VIDISIC 0.2% w/w Eye gel Ref.[49801] Active ingredients: Carbomer

Source: Health Products Regulatory Authority (IE)  Revision Year: 2020  Publisher: Bausch Health Ireland Limited, 3013 Lake Drive, Citywest Business Campus, Dublin 24, Ireland

4.3. Contraindications

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

Should not be used for undiagnosed conjunctivitis.

4.4. Special warnings and precautions for use

Wearers of contact lenses should remove their lenses before Vidisic is instilled and should wait for 15 minutes before they insert them again.

Intolerance reactions to one of the ingredients may be seen in isolated cases. Vidisic gel contains cetrimide as a preservative which, particularly when used frequently or for a long period, may cause ocular irritation (burning, redness, foreign body sensation) and may damage the corneal epithelium. Preservative-free medicinal products should therefore be preferred for long-term treatment of chronic keratoconjuctivitis sicca.

4.5. Interaction with other medicinal products and other forms of interaction

Vidisic may prolong the contact-time of topically applied drugs in ophthalmology.

Concomitant ocular medication should be administered 15 minutes prior to the instillation of Vidisic.

Vidisic should always be the last medication to be administered.

4.6. Pregnancy and lactation

Safety of Carbomer for use in pregnancy and lactation has not been established. Vidisic gel should not be used in pregnancy and lactation unless it is considered by the patient’s physician that the benefits of treatment outweigh the risks.

4.7. Effects on ability to drive and use machines

Even when administered as directed, this product may cause a transient blurring in vision and patients should exercise caution when driving or operating machinery.

4.8. Undesirable effects

Vidisic Gel is generally well tolerated. The following adverse reactions have been reported rarely:

Local burning, irritation, stinging, swelling, redness and inflammation of the eye.

If Vidisic Gel causes you any problems, tell your doctor or pharmacist.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via: HPRA Pharmacovigilance, Earlsfort Terrace, IRL – Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; E-mail: medsafety@hpra.ie.

6.2. Incompatibilities

Not applicable.

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