IOPIDINE

For topical ophthalmic use only.

Adults (including the elderly):

One drop of Apraclonidine 1% w/v Eye Drops, Solution should be instilled into the eye scheduled for operation one hour before initiating anterior segment laser surgery. A second drop should be instilled into the same eye immediately upon completion of the laser surgical procedure.

If for any reason, the drop of Apraclonidine 1% w/v Eye Drops, Solution does not remain in the eye, repeat the dose by placing another drop in the eye. Nasolacrimal occlusion or gently closing the eyelid after instillation is recommended.

This may reduce the systemic absorption of medications administered via the ocular route and result in a decrease in systemic side effects. There are no special precautions for administration to the elderly. Paediatric population Safety and effectiveness of apraclonidine ophthalmic solution in children have not been established and therefore this medicinal product is not recommended for use in children.

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.

6% of patients. Other common adverse drug reactions included eyelid retraction and mydriasis, occurring in approximately 3% to 4% of patients. All other drug reactions occurred in less than 2% of patients The following adverse reactions have been reported from clinical studies and post marketing surveillance and are classified according to the subsequent convention: 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) or not known (frequency cannot be estimated from available data.

Within each frequency-grouping, adverse reactions are presented in order of decreasing seriousness. 0) Immune systems disorders Not known: Hypersensitivity Nervous System Disorders Common: Dysgeusia.

Uncommon:

Syncope vasovagal, paraesthesia, libido decreased, irritability, dizziness postural, headache.

Rare:

Hypoaesthesia,.

Eye Disorders Common :

Ocular hyperaemia, mydriasis, dry eye, abnormal sensation in eye, eyelid retraction, eye disorder (conjunctival blanching) Uncommon : Conjunctival haemorrhage, eye inflammation, eyelid disorder (upper lid elevation), hypotony of eye, visual acuity reduced (dim vision),, vision blurred, eye allergy, eyelid disorder (upper lid elevation), eye pruritus, dry eye, eye irritation, ocular discomfort, punctate keratitis Cardiac Disorders Uncommon : Heart rate irregular, Bradycardia, palpitations.

Psychiatric Disorders Uncommon :

Insomnia, abnormal dreams.

Respiratory, Thoracic and Mediastinal Disorders Common:

Warnings:

While the topical administration of two drops of Apraclonidine 1% w/v Eye Drops, Solution had minimal effect on heart rate or blood pressure in clinical studies evaluating patients undergoing anterior segment laser surgery, 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.

Apraclonidine 1% w/v Eye Drops, Solution should be used with caution in patients with a history of angina, severe coronary insufficiency, recent myocardial infarction, overt cardiac failure, cerebrovascular disease, 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.

Precautions:

No data are available on the topical use of apraclonidine in patients with renal or hepatic failure. 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.

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

In patients with a history of severe or unstable and uncontrolled cardiovascular disease. For use in children In patients receiving monoamine oxidase inhibitor therapy, systemic sympathomimetic agents, tricyclic antidepressants In patients with hypersensitivity to the active substances (clonidine or apraclonidine) or to any of the excipients