1 ml of the product contains:

• active substance - xylometazoline hydrochloride 0.5 mg or 1 mg;
• excipients - hydrophosphate dodecahydrate, sodium dihydrophosphate dihydrate, sodium chloride, edetate disodium, benzalkonium chloride (as a 10 % solution), purified water.

Otrizol-DF^®, nasal spray 0.05%, 0.1%, 10 ml, 15 ml.

Respiratory system. Nasal preparations. Decongestants and other nasal medications for topical use. Simple sympathomimetics. Xylometazoline.

ATC code R01AA07

• The medicine is used to relieve nasal congestion associated with colds, allergic rhinitis (including hay fever), sinusitis.

• hypersensitivity to the components of the product;
• in high blood pressure, cardiovascular diseases (patients with prolonged QT interval syndrome have an increased risk of severe ventricular arrhythmias when treated with xylometazoline);
• concomitant administration of tricyclic or tetracyclic antidepressants with sympathomimetics may increase the sympathomimetic effect of xylometazoline and therefore is not recommended;
• atrophic rhinitis;
• closed angle glaucoma;
• surgical interventions on the cerebral membranes (history);
• hyperthyroidism;
• diabetes mellitus;
• pronounced atherosclerosis;
• arterial hypertension;
• tachycardia;
• severe eye diseases;
• pheochromacytoma;
• porphyria
• prostatic hyperplasia;
• concomitant use of monoamine oxidase inhibitors and a period of up to 14 days after the end of their use;
• patients with transsphenoidal pituitaryectomy or surgery;
• children under 6 years of age (for Otrizol-DF 0.05%);
• children under 12 years of age (for Otrizol-DF 0.1%);
• pregnancy and lactation period.

Intranasally.

Remove the protective cap, gently press the spray cap 1-2 times to make the solution to enter the atomizer and spray. Then place the nozzle of the bottle into the nasal passage, and with a sharp pressure on the atomizer, reproduce the injection, take out the nozzle without unclamping the atomizer.

• 0.05% spray for children of 6 to 12 years of age: 1 injection into each nasal passage 1-2 times a day.
• 0.1% spray for adults and children over 12 years of age: 1 injection into each nasal passage 1-2 times a day.

Do not use more than 3 times a day.

The course of treatment is not more than 5-7 days.

Common:

• with frequent or prolonged use, irritation or dryness of nasal mucosa, nasal mucous atrophy, burning, sneezing, dependence, hypersecretion, chronic rhinitis, headache are possible.

Uncommon:

• palpitations;
• heart rhythm disorder;
• increased blood pressure
• nausea;
• vomiting;
• allergic reaction (Quincke's edema, urticaria, itching);
• depression (with prolonged use of high doses);
• visual impairment.

Very rare:

• agitation;
• headache;
• fatigue;
• drowsiness;
• lethargy;
• insomnia;
• hallucinations and seizures (especially in children);
• bronchospasm;
• skin irritation.

Symptoms: anxiety, agitation, hallucinations and seizures; hypothermia, lethargy, somnolence, coma; miosis, mydriasis, increased sweating, fever, pale skin, cyanosis, nausea and vomiting, tachycardia, bradycardia, cardiac arrhythmia, cardiac arrest, palpitation, hypertension, shock-like hypotension, pulmonary edema, respiratory depression and apnea, psychiatric disorders. 

Treatment: immediately administer activated charcoal (absorbent), sodium sulfate (laxative) or gastric lavage. Non-selective alpha-blockers are prescribed for lowering blood pressure.

Not approved for use.

Use in children only on doctor's recommendation.

Children of 6 to 12 years of age - Otrizol-DF® 0.05%, over 12 years of age - Otrizol-DF® 0.1%.

Use with caution:

• in coronary heart disease (CHD);
• in increased inttraocular pressure, particularly in closed-angle glaucoma;
• in severe cardiac diseases associated with circulatory disorders (e.g., coronary heart disease, hypertension);
• in pheochromocytoma;
• in metabolic disorders (e.g., hyperthyroidism, diabetes mellitus);
• in porphyria;
• in prostatic hyperplasia.

Patients with prolonged QT interval syndrome have an increased risk of severe ventricular arrhythmias when treated with xylometazoline.

10 ml of the product in polypropylene bottles with a spray lid and a protective cap.

10 ml, 15 ml of the product in plastic brown bottles with a pump dispensing device, including an aluminum flap with a dip tube and a plastic spray tip with a protective cap.

Each bottle has a label made of label or writing or self-adhesive paper.

One bottle is with instruction for use in the state and Russian language are placed in a carton pack.

Store in a place protected from light, at a temperature below 25⁰С.

Keep out of the reach of children.

3 years

"DOSFARM" LLP, 3 Chaplygin street, Almaty city, 050034, Kazakhstan, tel.: (727) 253-03-88.

"DOSFARM" LLP, 3 Chaplygin street, Almaty city, 050034, Kazakhstan.

Name, address, contact information of the organization accepting claims (proposals) against quality of products from consumers in the territory of the Republic of Kazakhstan, which is responsible for post-authorization safety surveillance of the medicine:

"DOSFARM" LLP, 3 Chaplygin street, Almaty city, 050034, Kazakhstan,

Tel./Fax: (727) 253-07-07, 253-03-88, e-mail: Адрес электронной почты защищен от спам-ботов. Для просмотра адреса в вашем браузере должен быть включен Javascript.