Optrex Clear Eyes Eye Drops

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 15/01/20

files-icon(Click to Download)
Summary of Product Characteristics last updated on medicines.ie: 19/1/2018
print

Print ViewKeyword Search SmPC

Reckitt Benckiser Ireland Limited

Reckitt Benckiser Ireland Limited

Company Products

Medicine NameActive Ingredients
Medicine Name Bonjela Oromucosal Gel Active Ingredients Cetalkonium Chloride, Choline Salicylate
Medicine Name Bonjela Teething Gel Oromucosal Gel Active Ingredients Cetalkonium Chloride, Choline Salicylate
Medicine Name Dettol Antiseptic Disinfectant 4.8 % w/v Concentrate for Cutaneous Solution Active Ingredients Chloroxylenol
Medicine Name Disprin Direct 300mg Orodispersible Tablets Active Ingredients Aspirin
Medicine Name Disprin Extra Strength 500mg Effervescent Tablets Active Ingredients Acetylsalicylic Acid
Medicine Name Disprin Original 300mg Dispersible Tablets Active Ingredients Acetylsalicylic acid (Aspirin)
Medicine Name E45 Cream Active Ingredients Anhydrous Lanolin, Light Liquid Paraffin, White Soft Paraffin
Medicine Name Fybogel Citrus Active Ingredients Ispaghula Husk
Medicine Name Fybogel Mebeverine Active Ingredients Ispaghula Husk, Mebeverine Hydochloride
Medicine Name Fybogel Orange 3.5g Granules Active Ingredients Ispaghula Husk
Medicine Name Gaviscon Advance Oral Suspension Active Ingredients Potassium hydrogen carbonate, Sodium Alginate
Medicine Name Gaviscon Advance Tablets Active Ingredients Potassium Bicarbonate, Sodium Alginate
Medicine Name Gaviscon Extra Chewable Tablets Active Ingredients Calcium Carbonate, Sodium Alginate, Sodium Bicarbonate
Medicine Name Gaviscon Extra Liquid Sachets Peppermint Flavour Active Ingredients Calcium Carbonate, Sodium Alginate, Sodium Bicarbonate
Medicine Name Gaviscon Extra Oral Suspension Active Ingredients Calcium Carbonate, Sodium Alginate, Sodium Bicarbonate
Medicine Name Gaviscon Extra Oral Suspension 300ml Active Ingredients Calcium Carbonate, Sodium Alginate, Sodium Bicarbonate
Medicine Name Gaviscon Infant Active Ingredients Magnesium Alginate, Sodium Alginate
Medicine Name Gaviscon Liquid - Peppermint Flavour Active Ingredients Calcium Carbonate, Sodium Alginate, Sodium Bicarbonate
Medicine Name Gaviscon Liquid Aniseed Flavour Active Ingredients Calcium Carbonate, Sodium Alginate, Sodium Bicarbonate
Medicine Name Gaviscon Peppermint Chewable Tablets Active Ingredients Calcium Carbonate, Sodium Alginate, Sodium Hydrogen Carbonate
Medicine Name Gaviscon Suspension Active Ingredients Calcium Carbonate, Sodium Alginate, Sodium Bicarbonate
Medicine Name Hc45 Hydrocortisone Acetate 1% w/w Cream Active Ingredients Hydrocortisone Acetate
Medicine Name Lemsip Chesty Cough 50 mg/5 ml Oral Solution Active Ingredients Guaifenesin
Medicine Name Lemsip Cold & Flu Capsules with Caffeine Active Ingredients Caffeine, Paracetamol
Medicine Name Lemsip Cold & Flu Headcold 500mg Powder for Oral Solution Active Ingredients Paracetamol
1 - 0 of 66 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 15 January 2020 PIL

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 22 November 2018 PIL

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 3 - dose and frequency
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder

Updated on 19 January 2018 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 4.2:
Additional information give for adults and children over 12 years use:   "If symptoms do not resolve within 24 hours, the patient should see a healthcare professional.  This product is intended for intermittent or occasional use and should not be used for more than 72 hours unless under medical supervision."

