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Wednesday 27 May 2015
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Sinuforte®/Nasodren®

What is the composition of Sinuforte®?
Sinuforte® is a lyophilized powder obtained from the juice and natural extract of fresh Cyclamen europaeum tubers. The active ingredient is saponins.

How does Sinuforte® work?

Sinuforte® has a dual mechanism of action:

1. The product has a localized effect on the mucous membranes of the nasal cavity and paranasal sinuses, physically stimulating the trigeminal nerve endings and causing an intense, reflex secretion. This secretion results in a natural cleansing of the paranasal sinuses, a reduction in tissue swelling and a recovery of drainage and ventilation of the sinuses.
2. The extract reduces the surface tension of the cell membrane of the nasal mucosa and this facilitates mucin secretion that helps shrink nasal mucosa and decrease congestion through a direct osmotic effect.

For what conditions is Sinuforte® recommended?

Sinuforte® is a product indicated for the symptomatic relief of acute and chronic rhinosinusitis, postoperative care after sinonasal surgery, and otitis media with effusion.

What are the advantages of Sinuforte® compared to other medicines for treating sinusitis?

  • Sinuforte® efficacy has been demonstrated in 29 clinical trials (including more than 2,000 participants) conducted in several countries around the world (USA, Germany, Spain, Russia, Ukraine, etc.) and the results has been were published in the most prestigious scientific journals, including Rhinology, official organ of the European Society of Rhinology and The Laryngoscope, the official publication of the American Society of Rhinology.
  • Sinuforte® has proved effective both in subjective symptoms (congestion, facial pain, improvement of smell assessed by the patient) and objective signs (endoscopy, Computed Tomography, rhinomanometry, smell test etc.) assessed by the physician).
  • Sinuforte® is a very safe product since its active ingredient, saponins, is not absorbed and consequently they do not reach bloodstream and therefore don’t produce systemic side effects, i.e. do not affect the liver, the kidneys or other organs.
  • Sinuforte® is fast acting. Cleansing and discharge starts just 2 minutes after the first application. This discharge may last for up to 2 hours, leading to sinusitis symptoms relief. A significant improvement or total symptomatic relief is achieved for about 90% many of rhinosinusitis sufferers after 4-5 applications.
  • Sinuforte® is easy to apply and one application (nasal spray) per day produces 24 hours relief.
  • One Sinuforte® package constitutes a full treatment (7-10 days).
  • Sinuforte® is 100% natural, containing no preservatives.
  • Sinuforte® is included with high level of evidence and recommendation in the European Guidelines for the treatment of sinusitis (European Position Paper on Rhinosinusitis and Nasal Polyps), EPOS 2012.

How does Sinuforte® relieve symptoms?

Sinusitis symptoms such as headache, feelings of pressure and stuffiness, nasal congestion and nasal discharge are caused by an accumulation of mucus inside the sinuses.
Sinuforte® acts activating the physiological defense mechanisms of the upper airways that are impaired during rhinosinusitis. Sinuforte® stimulates the nociceptive terminals of the nerves of the nasal mucosa, which leads to a seromucus discharge, recovery of cilia function (cilia are microscopic filaments that sweep mucus put of the sinuses) reduction of the inflammation of the mucosa and opening of the ostiums (the passages that communicate the sinuses to the nasal cavity), and therefore cleaning sinuses and nasal cavity.

How long does treatment with Sinuforte® take?

Recommended treatment course is 7-10 days.

A significant improvement or total symptomatic relief is achieved for many rhinosinusitis sufferers after 4-5 applications, but in case symptoms persist, treatment can be extended up to 14 days.

If a second treatment is necessary in severe cases, this should only be initiated 7-10 days after completion of the previous course.

What side effects may Sinuforte® has?

Sinuforte® acts physiologically, physically stimulating the terminal endings of the trigeminal nerve in the nasal mucosa. This specific mechanism of action can produce some itching, sneezing, a brief sensation of mild to moderate burning sensation in the nasopharynx and more rarely, a brief lacrimation and flushing of the face. These are manifestations of the positive response to the product. All these effects usually diminish during the course of treatment.

Can Sinuforte® be applied with pregnant women and nursing mothers?

In these cases Sinuforte® can only be recommended at the discretion of your physician. There is no present existing clinical data.

Does Sinuforte® interact with other medications?

In clinical research no contraindications with other medications were observed. Sinuforte® may be combined with antibiotics, nasal vasoconstrictors (applied at least 2 hours before) or any other medications

Is it necessary to combine Sinuforte® with other medications?

Sinuforte® by itself cleans and drains accumulated mucus in the sinonasal area. Clinical trials have shown the efficacy of Sinuforte® in monotherapy as well as in combination with other rhinosinusitis treatments (antibiotics, corticosteroids, etc.) when they are needed.

How effective is Sinuforte®?

Results of numerous clinical studies have demonstrated:

Full recovery of nasal respiration in 94.5% of patients
- Significant or total reduction in pathologic excretions in 96.6% of patients
- Total disappearance of headache in 92.4% of patients
- A decrease in pain sensitivity in 94% of patients.

Can Sinuforte® be applied after sinus puncture?

It depends on whether the outflow from the sinus is blocked or not. If the outflow is not blocked, Sinuforte® can be applied after sinus puncture, even if the puncture was only made for diagnostic purposes.

Can Sinuforte® be applied after surgery (post-surgical period) on the nasal cavity?

After endonasal surgery for the treatment of nasal and paranasal sinus polyposis a daily application of Sinuforte® (instead of washes) will promote faster sinus cleansing (Khechinashvili S.N., with co-authors).

Does Sinuforte® create drug dependence?

Clinical trials have shown no evidence to suggest the possibility of developing drug dependence for Sinuforte®.

Is there a danger of overdosing?
No cases of overdosing are known to date. Nonetheless, exceeding the recommended dose may cause an intensive burning n the nasopharynx and will not increase the efficacy.

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