Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Novartis Pharmaceuticals UK Limited, 2nd Floor, The WestWorks Building, White City Place, 195 Wood Lane, London, W12 7FQ, United Kingdom
MAXITROL eye drops, suspension is indicated for the short-term treatment of steroid responsive conditions of the eye when prophylactic antibiotic treatment is also required, after excluding the presence of fungal and viral disease.
Apply one or two drops to each affected eye up to six times daily or, more frequently if required.
Maxitrol Eye Drops has not been studied in these subject populations. However, due to low systemic absorption of the active substances after topical administration of this product, dose adjustment is not necessary.
For ocular use only. Not for injection or ingestion.
Shake the bottle well before use.
After cap is removed, if tamper evident snap collar is loose, remove before using product.
In order to prevent contamination of the dropper tip and the suspension, caution should be exercised to ensure that the dropper tip does not touch the eyelids, the surroundings of the eye, or any other surfaces.
Nasolacrimal occlusion or gently closing the eyelid after administration is recommended. This may reduce the systemic absorption of medicinal products administered via the ocular route and result in a decrease in systemic adverse reactions.
No case of overdose has been reported.
Signs and symptoms of an overdosage of MAXITROL eye drops, suspension may be similar to adverse reaction effects seen in some patients (punctuate keratitis, erythema, increased lacrimation, oedema and lid itching).
Due to the characteristics of this preparation, intended for topical use, no toxic effects are expected when administered to the eye neither at the recommended dose nor in the event of accidental ingestion of the contents of a bottle.
A topical ophthalmic overdose of MAXITROL eye drops, suspension may be flushed from the eye(s) with lukewarm water.
Unopened 24 months.
Discard 28 days after first opening.
Do not store above 25°C. Keep away from direct sunlight. Do not refrigerate. Keep the container tightly closed.
5 ml & 10 ml DROP-TANIER, natural LDPE bottles and plugs with polystyrene or polypropylene caps.
Any unused product or waste material should be disposed of in accordance with local requirements.
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