Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2005 Publisher: Alcon Laboratories (UK) Limited, Pentagon Park, Boundary Way Hemel Hempstead, Hertfordshire, HP2 7UD, United Kingdom
Hypersensitivity to the active substance or any of the excipients.
VEXOL is contraindicated in epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, and most other viral diseases of cornea and conjunctiva; mycobacterial infection of the eye; fungal diseases of the eye; acute purulent untreated infections which, like other diseases caused by microorganisms may be masked or enhanced by the presence of the steroid; red eye, where the diagnosis is unconfirmed; and amoebic infections.
In more serious cases, and if the posterior part of the globe is affected, subconjunctival injection or treatment is recommended. But Vexol is not for injection. Prolonged use may result in ocular hypertension/glaucoma, damage to the optic nerve, defects in visual acuity and visual fields, and posterior subcapsular cataract formation. Prolonged use may also result in secondary ocular infections due to suppression of host response.
Acute purulent infections of the eye may be masked or exacerbated by the presence of corticosteroid medication. In those diseases causing thinning of the cornea or sclera, perforation has been known to occur with topical steroids. It is advisable that the intraocular pressure be checked frequently.
General: Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local steroid application. Fungus invasion must be considered in any persistent corneal ulceration where a steroid has been or is in use.
The wearing of contact lenses (hard or soft) is discouraged during treatment of an ocular inflammation. VEXOL should not be instilled while wearing contact lenses; lenses should not be inserted for 15 minutes after instillation of VEXOL. Additionally, the preservative benzalkonium chloride may cause eye irritation and is known to discolour soft lenses.
Specific drug interaction studies have not been conducted with VEXOL. No drug interactions were identified during the clinical development program.
If concomitant eye preparations are to be used, the patient should be advised to wait about 15 minutes between the two applications.
There are no adequate data from the use of Rimexolone in pregnant women.
Studies in animals have shown reproductive toxicity (see section 5.3). The potential risk for humans is unknown.
Vexol should not be used during pregnancy unless clearly necessary.
Infants born to mothers who have received substantial doses of corticosteroids during pregnancy should be observed carefully for signs of hypoadrenalism.
It is not known whether topical ophthalmic administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human breast milk. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman; a decision should be made whether to discontinue nursing or discontinue therapy, taking into consideration the importance of the drug to the mother.
Temporarily blurred vision or other visual disturbances may affect the ability to drive or use machines. If blurred vision or visual disturbances occur, the patient must wait until the vision clears before driving or using machinery.
In clinical studies with Vexol, the most frequently reported adverse events and local symptoms were: blurred vision (2.6%) and ocular discharge (2.2%).
The following undesirable effects were reported during clinical trials with Vexol:
Uncommon (≥0.1% <1%): rhinitis, pharyngitis.
Uncommon (≥0.1% <1%): headache (including browache), dysgeusia (taste perversion).
Common (≥1% <10%): vision blurred, eye discharge, ocular discomfort, eye pain, foreign body sensation in eye.
Uncommon (≥0.1% <1%): ocular hyperaemia, eye pruritus, abnormal sensation in eye (sticky sensation), anterior chamber fibrin, dry eye, conjunctival oedema, keratitis, lacrimation increased, photophobia, eye oedema, eye irritation, corneal ulcer, eyelid margin crusting, corneal oedema, corneal infiltrates, corneal erosion.
Uncommon (≥0.1% <1%): hypotension.
Common (≥1% <10%): intraocular pressure increased.
Uncommon (≥0.1% <1%): corneal staining.
In post-marketing experience, the most frequently reported events are eye irritation, lid margin crusting, ocular hyperaemia and intraocular pressure increase. These events are similar to those identified during clinical trials.
Use of topical corticosteroids may cause increased intraocular pressure (see section 4.4).
Not applicable.
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