| In Section 4.2, Posology and method of administration, the following text is added – ‘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.’
In Section 4.4, Special warnings and precautions for use, the following text is added – ‘Patients should be advised that instillation of eye drops may initially cause discomfort or transient burning or stinging (see section 4.8). Should these symptoms persist, the patient should be advised to contact the prescribing physician.’ Also, information regarding the preservative Benzalkonium has been amended.
In Section 4.5, Interaction with other medicinal products and other forms of interaction, ‘Not known’ is replaced with ‘No interaction studies have been performed’ and the following text is added – ‘If more than one topical ophthalmic medicinal product is being used, the medicines must be administered at least 5 minutes apart. Eye ointments should be administered last.’
In Section 4.6, Pregnancy and lactation, information regarding the use of Alomide during Pregnancy and Lactation has been updated.
In Section 4.7, Effects on ability to drive and use machines, the text has been amended in lines with QRD.
In Section 4.8, Undesirable effects, the text has been amended and represented in the MedDRA Preferred table.
In Section 4.9, Overdose, information regarding the actions to be taken on overdose has been updated, and the following text has been added – ‘Due to the characteristics of this preparation, no toxic effects are to be expected with an ocular overdose of this product.
In case of accidental ingestion of doses of 0.1 mg to 10.0 mg of lodoxamide, the following side adverse effects may occur: feeling of warmth, flushing, nausea, vomiting, diaphoresis and abdominal cramping. Transient elevations of systolic and diastolic blood pressure have been noted with doses of 3.0 and 10.0 mg of oral lodoxamide, but they resolve spontaneously after a short time. Other possible adverse effects after an oral overdose are: headache, dizziness, fatigue and loose stools.
If accidentally ingested, efforts to decrease further absorption may be appropriate. Lavage, if the overdose has been taken within 1 hour or treatment with activated charcoal should be considered.’
Also, the following sentence is removed – ‘Consideration may be given by the physician to emesis in the event of accidental ingestion.’
In Section 10, Date of revision of the text, the date of revision has been updated.
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