Sinuforte^® (Lyophilisate) Instructions for Use

Marketing Authorization Holder

Egis Pharmaceuticals PLC (Hungary)

Manufactured By

Laboratorio Reig Jofre, S.A. (Spain)

Solvent Manufacturer

B.BRAUN MEDICAL, S.A. (Spain)

Secondary Packaging

Laboratorios ENTEMA, S.L. (Spain)

ATC Code

R01AX (Other nasal preparations for topical use)

Dosage Form

Sinuforte®

Lyophilisate for preparation of solution for intranasal administration 50 mg: vial 1 pc. in set with solvent and spray nozzle

Dosage Form, Packaging, and Composition

Lyophilisate for preparation of solution for intranasal administration from white to light brown in color, hygroscopic; solvent – transparent colorless liquid; prepared solution – from colorless to light yellow in color.

Solvent water for injections – 5 ml.

50 mg – colorless glass vials (1) in a set with solvent (vial 1 pc.) and spray nozzle – plastic trays (1) – cardboard packs.

Clinical-Pharmacological Group

Herbal preparation with secretolytic and secretomotoric action for topical application in diseases of the paranasal sinuses

Pharmacotherapeutic Group

Herbal remedy for nasal conditions

Pharmacological Action

A herbal preparation for the treatment of inflammatory diseases of the paranasal sinuses and nasal cavity. The drug acts on the sensitive receptors of the trigeminal nerve in the area of the middle nasal passage and causes reflex secretion in the mucous membrane of the nasal cavity and paranasal sinuses.

Stimulated hypersecretion is accompanied by a change in the rheological properties of the secretion and normalization of its viscosity. Reflex hypersecretion in combination with the decongestant action of the drug leads to the evacuation of secretion from the sinuses into the nasopharynx and ensures physiological drainage of all sinuses simultaneously.

The drug helps to restore mucociliary transport in the nasal cavity and paranasal sinuses by increasing the presence of the liquid part of the secretion in the superficial layer of mucus.

Sinuforte^® enhances microcirculation of blood in the mucous membrane of the nose and paranasal sinuses. This is due to the fact that parasympathetic stimulation, which activates secretion, also causes vasodilation of the vessels supplying the glands.

Enhanced reflex secretion in the form of serous-mucous discharge is detected within a few minutes and can last from 30 to 120 minutes depending on the individual characteristics of the body.

Pharmacokinetics

The action of the drug Sinuforte^® is due to the cumulative effects of the components of cyclamen, the most studied of which are triterpene saponins.

Conducting kinetic studies is not possible, since all the components together cannot be traced using markers or bioassays. For the same reason, it is also impossible to detect drug metabolites.

Indications

• Complex therapy of acute and chronic sinusitis: maxillary sinusitis, frontal sinusitis, ethmoiditis and sphenoiditis (in the case of purulent sinusitis occurring with signs of generalization of infection and/or orbital complications, Sinuforte^® should be used only in combination with antibiotics). In uncomplicated disease, it is possible to use the drug as a monotherapy under the supervision of a physician;
• Complex therapy of rhinosinusitis accompanied by exudative otitis media;
• The period of early postoperative rehabilitation after endoscopic surgical interventions on the paranasal sinuses.

ICD codes

Dosage Regimen

The drug is used intranasally.

With each press, the dispenser sprays 0.13 ml (2-3 drops) of the drug, which is about 1.3 mg of the drug (a single dose).

Adults and children over 5 years old the drug is administered once a day by a single spray into each nasal passage. It is preliminarily recommended to make 2-3 test sprays into the air.

The drug is recommended to be used daily; if necessary, its use every other day is also allowed.

The duration of one course of treatment is 12-16 days when the drug is administered every other day or 6-8 days with daily use.

Method of application

1. Unscrew the cap from the drug vial and remove the stopper.
2. Open the solvent vial by breaking off the top part.
3. Completely pour the contents of the solvent into the drug vial.
4. Screw the spray dispenser onto the vial and shake until the drug is completely dissolved.
5. Remove the protective cap from the spray dispenser.
6. Perform 2-3 test sprays into the air.
7. With the head in a vertical position, insert the spray dispenser into each nasal passage, hold your breath and perform spraying with one press.

Adverse Reactions

Possible appearance of a feeling of mild or moderate burning in the nasal cavity, salivation and/or lacrimation in response to irritation of the sensitive receptors of the trigeminal nerve.

In some cases, facial redness, short-term headache in the frontal area, or pale pink-colored nasal discharge may occur as a result of capillary diapedesis. The above short-term physiological reactions confirm the reflex mechanism of the drug’s action and do not require discontinuation of treatment.

Allergic reactions are possible (including skin rash, shortness of breath and others). In these cases, the patient is recommended to stop taking the drug and consult a specialist.

Contraindications

• Polypous rhinosinusitis;
• Cysts of the paranasal sinuses;
• Allergic rhinosinusopathy;
• Allergic reactions (delayed and immediate type);
• Arterial hypertension stage II-III;
• Pregnancy (safety of use has not been studied);
• Lactation period (safety of use has not been studied);
• Children under 5 years of age (use in children under 5 years of age has not been studied);
• Hypersensitivity to the components of the drug.

Use in Pregnancy and Lactation

The use of the drug is contraindicated during pregnancy and lactation (safety of use has not been studied).

Pediatric Use

Contraindicated for children under 5 years of age.

Special Precautions

In the period of postoperative rehabilitation after performed endoscopic interventions, Sinuforte^® is used on the second day for cleansing (sanitation) of the paranasal sinuses and nasal cavity and to reduce swelling of the mucous membrane.

Contact of Sinuforte^® with the eyes should be avoided due to the irritating effect of the drug on the mucous membrane of the eye and the possible development of acute conjunctivitis.

It is recommended to hold your breath during the administration of the drug.

Direct spraying of the drug should be carried out with one press with the head in a vertical position.

Consultation with an otorhinolaryngologist is recommended before use.

Drug Interactions

It is necessary to refrain from preliminary administration, as well as simultaneous use of local anesthetics and/or local decongestants due to the possible disruption of the mechanism of action of the drug Sinuforte^®.

If necessary, a combination of the drug Sinuforte^® with antibacterial drugs is possible and acceptable.

Interactions with other drugs have not been studied to date.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

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.