Expiration date: 08/2025

Drops

The composition and form of issue:

100 ml of solution for local application contain Xylometazoline hydrochloride 0.1 and 0.05 g in vials of 10 ml or in vials of 10 ml with dropper cap., in box 1 vial.

Method of application and dose:

The intranasal route. Adults and children over 6 years — 1-2 drops 0.1% solution in each nostril 2-3 times a day, children under 6 years of age (including breast) — 1-2 drops 0.05% solution in each nostril 1-2 times a day for 3-5 days (no more).

Spray

Composition

In 1 ml of nasal spray contains:

The active ingredient

Of Xylometazoline hydrochloride 1 mg.

Excipients

Benzalkonium chloride in anhydrous 0.15 mg of disodium edetate dihydrate (Trilon B) 0.5 mg, potassium dihydrogen 3,63 mg, sodium hydrogen phosphate, dodecahydrate of 7.13 mg, sodium chloride 9 mg, purified water to 1 ml.

Plastic bottle 10 ml spray. In a cardboard box 1 vial.

Indications for use

Acute respiratory illness with symptoms of rhinitis (runny nose):

• Acute allergic rhinitis.
  
• Sinusitis.
  
• Otitis media (in a combination therapy to reduce swelling of the mucous nasopharynx).
  
• To facilitate rhinoscopy.
  

Pharmacokinetics

The local application of the drug is almost not absorbed, so its concentration in blood plasma is very small (modern analytical methods is not defined).

Clinical pharmacology

Xylometazoline belongs to a group of local vasoconstrictor (decongestants) with alpha-adrenomimetic activity, which causes constriction of the blood vessels of the mucous membrane of the nose, eliminating, thus, swelling and hyperemia of the nasal mucosa and restores the patency of the nasal passages, nasal breathing easier.

The effect of the drug occurs within minutes after application and lasts up to 10 hours.

Application of pregnancy and breastfeeding

During pregnancy, the drug should be used only after assessing the benefits to the mother and risk to the fetus.

Do not use Xylometazoline lactation without considering the benefits to the mother and the risk to the baby.

Contraindications

• Hypersensitivity to Xylometazoline and other components of the drug.
  
• Hypertension.
  
• Tachycardia .
  
• Marked atherosclerosis.
  
• Glaucoma.
  
• Atrophic rhinitis.
  
• Surgical interventions on the brain casings (in history).
  
• Children up to age 6 years.
  

With caution:

• Pregnancy.
  
• The period of breastfeeding.
  
• Coronary heart disease (angina).
  
• Diabetes.
  
• Hyperplasia of the prostate.
  
• Hyperthyroidism.
  
• Concurrent administration of monoamine oxidase inhibitors (MAOIS) and tricyclic antidepressants.
  

Side effects

Frequent and/or long-term use:

From the mucosa of the nasopharynx

Irritation and/or dryness of the mucous membrane of the nasopharynx, burning sensation, tingling, sneeze, hypersecretion.

Rarely - edema of the nasal mucosa.

CNS

Vomiting , headache, Depression (with long-term use of high doses), visual disturbances, Insomnia .

Cardio - vascular system

Palpitations, increase in blood pressure .

Interaction

The simultaneous use of Xylometazoline with MAO inhibitors and tricyclic antidepressants can cause increased blood pressure .

Overdose

Symptoms: increased side effects.

Treatment: symptomatic under medical supervision.

Method of application and doses

The intranasal route.

Adults and children over 6 years: 1 injection of 0.1% solution of Xylometazoline to each nostril 2 - 3 times a day.

Children 2 to 6 years of age: apply 0.05% solution of Xylometazoline on 1 injection in each nostril 1 - 2 times a day.

You should not use the drug more than 3 times a day.

Do not use the drug without interruption for more than 3 to 5 days.

Precautions

Before application it is necessary to clear the nasal passages.

Do not apply more than 5 days as Xylometazoline can cause swelling of the nasal mucosa, leading to atrophy.

The duration of the drug in children is determined by the physician.

Effects on ability to drive a vehicle or equipment

Xylometazoline at the dosages, exceeding recommended, you cannot exclude visual disturbances, the possibility of systemic effects on the cardiovascular system, which could lead to a deterioration in the ability to operate a vehicle or equipment.

Storage conditions

Store in a dry, protected from light place, at temperature not exceeding 25°C.

Shelf life: 3 years.

Store in places inaccessible to children.

Do not use after the expiry date.