MYDRIASERT

Restricted use to health-care professionals. 1). 3). There are no data in children aged 12 to 18 years. Mydriasert is not recommended in these patients. Method of administration Cut the sealed edge along the dotted line, open the sachet and locate the insert.

Hold the insert with disposable sterile forceps with rounded ends provided in the packaging, making sure not to damage it. Pull down the lower eyelid by pinching it between the thumb and index finger (A), and apply the ophthalmic insert, using the disposable sterile forceps, in the lower conjunctival sac (B).

Instructions for use Do not leave the ophthalmic insert for more than two hours in the lower conjunctival sac. The practitioner can remove the ophthalmic insert as soon as mydriasis is deemed sufficient for the operation or procedure to be carried out, and at the latest within the next 30 minutes.

In the event of discomfort, ensure that the insert has been placed correctly at the base of the lower conjunctival sac. Manipulate aseptically. It is recommended to avoid excessive manipulation of eyelids.

CAUTION:

Removal of the ophthalmic insert Before an operation or procedure, and as soon as the required mydriasis has been obtained, the ophthalmic insert should be removed from the lower conjunctival sac (C) by using either sterile surgical forceps, or a sterile swab or a sterile irrigation or washing solution, by lowering the lower eyelid.

Do not reuse the insert. Discard the insert after use immediately.

The following transient effects have been reported during clinical studies and in post-marketing safety data: Adverse events are categorised by frequency as follows: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000) and very rare (<1/10,000), not known (frequency cannot be estimated from the available data).

System Organ Class Very Common ≥1/10 Common ≥1/100 to <1/10 Uncommon ≥1/1,000 to <1/100 Rare ≥1/10,000 to <1/1,000 Very Rare <1/10,000 Nervous system disorders Convulsions Eye disorders Stinging; Blurred vision; Tearing; Irritation; Disabling Blepharitis; Conjunctivitis; Risk of angle- closure Visual discomfort.

mydriasis because of prolonged pupil dilation; Photophobia; Superficial punctuate keratitis. glaucoma; Intraocular hypertension. Very rare cases of corneal ulcer and corneal oedema were observed due to forgotten insert. Although administered via the topical route, the mydriatic agents contained in this insert may cause the following systemic effects which must be taken into account: -elevation of blood pressure, tachycardia, -very rarely, major accidents such as cardiac arrhythmia, -tremor, pallor, headaches, dry mouth.

Paediatric population - Eye disorders:

Periorbital pallor in preterm patients – Frequency not known (cannot be estimated from the available data). - Respiratory, thoracic and mediastinal disorders: Pulmonary oedema – Frequency not known (cannot be estimated from the available data).

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.

8). Protect the eye against bright lighting after the end of intervention/consultation. Ocular hyperemia can increase the absorption of the active ingredients contained in the insert.

Special precautions for use:

The shifting or, more rarely, the expulsion of the insert is possible. 2). Mydriasert should not be left in the conjunctival sac for more than 2 hours. 8). Because of uncommon potential irritation on conjunctiva, special care should be taken with patients suffering from severe dry eyes (use of Mydriasert in some patients may necessitate the addition of a drop of saline solution to improve insert tolerance).

All mydriatic agents may trigger an acute attack of glaucoma through the mechanical obstruction of the excretory pathways of aqueous humour in subjects presenting with a narrow iridocorneal angle. Although not anticipated with Mydriasert due to negligible systemic passage of active ingredients, it is however reminded that phenylephrine has sympathomimetic activity that might affect patients in the event of hypertension, cardiac disorders, hyperthyroidism, atherosclerosis or prostate disorders and all subjects presenting with a contraindication to the systemic use of pressor amines.

Sportsmen and athletes should be warned that this proprietary medicinal product contains an active principle (phenylephrine) which may produce positive results to tests for prohibited substances. The wearing of soft hydrophilic contact lenses is inadvisable during treatment.

5% solution of tropicamide. Paediatric population Use in children aged below 12 years is contraindicated, since serious systemic adverse reactions have been reported with ophthalmic products containing phenylephrine and tropicamide particularly in the paediatric population, such as cardiovascular derangement with severe hypertension, heart rate alterations, and pulmonary oedema.

1.

Risk of angle-closure glaucoma:

Patients with closed angle glaucoma (unless previously treated with iridectomy) and patients with narrow angle prone to glaucoma precipitated by mydriatics. 4).