Opatanol 1 mg/ml 5 ml eye drops solution

Opatanol 1 mg/ml 5 ml eye drops solution is an antihistamine eye drop specifically formulated for the treatment of ocular symptoms associated with seasonal allergic conjunctivitis . The active ingredient, olopatadine , works by blocking the action of histamine, the substance responsible for allergic reactions, providing rapid relief from itching, eye irritation, redness and burning . Thanks to its targeted effectiveness, Opatanol is particularly suitable for those who suffer from ocular allergies during periods of increased exposure to pollens and environmental allergens.

Opatanol ophthalmic solution comes in a convenient 5ml bottle that is easy to use and ideal for daily topical use . The presence of benzalkonium chloride as an excipient ensures the stability of the formulation, while its gentle action is also suitable for prolonged treatments. Produced by Alcon , a leader in the ophthalmology sector, Opatanol is a reliable choice for those looking for an effective over-the-counter medicine against seasonal eye disorders.

Opatanol 1 mg/ml is indicated for adults and children aged 3 years and above, offering a safe and well-tolerated solution for the whole family. The eye drops are easy to apply and act quickly to reduce the discomfort associated with red eyes, dryness, foreign body sensation and excessive tearing . Choose Opatanol for a targeted and rapid treatment of eye allergies , with the guarantee of a quality product with proven efficacy.

ACTIVE INGREDIENTS

Active ingredients in Opatanol 1 mg/ml 5 ml eye drops solution - What is the active ingredient in Opatanol 1 mg/ml 5 ml eye drops solution?

One mL of solution contains 1 mg olopatadine (as hydrochloride). Excipient(s) with known effect : Benzalkonium chloride 0.1 mg/ml. Sodium phosphate dibasic dodecahydrate (E339) 12.61 mg/ml (equivalent to 3.34 mg/ml of phosphates). For the full list of excipients, see section 6.1.

EXCIPIENTS

Composition of Opatanol 1 mg/ml 5 ml eye drops solution - What does Opatanol 1 mg/ml 5 ml eye drops solution contain?

Benzalkonium chloride Sodium chloride Disodium phosphate dodecahydrate (E339) Hydrochloric acid (E507) (to adjust pH) Sodium hydroxide (E524) (to adjust pH) Purified water

DIRECTIONS

Therapeutic indications Opatanol 1 mg/ml 5 ml eye drops solution - Why is Opatanol 1 mg/ml 5 ml eye drops solution used? What is it used for?

Treatment of ocular signs and symptoms of seasonal allergic conjunctivitis.

CONTRAINDICATIONS AND SIDE EFFECTS

Contraindications Opatanol 1 mg/ml 5 ml eye drops solution - When should Opatanol 1 mg/ml 5 ml eye drops solution not be used?

Hypersensitivity to the active substance or to any of the excipients listed in paragraph 6.1.

DOSAGE

Amount and method of taking Opatanol 1 mg/ml 5 ml eye drops solution - How to take Opatanol 1 mg/ml 5 ml eye drops solution?

Posology The dose is one drop of Opatanol in the conjunctival sac of the affected eye(s) twice daily (every 8 hours). Treatment may be extended for up to four months if considered necessary. Use in the elderly No dose adjustment is necessary in elderly patients. Paediatric population Opatanol can be used in paediatric patients (3 years and above) at the same dose as in adults. The safety and efficacy of Opatanol in children under 3 years have not yet been established. No data are available. Use in patients with hepatic and renal impairment Olopatadine, in the form of eye drops (Opatanol), has not been studied in patients with liver or kidney disease. However, in cases of hepatic or renal impairment, it is not considered necessary to adjust the dosage (see section 5.2). Method of administration For ophthalmic use only. After the cap has been removed, if the safety ring has become loose, remove it before using the product. To prevent contamination of the dropper tip and solution, take special care 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 medicinal products, an interval of five minutes should be left between one administration and the next. Eye ointments should be administered last.

CONSERVATION

Storage Opatanol 1 mg/ml 5 ml eye drops solution - How to store Opatanol 1 mg/ml 5 ml eye drops solution?

This medicinal product does not require any special storage conditions.

WARNINGS

Warnings Opatanol 1 mg/ml 5 ml eye drops solution - About Opatanol 1 mg/ml 5 ml eye drops solution it is important to know that:

Opatanol is an antiallergic/antihistamine which, although administered topically, is absorbed systemically. In case of severe reactions or hypersensitivity, discontinue treatment. Opatanol contains benzalkonium chloride, which may cause eye irritation. Benzalkonium chloride has been reported to cause punctate keratopathy and/or toxic ulcerative keratopathy. Patients with dry eyes or other conditions where the cornea is compromised should be carefully monitored in case of frequent or prolonged use. Contact lenses Benzalkonium is known to discolor soft contact lenses. Avoid contact with soft contact lenses. Patients should be instructed to remove contact lenses prior to administration of the eye drops and to wait at least 15 minutes after instillation before reinserting contact lenses.

