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Pinosol® (Ointment, Spray, Drops) Instructions for Use

ATC Code

R01AX30 (Other nasal preparations for topical use in combination)

Clinical-Pharmacological Group

A drug with antimicrobial and anti-inflammatory action for topical use in ENT practice

Pharmacotherapeutic Group

Decongestant of plant origin

Pharmacological Action

A decongestant of plant origin. It has an anti-inflammatory, decongestant effect, reduces the viscosity of the secretion of the mucous membrane of the respiratory tract.

It exhibits antibacterial activity against some strains of gram-positive and gram-negative bacteria (Streptococcus pyogenes, Staphylococcus aureus, Staphylococcus epidermidis, Micrococcus luteus, Bacillus cereus, Escherichia coli), as well as an antifungal effect against yeast and mold fungi (Candida albicans, Aspergillus niger).

Pharmacokinetics

In accordance with the International Convention (EMEAHMPWG11/99), isolated studies of pharmacokinetic parameters are not required during clinical trials of herbal medicinal products.

Indications

  • Acute and chronic rhinitis of non-allergic etiology;
  • Rhinopharyngitis;
  • Infectious and inflammatory diseases of the nasal mucosa and nasopharynx.

ICD codes

ICD-10 code Indication
J00 Acute nasopharyngitis (common cold)
J31 Chronic rhinitis, nasopharyngitis and pharyngitis
ICD-11 code Indication
CA00 Acute nasopharyngitis
CA09 Chronic rhinitis, nasopharyngitis or pharyngitis

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Spray

The drug is administered as 1 dose into each nostril 3-6 times/day, depending on the severity of the inflammatory process.

To do this, remove the protective cap from the pump dispenser, gently press with your fingers to spray the drug, and close the pump dispenser with the protective cap.

Before using the drug after removing the protective cap of the pump dispenser, gently press with your fingers to make 2 test sprays (not into the nose!).

The course of treatment is 10 days. Increasing the duration and conducting repeated courses of treatment is possible on the recommendation of a doctor.

Drops

Topically. The dosage regimen depends on the stage of the disease and the age of the patient. The duration of treatment is 5-7 days.

Use of the drug in the form of inhalations is possible.

Ointment

Adults and children over 2 years apply the drug in an amount of approximately 0.5 cm into each nostril onto the surface of the mucous membrane of the anterior parts of the nasal cavity.

For administration, a cotton swab (a stick wrapped at the end with a ball of cotton wool) can be used. Then, with moderate pressure on the wings of the nose, rub the ointment over the nasal mucosa.

The procedure is repeated 3-4 times/day. The duration of treatment is 7-14 days. Increasing the duration of the course of treatment is possible on the recommendation of a doctor.

Adverse Reactions

In rare cases: allergic reactions, mild burning, itching, swelling of the nasal mucosa.

Contraindications

  • Allergic rhinitis;
  • Children under 3 years of age;
  • Hypersensitivity to the components of the drug.

Use in Pregnancy and Lactation

Data on the safety of using the drug Pinosol® during pregnancy and lactation (breastfeeding) are not provided.

Pediatric Use

The drug is prescribed to children over 3 years of age.

Special Precautions

Before starting treatment with Pinosol®, it is necessary to check the patient’s individual reaction to the drug after a single instillation into the nose. In case of development of allergic reactions, the drug should be discontinued.

After use, always close the pump dispenser with the cap.

Overdose

To date, no cases of overdose have been observed.

Drug Interactions

Not described.

Storage Conditions

The drug should be stored out of the reach of children, protected from light, at a temperature from 15°C (59°F) to 25°C (77°F).

Shelf Life

Shelf life – 2 years.

Dispensing Status

The drug is approved for use as an over-the-counter product.

RU.PIN.15.09.81

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.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Opella Healthcare, LLC (Russia)

Manufactured By

Farmak, JSC (Ukraine)

Quality Control Release

SANECA PHARMACEUTICALS, a.s. (Slovakia)

Contact Information

SANOFI

Dosage Form

Bottle OTC Icon Pinosol® Nasal spray: bottle 10 mL with pump dispenser and adapter

Dosage Form, Packaging, and Composition

Nasal spray as a clear, colorless or slightly yellowish oily liquid with a specific odor.

1 L
Dwarf pine oil 35 g
Mint oil 10 g
Eucalyptus oil 5 g
α-Tocopherol acetate 15 g
Thymol 0.3 g

Excipients: medium-chain triglycerides – up to 1 L.

10 ml – dark glass bottles (1) with a pump dispenser and adapter for nasal spraying – cardboard packs.

Marketing Authorization Holder

Opella Healthcare, LLC (Russia)

Manufactured By

Saneca Pharmaceuticals, a.s. (Slovakia)

Dosage Form

Bottle OTC Icon Pinosol® Nasal drops: 10 ml bottle with dropper

Dosage Form, Packaging, and Composition

Nasal drops as a clear liquid from blue to greenish-blue in color, with a menthol-eucalyptus odor.

10 g (1 bottle)
Scots pine oil 0.3752 g
Eucalyptus oil 0.05 g
Thymol 0.0032 g
α-Tocopherol acetate 0.17 g
Peppermint oil 0.1 g

Excipients: butylated hydroxyanisole, macrogol and apricot kernel oil glycerides esters (Labrafil M-1944-CS), vegetable oil, guaiazulene.

10 ml – brown glass bottles with a rubber dropper and cap (1) – cardboard packs.

Marketing Authorization Holder

Sanofi Russia JSC (Russia)

Manufactured By

Saneca Pharmaceuticals, a.s. (Slovakia)

Dosage Form

Bottle OTC Icon Pinosol® Nasal ointment: tube 10 g

Dosage Form, Packaging, and Composition

Nasal ointment white in color, transparent, with the odor of essential oils.

10 g
Pine oil 685 mg
Eucalyptus oil 432.5 mg
α-Tocopherol acetate 288.5 mg
Thymol 21.75 mg
Levomenthol 72.25 mg

Excipients: white petrolatum, white wax, macrogol and apricot kernel oil glycerides esters (Labrafil M-1944-CS), butylated hydroxyanisole.

10 g – aluminum tubes (1) – cardboard packs.

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