Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2014 Publisher: Laboratoires Thea, 12, rue Louis-Blériot, 63017 Clermont-Ferrand Cedex 2, France
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.
There is practically no risk of adverse effects due to accidental oral ingestion, since a 5ml bottle of the eye drops contains only 5mg of diclofenac sodium, corresponding to about 3% of the recommended maximum daily adult dose of Voltarol after oral administration. By way of comparison, the maximum oral daily dose for diclofenac sodium recommended in children is 2mg/kg body weight.
Unopened: 24 months.
Opened: 4 weeks.
No special precautions for storage.
5ml white LDPE bottle with LDPE dropper and HDPE closure.
No special requirements.
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