INTERACTIONS

Interactions Opatanol 1 mg/ml 5 ml eye drops solution - Which medicines or foods can modify the effect of Opatanol 1 mg/ml 5 ml eye drops solution?

No interaction studies with other medicinal products have been performed. In vitro studies have shown that olopatadine does not inhibit metabolic reactions involving cytochrome P-450 isoenzymes 1A2, 2C8, 2C9, 2C19, 2D6, 2E1 and 3A4. These results indicate that olopatadine is unlikely to induce metabolic interactions with other concomitantly administered active substances.

SIDE EFFECTS

Like all medicines, Opatanol 1 mg/ml 5 ml eye drops solution can cause side effects - What are the side effects of Opatanol 1 mg/ml 5 ml eye drops solution?

Summary of safety profile In clinical studies involving 1680 patients, Opatanol was administered one to four times daily to both eyes for up to four months, as monotherapy or adjunctive therapy to loratadine 10 mg. Approximately 4.5% of patients may experience adverse reactions associated with the use of Opatanol, however, only 1.6% of patients discontinued the clinical study due to these adverse reactions. Clinical studies have not reported any serious ophthalmic or systemic adverse reactions related to Opatanol. The most frequent treatment-related adverse reaction is ocular pain, reported with an overall incidence of 0.7%. Tabulated list of adverse reactions The following adverse reactions have been reported during clinical trials 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 ≤1/1,000), 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.

Classification by systems and organs	Frequency	Adverse Reactions
Infections and infestations	Uncommon	Rhinitis
Immune system disorders	Not known	Hypersensitivity, facial swelling
Nervous system disorders	Common	Headache, dysgeusia
	Uncommon	Dizziness, hypoesthesia
	Not known	Drowsiness
Eye pathologies	Common	Eye pain, eye irritation, dry eye, abnormal sensation in eyes
	Uncommon	Corneal erosion, corneal epithelial defect, corneal epithelial 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 eye, lacrimation increased, eyelid erythema, eyelid oedema, eyelid disorder ocular hyperaemia
	Not known	Corneal edema, eye edema, eye swelling, conjunctivitis, mydriasis, vision disturbance, eyelid margin crusting
Respiratory, thoracic and mediastinal pathologies	Common	Nasal dryness
	Not known	Dyspnea, sinusitis
Gastrointestinal disorders	Not known	Nausea, vomiting
Skin and subcutaneous tissue disorders	Uncommon	Contact dermatitis, burning sensation of the skin, dry skin
	Not known	Dermatitis, erythema
Systemic disorders and conditions related to the administration site	Common	Fatigue
	Not known	Asthenia, malaise

Cases of corneal calcification associated with the use of phosphate-containing eye drops in patients with significantly damaged corneas have been reported very rarely. Reporting of suspected adverse reactions Reporting suspected adverse reactions that occur 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 Italian Medicines Agency, website: http://www.aifa.gov.it/content/segnalazioni-reazioniavverse .

OVERDOSE

Overdose Opatanol 1 mg/ml 5 ml eye drops solution - What are the risks of Opatanol 1 mg/ml 5 ml eye drops solution in case of overdose?

There are no data available on overdose in humans following accidental or deliberate ingestion. Olopatadine has a low order of acute toxicity in animals. Accidental ingestion of the entire contents of a vial of Opatanol would result in a maximum systemic exposure of 5 mg olopatadine. This exposure would be equivalent to a final dose of 0.5 mg/kg in a 10 kg child, assuming 100% absorption. QTc interval prolongation was observed in dogs only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use. An oral dose of 5 mg was administered twice daily for 2.5 days to 102 healthy young and elderly male and female volunteers and no significant QTc interval prolongation was observed compared to placebo. The range of steady-state peak plasma concentrations of olopatadine (35 to 127 ng/mL) observed in this study represents at least a 70-fold safety margin for topical olopatadine with respect to effects on cardiac repolarization. Appropriate patient monitoring and management should be performed in the event of overdose.

PREGNANCY AND BREASTFEEDING

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking Opatanol 1 mg/ml 5 ml eye drops solution.

Pregnancy 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. Breast-feeding Available data in animals have shown excretion of olopatadine in milk following oral administration (for details see section 5.3). A risk to the newborns/infants cannot be excluded. Opatanol should not be used during breast-feeding. Fertility No studies have been performed to evaluate the effect on human fertility of topical ophthalmic administration of olopatadine.

DRIVING AND USE OF MACHINERY

Taking Opatanol 1 mg/ml 5 ml eye drops solution before driving or using machines - Does Opatanol 1 mg/ml 5 ml eye drops solution affect driving or using machines?

Opatanol has no or negligible influence on the ability to drive or use machines. As with any other eye drops, transient blurred vision or other visual disturbances may affect the ability to drive or use machines. If blurred vision occurs after instillation, the patient should wait until the vision clears before driving or using machines.