Allodrop 1mg/ml Eye drops

ALLODROP is indicated for the temporary prevention of itching of the eye due to allergic conjunctivitis.

Posology
Instil one drop of ALLODROP in the conjunctival sac of the affected eye(s) twice daily. To prevent contamination of the dropper tip and solution, care must be taken not to touch the eyelids, surrounding areas, or other surfaces with the dropper tip of the bottle. Keep the bottle tightly closed when not in use.
Use in elderly
No dosage alteration in elderly patients is necessary.
Use in children
ALLODROP may be used in paediatric patients (3 years of age and older) at the same posology as in adults.
Use in hepatic and renal impairment
ALLODROP eye drops has not been studied in patients with renal or hepatic disease. However, a renal impairment study after oral dosing of olopatadine in patients with severe renal impairment indicates that a higher plasma concentration can be expected with ALLODROP in this population. However, because of the low plasma exposure following topical ocular administration, no dose adjustment is necessary. Hepatic metabolism represents a small fraction of olopatadine elimination. Therefore, hepatic impairment is not expected to alter the pharmacokinetics of olopatadine and no dose adjustment is necessary.
Method of administration
For ocular use only. After the bottle cap is removed, if the tamper evident snap collar is loose, remove before using the product. To prevent contamination of the dropper tip and solution, care must be taken not to touch the eyelids, surrounding areas, or other surfaces with the dropper tip of the bottle. Keep the bottle tightly closed when not in use. In case of concomitant therapy with other topical ocular medicines, an interval of five minutes should be allowed between successive applications. Eye ointments should be administered last.

Known hypersensitivity to olopatadine, benzalkonium, or to any of the excipients of ALLODROP listed in 6.1.

ALLODROP is an antiallergic/antihistaminic medicine and, although administered topically, is absorbed systemically. If signs of serious reactions or hypersensitivity occur, discontinue the use of this treatment.
Benzalkonium chloride:
ALLODROP contains benzalkonium chloride which may cause eye irritation. Benzalkonium chloride has also been reported to cause punctate keratopathy and/or toxic ulcerative keratopathy. Close monitoring is required with frequent or prolonged use in dry eye patients, or in conditions where the cornea is compromised.
Contact lenses
Benzalkonium is known to discolour soft contact lenses. Avoid contact with soft contact lenses. Patients should be instructed to remove contact lenses prior to administration of the eye drop and wait at least 15 minutes after instillation before re-inserting contact lenses.

In case of concomitant therapy with other topical ocular medicines, an interval of 5 minutes should be allowed between successive applications. No human clinical medicine interaction studies were performed with ALLODROP. In vitro studies have shown that olopatadine did not inhibit metabolic reactions which involve cytochrome P- 450 isozymes 1A2, 2C8, 2C9, 2C19, 2D6, 2E1 and 3A4. These results indicate that ALLODROP is unlikely to result in metabolic interactions with other concomitantly administered active substances.

Pregnancy
No adequate and well-controlled studies were performed in pregnant women. Studies in animals have shown reproductive toxicity at systemic doses well in excess of the maximal level recommended for human ocular use. Because animal studies are not always predictive of human responses, the use of ALLODROP in pregnancy is not recommended.
Breastfeeding
It is not known whether topical administration to humans could result in sufficient systemic absorption to produce detectable quantities in human breast milk. ALLODROP is not recommended for breastfeeding mothers.
Fertility
No human data available.

Temporary blurred vision or other visual disturbances may affect the ability to drive or use machines. If blurred vision occurs at instillation, the patient must wait until the vision clears before driving or using machinery.

Summary of the safety profile
No serious ophthalmic or systemic adverse reactions related to ALLODROP were reported in clinical studies. The most frequent treatment-related adverse reaction was eye pain, reported at an overall incidence of 0,7 %.
Tabulated summary of adverse reactions
System Organ Classification Frequency Undesirable effects
Infections and infestations Less frequent rhinitis
Immune system disorders Frequency unknown hypersensitivity, swelling face
Nervous system disorders Frequent headache, dysgeusia Less frequent dizziness, hypoaesthesia Frequency unknown somnolence
Eye disorders Frequent eye pain, eye irritation, dry eye, abnormal sensation in eyes Less frequent corneal erosion, corneal epithelium defect, corneal epithelium disorder, punctate keratitis, keratitis, corneal staining, eye discharge, photophobia, vision blurred, visual acuity reduced, blepharospasm, ocular discomfort, eye pruritus, conjunctival follicles, conjunctival disorder, foreign body sensation in eyes, lacrimation increased, erythema of eyelid, eyelid oedema, eyelid disorder, ocular hyperaemia Frequency unknown corneal oedema, eye oedema, eye swelling, conjunctivitis, mydriasis, visual disturbance, eyelid margin crusting
Respiratory, thoracic and mediastinal disorders Frequent nasal dryness Frequency unknown dyspnoea, sinusitis
Gastrointestinal disorders Frequency unknown nausea, vomiting
Skin and subcutaneous tissue disorders Less frequent dermatitis contact, skin burning sensation, dry skin Frequency unknown dermatitis, erythema
General disorders and administration site conditions Frequent fatigue Frequency unknown asthenia, malaise
Cases of corneal calcification have been reported very rarely in association with the use of phosphate containing eyedrops in some patients with significantly damaged corneas.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Healthcare providers are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Drug Reactions Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8.

In the case of overdose, appropriate monitoring and management of the patient should be implemented.