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 DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Nasal spray: bottle 10 mL with pump dispenser and adapter
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
| 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.
Nasal drops: 10 ml bottle with dropper
Marketing Authorization Holder
Opella Healthcare, LLC (Russia)
Manufactured By
Saneca Pharmaceuticals, a.s. (Slovakia)
Dosage Form
| 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.
Nasal ointment: tube 10 g
Marketing Authorization Holder
Sanofi Russia JSC (Russia)
Manufactured By
Saneca Pharmaceuticals, a.s. (Slovakia)
Dosage Form
| 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.
