Lasolvan^® Rhino (Spray) Instructions for Use

Marketing Authorization Holder

A. Nattermann and Cie., GmbH (Germany)

Manufactured By

Instituto De Angeli S.r.l. (Italy)

Contact Information

OPELLA HEALTHCARE LLC (Russia)

ATC Code

R01AA09 (Tramazoline)

Active Substance

Tramazoline (Rec.INN registered by WHO)

Dosage Form

Lasolvan® Rhino

Dosed nasal spray 82 mcg/1 dose: 10 ml bottle with dosing device and nasal adapter

Dosage Form, Packaging, and Composition

Dosed nasal spray in the form of a transparent, pale yellow solution with a eucalyptus smell.

Excipients: citric acid monohydrate, sodium hydroxide, benzalkonium chloride, hypromellose (hydroxypropyl methylcellulose), povidone, glycerol 85%, magnesium sulfate heptahydrate, magnesium chloride hexahydrate, calcium chloride dihydrate, sodium bicarbonate, sodium chloride, cineole (eucalyptol), L-menthol (levomenthol), racemic camphor, purified water.

10 ml – brown glass bottles (1) with a dosing device and nasal adapter – cardboard packs.

Clinical-Pharmacological Group

Decongestant drug – alpha-adrenomimetic

Pharmacotherapeutic Group

Drugs for the treatment of nasal diseases; decongestants and other drugs for topical use; sympathomimetics

Pharmacological Action

The active substance of Lasolvan^® Rhino – tramazoline hydrochloride, an alpha₂-adrenomimetic, causes vasoconstriction. When applied to the nasal mucous membranes, the drug reduces swelling due to its vasoconstrictive action. As a result, the patency of the nasal passages is quickly restored, and nasal breathing is relieved for a long time.

The drug’s action begins within the first 5 minutes and lasts for 8-10 hours.

Pharmacokinetics

Pharmacokinetic studies in humans have not been conducted. The pharmacokinetics of tramazoline have been studied in rats, rabbits, and monkeys. It has been shown that after oral or intranasal administration, 50-80% of the administered dose is absorbed. Tramazoline and its metabolites are distributed in all internal organs, with the highest concentration consistently found in the liver.

After oral or topical administration, the main metabolites are determined in the urine. The terminal half-life is from 5 to 7 hours.

Indications

For adults and children over 6 years old

• Edema of the nasal mucosa, nasal congestion caused by acute respiratory diseases and/or hay fever (rhinitis, hay fever);
• Sinusitis and otitis media (eustachitis) – to facilitate the outflow of contents from the paranasal sinuses.

ICD codes

Dosage Regimen

The drug Lasolvan^® Rhino is intended for spraying into each nasal passage.

For adults – 1 spray into each nasal passage, up to 4 sprays into each nasal passage per day. The drug should not be used for more than 5-7 days without a doctor’s prescription.

For children over 6 years old, 1 spray into each nasal passage is recommended, up to 4 sprays into each nasal passage per day. The drug should not be used for more than 5-7 days without a doctor’s prescription.

The drug in children should be used under adult supervision.

The efficacy and safety of Lasolvan^® Rhino in children aged 0 to 6 years have not been established.

Instructions for using the bottle with the dosing device

Before spraying, the nasal passages should be cleaned.

1. Remove the protective cap.
2. Before first use, it is necessary to make several sprays into the air until a steady aerosol cloud appears.

Fig. 1

After that, the dosing device is ready for use.

1. Holding your head straight, insert the tip into the nasal passage and make one spray.

Fig. 2

Repeat the procedure for the other nasal passage. After removing the tip, take a normal breath through the nose.

1. Put the protective cap back on.

It is recommended to clean the tip after each use.

Adverse Reactions

Nervous system disorders rarely – dizziness, taste disorders; infrequently – headache; frequency unknown* – drowsiness, sedative effect.

Psychiatric disorders infrequently – anxiety; frequency unknown* – hallucinations, insomnia.

Cardiac disorders infrequently – palpitations; frequency unknown* – arrhythmia, tachycardia.

Vascular disorders frequency unknown* – increased blood pressure.

Respiratory, thoracic and mediastinal disorders often – nasal discomfort; infrequently – nasal edema, dry mouth, rhinorrhea, sneezing; rarely – epistaxis.

