Tizin® panthenol

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT TYZINE® PANTHENOL (TYZINE® PANTHENOL)

Composition:

Active substances: xylometazoline hydrochloride and dexpanthenol;

1 mL of solution contains 1 mg of xylometazoline hydrochloride and 50 mg of dexpanthenol;

1 spray of 0.1 mL of solution contains 0.1 mg of xylometazoline hydrochloride and 5.0 mg of dexpanthenol;

Excipients: potassium dihydrogen phosphate, disodium hydrogen phosphate dodecahydrate, water for injections.

Pharmaceutical form. Nasal spray, solution.

Main physicochemical properties: solution ranging from clear to slightly opalescent, colorless to slightly yellowish.

Pharmacotherapeutic group. Decongestants and other nasal preparations for local use. Sympathomimetics, combinations, excluding corticosteroids.

ATC code: R01A B06.

Pharmacological Properties

Pharmacodynamics

A nasal preparation combining an alpha-sympathomimetic agent with a vitamin analogue for local application to the nasal mucosa. Xylometazoline has vasoconstrictor activity, thereby reducing swelling of the mucous membrane. Dexpanthenol is a derivative of pantothenic acid (vitamin B5) that promotes wound healing and protects mucous membranes.

Xylometazoline hydrochloride

Xylometazoline hydrochloride, an imidazole derivative, is an alpha-adrenergic sympathomimetic agent. The onset of action typically occurs within 5–10 minutes, resulting in improved nasal breathing due to reduction of swelling and enhanced drainage of secretions.

Dexpanthenol

Dexpanthenol (D-(+)-pantothenyl alcohol) is a synthetic alcohol analogue of pantothenic acid. Through intermediate conversion, it exhibits the same biological activity as pantothenic acid, although only the dextrorotatory D-configuration is biologically active. Pantothenic acid and its salts are water-soluble vitamins that, as coenzyme A, participate in numerous metabolic processes, including supporting the synthesis of proteins and corticosteroids, as well as antibody production. Coenzyme A is also involved in the formation of lipids, including the secretion of sebaceous glands, which plays an important protective role. Furthermore, coenzyme A participates in the acetylation of aminosugars, which serve as fundamental building blocks for various mucopolysaccharides.

Dexpanthenol protects epithelial layers and promotes wound healing.

Pharmacokinetics

Xylometazoline hydrochloride

In some cases, intranasal administration results in significant absorption, potentially leading to systemic effects on the central nervous and cardiovascular systems.

Pharmacokinetic data in humans are lacking.

Dexpanthenol

Dexpanthenol is absorbed through the skin and undergoes enzyme-catalyzed oxidation to pantothenic acid in the body and skin cells. The vitamin is transported in the blood plasma in protein-bound form. As an essential structural component, pantothenic acid combines with coenzyme A and is distributed throughout the body. Detailed studies on metabolism in the skin and mucous membranes are lacking. Approximately 60–70% of an orally administered dose is excreted in urine and 30–40% in feces.

Clinical characteristics.

Indications.

• Nasal congestion due to acute rhinitis.
• To promote healing of the skin around the nasal passages and injuries of the mucous membrane in the nasal cavity.
• Vasomotor rhinitis.
• Impaired nasal breathing following surgical interventions in the nasal cavity.

Contraindications.

Hypersensitivity to any component of the medicinal product, dry inflammation of the nasal mucosa, acute coronary conditions including cardiac asthma, hyperthyroidism, closed-angle glaucoma, transsphenoidal hypophysectomy, and surgical procedures involving exposure of the meninges in medical history. Concomitant use with monoamine oxidase inhibitors (MAOIs) and within 2 weeks after discontinuation of such treatment.

Do not use in children under 6 years of age.

Interaction with other medicinal products and other forms of interaction.

Xylometazoline hydrochloride

Concomitant use of the drug with tranylcypromine, monoamine oxidase inhibitors (MAOIs), tricyclic or tetracyclic antidepressants, or β-adrenoblockers may lead, due to the effects of these drugs on the cardiovascular system, to increased arterial pressure.

Special precautions for use

This medicinal product should only be used after careful assessment of the risk/benefit ratio in the following patients:

• those taking medicinal products capable of increasing blood pressure;
• patients with elevated intraocular pressure;
• patients with phaeochromocytoma;
• patients with benign prostatic hyperplasia;
• patients with porphyria.

Patients with long QT syndrome who use xylometazoline are at increased risk of serious ventricular arrhythmias.

Decongestant sympathomimetics may, especially with prolonged use or in cases of overdose, cause reactive hyperemia of the nasal mucosa.

This rebound effect causes narrowing of the airways, forcing the patient to reapply the medicinal product repeatedly.

This leads to chronic edema and, eventually, to atrophy of the nasal mucosa.

In mild cases, it may be sufficient to discontinue the sympathomimetic agent first in one nostril, and then, once symptoms have subsided, in the other, in order to maintain at least partial nasal breathing.

Tizin® Pantothenol, like other drugs in this class, should be used with caution in patients who experience strong reactions to sympathomimetics, such as insomnia, dizziness, tremor, cardiac arrhythmia, or increased blood pressure.

The recommended dose of the medicinal product should not be exceeded, especially when treating children and elderly patients.

The drug should be prescribed with caution to patients with cardiovascular disorders, arterial hypertension, diabetes mellitus, thyroid disorders, or prostate hyperplasia.

