ireland, Luxembourg, The Netherlands, Romania, Slovenia, United Kingdom (Northern Ireland)

Saflutan

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This leaflet was last revised in 0812/2021

6.3       Shelf life

3 years.

After first opening the bottle: 3 months28 days.

6.4       Special precautions for storage

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.

6.5 Nature and contents of container

Transparent low-density polyethylene (LDPE) bottles with white Aptar OSD (polyethylene, polypropylene, cyclic olefin copolymer) with blue polyethylene cap. Each bottle has a fill volume of 3 ml, 5 ml or 7 ml.

The following pack sizes are available: cartons containing 1 or 3 bottles of 3 ml (each intended for 1 month patient’s in use period), 1 bottle of 5 ml (for 2 months) or 1 bottle of 7 ml (for 3 months).

Not all pack sizes may be marketed.

10.       DATE OF REVISION OF THE TEXT

17 September 2021 03 February 2022

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

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

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

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

Section 4

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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.

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Section 6

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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

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

Section 3

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11. 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.

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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

section 4.2

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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.

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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

new leaflet for new product

New leaflet for new product.