Galazolin® combi
Ukraine
Table of Contents
INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT GAZOLINE® COMBI (GALAZOLIN® COMBI)
Composition:
Active substances: xylometazoline; dexpanthenol;
1 ml of solution contains 1 mg of xylometazoline hydrochloride and 50 mg of dexpanthenol, or 0.5 mg of xylometazoline hydrochloride and 50 mg of dexpanthenol;
one spray of 0.1 ml of solution contains 0.1 mg of xylometazoline hydrochloride and 5 mg of dexpanthenol, or 0.05 mg of xylometazoline hydrochloride and 5 mg of dexpanthenol;
Excipients: disodium phosphate dodecahydrate, potassium dihydrogen phosphate, benzalkonium chloride solution, purified water.
Pharmaceutical form. Nasal spray, solution.
Main physicochemical properties: colorless transparent liquid.
Pharmacotherapeutic group. Anti-edematous and other rhinological preparations for local use. Sympathomimetics, combinations, excluding corticosteroids. ATC code R01AB06.
Pharmacological properties.
Pharmacodynamics.
GALAZOLINE® COMBI is a combined preparation containing an alpha-sympathomimetic agent and a vitamin analogue for local application to the nasal mucosa. Xylometazoline exerts a vasoconstrictive effect, thereby reducing mucosal swelling. Dexpanthenol is a derivative of pantothenic acid that promotes wound healing and protects mucous membranes.
Xylometazoline hydrochloride
Xylometazoline is an imidazoline derivative and an alpha-adrenergic sympathomimetic agent. It acts as a direct agonist of alpha-adrenergic receptors. The drug induces vasoconstriction of the blood vessels in the nasal mucosa, thereby reducing swelling, decreasing hyperemia of the nasal and pharyngeal mucosa, and reducing exudate production. Reduction of nasal mucosal hyperemia improves nasal breathing in patients with symptoms of nasal airway obstruction during colds and after surgical interventions in the nasal cavity.
The onset of action usually occurs within 5–10 minutes, manifested by improved nasal breathing due to reduction of swelling and enhanced drainage of secretions.
Dexpanthenol
Dexpanthenol is an alcohol analog of pantothenic acid (vitamin B5) and, through intermediate conversion, exhibits the same biological activity as pantothenic acid. Pantothenic acid and its salts are water-soluble vitamins that, as coenzyme A, participate in numerous metabolic processes, including promoting the synthesis of proteins and corticosteroids, as well as antibody production. Coenzyme A is also involved in the formation of lipids, including those that constitute sebum secreted by sebaceous glands, which plays an important protective role. Furthermore, coenzyme A plays a role in the acetylation of amino sugars, which are key building blocks for various mucopolysaccharides.
Dexpanthenol protects epithelial layers and promotes wound healing.
Pharmacokinetics.
Xylometazoline hydrochloride
Nasal administration occasionally results in significant absorption of xylometazoline, 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. The vitamin is transported in the blood plasma in a 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. 60–70% of an orally administered dose is excreted in urine, and 30–40% in feces.
Clinical characteristics.
Indications.
- Nasal congestion in acute rhinitis;
- Promoting healing of the skin around the nasal passages and injuries of the mucous membrane in the nasal cavity;
- Vasomotor rhinitis (rhinitis vasomotorica);
- Impaired nasal breathing after surgical interventions in the nasal cavity.
Contraindications.
- Hypersensitivity to xylometazoline hydrochloride, dexpanthenol, or to any excipient of the medicinal product;
- Atrophic rhinitis (rhinitis sicca);
- Transsphenoidal hypophysectomy and surgical interventions with exposure of the meninges in medical history;
- Acute coronary diseases, including cardiac asthma;
- Closed-angle glaucoma;
- Hyperthyroidism;
- Concomitant treatment with monoamine oxidase inhibitors (MAOIs) and within 2 weeks after discontinuation of their use;
- Pregnancy or breastfeeding.
The medicinal product GALEZOLIN® COMBI (0.5 mg + 50 mg)/ml should not be used in children under 2 years of age.
The medicinal product GALEZOLIN® COMBI (1 mg + 50 mg)/ml should not be used in children under 6 years of age.
