Pinovit®
Ukraine
Table of Contents
INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT PİNOVİT® (PINOVIT)
Composition:
Active substances: 1 ml of the preparation contains 35 mg of mountain pine oil (Oleum Pini pumilionis), 10 mg of peppermint oil (Mentha oil), 5 mg of eucalyptus oil (Eucalypti oleum), 15 mg of α-tocopheryl acetate, 0.3 mg of thymol;
Excipients: medium-chain triglycerides.
Pharmaceutical form. Nasal drops.
Main physicochemical properties: transparent, colorless or slightly yellowish oily liquid with a characteristic odor.
Pharmacotherapeutic group.
Decongestants and other products for local use in the nasal cavity. Agents used in nasal cavity disorders. Combined preparations.
ATC code R01AX30.
Pharmacological properties.
Pharmacodynamics.
Pynovit® exerts anti-inflammatory and anti-edematous effects, reduces the severity of local exudative reactions, and decreases the viscosity of respiratory tract mucosal secretions. The drug exhibits antibacterial activity against certain strains of Gram-positive and Gram-negative bacteria, as well as antifungal activity against yeast and mold fungi.
Pharmacokinetics.
Not studied.
Clinical characteristics.
Indications.
Acute and chronic non-allergic rhinitis, rhinopharyngitis, infectious-inflammatory diseases of the nasal and nasopharyngeal mucosa, laryngotracheitis.
Contraindications.
Allergic rhinitis, hypersensitivity to the components of the drug.
Interaction with other medicinal products and other forms of interaction.
Not described.
Special precautions for use
Before use, it is necessary to check the patient's individual response to the drug after a single intranasal instillation of Pynovit®. If allergic reactions develop, the drug must not be used.
Use with caution in patients with severe liver disease.
Avoid contact of the drug with the eyes!
Use during pregnancy or breastfeeding.
The drug can be used during pregnancy or breastfeeding at therapeutic doses.
Ability to affect reaction rate while driving or operating machinery.
The use of the drug does not affect the ability to drive or operate machinery.
Method of Administration and Dosage.
Before use, hold the bottle containing the medication in the palm of your hand to warm it to body temperature. Remove the cap and, by gently pressing the rubber dropper insert, instill the solution into the nose. After use, always close the bottle with the cap.
Adults. On the first day, instill 2–3 drops of Pynovit® into each nostril 3–6 times daily; from the second day, 2–3 drops into each nostril 3–4 times daily.
Children from 2 years of age. 1–2 drops of the medication 3–4 times daily.
The duration of treatment is determined individually by a physician, depending on the therapeutic effect and the drug's tolerability. Usually, the treatment course lasts 5–7 days.
Children.
Pynovit® should be used in children aged 2 years and older.
Use with caution in children due to the possibility of bronchospasm.
Overdose.
With local application, there is no danger of overdose.
Adverse reactions.
The table below summarizes adverse reactions to pine needle oil, peppermint oil, eucalyptus oil, α-tocopherol acetate, and thymol, grouped according to MedDRA terminology and frequency: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to < 1/100); rare (≥ 1/10000 to < 1/1000); very rare (< 1/10000); frequency not known (cannot be estimated from available data):
| System organ |
Frequency |
Adverse reactions |
| Respiratory, thoracic and mediastinal disorders |
rare |
nasal itching, nasal burning, swelling of nasal mucosa, bronchospasm; with prolonged use, dryness of respiratory mucous membranes possible |
| Immune system disorders |
frequency unknown |
hypersensitivity reactions, including skin rash, erythema, angioneurotic edema, urticaria |
| Eye disorders |
frequency unknown |
eye irritation |
| Skin and subcutaneous tissue disorders |
frequency unknown |
skin irritation, contact dermatitis |
Reporting of possible adverse reactions.
Reporting of possible adverse reactions following registration of a medicinal product is an important procedure. It allows continued monitoring of the benefit-risk balance for the medicinal product. Healthcare professionals are requested to report any suspected adverse reactions via the national reporting system.
Shelf life.
2 years.
Do not use the medicinal product after the expiry date stated on the packaging.
Storage conditions.
Store in a light-protected place at a temperature not exceeding 25 °C.
Keep out of reach and sight of children.
Packaging.
10 ml in a vial. 1 vial in a carton.
Availability. Over-the-counter (without prescription).
Manufacturer. JSC "Farmak".
Manufacturer's name and address of the place of business.
74, Kyrylivska Street, Kyiv, 04080, Ukraine.