Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Opatanol is an antiallergic/antihistaminic agent and, although administered topically, is absorbed systemically. If signs of serious reactions or hypersensitivity occur, discontinue the use of this treatment.
Opatanol 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.
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.
No interaction studies with other medicinal products have been performed.
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 olopatadine is unlikely to result in metabolic interactions with other concomitantly administered active substances.
There are no or limited amount of data from the use of ophthalmic olopatadine in pregnant women.
Studies in animals have shown reproductive toxicity following systemic administration (see section 5.3).
Olopatadine is not recommended during pregnancy and in women of childbearing potential not using contraception.
Available data in animals have shown excretion of olopatadine in milk following oral administration (for details see section 5.3).
A risk to the newborn/infants cannot be excluded.
Opatanol should not be used during breast-feeding.
Studies have not been performed to evaluate the effect of topical ocular administration of olopatadine on human fertility.
Opatanol has no or negligible influence on the ability to drive and use machines.
As with any eye drop, 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.
In clinical studies involving 1680 patients, Opatanol was administered one to four times daily in both eyes for up to four months as monotherapy or adjunctive therapy to loratadine 10 mg. Approximately 4.5% of patients can be expected to experience adverse reactions associated with the use of Opatanol; however, only 1.6% of patients discontinued from the clinical studies due to these adverse reactions. No serious ophthalmic or systemic adverse reactions related to Opatanol were reported in clinical studies. The most frequent treatment-related adverse reaction was eye pain, reported at an overall incidence of 0.7%.
The following adverse reactions have been reported during clinical studies and post-marketing data and are classified according to the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1000)very rare (<1/10,000) or not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
| System Organ Classification | Frequency | Adverse Reactions |
|---|---|---|
| Infections and infestations | Uncommon | rhinitis |
| Immune system disorders | Not known | hypersensitivity, swelling face |
| Nervous system disorders | Common | headache, dysgeusia |
| Uncommon | dizziness, hypoaesthesia | |
| Not known | somnolence | |
| Eye disorders | Common | eye pain, eye irritation, dry eye, abnormal sensation in eyes |
| Uncommon | 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 | |
| Not known | corneal oedema, eye oedema, eye swelling, conjunctivitis, mydriasis, visual disturbance, eyelid margin crusting | |
| Respiratory, thoracic, and mediastinal disorders | Common | nasal dryness |
| Not known | dyspnoea, sinusitis | |
| Gastrointestinal disorders | Not known | nausea, vomiting |
| Skin and subcutaneous tissue disorders | Uncommon | dermatitis contact, skin burning sensation, dry skin |
| Not known | dermatitis, erythema | |
| General disorders and administration site conditions | Common | fatigue |
| Not known | asthenia, malaise |
Cases of corneal calcification have been reported very rarely in association with the use of phosphate containing eye drops in some patients with significantly damaged corneas.
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 national reporting system listed in Appendix V.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
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