Noninfectious irritative conjunctivitis, allergic and inflammatory conjunctival conditions, conjunctivitis of hay fever, and spring conjunctivitis.

Dosage Adults and adolescents: 1 drop, 2 to 3 times a day up to 14 days. Children (more than 2 years old): There were no specific studies in this group of patients. Due to the possible systemic effects the dosage must not exceed 1 to 2 drops per day. Medicinal products may not be used in children under 2 years of age. Apillerg may not be used for periods longer than 14 days, as this could result in a reverse hyperaemia and toxic follicular conjunctivitis. Method of Use Ocular Use After dropping eye drops, the nasolacrymal trap can be blocked for 3-minute insistence with closed eyes reduces systemic absorption. This can reduce the extent of systemic adverse effects and increase local performance.

If several different medicines need to be inserted into the eye, the next drug should be used for at least 5 minutes. The bottle remains sterile until the first opening of the cap. Patients should be instructed not to touch the eye and surrounding structures with the top of the bottle, as this could contaminate the solution.

In elderly patients with severe cardiovascular disease, including arrhythmia, with poorly regulated hypertension or diabetes, Apillerg should be used with caution. Sympathomimetic medications should be used with caution in patients with diabetes, hypertension, with hyperthyroidism and with elevated concentrations of thyroid hormones, with arrhythmias or with tachycardia and pheochromocytoma. Caution is required for patients with a risk of developing a closed-angle glaucoma or already with a closed-angle glaucoma, unless they have already performed surgically removed part of the iris. Patients should be told that excessive use of vasoconstrictives can cause a return hyperaemia. Apillerg is not suitable for patients who have problems with dry eyes if they have not previously sought medical attention. Patients who have symptoms of dry eyes must discontinue the use of this drug and consult their doctor. Apillerg can conceal signs of an eye infection. Patients who have rhinitis Sicca must pay special attention to the proper implementation of the drop in order to prevent the Apillerg from accessing the nasal mucosa. If at the time of the use of the drug Apillerg symptoms persist for more than 3 to 4 days, if they become more severe or in cases of onset of pain in sight or blurred vision, patient must consult his doctor. Patients using contact lenses should be removed before dropping, but can only be inserted again after 15 minutes. In addition, Apillerg contains in the multidose containers a preservative benzalkonium chloride which can cause eye irritation and discolor soft contact lenses

The use of sympathomimetic agents at the time of treatment with MAO inhibitors can lead to a hypertensive crisis. Therefore, simultaneous use with MAO inhibitors is contraindicated (see section 4.3 contra-indications). Sedative antihistamines can increase the sedative effect of the central nervous system depressor, which also include alcohol, sleeping pills, opioid analgesics, anxiolytic sedatives and antipsychotics. In addition, they have an additive antimuscarinic effect along with other antimuscarinic drugs such as atropine and some antidepressants (both tricyclic as MAO inhibitors). As the systemic absorption of the Antazoline may occur, the Apillerg should be used with care at the same time.

Pregnancy No sufficient data on the use of Tetrahydrozoline hydrochloride and Antazoline hydrochloride in pregnant women. Apillerg should not be used during pregnancy unless it is absolutely necessary.

Breastfeeding It is not known whether the active substance in the Apillerg is going into breast milk. When using the medication at the time of breastfeeding it is necessary to caution.

Apillerg can cause drowsiness, dizziness, somnolence or blurred vision. Patients who experience any of these side effects may not drive motor vehicles or operate machinery until the aforementioned problems are passed.

Patients may experience any undesirable effect that is indicated in the individual active substance. The most common adverse effect is the burning sensation/stinging in the eyes after administering the medication, but this effect is mild and transient Ocular diseases Having used Apillerg have reported a burning sensation/stinging in the eyes after administration of the medication and symptoms suggesting a topical allergic reaction. There may be further: dispersion of the pigment of the iris, midriasis (pupil prevalence), blurred vision, acute conjunctivitis, chronic conjunctivitis, toxic follicular conjunctivitis, dryness of the eye, reverse congestion, reactive hyperemia and glaucoma with closed-angle corner.

Nerve disease Side effects may include headache, somnolence, drowsiness, dizziness, tremor and excitation (rash) of the central nervous system. Heart disease Side effects may include angina (stinging for a thorax), hypertension and tachycardia. General problems and changes on site applications They reported a burning sensation in the eye. There may also be sweating. Immune system diseases Hypersensitivity reactions may very rarely occur.

In the case of accidental ingestion of the contents of one 10 ml bottle of Apillrge, corresponding to 4 mg Tetrahydrozoline hydrochloride and 5 mg Antazoline hydrochloride, there is no high likelihood of serious effects in adults. In children, especially for those who are under 2 years of age, may experience nausea, somnolence, arrhythmias/tachycardias and even shock. In the Tetrahydrozoline overdose, there was a depression of the central nervous system, hypotension in the form of shock and coma. In case of overdose after ingestion, the patient must be subjected to vomiting if he is still conscious. Otherwise, it is necessary to consider gastric lavage and/or using activated charcoal. If necessary, perform artificial breathing. In more severe cases, general intensive medical measures may be necessary.

Pharmacotherapeutic group: Sympathomimetics for vascular blood vessels; tetrizoline in combination, ATC code: S01G A52 Tetrisolinium chloride, sympathomimetic, antacidinium chloride, antihistamine Tetrizoline is a sympathomimetic with alpha-adrenergic activity. Its vasoconstrictor effect reduces redness and swelling in allergic conjunctivitis. Antazoline is a histamine antagonist from the group of ethylenediamines, which are selective H1-antagonists. On systemic use, this group of antihistamines may cause moderate sedation (although it only affects the central nervous system), stomach problems, and skin sensitization. Antazoline selectively blocks H1 receptors. Effects mediated by H1 receptors include smooth muscle contractions and dilatation and an increase in capillary permeability. Antihistamines that act by blocking H1 histamine receptors are very effective in relieving stinging in the eyes but are not very effective in reducing associated redness. The use of products containing a combination of an antihistamine and vasoconstrictor is an established method of symptomatic treatment of allergic diseases of the eyes. In a double-blind, multicentre randomized study, Spersallerg was found to be statistically better than left-arm fasting after a short observation time (30 minutes) after the drug was injected. In the longer observation periods (4 and 15 days), there was no difference, which suggests a faster start of Spersallerg, especially with respect to hyperaemia (p = 0.0004) and hemosomal (p = 0.0029). In an open study of 1156 patients, it was found that the effect of tetriolin lasts between 1 and 4 hours, starting from 1 to 5 minutes after ingestion. Tetrizoline has a rapid onset, and its effect may take 4 to 8 hours.

Apillerg did not perform specific pharmacokinetic studies in humans. However, following local application of nafazolin (which is very similar to tetrisolin), systemic effects have been reported.

The standard studies of mutagenicity, carcinogenicity, teratogenicity and reproductive toxicity and the impact on the ability to propagate with the Apillerg have not been carried out. Pre-clinical effects observed only in the case of exposures which are considered sufficient to exceed the maximum exposure in humans that have no relevance for clinical use.

Disodium edetate

Sodium chloride

Benzalkonium chloride

Sodium hydroxide

Highly purified water

`The indication is not necessary.

Store at a temperature of up to 30 º C

Apillerg is an eye drop in a plastic bottle. Each carton contains 1 plastic bottle with a screw cap. Each bottle contains 10 ml of the eye/ear drops as written on the front of the carton.

None.