Special Warning : אזהרת שימוש

4.4     Special warnings and precautions for use

While the topical administration of IOPIDINE 0.5% had minimal effect on heart rate or blood pressure in clinical studies evaluating glaucoma patients including those with cardiovascular disease, the possibility of a vasovagal attack should be considered and caution should be exercised in patients with a history of such episodes.

IOPIDINE 0.5% should be used with caution in patients with a history of angina, severe coronary insufficiency, recent myocardial infarction, overt cardiac failure, hypertension, cardiovascular disease, including apoplexy, cerebrovascular disease, Parkinson’s syndrome, chronic renal failure, Raynaud's disease or thromboangiitis obliterans. Caution in and monitoring of depressed patients are advised since apraclonidine has been rarely associated with depression.

In end‐stage glaucoma, if reduction in vision occurs immediately following IOPIDINE 0.5% therapy, treatment should be suspended.

As with all glaucoma patients on maximally tolerated medical therapy, those who are treated with IOPIDINE 0.5% to delay surgery should have frequent follow‐up examinations and treatment should be discontinued if the intraocular pressure rises significantly. The loss of effect which occurs over time in most patients appears to be an individual occurrence with a variable time of onset and should be closely monitored. Furthermore, these patients should have their visual fields evaluated periodically.

No data are available on the topical use of apraclonidine in patients with renal or hepatic failure. Systemic absorption of apraclonidine following topical administration is low, resulting in plasma levels less than 1.0 ng/ml.
Nonetheless, monitoring of patients with impaired renal or hepatic function is advised. Close monitoring of cardiovascular parameters in patients with impaired liver function is also advised as the systemic dosage form of clonidine is partly metabolised in the liver.

Use of IOPIDINE 0.5% can result in an ocular intolerance reaction characterized wholly or in part by the symptoms of ocular hyperaemia, eye pruritus, ocular discomfort, lacrimation increased, abnormal sensation and oedema of the lids and conjunctival oedema (see section 4.8). If such ocular symptoms occur, IOPIDINE 0.5% therapy should be discontinued. Also, preclinical data suggest that there may be patients who develop a contact sensitization response with repeated use of the drug. Ocular intolerance responses are more common in patients treated for more than one month.

Discontinuation of therapy in the event of rising intraocular pressure should coincide with the initiation of alternative therapy, or pressure‐relieving surgery.

Since apraclonidine is a potent depressor of intraocular pressure, patients who develop an exaggerated reduction in intraocular pressure should be closely monitored.

IOPIDINE contains benzalkonium chloride

This medicine contains 0.5 mg benzalkonium chloride in 5mL of the product, which is equivalent to a concentration of 0.1 mg/ml.

IOPIDINE contains benzalkonium chloride which may cause eye irritation and is known to discolour soft contact lenses. Contact with soft contact lenses should be avoided. Patients must be instructed to remove contact lenses prior to the application of IOPIDINE and wait 15 minutes after instillation of the dose before reinsertion.

Benzalkonium chloride has been reported to cause eye irritation, symptoms of dry eyes and may affect the tear film and corneal surface. Should be used with caution in dry eye patients and in patients where the cornea may be compromised. Patients should be monitored in case of prolonged use.

Effects on Driving

4.7     Effects on ability to drive and use machines
IOPIDINE 0.5% has a moderate influence on the ability to drive and use machines.

Since clonidine‐like drugs may cause dizziness or somnolence, patients so affected are advised not to drive or operate machinery. The attention of drivers and machinery operators should be drawn to the risks related to the use of this drug.