Interaction with other medicinal products and other forms of interaction.
Xylometazoline hydrochloride
Concomitant use with tranylcypromine, MAO inhibitors, tricyclic or tetracyclic antidepressants, or β-adrenoblockers may lead to increased arterial pressure due to the effects of these drugs on the cardiovascular system.
Concomitant use of xylometazoline with other sympathomimetic agents (e.g., ephedrine, pseudoephedrine) should be avoided due to their combined action.
Dexpanthenol
No studies on interactions have been conducted.
Special precautions for use
This medicinal product should be used only after careful assessment of the risk-benefit ratio:
- in patients taking MAO inhibitors or other medicinal products capable of increasing blood pressure;
- in patients with elevated intraocular pressure, particularly in the case of closed-angle glaucoma (see section "Contraindications");
- in patients with cardiovascular disorders (e.g., ischemic heart disease, arterial hypertension);
- in patients with phaeochromocytoma;
- in patients with metabolic disorders (e.g., in diabetes mellitus);
- in patients who have previously experienced adverse reactions to sympathomimetics, such as insomnia, dizziness, tremor, cardiac arrhythmia, or increased blood pressure;
- in patients with benign prostatic hyperplasia;
- in patients with porphyria.
Decongestant sympathomimetics, especially when used long-term or in cases of overdose, may lead to reactive hyperemia of the nasal mucosa.
This rebound effect causes narrowing of the airways, forcing the patient to repeatedly re-administer the medicinal product, potentially leading to chronic use.
This may result in chronic nasal edema (rhinitis medicamentosa) with a risk of atrophy of the nasal mucosa.
In mild cases, discontinuation of the sympathomimetic agent may be sufficient, initially in one nostril and then, once symptoms resolve, in the other, to maintain at least partial nasal breathing.
The recommended dose of the drug should not be exceeded, particularly when treating children or elderly patients.
Patients with prolonged QT interval syndrome who use xylometazoline may be at increased risk of serious ventricular arrhythmias.
The product contains benzalkonium chloride, which may cause irritation of the nasal mucosa or swelling, particularly with prolonged use.
Use during pregnancy or breastfeeding
GALAZOLINE® COMBI should not be used during pregnancy or breastfeeding due to lack of adequate studies.
Fertility
There are no data available on the effect of the drug on fertility.
Since systemic exposure to xylometazoline hydrochloride is very low, the likelihood of an effect on fertility is very small.
Ability to affect reaction speed when driving or operating machinery
When used according to the instructions for medical use, no effect of the drug on reaction speed while driving or operating machinery is expected.
Method of Administration and Dosage
For nasal use.
The medicinal product HALAZOLINE® COMBI should be administered as one spray into each nostril no more than 3 times daily. Dosage depends on individual sensitivity and clinical response.
HALAZOLINE® COMBI should not be used for longer than 7 days, except when recommended by a physician.
HALAZOLINE® COMBI (0.5 mg + 50 mg)/ml (one spray delivers 0.05 mg of xylometazoline hydrochloride and 5.0 mg of dexpanthenol) is indicated for children aged 2 years and older.
Children aged 2 to 6 years:
1 spray dose into each nostril 3 times daily (every 8–10 hours).
Use in children should be under adult supervision.
HALAZOLINE® COMBI (1 mg + 50 mg)/ml (one spray delivers 0.1 mg of xylometazoline hydrochloride and 5.0 mg of dexpanthenol) is indicated for adults and children aged 6 years and older.
Adults and children aged 6 years and older:
1 spray dose into each nostril 3 times daily (every 8–10 hours).
Method of Administration:
- Before each use, remove the protective cap (Fig. 1).
- Before the first use of a new spray bottle, prime the pump by pressing 3–5 times until a fine, even spray appears.
- Insert the nozzle into the nostril (Fig. 2).
- While holding the bottle upright, press the pump.
- Repeat administration in the other nostril.
- After use, cover the pump nozzle with the protective cap.
| Fig. 1 |
Fig. 2 |
For hygienic reasons, each package should be used by only one person to avoid infection.
Children.