Addition of other information:
"Children under 12 years:  Not to be used (see section 4.3)
Method of administration:  For topical application to the eye"


Section 4.3:
Addition of the following contraindications:
hypersensitivity to hamamelis water, naphazoline
closed-angle glaucoma
children younger than 12 years of age


Section 4.4:
Addition of the following warnings and precautions for use:
If you are being treated for.....arteriosclerosis, cardiovascular disease......as naphazoline may exacerbate vasoconstriction.  Because of these possible adverse events, ocular decongestants should not be used as ocular irrigants.
If the solution changes colour or becomes cloudy do not use 
Use of naphazoline in the eye may liberate pigment granules from the iris, especially when given in high doses to elderly patients.


Section 4.6:
Addition of the following text:
Pregnancy - there are limited data from the use of hamamelis water and naphazoline in pregnant women.  as a precautionary measure it is preferable to avoid the use of the product during pregnancy unless recommended by a healthcare professiona.
Breast-feeding - although the safety of Optrex Clear Eyes eye drops during lactation has not been established, it is unlikely that sufficient of the active ingredients will reach the breast-fed infant.  This product can be used during breast-feeding.
Fertility - no known effects.


Section 4.7:
Addition of the following text:
This product may have a minor influence on the ability to drive and use machines.  Dizziness may occur following administration of the product (see section 4.8) and vision may be blurred due to adding liquid to the eye.


Section 4.8
Addition of adverse events frequencies and system organ class
Immune system disorders - not known - hypersensitivity
Nervous system disorders - not known - headache, dizziness
Eye disorders - not known - eye irritation, eye pain
Gastrointestinal disorders - not known - nausea

Information added on how to report a suspected adverse reaction


Section 4.9:
Addition of the following text:
Excessive or long-term use of this product may result in allergic conjunctivitis, allergic blepharitis or rebound conjunctival hyperaemia.  Prolonged use may also lead to epithelial xerosis which can exacerbate symptoms of irritation, pain and dryness experienced in allergic conjunctivitis.
Indiscriminate use of decongestants, such as naphazoline, in an irritated eye can induce papillary dilation and precipitate angle-closure glaucoma in eyes that have narrow anterior changer angles.
There are no or limited data on overdose of topical hamamelis water, but risks are negligible.


Section 5.1:
Addition of the following text:
Pharmacotherapeutic group:  Sensory organs; opthalmologicals; decongestants and antiallergics; sympathomimetics.  Used as decongestants.
Applied as an eye drop, it caused conjunctival vasoconstriction within 10 minutes.  Effects can last for up to 6 hours.
Distilled witch hazel (hamamelis water) has cooling and astringent properties.


Section 5.2:
Addition of the following text:
There are no relevant pharmacokinetic data for hamamelis water.

 


Updated on 19 January 2018 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through pharmacy only

Updated on 18 November 2011 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 5.1 - Pharmacodynamic properties

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Wording in Section 4.3 revised to state

Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.

Section 5.1 updated to inlcude:

ATC code:  S01GA51

Updated on 22 June 2011 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.1 - List of excipients
  • Change to section 6.6 - Special precautions for disposal and other handling

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 1 -
updated to include pharmaceutical form and strength
Section 2 - a
s above, and also the inclusion of 

Excipients:  Contains benzalkonium chloride solution 0.005 % w/v and ethanol 2.0 % v/v.

Section 4.4:  updated to include the following:

Contains benzalkonium chloride which may cause eye irritation.  Avoid contact with soft contact lenses.  Remove contact lenses prior to application and wait at least 15 minutes before reinsertion.  Known to discolour soft contact lenses.

Section 6.1 updated to state the following:

Sodium Hydroxide (for pH adjustment)

Hydrochloric Acid (for pH adjustment)

Ethanol (component of distilled witch hazel)

Section 6.6 updated to state the following:

                        Do not use if the drops change colour or become cloudy.

 

 

 

 

Updated on 21 June 2011 PIL

Reasons for updating

  • New PIL for new product

Updated on 21 June 2011 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 30 June 2009 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 15 July 2008 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 9 July 2007 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 7 - Marketing authorisation holder

Legal category: Supply through pharmacy only

Free text change information supplied by the pharmaceutical company

Section 1 and 7 - correction of formatting errors

Updated on 24 May 2006 SmPC

Reasons for updating

  • New SPC for new product

Legal category: Supply through pharmacy only