Rinazal Extra nasal spray dosed 0.5 mg/ml bottle 10 ml

Active ingredient: oxymetazoline (1 ml of solution contains oxymetazoline hydrochloride 0.5 mg).

Excipients: sodium citrate; citric acid monohydrate; disodium edetate; polysorbate 20; sorbitol liquid, non-crystallizing; levomenthol; cineole; chlorhexidine digluconate solution; benzalkonium chloride; aloe extract dry; (-)-carvone; sodium hydroxide; purified water.

• hypersensitivity to the active substance, other adrenomimetics or to any of the excipients;
• atrophic rhinitis;
• inflammation or damage to the nasal mucosa or skin around the nostrils;
• use simultaneously with monoamine oxidase inhibitors (MAO) and within 2 weeks after discontinuation of treatment with MAO inhibitors, as well as simultaneous use with other drugs that contribute to an increase in blood pressure;
• increased intraocular pressure, especially angle-closure glaucoma;
• severe forms of cardiovascular diseases (e.g., coronary heart disease, arterial hypertension);
• cardiac asthma, tachysystolic heart rhythm disturbances, angina pectoris;
• pheochromocytoma;
• metabolic disorders (hyperthyroidism, diabetes mellitus, porphyria);
• history of transsphenoidal hypophysectomy;
• difficulty urinating due to an enlarged prostate gland (prostatic hypertrophy).

One inhalation dose (50 μl) contains approximately 25 μg of oxymetazoline hydrochloride.

Adults and children over 6 years of age – one injection into each nostril 2-3 times a day.

The drug should not be used for longer than 5-7 days. Do not use doses higher than recommended.

The medicine can be used again only after a few days.

Pregnant women

The use of the drug in women during pregnancy is possible only if, in the opinion of the doctor, the benefit of use for the mother outweighs the potential risk to the fetus / child. During pregnancy, the drug should be used with caution, and with special caution in patients with hypertension or signs of reduced placental blood supply. Frequent or prolonged use of high doses may lead to a decrease in placental blood flow.

It is not known whether oxymetazoline passes into breast milk. In the absence of these data, the drug should not be used during breastfeeding.

Children

The medicine should not be used in children under 6 years of age.

Drivers

After prolonged use of the drug in doses exceeding the recommended ones, a general effect on the cardiovascular and nervous systems cannot be excluded. In such cases, the ability to drive may be impaired.

After a significant overdose or accidental ingestion, the following symptoms may occur: mydriasis, nausea, vomiting, cyanosis, fever, cramps, tachycardia, palpitations, arrhythmia, cardiovascular failure, cardiac arrest, increased sweating, agitation, convulsions, arterial hypertension, pulmonary edema, respiratory disorders, pallor, miosis, hyposmia, mental disorders.

In addition, depression of the central nervous system functions may occur, which is manifested by drowsiness, decreased body temperature, bradycardia, arterial hypotension, apnea, and the possible development of coma.

Clinical manifestations of overdose in children include central nervous system manifestations such as convulsions and coma, hallucinations, bradycardia, apnea, hypertension alternating with hypotension.

Treatment: gastric lavage, administration of activated charcoal, ventilation of the lungs. If blood pressure drops, use phentolamine. Vasopressors should not be taken. If necessary, anticonvulsant therapy is indicated. In severe cases, intubation and artificial ventilation of the lungs may be necessary.

On the part of the organs of vision: eye irritation, redness or discomfort, blurred vision.

From the respiratory system, chest and mediastinal organs: nasal discomfort, burning or dryness of the nasal mucosa, dryness and irritation in the mouth and throat, sneezing, nosebleeds. After the effect of the drug wears off, a feeling of severe nasal congestion (reactive hyperemia) may occur. Apnea in newborns and young children (especially in case of overdose).

From the nervous system: headache, insomnia, anxiety, drowsiness, restlessness, tremor, sedative effect, irritability, convulsions, hallucinations (especially in children), increased fatigue.

From the cardiovascular system: tachycardia, palpitations, arterial hypertension, pain in the heart area, flushing of the face.

Immune system disorders: allergic reactions, including rash, itching, angioedema.

General disorders and administration site reactions: reactive hyperemia, headache, nausea, rash and visual disturbances.

Store in the original packaging at a temperature not exceeding 25 °C, out of the reach of children. Do not freeze.

Shelf life – 1.5 years. After first opening the bottle, store for no more than 2 months.