POLLIVAL COLL FL 10ML 0.5MG/ML

POLLIVAL 0.5 MG/ML COLLIRIO, DEOLUTION

active ingredients

Azelastina Hydrochloride 0.05% (0.50 mg/ml). A drop of about 30 mcl contains 0.015 mg of Azelastina Hydrochloride. For the full list of excipients, see paragraph 6.1.

Excellent

Edetate disode, Ipromellose, Sorbitol, Sodium Hydroxide (for pH adjustment), Water for injectable preparations.

Therapeutic indications

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

Contraindications

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

Population

Seasonal allergic conjunctivitis: The usual dose in adults and children from 4 years on is a drop in each eye twice a day (morning and evening) which can be increased, if necessary, four times a day. If an allergen exposure is expected, Pollival can be administered prophylactically before exposure. Non-seasonal allergic conjunctivitis (perennial): The usual dose in adults and children from 12 years on is a drop in each eye twice a day (morning and evening) which can be increased, if necessary, four times a day. Since safety and effectiveness have been demonstrated in clinical studies for a period of 6 weeks, the duration of each treatment cycle must be limited to a maximum of 6 weeks. Patients should be advised to contact the doctor if symptoms worsen or do not improve after 48 hours. It should be noted that the use for more than 6 weeks must take place under medical supervision even in case of seasonal conjunctivitis.

Conservation

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

Warnings

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

Interactions

Interaction studies with Pollival were not carried out. Interaction studies with formulations have been carried out oral of Azelastina at high doses however are not relevant to POLLIVAL since the systemic levels, after the administration of the colliery, are in the order of the picograms.

Effects

Evaluation of unwanted effects follows the following frequencies: Very common: (≥ 1/10); Common: (≥ 1/100, Disorders of the immune system. Very rare: Allergic reactions (such as rash and itching). Diseases of the nervous system. Not common: bitter taste. Pathologies of the eye. Common: mild, transitory irritation of the eye. Reporting of suspicious adverse reactions . The reporting of suspicious adverse reactions that occur after the authorization of the medicinal product is important, as it allows continuous monitoring of the benefit/risk ratio of the medicinal product. Healthcare workers are required to report any suspected adverse reaction via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

Overdosing

Specific reactions are not known after an overdose by ophthalmic means and by ocular administration there are no overdose reactions. There is no experience of administering toxic doses of azelastina hydrochloride in man. In case of overdose or intoxication, you can wait for disturbances of the central nervous system based on the results of experiments on animals. Treatment of these disorders must be symptomatic. No antidote is known.

Fertility

: The effects on fertility in man have not been studied.

Pregnancy

: There is no sufficient information available to establish the safety of azalastin during pregnancy. At high oral dosages, azalastina has shown to induce, in experimental animal models, adverse effects (fetal death, delay in growth and skeleton malformations). A local ophthalmic application determines a minimal systemic exposure with plasma levels in the order of the picograms. However, you should use caution when using POLLIVAL during pregnancy.

Food

: Azelastina is excreted in breast milk in small quantities. For this reason POLLIVAL is not recommended during breastfeeding.

Source: Farmadati