VOLTAROL OPHTHA MULTIDOSE

Voltarol Ophtha eye drop solution is for instillation into the conjunctival sac only. It should never be injected subconjunctivally, nor should it be directly introduced into the anterior chamber of the eye.

Adults:

Prophylaxis of preoperative miosis Apply 1 drop four times during the 2 hours before surgery. Control of post-operative inflammation Apply 1 drop 4 times daily for up to 28 days. Control of Post-PRK pain and discomfort Apply 1 drop 2 times in the hour prior to surgery, 1 drop 2 times five minutes apart immediately after PRK surgery and then post-operatively 1 drop every 2-5 hours while awake for up to 24 hours.

Control of ocular pain associated with corneal epithelial defects after accidental non-penetrating trauma. Apply 1 drop 4 times daily for up to 2 days. Control of post-ALT inflammation. Apply one drop 4 times during the 2 hours before ALT, and then one drop 4 times daily for up to 7 days.

The relief of the ocular signs and symptoms of Seasonal Allergic Conjuctivitis. Apply one drop 4 times daily for as long as required. Treatment of inflammation and discomfort after strabismus surgery One drop 4 times daily in the 1st week, thrice daily in the 2nd week, twice daily in the 3rd week and as required in the 4th week Treatment of ocular pain and discomfort after radial keratotomy.

Pre-operatively one drop before surgery, post-operatively one drop immediately after surgery, and then one drop 4 times daily for up to 2 days.

Paediatric use:

Voltarol Ophtha and Voltarol Ophtha SDU are not indicated for use in children. Paediatric experience is limited to a few published clinical studies in strabismus surgery. Following instillation of the eye drops, nasolacrimal occlusion or closing the eyes for 5 minutes may reduce the systemic absorption.

This may result in a decrease in systemic side effects and an increase in local activity.

Very frequent:

Eye pain. The other frequently observed adverse reaction is a transient, mild to moderate eye irritation. Other less frequently observed reactions are eye pruritus, ocular hyperaemia and blurred vision immediately after instillation of the eye drops.

Punctate keratitis or corneal disorders have been observed, usually after frequent application. In patients with risk factors of corneal disorders such as during the use of corticosteroids or with concomitant diseases such as infections or rheumatoid arthritis, diclofenac has been associated, in rare cases, with ulcerative keratitis, corneal thinning, punctuate keratitis, corneal epithelium defect and corneal oedema, which might become sight-threatening.

Most patients were treated for a prolonged period of time. Allergic conditions have been reported for ocular reactions such as conjunctival hyperaemia, allergic conjunctivitis, eyelid erythema, oedema, and pruritus, and systemic hypersensitivity reactions such as urticaria, rash, eczema, erythema, pruritus, cough and rhinitis.

In rare cases dyspnoea and exacerbation of asthma have been reported. 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 the Yellow Card Scheme. uk/yellowcard

The anti-inflammatory activity of ophthalmic non-steroidal anti-inflammatory agents (NSAIDs) may mask the onset and/or progression of ocular infections. g. antibiotics) should be given concurrently with Voltarol Ophtha Multidose. Although there have been no reported adverse events, there is a theoretical possibility that patients receiving other medications which may prolong bleeding time, or with known haemostatic defects may experience exacerbation with Voltarol Ophtha Multidose.

Caution should be exercised when topical NSAIDs such as diclofenac are used concomitantly with topical steroids (see section

Patients with known hypersensitivity to any of the ingredients. Like other non-steroidal anti-inflammatory agents, Voltarol is also contraindicated in patients in whom attacks of asthma, urticaria or acute rhinitis are precipitated by acetylsalicylic acid or by other drugs with prostaglandin synthetase inhibiting activity.

Intraocular use during surgical procedure is also contraindicated.