Tizin Classic for children, spray 0.05% 10 ml

Allergies, colds, stuffy nose, maxillary sinusitis, otitis media, flu, runny nose (rhinitis), allergic rhinitis, sinusitis For reduction of nasopharyngeal mucous membrane edema and discharge during acute allergic rhinitis, acute cold with rhinitis phenomena, sinusitis, pollinosis, otitis media.

Preparation of the patient for diagnostic manipulations in the nasal passages.

Active ingredient

Xylometazoline

Composition

1 ml of solution contains:

the active ingredient:

xylometazoline hydrochloride 0.5 mg (0.05%) or 1.0 mg (0.1%);
amount of active ingredient in one dose for 0.05% – 0.035 mg xylometazoline hydrochloride;
For 0,1 % – 0,14 mg of xylometazoline hydrochloride;

excipients:

benzalkonium chloride – 0.2 mg,
sorbitol 70% – 20.0 mg,
sodium chloride – 4.16 mg,
sodium dihydrophosphate dihydrate – 3.38 mg,
disodium hydrophosphate dihydrate – 2,08 mg,
disodium edetate – 1,0 mg,
purified water – enough.

How to take, the dosage

Children 2-6 years of age

Unless otherwise prescribed, one dose of Tisin® Classic as 0.05% nasal spray dosed into each nasal passage 1 to 2 times daily.

Adults and school-age children (over 6 years)

Tisin® Classic is given as a single dose of 0.1% nasal spray dosed into each nostril 3 times daily. The dose depends on individual patient sensitivity and clinical effect. Xylomethasoline nasal dosage spray should not be used for more than 5-7 days unless a different duration of treatment has been recommended by the physician.

After completion of therapy, the drug may only be prescribed again after a few days.

Always check with your doctor about the duration of use in children.

General recommendations for administration

Please remove the protective cap. Before first use, squeeze the spray nozzle several times until an even cloud of “mist” appears. The bottle is ready for future use. Press once during use. The product is to be inhaled through the nose. If possible, hold the spray bottle vertically. Do not spray horizontally or downwards. Close the bottle with the cap after use.

Interaction

Concomitant use of MAO inhibitors such as tranylcypromine or tricyclic antidepressants may lead to increased blood pressure due to the cardiovascular effects of these substances.

Special Instructions

Long-term use and overdose of sympathomimetics with decongestive effects may result in reactive nasal mucosal hyperemia.

The recoil phenomenon can cause airway obstruction, which leads the patient to use the drug repeatedly or even continuously. This can lead to chronic swelling (medicated rhinitis) and eventually even atrophy of the nasal mucosa (ozenema).

In case of chronic rhinitis Tisin® Classic 0.05% and 0.1% can only be used under medical supervision taking into account the risk of nasal mucosal atrophy.

Tisin® Classic should not be used if there is hypersensitivity to benzalkonium chloride, which is included in the drug as a preservative.

The recommended doses should not be exceeded, especially in children and the elderly.

Impact on the ability to drive a car and operate machinery

Long-term treatment or use of Tisin® Classic at higher doses cannot exclude its possible systemic effect on the cardiovascular system, which may impair driving ability and use of machinery.

Contraindications

Hypersensitivity to any drug component; concomitant use of monoamine oxidase inhibitors (MAOIs) or other drugs that may cause increase in arterial pressure; arterial hypertension, tachycardia, expressed atherosclerosis, glaucoma, atrophic rhinitis, brain surgery (in anamnesis), children (under 6 years – for 0.1 % dosage, under 2 years – for 0.05 % dosage).

With caution – CHD (angina pectoris), prostatic hyperplasia, thyrotoxicosis, diabetes, pheochromocytoma, in patients with hypersensitivity to adrenomimetics accompanied by symptoms of insomnia, dizziness.

Side effects

Tisin® Classic may cause transient mild nasal irritation (burning), paraesthesia, sneezing and hypersecretion in susceptible persons.