Tizin Expert, spray 0.1% 10 ml

Nasal congestion, sinusitis, flu, allergies, otitis media, runny nose (rhinitis), Pollinosis, colds, allergic rhinitis – Reducing nasal mucous membrane swelling in rhinitis, including allergic rhinitis, colds with rhinitis phenomena, pollinosis.

– Relief of nasal discharge in paranasal sinusitis and middle ear inflammation caused by colds.

– Preparation of patients for diagnostic manipulations in the nasal passages.

“Tisin® Expert”, nasal spray dosed 0,05 % is intended for children aged from 2 to 6 years.

“Tisin® Expert”, nasal spray dosed 0.1 % is intended for adults and children over 6 years old.

Indications

• Reducing swelling of the nasal mucosa during rhinitis, including allergic rhinitis, acute respiratory infections with symptoms of rhinitis, hay fever.

• Facilitation of nasal discharge in case of paranasal sinusitis and inflammation of the middle ear caused by colds.

• Preparing patients for diagnostic manipulations in the nasal passages.

“Tizin® Expert”, dosed nasal spray 0.05% is intended for children aged 2 to 6 years.

“Tizin® Expert”, 0.1% dosed nasal spray is intended for adults and children over 6 years of age.

Special instructions

Long-term use (more than 7 days) and overdose of sympathomimetics that have a decongestive effect can lead to reactive hyperemia of the nasal mucosa. As a result, difficulty in nasal breathing occurs, which leads to the patient starting to use the drug repeatedly or even constantly. This can lead to chronic swelling (medicinal rhinitis), and eventually even to atrophy of the nasal mucosa (ozena).

In milder cases, to improve the patient’s condition, you can first stop injecting the sympathomimetic into one nostril, and after the complaints have subsided, continue to inject it into the other nostril to at least partially ensure nasal breathing.

Do not exceed recommended doses, especially in children and the elderly.

It is not recommended to use the drug continuously for more than 7 days.

If the medicine has become unusable or has expired, do not throw it into wastewater or onto the street! Place the medication in a bag and place it in the trash. These measures will help protect the environment!

Active ingredient

Xylometazoline

Composition

1 ml of solution contains:

active ingredient:

xylometazoline hydrochloride 1 mg (0.1%);

the amount of active component in one dose is 0.14 mg of xylometazoline hydrochloride;

excipients:

glycerol – 8.5 mg,

sorbitol – 5 mg,

sodium dihydrogen phosphate dihydrate – 4 mg,

sodium chloride – 3 mg,

sodium phosphate dihydrate – 0.628 mg,

sodium hyaluronate – 0.2 mg,

water for injection – up to 1 ml.

Pregnancy

Xylometazoline should not be used during pregnancy, because the effect on the fetus has not been studied in clinical studies.

The drug should not be used during breastfeeding, because It is unknown whether the active substance is excreted in breast milk.

Contraindications

• hypersensitivity to any of the components of the drug;
• atrophic rhinitis, thyrotoxicosis;
• newborns and children under 2 years of age (for nasal spray dosed 0.05%); children under 6 years of age (for 0.1% dosed nasal spray);
• patients with severe cardiovascular diseases (for example, coronary heart disease, angina pectoris, tachycardia, arterial hypertension, severe atherosclerosis);
• patients with a history of surgical interventions on the meninges;
• patients receiving monoamine oxidase inhibitors (MAOIs) or other drugs that can cause an increase in blood pressure;
• patients with increased intraocular pressure, especially with angle-closure glaucoma;
• condition after transsphenoidal hypophysectomy.

Side Effects

Airways

“Tizin® Expert” may cause transient mild nasal irritation (burning) in susceptible people, sneezing.

Often (>1–<10%) increased swelling of the nasal mucosa (reactive hyperemia) may occur after discontinuation of the drug.Long-term or too frequent use of xylometazoline, or its use in high doses, can lead to a burning sensation in the nose or dry mucous membrane, as well as reactive nasal congestion, with the development of drug-induced rhinitis, paresthesia, sneezing, hypersecretion.This effect can be observed even 5-7 days after completion of treatment, and with prolonged use it can cause chronic inflammation of the mucous membrane with the formation of crusts (rhinitis sicca).Nervous systemIn rare cases (>0.01% – <1%), headache, insomnia, blurred vision, fatigue and depression may occur (with long-term use in high doses).Cardiovascular systemIn isolated cases (0.1% – < 1%), local intranasal use of sympathomimetics may be accompanied by systemic effects such as palpitations, tachycardia, arrhythmia and increased blood pressure.

Interaction

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

Overdose

Symptoms: overdose or accidental ingestion of the drug can lead to the following symptoms: dilated pupils, nausea, vomiting, cyanosis, fever, convulsions, tachycardia, arrhythmia, collapse, cardiac arrest, hypertension, pulmonary edema, respiratory failure, mental disorders.

In addition, the following symptoms may be observed: suppression of the function of the central nervous system, accompanied by drowsiness, decreased body temperature, bradycardia, hypotension, apnea and coma.

Treatment: the use of activated carbon, gastric lavage, artificial respiration with the introduction of oxygen. To lower blood pressure, use phentolamine 5 mg in saline solution intravenously slowly or 100 mg orally.

Vasopressor drugs are contraindicated. If necessary, antipyretic and anticonvulsants are used.

Clinical pharmacology

Pharmacodynamics:

Xylometazoline (imidazole derivative) is an alpha-adrenergic stimulant that constricts the blood vessels of the nasal mucosa, eliminating swelling and hyperemia of the mucous membrane. Facilitates nasal breathing during rhinitis.

Hyaluronic acid, which is part of the drug, has a moisturizing effect when used in nasal medications due to its ability to maintain mucous membranes in a hydrated state and creates optimal conditions for regenerative processes.
Action usually begins within 5–10 minutes.

Pharmacokinetics:

When applied topically, it is practically not absorbed; plasma concentrations are so small that they cannot be determined by modern analytical methods.

Pharmacokinetic studies have not been conducted in humans.

Short product description

A spiral with SILVER IONS in the sprayer fights bacteria (1)

1. A spiral in the atomizer containing silver, which has bacteriostatic properties to prevent bacteria from entering the preparation. This is not a property of Tizin® Expert.

Recommendations for use

Adults and children over 6 years of age are prescribed a 0.1% dosed nasal spray, 1 dose in each nasal passage up to 3 times a day. The dose depends on the individual sensitivity of the patient and the clinical effect.

Children aged 2-6 years are prescribed a nasal spray dosed at 0.05%, 1 dose in each nasal passage 1-2 times a day.

You should not use the drug for more than 5-7 days, unless your doctor recommends a different duration of treatment. After completion of therapy, the drug can be re-administered only after a few days.

For chronic rhinitis, the drug can only be used under the supervision of a doctor, taking into account the risk of developing atrophy of the nasal mucosa.

Method of use of the drug

Remove the protective cap. Before first use, press the spray nozzle several times until a uniform cloud of “fog” appears. The bottle is ready for further use.

When using, press 1 time. Inhale the drug through the nose. If possible, keep the spray bottle vertical. Do not spray horizontally or downward. After use, close the bottle with a cap.

Storage conditions

Store at a temperature not exceeding 25°C.

Keep out of the reach of children.

Shelf life

2 years.

Manufacturer

Famar Health Care Services Madrid S.A.U., Spain