Saflutan 15 micrograms/ml eye drops, solution
- Name:
Saflutan 15 micrograms/ml eye drops, solution
- Company:
Santen UK Limited
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may be renewed (B)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 24/03/20
(Click to Download)XPIL
Package leaflet: Information for the patient
Package leaflet: Information for the patient
1. What Saflutan is and what it is used for
1. What Saflutan is and what it is used for
2. What you need to know before you use Saflutan
2. What you need to know before you use Saflutan
3. How to use Saflutan
3. How to use Saflutan
4. Possible side effects
4. Possible side effects
5. How to store Saflutan
5. How to store Saflutan
6. Contents of the pack and other information
6. Contents of the pack and other information
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Santen UK Limited
Company Products
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 24 March 2020 PIL
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.
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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
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
…
- 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
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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
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.
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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 elastomer
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)