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.

 

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

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.

 

 

 

 

Section 1 and 7 - correction of formatting errors