Pollival eye drops azelastine antihistamine 10ml

POLLIVAL * COLL FL 10ML 0,5MG / ML

Therapeutic indications

Treatment and prevention of symptoms of seasonal allergic conjunctivitis in adults and children aged 4 years and over. Treatment of symptoms of non-seasonal (perennial) allergic conjunctivitis in adults and children 12 years and older.

Dosage and method of use

Seasonal allergic conjunctivitis:The usual dose in adults and children aged 4 years and over is one drop in each eye twice a day (morning and evening) which can be increased if needed to four times a day. If exposure to the allergen is anticipated, Pollival can be administered prophylactically, prior to exposure.Non-seasonal (perennial) allergic conjunctivitis: The usual dose in adults and children aged 12 years and over is one drop in each eye twice a day (morning and evening) which can be increased if needed to four times a day. As safety and efficacy have been demonstrated in clinical studies over a period of 6 weeks, the duration of each treatment cycle should be limited to a maximum of 6 weeks. Patients should be advised to contact their physician if symptoms worsen or do not improve after 48 hours. It should be emphasized that use for more than 6 weeks must be under medical supervision even in the case of seasonal conjunctivitis.

Contraindications

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

Side effects

Evaluation of undesirable effects follows the following frequencies: Very common: (≥ 1/10); Common: (≥ 1/100, Immune system disorders. Very rare: Allergic reactions (such as rash and itching).Nervous system disorders. Uncommon: bitter taste.Eye disorders. Common: mild, transient eye irritation. Reporting of suspected adverse reactions . Reporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at:https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Special warnings

Pollival is not indicated for the treatment of eye infections. For further warnings see sections 4.5 and 4.6. Pollival should not be used while wearing soft contact lenses.

Pregnancy and breastfeeding

FertilityEffects on human fertility have not been studied.Pregnancy: There is insufficient information available to establish the safety of azelastine during pregnancy. At high oral doses, azelastine has been shown to induce adverse effects (fetal death, growth retardation and skeletal malformations) in experimental animal models. Local ophthalmic application results in minimal systemic exposure with plasma levels in the order of picograms. However, caution should be used when using POLLIVAL during pregnancy.Feeding time: Azelastine is excreted in breast milk in small quantities. For this reason, POLLIVAL is not recommended during breastfeeding.

Expiry and retention

Do not store above 25 ° C. Do not use this medicine if you notice that the seal on the package is not intact before first opening.

Interactions with other drugs

No interaction studies have been performed with Pollival. Interaction studies with formulations have been performedoralhowever, high doses of Azelastine are not relevant for POLLIVAL since the systemic levels, after administration of the eye drops, are in the order of picograms.

Overdose

No specific reactions are known after ophthalmic overdose and ocular administration no overdose reactions are expected. There is no experience with the administration of toxic doses of azelastine hydrochloride in humans. In case of overdose or intoxication, CNS disturbances can be expected based on the results of animal experiments. Treatment of these disorders must be symptomatic. There is no known antidote.

Active principles

Azelastine hydrochloride 0.05% (0.50 mg / ml). One drop of about 30 mcl contains 0.015 mg of Azelastine hydrochloride. For the full list of excipients, see section 6.1.

Excipients

Disodium edetate, Hypromellose, Sorbitol, Sodium hydroxide (for pH adjustment), Water for injections.