GALAZOLINE® COMBI (0.5 mg + 50 mg)/ml must not be used in children under 2 years of age.
GALAZOLINE® COMBI (1 mg + 50 mg)/ml must not be used in children under 6 years of age.
Overdose.
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 and cardiovascular systems.
Overdose, especially in children, may lead to significant effects on the central nervous system, including spasms, coma, bradycardia, apnea, and arterial hypertension, which may progress to arterial hypotension and increased muscle tone.
Symptoms of central nervous system stimulation include anxiety, excitement, 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 sometimes impaired consciousness.
Treatment in case of overdose
Severe overdose requires hospital treatment. Since xylometazoline hydrochloride is rapidly absorbed, activated charcoal (adsorbent), sodium sulfate (laxative) should be administered immediately, or gastric lavage should be performed (in case of high doses). Reduction of blood pressure can be achieved using non-selective alpha-blockers. Vasoconstrictors are contraindicated. If necessary, antipyretic and anticonvulsant agents should be used, and artificial respiration is recommended.
Pantothenic acid and its derivatives, such as dexpanthenol, have very low toxicity. In case of overdose, no therapeutic measures are required.
Adverse Reactions
The adverse reactions listed below are categorized by organ class and frequency of occurrence: very common (≥ 1/10), common (≥1/100 – <1/10), uncommon (≥ 1/1000 – <1/100), rare (≥ 1/10,000 – <1/1000), very rare (< 1/10,000), frequency not known (frequency cannot be estimated from the available data, including isolated cases).
Xylometazoline hydrochloride
From the nervous system:
Very rare: excitation, insomnia, increased fatigue, drowsiness, sedative effect, hallucinations (especially in children), headache.
From the cardiovascular system:
Rare: systemic effects of sympathomimetics such as tachycardia, palpitations, increased blood pressure;
Very rare: arrhythmia.
From the immune system:
Very rare: hypersensitivity reactions, including angioneurotic edema, rash, pruritus.
From the musculoskeletal and connective tissue system:
Very rare: convulsions (especially in children).
From the respiratory system, thoracic organs and mediastinum:
Uncommon: epistaxis;
Very rare: increased mucosal swelling upon reduction of drug effect (reactive hyperemia);
Frequency not known: nasal mucosa discomfort (dryness, burning sensation), sneezing.
From the visual organs:
Very rare: transient visual disturbances.
From the gastrointestinal system:
Common: nausea.
Prolonged or frequent use of the medicinal product, as well as use in higher doses than recommended, may lead to irritation of the mucous membrane and increased swelling. This effect may occur after 5 days of treatment, and continued treatment may result in irreversible damage to the nasal mucosa and dry rhinitis (rhinitis sicca).
Dexpanthenol
From the immune system:
Frequency not known: individual hypersensitivity reactions.
Reporting of suspected adverse reactions
Reporting of suspected adverse reactions after medicinal product registration is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are required to report any suspected adverse reactions.
Shelf life. 3 years.
Shelf life after first opening – 12 weeks.
Do not use after the expiry date.
Storage conditions.
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach and sight of children.
Packaging.
10 ml of solution (0.5 mg + 50 mg)/ml or (1 mg + 50 mg)/ml in a 15 ml polyethylene dropper bottle with mechanical pump and dosing device, closed with a cap with an applicator. 1 bottle in a cardboard box.
Classification of supply. Over-the-counter (without prescription).
Manufacturer.
Pharmaceutical Works “POLPHARMA” S.A. /
Pharmaceutical Works POLPHARMA S.A.
Manufacturer's address and place of business.
Medana Branch in Sieradz, 10, Wladyslawa Lokietka Str., 98-200 Sieradz, Poland /
Medana Branch in Sieradz, 10, Wladyslawa Lokietka Str., 98-200 Sieradz, Poland
Marketing Authorization Holder.
Pharmaceutical Works «POLPHARMA» S.A. /
Pharmaceutical Works «POLPHARMA» S.A.
Address of the Marketing Authorization Holder and place of business.
19, Pelplinska Str., 83-200 Starogard Gdanski, Poland.
19, Pelplinska Str., 83-200 Starogard Gdanski, Poland.