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Notes

Details

How Supplied
Sterilised clear and colourless liquid aqueous eye drops (5ml) in plastic bottle with cap.
Dosing
ECP/HCP to advise. Generally 1 drop two times daily on each affected eye. Not for use more than 4 consecutive months. Always read SmPC via link in Notes below.
Formulation
Sterile solution containing:, Olopatadine 1mg/ml (as Hydrochloride), Benzalkonium Chloride, Sodium Chloride, Disodium Phosphate Dodecahydrate (E339), Hydrochloric Acid (E507) (to adjust pH), Sodium Hydroxide (E524) (to adjust pH), Purified Water. Always read SmPC via link in Notes below.
Contact Lens Use
No, see Contra-Indications/Cautions
Indications
Seasonal Allergic Conjunctivitis (Hay Fever - EDDB). Perennial Allergic Conjunctivitis. "Opatanol is used for the treatment of signs and symptoms of seasonal allergic conjunctivitis. Allergic conjunctivitis. Some materials (allergens) like pollens, house dust or animal fur may cause allergic reactions resulting in itching, redness as well as swelling of the surface of your eye". Always read SmPC via link in Notes below.
Contra-Indications/Cautions
Hypersensitivity to product/class/component. Contact Lenses must be removed before using product. Discard 4 weeks after first opening. Attention is drawn to this products POM classification. Pt to read Patient Information Leaflet before using. Pregnancy/lactation - EDDB. Advise pt to read and understand all accompanying product information before first use - EDDB. "Do not use Opatanol in children under the age of 3 years". "You should not use Opatanol if you are breast-feeding". "If you wear contact lens you should remove contact lenses prior to application and wait at least 15 minutes before putting your lenses back in". "If you are using other eye drops or eye ointment medicines, leave at least 5 minutes between each medicine. Eye ointments should be administered last". Always read SmPC via link in Notes below.
Adverse Reactions
"Common: eye pain, eye irritation, dry eye, abnormal sensation in eyes" Uncommon: corneal erosion, corneal epithelium defect, corneal epithelium disorder, punctate keratitis, keratitis, corneal staining, eye discharge, photophobia, vision blurred, visual acuity reduced, blepharospasm, ocular discomfort, eye pruritus, conjunctival follicles, conjunctival disorder, foreign body sensation in eyes, lacrimation increased, erythema of eyelid, eyelid oedema, eyelid disorder, ocular hyperaemia" "Cases of corneal calcification have been reported very rarely in association with the use of phosphate containing eye drops in some patients with significantly damaged corneas". Due to the potentially wide range and seriousness of the Adverse Reactions relating to this product the prescriber of this medicine should fully aware of original documentation, including SPC and PIL - see Notes. All pts should be instructed to read the Patient Information Leaflet before using product. If irritation occurs, persists or increases, pt to discontinue use and consult ECP/HCP - EDDB. If vision changes or irritation occurs, persists or increases, pt to discontinue use and consult ECP/HCP. Always read SmPC via link in Notes below.
Legal Category
POM.
Notes

1. Attention is drawn to this product's POM classification.

2. SmPC: https://www.medicines.org.uk/emc/product/6768/smpc

3. PIL: https://www.medicines.org.uk/emc/product/6768/pil

4. ON NO ACCOUNT SHOULD THE DATA CONTAINED ON THIS PAGE BE USED AS A BASIS FOR CLINICAL DECISION MAKING/PX ADVICE  - THIS SHOULD ONLY BE DONE BY REFERENCE TO THE ORIGINAL PRESCRIBER AND/OR PRODUCT DOCUMENTATION.

5. Because products are regularly improved and change, product data and advice may occasionally change. As a result, EDDB recommends that you and your patient always read the product label and Patient Information Leaflet carefully before using any products. Please do not solely rely on the information provided on this website. Because of this, EDDB is unable to accept liability for any inaccuracies or incorrect information contained on this site.

6. Pt MUST BE INSTRUCTED TO READ ACCOMPANYING PATIENT INFORMATION LEAFLET BEFORE USE.

7. Attention is drawn to this product's POM/P category and the full relevant legal restrictions therof.

8. Attention is drawn to specific warnings in Contra-Indications/Cautions and Adverse Reactions on this page and the full text of the SPC and PIL, all of which should be read and understood.

8.REMINDER: TERMS OF USE. By using this website I agree I am an Eye Care/Health Care Professional and have read, understood and accepted all the terms of use as outlined in the Disclaimer and the Privacy Policy.

Product information

Not every product may be listed, or have full data. Every effort is being made to fill in the gaps as soon as possible. It will continue to grow in breadth and depth as data arrives and products are released, almost on a daily basis. Endeavours will be made to include information on 'retailers' drops such as Sainsbury's, Superdrug etc, so you can have data available when your patient tells you they are using Tesco Allergy Drops (Sodium Cromoglicate) and asks "can I use it with my contact lenses?". If you would like to propose products for the database, have any ideas, suggestions, would like to provide missing data or see any factual inaccuracies please email adpconsultancy@gmail.com