Expiration date: 12/2025

The composition and form of issue:

Spray for nasal application of 0.05% 1 FL.

Oxymetazoline hydrochloride 0.05 g

Excipients: benzalkonium chloride (50% solution) camphor evkaliptola menthol benzyl alcohol disodium edetate Polysorbate 80 propylene glycol sodium hydrogen phosphate sodium dihydrogen phosphate purified water to 100 ml 

in plastic bottles or PE low density with twist cap and spray at 10, 15 and 30 ml cartons 1 a bottle.

Description pharmaceutical form:

Clear, colorless solution with faint smell of menthol and camphor.

Description pharmacological action:

Oxymetazoline belongs to the group of alpha-agonists for topical application.

Has a vasoconstrictor effect. In intra reduces swelling of mucous membrane upper divisions respiratory tract, which leads to relief of nasal breathing and opening of the orifices of the paranasal sinuses and evstafievich pipes.

The drug is 10-15 minutes after application and lasts for 10-12 hours.

Indications:

To facilitate nasal breathing:

• colds
  
• viral infection of the upper respiratory tract
  
• sinusitis
  
• rhinitis of any etiology.
  

Contraindications:

• hypersensitivity to drug or its components
  
• atrophic rhinitis
  
• children up to age 6 years
  
• pregnancy
  
• lactation.
  

With caution:

• patients suffering from diseases of cardiovascular system (arterial hypertension, ischemic heart disease, congestive heart failure, tachycardia, arrhythmia)
  
• a violation of carbohydrate metabolism (diabetes)
  
• dysfunction of the thyroid gland (hyperthyroidism)
  
• pheochromocytoma
  
• prostatic hyperplasia with clinical symptoms
  
• chronic renal failure
  
• angle-closure glaucoma
  
• patients taking monoamine oxidase inhibitors, tricyclic antidepressants.
  

Side effects:

Sometimes, burning or dryness of the nasal membranes, dryness of the mouth and throat, sneezing, increase in the volume of secretion produced from nose. In rare cases after affect from the drug, a strong sense of nasal congestion (reactive hyperemia).

Side effects due to systemic action of the drug: increased blood pressure, headache, dizziness, palpitations, increased anxiety, nausea, insomnia.

Long-term use of the drug (more than 7 days) are possible: reactive hyperemia of the nasal mucosa, atrophy of the nasal mucosa.

Drug interactions:

With simultaneous use with MAO inhibitors and tricyclic antidepressants may experience increased blood pressure. The drug slows the absorption of local anaesthetic drugs, extends the effect.

Joint appointment other vasoconstrictor drugs increases the risk of side effects.

Method of application and dose:

The intranasal route.

Adults and children over 12 years — on 2-3 injection in each nasal passage 2 times a day.

Children 6 to 12 years — 1 injection into each nasal passage 2 times a day. You should not use the drug more than 2 times a day.

Duration of treatment: not recommended to use the drug more than 3 days. For frequent or prolonged use of the drug feeling difficulties in nasal breathing may reappear or get worse. If you encounter these symptoms should stop treatment and seek medical attention. When injecting you should not hold your head back and use only in the lying position.

Overdose:

Symptoms: prolonged or frequent use of the drug may cause nausea, increased blood pressure, tachycardia, CNS depression.

Treatment: symptomatic.

Special instructions:

In the recommended dosage without consulting your doctor and use no more than 3 days. To avoid preparation hit in eyes. The drug has an effect on vision, the decline in the rate of the reaction.

To avoid infection you need to use the drug individually.