Edem® rino

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT EDEM® RINO (EDEMRINO)

Composition:

Active substances: phenylephrine, dimetindene maleate;

1 ml of the preparation contains phenylephrine 2.5 mg, dimetindene maleate 0.25 mg;

Excipients: benzalkonium chloride; lavender extract; sorbitol (E 420); citric acid, monohydrate; sodium hydrogen phosphate, dodecahydrate; water for injections.

Pharmaceutical form. Nasal spray, solution.

Main physicochemical properties: clear, colorless or slightly yellowish liquid with a faint lavender odor.

Pharmacotherapeutic group.

Decongestants and other rhinological preparations for local use. Sympathomimetics, combinations, excluding corticosteroids. ATC code R01A B.

Pharmacological properties.

Pharmacodynamics.

Edem® Rhino is a combination medication containing phenylephrine and dimetindene.

The medication reduces nasal discharge and promotes clearing of the nasal passages without impairing the physiological functions of the ciliated epithelium and nasal mucosa.

Phenylephrine belongs to sympathomimetic amines. It is used as a nasal decongestant with moderate vasoconstrictive action, selectively stimulating α1-adrenergic receptors of the cavernous venous tissue of the nasal mucosa, thereby rapidly and persistently reducing nasal mucosal and paranasal sinus edema.

Dimetindene is an H1-histamine receptor antagonist with antiallergic effects. It is effective at low doses and is well tolerated.

Edem® Rhino is intended for local use; therefore, its activity does not correlate with plasma concentrations of the active substances.

Pharmacokinetics.

Following accidental oral administration, the bioavailability of phenylephrine is reduced and amounts to approximately 38%, with a half-life of about 2.5 hours.

Systemic bioavailability of dimetindene after oral administration in solution is approximately 70%, with a half-life of about 6 hours.

Clinical characteristics.

Indications.

In adults and children aged 6 years and older:

symptomatic treatment of colds, nasal congestion, acute and chronic rhinitis, seasonal (hay fever) and non-seasonal allergic rhinitis, acute and chronic sinusitis, vasomotor rhinitis. Adjunctive therapy in acute otitis media.

Preparation for nasal surgery, relief of mucosal edema of the nasal cavity and paranasal sinuses following surgical intervention.

Contraindications.

Hypersensitivity to phenylephrine, dimephenidene maleate, or to any of the excipients of the medicinal product.

Due to the presence of phenylephrine, the medicinal product, like other vasoconstrictive agents, is contraindicated in atrophic rhinitis, closed-angle glaucoma, and in patients receiving monoamine oxidase inhibitors (MAOIs) or who have received them within the previous 14 days.

Interaction with other medicinal products and other forms of interaction.

Concomitant use of the medicinal product with MAO inhibitors and within 14 days after their use is contraindicated.

Vasoconstrictive agents should be prescribed with caution when used concomitantly with tricyclic and tetracyclic antidepressants and antihypertensive agents such as β-adrenoblockers, as their simultaneous use may potentiate the pressor effect of phenylephrine.

Special precautions for use

Edem® Rhinoo, like other sympathomimetics, should be used with caution in patients who exhibit pronounced reactions to adrenergic agents, manifested by symptoms such as insomnia, dizziness, tremor, cardiac arrhythmias, or increased arterial pressure.

Edem® Rhinoo should not be used continuously for more than 3 days. If symptoms persist beyond 3 days or worsen, medical advice should be sought. Prolonged or excessive use of the drug may lead to tachyphylaxis and rebound effect (drug-induced rhinitis).

As with other vasoconstrictive agents, the recommended dose of the drug should not be exceeded. Excessive use of the drug, especially in children and elderly patients, may result in systemic effects of the drug.

The drug should be prescribed with caution to patients with cardiovascular diseases, arterial hypertension, hyperthyroidism, diabetes mellitus, and to patients with bladder neck obstruction (e.g., due to prostate hyperplasia).

Due to the presence of the H1-antihistamine dimetindene maleate, Edem® Rhinoo should be used with caution in patients with epilepsy.

Use during pregnancy or breastfeeding

Studies on the use of phenylephrine and dimetindene maleate during pregnancy or breastfeeding have not been conducted. Due to the potential systemic vasoconstrictive effect of phenylephrine, the use of the drug during pregnancy is not recommended.

Use of the drug during breastfeeding is not recommended.

Fertility

There are no adequate data on the effects of phenylephrine and dimetindene maleate on human fertility.

Ability to influence reaction speed when driving or operating machinery

Data are lacking.

Method of Administration and Dosage

Before administering the medication, the nose should be thoroughly cleaned.

Children aged 6 years and older, and adults:

1–2 sprays into each nostril 3–4 times daily.

The bottle should be held vertically with the spray nozzle pointing upwards. Keeping the head upright, insert the nozzle into the nostril and press the pump once with a short, sharp motion, then remove the nozzle from the nose and release. During spraying, it is recommended to gently inhale through the nose to ensure even distribution of the medication. The duration of continuous treatment should not exceed 3 days and depends on the course of the illness.

Use of this medication in children aged 6 to 12 years should be supervised by an adult.

Children.

This medicinal form of the drug is intended for use in children aged 6 years and older.

The medication should not be used in children under 6 years of age. An alternative medicinal form, "Milt nasal drops," should be used instead.

Overdose.

In case of overdose, Edem® Rhino nasal spray may cause sympathomimetic and anticholinergic effects such as increased heart rate, premature ventricular contractions, occipital headache, tremor or shaking, mild tachycardia, elevated blood pressure, mydriasis, numbness, excitation, hallucinations, seizures, insomnia, and pallor. Overdose may also cause moderate sedation, dizziness, increased fatigue, coma, stomach pain, nausea, and vomiting.

No serious adverse effects have been reported following accidental use of Edem® Rhino. Accidental ingestion of up to 20 mg of dimetindene has not led to severe symptoms.

Treatment: administration of activated charcoal; in younger children, laxatives may be considered (gastric lavage is not necessary). Adults and older children should be given large amounts of fluids to drink.

Phenylephrine-induced arterial hypertension, which does not respond adequately to benzodiazepines, can be managed with an alpha-adrenergic blocker.

Central anticholinergic symptoms can be treated with physostigmine. It is advisable to consult a physician regarding the use of antidotes. Since data on ingestion of dimetindene doses exceeding 20 mg are lacking, patients with significant overdose should receive medical supervision and, if deemed necessary by a physician, a single dose of activated charcoal.

Severe agitation and seizures should be treated with benzodiazepines.

Adverse reactions.

The product is usually well tolerated. The adverse reactions listed below are categorized by frequency as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1000 to < 1/100), rare (≥ 1/10000 to < 1/1000), very rare (< 1/10000), frequency not known (cannot be estimated based on available data).

Respiratory, thoracic and mediastinal disorders: rare – nasal discomfort, dryness of the nasal cavity, epistaxis.

General disorders and administration site conditions: rare – burning sensation at the application site; very rare – general weakness, development of allergic reactions (including skin reactions at the site of application, body pruritus, eyelid swelling, facial swelling).

Shelf life. 2 years.

Do not use the medicinal product after the expiry date stated on the packaging.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of the reach and sight of children.

Packaging. 10 ml in a bottle. 1 bottle in a carton.

Classification. Over-the-counter (OTC).

Manufacturer. JSC "Farmak".

Manufacturer's address and place of business.

74, Kyrylivska Street, Kyiv, 04080, Ukraine.