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Otrivine Antistin Eye Drops. Laboratoires Thea.

Formulation
  • Sterile solution containing:
  • Xylometazoline 0.05% w/v
  • Antazoline 0.5% w/v
  • Bezalkonium Chloride
  • Boric Acid
  • Disodium Edetate
  • Sodium Tetraborate
  • Water for injections.
Suppliers
Thea Pharmaceuticals and wholesalers.
How supplied
Sterilised eye drops (10ml) in plastic bottle.
Dosing
For teenagers and adults only. ECP/HCP to advise. Generally adults: 1-2 drops into each affected eye two or three times per day. Elderly: 1 drop two or three times per day. Not to be used for more than seven consecutive days.
CL Use
No, see Contra-Indications/Cautions
Indications
Seasonal Allergic Conjunctivitis. Ocular Allergy. "For the temporary relief of redness and itching of the eye due to seasonal and perennial allergies such as hay fever or house dust allergy".
Contra-Indications / Cautions
Hypersensitivity to product/class/component. Attention is drawn to this products P classification. Not for use with Contact Lenses. Use with other eye products: Pt to wait at least 5 minutes between using product and administering any other product into the eye. If pt experiences blurring of vision, not drive or operate machinery until sight has cleared. Discard after 28 days of opening. Store at room temperature below 25C. Pregnancy/lactation. Due to the potentially wide range and seriousness of the Contra-indications/Cautions relating to this product the prescriber of this medicine should fully aware of original documentation, Patient Information Leaflet etc. All pts should be instructed to read the Patient Information Leaflet before using product. Attention is drawn to this products P classification. If symptoms do not improve within 48 hours - pt to seek medical advice. If symptoms become worse - Px to seek medical advice immediately. Advise pt to read and understand all accompanying product information before first use - EDDB.
Adverse Reactions
Transient stinging, local allergic reactions, headache, drowsiness, blurred vision. 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.
Legal Category
P/NHS Rx.

Notes:

1. Attention is drawn to this products P classification.

2. Attention is drawn to specific warnings in Contra-Indications/Cautions and Adverse Reactions.

3a. SmPC: http://www.medicines.org.uk/emc/medicine/20937   

3b.  Important note: Check SmPC revision update 09/01/2019 is current. Shelf-life reduced from 36 to 24 months.

4. PIL: http://www.medicines.org.uk/emc/PIL.28204.latest.pdf 

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

6. 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.