Taptiqom 15 micrograms/ml + 5 mg/ml eye drops, solution in single-dose container

*
Pharmacy Only: Prescription
  • 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

Updated on 19 January 2023

File name

spc-taptiqom-sd-ie-APPR-20210209.pdf

Reasons for updating

  • Document format updated

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

Updated on 16 June 2022

File name

pil-taptiqom-sd-en-ie-UK APPR 20220609.pdf

Reasons for updating

  • Addition of information on reporting a side effect.

Free text change information supplied by the pharmaceutical company

Details for Malta added to leaflet:

Section 4 - add Malta AE reporting

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

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


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

Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Latvia, Lithuania, Luxembourg, Malta, The Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom (Northern Ireland)

Loyada: Italy


This leaflet was last revised in January May 2022

Updated on 26 January 2022

File name

pil-taptiqom-sd-en-ie-uk 202201.pdf

Reasons for updating

  • Change to section 6 - date of revision
  • Change to further information section

Free text change information supplied by the pharmaceutical company

Malta and Romania deleted from country list in section 6.

Updated on 07 December 2021

File name

pil-taptiqom-sd-en-uk_ie-APPR 20211206.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

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Santen Oy

Niittyhaankatu 20

33720 Tampere

Finland

 

Manufacturer

Santen Oy

Kelloportinkatu 1

33100 Tampere

Finland

 

Laboratoire Unither

ZI La Guerie

F-50211 Coutances Cedex

France

 

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

Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Latvia, Lithuania, Luxembourg, Malta, The Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom

 

Loyada: Italy

This leaflet was last revised in 08/2020December 2021

Updated on 11 February 2021

File name

pil-taptiqom-sd-uk_ie-APPR 20210209.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

2.         What you need to know before you use Taptiqom

....

Taptiqom contains phosphate buffers

This medicine contains approximately 0.04 mg phosphates in each drop which is equivalent to 1,3 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.

4.         Possible side effects

...

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  08/2020

Updated on 11 February 2021

File name

spc-taptiqom-sd-ie-APPR-20210209.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 solution contains: tafluprost 15 micrograms and timolol (as maleate) 5 mg.

One single-dose container (0.3 ml) of eye drops, solution, contains 4.5 micrograms of tafluprost and 1.5 mg of timolol.

One drop (about 30 µl) contains about 0.45 micrograms of tafluprost and 0.15 mg of timolol.

Excipient with known effect: One ml of eye drops solution contains 1.3 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   9 February 2021

Updated on 24 March 2020

File name

pil-taptiqom-sd-en-ie-20200316.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

.....

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Santen Oy

Niittyhaankatu 20

Finland

Manufacturer

Santen Oy

Niittyhaankatu 20Kelloportinkatu 1

3372033100 Tampere

Finland

 

Laboratoire Unither

ZI La Guerie

F-50211 Coutances Cedex

France

.....

This leaflet was last revised in 11/201903/2020

Updated on 14 January 2020

File name

spc-taptiqom-sd-en-ie-APPR 20200110rev.pdf

Reasons for updating

  • 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

Revision date added (January 2020), which was omitted in previous version

Updated on 14 January 2020

File name

pil-taptiqom-sd-en-ie-APPR 20200110.pdf

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

Section 4

....

The following side effects have been seen with timolol:

....

Psychiatric disorders

Depression. Difficulty sleeping. Nightmares. Memory loss. Nervousness. Hallucination.

...

Section 6

...

This leaflet was last revised in 09/2019 11/2019

Updated on 14 January 2020

File name

spc-taptiqom-sd-en-ie-APPR 20200110.pdf

Reasons for updating

  • 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 4.8

....

Psychiatric disorders

Depression, insomnia, nightmares, memory loss, nervousness, hallucination.

....

Section 10

November 2019  January 2020

Updated on 03 January 2020

File name

pil-taptiqom-en-ie-APPR-20191220.pdf

Reasons for updating

  • XPIL Updated

Free text change information supplied by the pharmaceutical company

Change to XPIL to align with leaflet pdf:

Removed Malta and Romania from list of countries where Taptiqom is licenced (section 6)

Updated on 03 January 2020

File name

pil-taptiqom-en-ie-APPR-20191220.pdf

Reasons for updating

  • Change to section 6 - date of revision

Free text change information supplied by the pharmaceutical company

This leaflet was last revised in 06/2017 09/2019

Updated on 03 January 2020

File name

spc-taptiqom-en-ie-APPR-20191220.pdf

Reasons for updating

  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • 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

9.       DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 28th November 2014

Date of last renewal: 2nd October 2019

10.     DATE OF REVISION OF THE TEXT

September 2017 November 2019

Updated on 27 September 2017

File name

PIL_16439_485.pdf

Reasons for updating

  • New PIL for new product

Updated on 27 September 2017

Reasons for updating

  • New SPC for new product

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

Updated on 27 September 2017

Reasons for updating

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

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
 
Tafluprost
Reduced visual acuity, increased iris pigmentation , blepharal pigmentation, conjunctival oedema, eye discharge, anterior chamber cell, anterior chamber flare, allergic conjunctivitis, conjunctival pigmentation, conjunctival follicles, deepening of eye lid sulcus, iritis/uveitis, macular oedema/cystoid macular oedema.
 
10.       DATE OF REVISION OF THE TEXT
 
September 2017

 

Updated on 27 September 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 03 August 2015

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

Updated on 03 August 2015

Reasons for updating

  • New PIL for new product