Rhinopront^® (Capsules) Instructions for Use

Marketing Authorization Holder

Hexalo Trading, Limited (Cyprus)

Manufactured By

October Pharma, S.A.E. (Egypt)

ATC Code

R01AB01 (Phenylephrine in combination with other drugs)

Active Substances

Phenylephrine (Rec.INN registered by WHO)

Carbinoxamine (Rec.INN registered by WHO)

Dosage Form

Rhinopront®

Capsules 4 mg+20 mg: 10 pcs.

Dosage Form, Packaging, and Composition

Capsules are hard gelatin, size No. 3, with an olive-colored cap and a colorless, transparent body; the capsule contents are round granules of white or yellowish-white color.

Excipients: sucrose, corn starch, Eudragit RS 100, diethyl phthalate, medium-chain triglycerides, talc, indigo carmine (E132), iron oxide yellow (E172), titanium dioxide (E171), gelatin.

10 pcs. – blisters (1) – cardboard packs.

Clinical-Pharmacological Group

Drug with vasoconstrictive and antiallergic action for systemic use in ENT practice

Pharmacotherapeutic Group

Combined antiallergic agent (H₁-histamine receptor blocker + alpha-adrenomimetic)

Pharmacological Action

It is a combined medicinal product that has antihistamine, local anti-inflammatory, and vasoconstrictive effects.

It reduces the severity of local exudative manifestations and decreases the permeability of the capillaries of the nasal mucosa.

Due to phenylephrine, it causes vasoconstriction and a reduction in swelling of the nasal mucosa.

It eliminates the symptoms of rhinitis, eye burning, and a feeling of heaviness in the head for 10-12 hours.

Indications

Acute rhinitis (vasomotor, allergic, infectious-inflammatory); sinusitis; hay fever.

ICD codes

Dosage Regimen

Administer the capsules orally with a sufficient amount of water.

For adults and children over 12 years of age, the standard dose is one capsule taken twice daily.

Maintain a 12-hour interval between doses, for example, one capsule in the morning and one in the evening.

Do not exceed the recommended daily dose of two capsules.

The duration of continuous treatment should not exceed 10 days without medical supervision.

For patients with renal or hepatic impairment, use requires caution and medical consultation.

If symptoms persist beyond one week, discontinue use and seek medical advice.

Adverse Reactions

From the digestive system: dryness of the oral mucosa, decreased appetite, dyspepsia.

From the organ of vision: visual impairment.

From the nervous system: dizziness, headache, insomnia, anxiety, lethargy.

From the cardiovascular system: palpitations, cardialgia, increased blood pressure, changes in the peripheral blood picture.

Other: skin allergic reactions.

Contraindications

Arterial hypertension; thyrotoxicosis; pheochromocytoma; angle-closure glaucoma; prostatic hypertrophy; pregnancy; lactation period; children under 12 years of age; hypersensitivity to the components of the combination.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and during the lactation (breastfeeding) period.

Pediatric Use

Contraindicated for children under 12 years of age.

Special Precautions

Caution should be exercised in patients with chronic heart and vascular diseases, as well as cardiac arrhythmia.

Influence on the ability to drive vehicles and machinery

It should be prescribed with caution to patients engaged in potentially hazardous activities that require increased attention and rapid speed of psychomotor reactions.

Drug Interactions

Incompatible with MAO inhibitors; the adrenomimetic effect is enhanced against the background of guanethidine and isobarine.

Halothane increases the risk of arrhythmia.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

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.