Septanasal®

INSTRUCTIONS for medical use of the medicinal product SeptaNazal® (SeptaNazal®)

Composition:

Active substances: xylometazoline hydrochloride, dexpanthenol;

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

one spray of 0.1 ml of solution contains 0.1 mg xylometazoline hydrochloride and 5.0 mg dexpanthenol;

Excipients: potassium dihydrogen phosphate, disodium hydrogen phosphate dodecahydrate, purified water.

Pharmaceutical form. Nasal spray, solution.

Main physicochemical properties: clear, colorless liquid.

Pharmacotherapeutic group.

Anti-edematous and other drugs for local nasal 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 exerts a vasoconstrictive effect, thereby reducing swelling of the mucous membrane. Dexpanthenol is a derivative of pantothenic acid (vitamin B5) that promotes wound healing and tissue repair, and protects mucous membranes.

Xylometazoline hydrochloride

Xylometazoline hydrochloride, an imidazole derivative, is an alpha-adrenergic sympathomimetic agent. It produces vasoconstriction, thereby reducing swelling and hyperemia of the nasal and nasopharyngeal mucosa (decongesting the nasal passages). The onset of action usually occurs within 5–10 minutes, resulting in improved nasal breathing due to reduced swelling and enhanced drainage of secretions.

Dexpanthenol

Dexpanthenol (D-(+)-pantothenyl alcohol) is an alcohol analogue of pantothenic acid and, through intermediate conversion (transformation), exhibits the same biological activity as pantothenic acid. Only the dextrorotatory D-configuration is biologically active. Pantothenic acid and its salts are water-soluble vitamins that, like coenzyme A, participate in numerous metabolic processes, including supporting the synthesis of proteins and corticosteroids, as well as antibody production. Coenzyme A also plays a role in the formation of lipids, including those comprising sebum secreted by sebaceous glands, which provides an important protective function. Furthermore, coenzyme A is involved in the acetylation of amino sugars, which serve as fundamental building blocks for various mucopolysaccharides. Pantothenic acid is essential for the regeneration (repair) of damaged nasal mucosa and perinasal skin.

Dexpanthenol protects epithelial layers and promotes wound healing and tissue repair.

When applied topically, dexpanthenol/pantenol may compensate for increased demand for pantothenic acid in cases of skin or mucous membrane damage.

Pharmacokinetics.

Xylometazoline hydrochloride

In some cases, intranasal administration leads to significant systemic absorption, potentially causing 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 plasma in protein-bound form. As an essential structural component, pantothenic acid is incorporated into coenzyme A and 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 during acute rhinitis;
• vasomotor rhinitis (rhinitis vasomotorica);
• impaired nasal breathing following surgical interventions in the nasal cavity.

The drug promotes healing and regeneration (recovery) of damaged nasal mucosa and skin around the nasal passages.

Contraindications.

Hypersensitivity to any of the components of the drug; dry inflammation of the nasal mucosa (rhinitis sicca); acute coronary conditions, including cardiac asthma; hyperthyroidism; closed-angle glaucoma; transsphenoidal hypophysectomy and surgical interventions involving exposure of the meninges in medical history; concomitant treatment with monoamine oxidase inhibitors (MAOIs) and within 2 weeks after discontinuation of their use. Children under 6 years of age.

Interaction with other medicinal products and other forms of interaction.

Xylometazoline hydrochloride

Concomitant use of SeptaNasal® with tranylcypromine, MAO inhibitors of tricyclic or tetracyclic antidepressants, or with drugs capable of increasing blood pressure, may lead to elevated arterial pressure due to the effects of these drugs on the cardiovascular system.

Concomitant use of SeptaNasal® with drugs for local or systemic treatment of colds and with sympathomimetics contained in cold remedies (such as pseudoephedrine, ephedrine, phenylephrine, oxymetazoline, tramazoline, naphazoline, thiamine heptanone) may result in additive effects on the cardiovascular and nervous systems.

Dexpanthenol

Unknown.

Special precautions for use

This medicinal product should be used only after careful assessment of the risk-benefit ratio:

• in patients taking medicinal products capable of increasing blood pressure;
• in patients with elevated intraocular pressure;
• in patients with phaeochromocytoma;
• in patients with porphyria;
• in patients with prostate hyperplasia.

Patients with prolonged QT interval syndrome who are using xylometazoline are at increased risk of serious ventricular arrhythmias.

Use during chronic rhinitis should be under medical supervision due to the risk of nasal mucosal atrophy.

Decongestant sympathomimetics may, particularly with prolonged use or in cases of overdose, lead to reactive hyperemia of the nasal mucosa.

This reversible effect leads to nasal passage constriction, prompting the patient to reapply the medicinal product repeatedly, potentially leading to chronic use. This may result in chronic edema (rhinitis medicamentosa) and even atrophy of the nasal cavity mucosa.

