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

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

Malta and Romania deleted from country list in section 6.

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:

Loyada: Italy

This leaflet was last revised in 08/2020December 2021

2.         What you need to know before you use Taptiqom

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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

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

Section 6

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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

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

Section 4

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The following side effects have been seen with timolol:

....

Psychiatric disorders

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

...

Section 6

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

Section 4.8

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Section 10

November 2019  January 2020

Change to XPIL to align with leaflet pdf:

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

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

9.       DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 28^th November 2014

Date of last renewal: 2^nd October 2019

10.     DATE OF REVISION OF THE TEXT

September 2017 November 2019