Gastrointestinal disorders infrequently – nausea.

Immune system disorders frequency unknown* – hypersensitivity.

Skin and subcutaneous tissue disorders** frequency unknown* – rash, pruritus, skin edema.

General disorders and administration site conditions frequency unknown* – mucosal edema**, fatigue.

* Adverse events, the relationship of which with the drug was assessed as possible, registered during widespread use of the drug. The frequency of these rare events is difficult to estimate.

** as symptoms of hypersensitivity

Contraindications

• Hypersensitivity to tramazoline or to any of the excipients included in the drug;
• Closed-angle glaucoma;
• Atrophic rhinitis;
• History of skull surgery performed through the nasal cavity;
• Children under 6 years of age.

With caution

Patients with arterial hypertension, heart disease, long QT syndrome, hyperthyroidism, diabetes mellitus, prostatic hypertrophy, pheochromocytoma, porphyria, during breastfeeding should use Lasolvan^® Rhino only on the recommendation of a doctor due to the potential risk of systemic absorption of the drug.

Patients with long QT syndrome using Tramazoline may be at increased risk of developing serious ventricular arrhythmias.

Caution should be exercised when taking MAO inhibitors, tricyclic antidepressants, vasopressor drugs and antihypertensive drugs.

Use in Pregnancy and Lactation

Pregnancy

Long-term experience of use shows that Lasolvan^® Rhino does not have a negative effect on pregnancy.

The drug should not be used in the first trimester of pregnancy. At later stages of pregnancy, the use of Lasolvan^® Rhino is allowed only after consultation with a doctor.

Breastfeeding period

The safety of using Lasolvan^® Rhino during breastfeeding has not been confirmed. The use of the drug during breastfeeding is allowed only after consultation with a doctor.

Fertility

Studies on the effect of Lasolvan^® Rhino on fertility have not been conducted. Based on available data, there are no mentions of a possible effect of tramazoline hydrochloride on fertility.

Pediatric Use

Contraindicated in children under 6 years of age.

Special Precautions

If after 7 days of taking the drug there is no positive dynamics of symptoms, the issue of discontinuing the drug or continuing treatment should be decided.

Long-term use of nasal decongestants can lead to the development of chronic inflammation and nasal congestion, as well as to atrophy of the nasal mucosa.

Avoid getting the drug in the eyes.

Excipients

Benzalkonium chloride, which is part of the drug, can cause irritation and swelling of the nasal mucosa.

Effect on the ability to drive vehicles and mechanisms

Studies on the effect of the drug on the ability to drive vehicles and mechanisms have not been conducted. However, when taking the drug, adverse reactions such as hallucinations, drowsiness, sedative effect, dizziness and fatigue are possible. Therefore, caution must be exercised when driving vehicles and mechanisms.

If adverse reactions occur, it is necessary to avoid performing such potentially hazardous tasks as driving vehicles and mechanisms.

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Overdose

Symptoms following an increase in blood pressure and tachycardia, a decrease in blood pressure (especially in children), development of shock, reflex bradycardia, and a decrease in body temperature are possible.

By analogy with other alpha-sympathomimetics, the clinical picture of intoxication may be unclear, since the phases of stimulation and depression of the CNS and cardiovascular system may alternate.

Especially in children, intoxication leads to effects on the CNS with the development of convulsions and coma, bradycardia, and respiratory depression. Symptoms of CNS stimulation are anxiety, agitation, hallucinations and convulsions. Symptoms of CNS depression include decreased body temperature, lethargy, drowsiness and coma.

In addition, the following symptoms may develop: mydriasis, miosis, increased sweating, fever, pallor, cyanosis of the lips, impaired cardiovascular function (including cardiac arrest); respiratory impairment (including respiratory failure, respiratory arrest); psychological disorders.

Treatment in case of nasal overdose, immediately rinse or clean the nose. Symptomatic treatment may be required.

Drug Interactions

Some antidepressants (MAO inhibitors and tricyclic antidepressants) and vasoconstrictor drugs when prescribed simultaneously can cause an increase in blood pressure.

Combined use with tricyclic antidepressants may lead to the development of arrhythmia.

Concomitant use with antihypertensive agents (especially those that affect the sympathetic nervous system) may lead to various cardiovascular effects.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 3 years. Do not use after the expiration date.

Dispensing Status

The drug is available without a prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.