When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
In Section 2, Qualitative and quantitative composition, the text has been amended to QRD template.
In Section 4.1, Therapeutic indications, ‘Maxitrol Eye Drops’ is replaced with ‘Maxitrol Eye Drops, Suspension’
In Section 4.3, Contraindications, the whole section has been updated according to updated safety data, and is presented according to QRD.
In Section 4.4, Special warnings and precautions for use, the whole section has been updated according to updated safety data, and is presented according to QRD.
In Section 4.5, Interaction with other medicinal products and other forms of interaction, ‘None relevant to topical use’ is replaced by ‘No interaction studies have been performed.
Concomitant and/or sequential use of an aminoglycoside (neomycin) and other systemic, oral, or topical drugs that have neurotoxic, ototoxic, or nephrotoxic effects may result in additive toxicity and should be avoided, whenever possible.
If more than one 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, the whole section has been updated according to updated safety data, and is presented according to QRD.
In Section 4.7, Effects on ability to drive and use machines, the whole section has been replaced with ‘MAXITROL eye drops, suspension has no or negligible influence on the ability to drive and use machines. As with any other eye drop, temporarily blurred vision or other visual disturbances may affect the ability to drive or use machines. If transient blurred vision occurs upon instillation, the patient must wait until the vision clears before driving or using machinery.’
In Section 4.8, Undesirable effects, the whole section has been rewritten to represent it in the MedRA format.
In Section 4.9, Overdose, the whole section is replaced with ‘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). A topical ophthalmic overdose of MAXITROL eye drops, suspension may be flushed from the eye(s) with lukewarm water.’
In Section 5.1, Pharmacodynamic properties, the whole section has been updated according to updated safety data, and is presented according to QRD.
In Section 5.3, Preclinical safety data, the whole section has been updated according to updated safety data, and is presented according to QRD.
In Section 6.3, Shelf life, ‘Once opened: Discard one month after first opening’ is replaced with ‘Discard one month after first opening.’
In Section 6.4, Special precautions for storage, the following storage condition has been added – ‘Store in the original package (to protect from light).’
In Section 7, Marketing Authorisation holder, ‘England’ in the address is replaced with ‘U.K.’
In Section 10, Date of revision of the text, the date is updated.