In mild cases, discontinuation of the sympathomimetic agent may be sufficient—initially in one nostril, and then, once symptoms have resolved, repeating this in the other nostril, to maintain at least partial nasal breathing.

The product, like other agents in this class, should be used with caution in patients who exhibit strong reactions to sympathomimetics, such as insomnia, dizziness, tremor, cardiac arrhythmia, or increased blood pressure. Direct contact of the product with the eyes should be avoided.

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

The product should be prescribed with caution in patients with cardiovascular disorders, arterial hypertension, diabetes mellitus, thyroid disorders, or urinary retention.

Incorrect use or excessive use of the aerosol may lead to systemic absorption of xylometazoline, potentially causing systemic adverse effects, particularly in children (cardiovascular and neurological adverse effects—see sections "Adverse reactions" and "Overdose").

The spray bottle should be used by only one person to prevent infection.

The product does not contain preservatives.

Use during pregnancy or breastfeeding

Pregnancy

Septanazal® should not be used during pregnancy due to lack of data on the use of xylometazoline hydrochloride in pregnant women.

Breastfeeding period

Septanazal® should not be used during breastfeeding due to lack of data on the passage of xylometazoline hydrochloride into breast milk.

Fertility

It is unknown whether the use of Septanazal® affects fertility.

Since systemic exposure to xylometazoline hydrochloride is very low, the likelihood of an effect on fertility is extremely low.

Ability to influence the speed of reactions while driving or operating machinery

When used correctly, Septanazal® does not affect the ability to drive or operate machinery.

Method of Administration and Dosage

For nasal use in adults and children aged 6 years and older.

Administer one spray of SeptaNazal® into each nostril no more than 3 times daily. Dosage depends on individual sensitivity and clinical response.

The medicinal product should not be used for longer than 7 days, except when recommended by a physician. Repeated use should only be initiated after a several-day break and following consultation with a physician. The duration of treatment in children is determined individually by the physician.

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

Use in children aged 6 years and older

Children under 12 years of age should use the product under adult supervision.

If no improvement or worsening of symptoms occurs after 3 days of treatment, the clinical condition should be re-evaluated.

Method of Administration

Remove the protective cap from the spray nozzle. Before first use, press the nozzle several times until a fine, even mist appears (Fig. 1).

Fig. 1

Insert the nozzle into the nostril and press once (Fig. 2). The patient should gently inhale through the nose during spraying. Repeat for the other nostril if necessary.

Fig. 2

After use, wipe the nozzle with a paper tissue and cover the spray pump with the protective cap.

Children

SeptaNazal® is indicated for children aged 6 years and older. For children aged 2 to 6 years, use SeptaNazal® for children.

Overdose

Xylometazoline hydrochloride

The clinical picture of intoxication with imidazole derivatives may be unclear, as periods of stimulation may alternate with periods of depression of the central nervous system and cardiovascular system.

Overdose, especially in children, may lead to significant effects on the central nervous system, including seizures, coma, bradycardia, apnea, and arterial hypertension, which may progress to arterial hypotension.

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

Symptoms of central nervous system depression manifest as 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 and apnea, and occasionally impaired consciousness.

Treatment in case of overdose

In cases of severe overdose, treatment should be conducted in a hospital setting. Since xylometazoline hydrochloride is rapidly absorbed when administered orally, activated charcoal (adsorbent), sodium sulfate (laxative), or gastric lavage (in cases of high doses) should be administered immediately. Reduction of arterial pressure can be achieved using non-selective alpha-blockers. Vasoconstrictors are contraindicated. If necessary, antipyretics, anticonvulsants, and artificial ventilation should be used.

Dexpanthenol

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

Side effects.

Immune system: hypersensitivity reactions, including angioedema, rash, itching.

Nervous system: excitement, insomnia, increased fatigue (drowsiness, sedative effect), headache, hallucinations (especially in children).

Cardiac disorders: rapid heartbeat, accelerated pulse, increased blood pressure, arrhythmia.

Respiratory, thoracic and mediastinal disorders: reactive hyperemia, nosebleeds, dryness and burning sensation of the nasal mucosa, sneezing, discomfort of nasal mucosa, increased swelling of the mucosa.

Musculoskeletal and connective tissue disorders: cramps (especially in children).

Eye disorders: transient visual disturbances.

Gastrointestinal disorders: nausea, burning sensation in the throat.

Shelf life.

3 years.

After first opening of the bottle, the product should be used within 12 months.

Storage conditions.

This medicinal product does not require special storage conditions.

After opening, store at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

10 ml solution in a white high-density polyethylene plastic bottle with a white metered spray pump and a transparent plastic cap, placed in a cardboard box.

Availability. Over-the-counter (without prescription).

Manufacturer.

KRKA, d.d., Novo mesto, Slovenia.

Manufacturer's address and place of business.

Smarjeska cesta 6, 8501 Novo mesto, Slovenia.