Tizin® Pantothenol is contraindicated in children under 6 years of age. A different dosage formulation should be used for this age group.

The medicinal product container should be used by only one person to avoid risk of infection.

Use during pregnancy or breastfeeding.

Tizin® Pantothenol should not be used during pregnancy, as there are insufficient data on the use of xylometazoline hydrochloride in pregnant women.

The use of this drug should be avoided during lactation, as it is unknown whether the active ingredient, xylometazoline hydrochloride, passes into breast milk.

There is no information available on the effect of xylometazoline hydrochloride on fertility.

Ability to affect reaction speed when driving vehicles or operating machinery.

When used according to instructions, no effect is expected.

Method of Administration and Dosage

For nasal use.

Tizin® Pantothenol should be administered as 1 spray into each nostril no more than 3 times daily. Dosage depends on individual sensitivity and clinical response.

Tizin® Pantothenol should not be used for longer than 7 days, except when recommended by a physician.

For children, duration of use should always be discussed with a doctor.

Repeated use should only be initiated after a break of several days and only after consulting a physician. The treatment duration for children is determined individually by a doctor.

In cases of chronic rhinitis, the medication should be used only under medical supervision due to the risk of developing nasal mucosal atrophy.

Method of Administration

Remove the protective cap from the spray nozzle. Before the first use, prime the nasal spray by pressing down 5 times on the nozzle until a fine, even mist is produced. Hold the bottle vertically, insert the nozzle into the nostril, and press once. Repeat the procedure for the other nostril if necessary. The patient should gently inhale through the nose during spraying. After each use, wipe the nozzle with a paper tissue and cover it with the protective cap.

Children

Tizin® Pantothenol must not be used in children under 6 years of age. For children aged 2 to 6 years, use "Tizin® Pantothenol Children's".

Overdose

Symptoms of intoxication with imidazole derivatives may be clinically unclear, as periods of stimulation may alternate with periods of depression of the central nervous and cardiovascular systems.

Overdose, especially in children, may cause disturbances of the central nervous system, including spasms, coma, bradycardia, apnea, and arterial hypertension, which may later shift to arterial hypotension.

Symptoms of central nervous system excitation include anxiety, agitation, hallucinations, and convulsions.

Symptoms of central nervous system depression include decreased body temperature, lethargy, drowsiness, and coma.

Additional possible symptoms include miosis, mydriasis, sweating, nausea, cyanosis, fever, pallor, tachycardia, bradycardia, cardiac arrest, cardiac arrhythmia, arterial hypertension, shock-like hypotension, pulmonary edema, respiratory depression, apnea, and occasionally impaired consciousness.

Treatment in case of overdose

Severe overdose requires hospital treatment. Since xylometazoline hydrochloride is rapidly absorbed, activated charcoal (adsorbent) or sodium sulfate (laxative) should be administered immediately, or gastric lavage should be performed (in cases of high doses). Decreased arterial pressure can be managed with non-selective alpha-blockers. Vasoconstrictors are contraindicated. If necessary, antipyretics and anticonvulsants should be administered, along with artificial oxygen ventilation.

Pantothenic acid and its derivatives, such as dexpanthenol, have very low toxicity. In case of overdose, no therapeutic measures are required.

Adverse Reactions

The following frequency categories are used to assess the incidence of adverse effects:

Very common (≥ 1/10);
Common (≥ 1/100 to <1/10);
Uncommon (≥ 1/1,000 to <1/100);
Rare (≥ 1/10,000 to <1/1,000);
Very rare (<1/10,000);
Frequency not known (cannot be estimated from the available data).

Nervous system:
Very rare: anxiety, insomnia, fatigue (drowsiness, sedative effect), headache, hallucinations (mainly in children).

Cardiovascular system:
Rare: palpitations, tachycardia, hypertension.
Very rare: arrhythmia.

Respiratory system:
Very rare: increased nasal mucosal swelling after waning of effect, epistaxis (nosebleed).
Frequency not known: burning sensation and dryness of nasal mucosa, sneezing.

Musculoskeletal system:
Very rare: muscle cramps (especially in children).

Immune system:
Uncommon: hypersensitivity reactions (angioedema, rash, pruritus).

Shelf life: 3 years.
Shelf life after first opening of the container: 6 months.

Storage conditions:
Store at temperatures not exceeding 25 °C. Keep in a place inaccessible to children.

Packaging:
10 ml in a bottle, 1 bottle with patient information leaflet in a cardboard box.

Supply classification:
Over-the-counter (without prescription).

Manufacturer:
Famar Health Care Services Madrid, S.A.U. / Famar Health Care Services Madrid, S.A.U.

Manufacturer's address:
Avda. Leganes, 62, Alcorcon, Madrid, 28923, Spain / Avda. Leganes, 62, Alcorcon, Madrid, 28923, Spain

Marketing Authorization Holder:
McNeil Products Limited / McNeil Products Limited.

Address of Marketing Authorization Holder:
50–100 Holmers Farm Way, High Wycombe, HP12 4EG, England / 50–100 Holmers Farm Way, High Wycombe, HP12 4EG, England.

Representative of the Marketing Authorization Holder:
LLC "Johnson and Johnson Ukraine" / TOV "Dzhonson i Dzhonson Ukraina"

Address of the Representative:
32/2 Moskovska St., Kyiv, 01010, Ukraine.
+38 (044) 498 0888
+38 (044) 498 7392