Lumigan 0.1mg/ml

  • Name:

    Lumigan 0.1mg/ml

  • Company:
    info
  • Active Ingredients:

    Bimatoprost

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 02/04/19

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XPIL

Summary of Product Characteristics last updated on medicines.ie: 1/2/2019

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Allergan Ltd

Allergan Ltd

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1 - 0 of 23 items.Total: Infinity pages

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 2 April 2019 PIL

Reasons for updating

  • Change to other sources of information section

Updated on 1 February 2019 PIL

Reasons for updating

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

Updated on 1 February 2019 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

In section 4.8 (undesirable effects), the adverse reactions dizziness, ocular discomfort photophobia, skin discoloration (periocular) and hypertension were added (frequency not known).

In section 10 (date of revision of text), the revised date was updated to 01/2019.

Updated on 28 June 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Updated on 28 June 2017 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

In section 4.8 (Undesirable effects) - addition of 4 adverse events in the Eye disorders SOC, frequency not known, in line with the Company Core Data Sheet: Eye discharge, Lacrimation increased, Eye oedema and Foreign body sensation in eyes.

In section 10 (Date of revision of the text) - date of revision of the text is May 2017 (05/2017).

Updated on 26 June 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 26 June 2017 PIL

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - excipient warnings
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 7 April 2016 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • addition of the following adverse reactions under the SOC (system organ class) Eye disorders with a frequency not known: blepharal pigmentation, macular oedema, periorbital and lid changes including deepening of the eyelid sulcus and dry eye;
  • addition of the following adverse reactions under the SOC Immune system disorders with a frequency not known: hypersensitivity reaction including signs and symptoms of eye allergy and allergic dermatitis.

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

In section 4.4 (special warnings and precaution for use) - correction of a typo in word "prostaglandin".

In section 4.8 (undesirable effects):

Table 1:

  • addition of the following adverse reactions under the SOC (system organ class) Eye disorders with a frequency not known: blepharal pigmentation, macular oedema, periorbital and lid changes including deepening of the eyelid sulcus and dry eye;
  • addition of the following adverse reactions under the SOC Immune system disorders with a frequency not known: hypersensitivity reaction including signs and symptoms of eye allergy and allergic dermatitis.

Table 2 - removed enophthalmos from the SOC Eye disorders with a frequency not known

In section 10 (date of revision of the text) - new revision date is 03/2016.

Updated on 6 April 2016 PIL

Reasons for updating

  • Change to side-effects
  • Addition of information on reporting a side effect.

Updated on 16 March 2016 PIL

Reasons for updating

  • Change to date of revision
  • Change to improve clarity and readability

Updated on 9 February 2016 SmPC

Reasons for updating

  • Previous version of SPC reinstated

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Previous version of SPC reinstated.

Updated on 4 February 2016 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

In section 4.4 (special warnings and precautions for use) correction of the typo of the word "prostaglandin".

In section 4.8 (undesirable effects) addition of the following adverse reactions under System Organ class (SOC) Immune system disorders with a frequency not known: Hypersensitivity reaction including signs and symptoms of eye allergy and allergic dermatitis." ;  addition of the following adverse reactions under the SOC Eye disorders with a frequency not known in Table 1: blepharal pigmentation, macular oedema, periorbital and lid changes including deepening of the eyelid sulcus, dry eye;  removal of the "enophthalmos" adverse reaction from the SOC Eye disorders with the frequency not known in Table 2.

In section 10 (date of revision of the text) the new date of the revision of the text is 01/2016.

Updated on 9 July 2015 SmPC

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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

To change Irish Medicines Board (IMB) to Health Products Regulatory Agency (HPRA)

Updated on 13 August 2014 PIL

Reasons for updating

  • Change to side-effects
  • Change to marketing authorisation holder

Updated on 30 January 2014 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.4 of the SPC now include new text to warn about reports of exacerbation of asthma, dyspnea and COPD, as well as reports of asthma, in post marketing experience. Patients with COPD, asthma or compromised respiratory function due to other conditions should be treated with caution. In addition, asthma, asthma exacerbation, COPD exacerbation and dyspnea were added to section 4.8 of the SPC.

Updated on 22 January 2014 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 4 November 2013 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • 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 not be renewed (A)

Free text change information supplied by the pharmaceutical company

Sec. 2 Qualitative and Quantitative Composition
Updating "Excipients" to read "Excipients with known effect"

Sec. 4.2 Posology and method of administration
Updating "USe in hepatic and renal impairment" to read "Patients with hepatic and renal impairment".

Sec.4.4 Special warnings and precautions for use 
Updating "The tip of the bottle should not be allowed to contact the eye, surrounding structures, fingers or any other surface in order to avoid contamination of the solution" to read "Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye or surrounding structures, to avoid eye injury and contamination of the solution".
 
Sec. 4.6 Heading updated from "Pregnancy and lactation" to "Fertility, pregnancy and lactation".

4.8         Undesirable effects
- moving the side effects in the table
- adding ADR reporting statement 
- inclusion of PhWVP warning wording for phosphate containing eyedrops

10. DATE OF REVISION OF THE TEXT
Updating revision date from July 2012 to 09/2012

Updated on 21 October 2013 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision
  • Change of special precautions for disposal
  • Addition of marketing authorisation holder
  • Addition of information on reporting a side effect.

Updated on 26 February 2013 PIL

Reasons for updating

  • Change to MA holder contact details
  • Correction of spelling/typing errors

Updated on 2 August 2012 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Correction of spelling/typing errors

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

·         4.4 Special Warnings and Precautions section of the SmPC:

§  iris hyperpigmentation is likely to be permanent (as opposed to may be permanent)

§  hair growth precaution

§  information relating the more frequent than once a daily administration of bimatoprost

§  information relating to bacterial keratitis with multidose containers

·         4.5 Interactions with other medicinal products section

§  information relating to a lack of information on concomitant use of bimatoprost with other prostaglandin analogues

·         4.8 Undesirable effects section

§  ‘eye pain’ was added as adverse reaction with Lumigan 0.1 mg/ml

§  ‘periorbital erythema’ with Lumigan 0.3 mg/ml

§  ‘blurred vision’ added to the list of common adverse effects for Lumigan 0.3 mg/ml

 

There are also a number of administrative changes.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Updated on 27 July 2012 PIL

Reasons for updating

  • Change to side-effects
  • Change to drug interactions
  • Change of contraindications

Updated on 25 July 2011 PIL

Reasons for updating

  • Change to date of revision
  • Change to MA holder contact details

Updated on 6 July 2011 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Summary of Changes to Lumigan® 0.1mg/ml Summary of Product Characteristics (SPC)

 

The current Lumigan® 0.1mg/ml is dated 21st January 2011

This supersedes SPC dated 7th January 2010

 

 

Section Number

Subject

Change

10

DATE OF REVISION OF THE TEXT

Text Removed/Added

 

01/2010 01/2011

 

 

 

Key:

Unchanged text appears as follows: eg Paediatric population

Added text appears as follows: eg Uveitis

Deleted (Removed) text appears as follows: eg Not applicable

Updated on 5 July 2011 PIL

Reasons for updating

  • Change to MA holder contact details

Updated on 31 March 2010 PIL

Reasons for updating

  • New PIL for new product

Updated on 30 March 2010 SmPC

Reasons for updating

  • New SPC for new product

Legal category: Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

None provided