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Ciliacell nasal spray 15 ml (Sinuclean)

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Non-sterile solution indicated in nasosinusal diseases and their complications (acute rhinosinusitis, chronic bacterial rhinosinusitis, nasosinusal polyposis, allergic rhinopathies, fungal rhinitis, otitis media with effusion) characterised by: nasosinusal mucosal edema, altered pneumatisation of the sinuses, reduction or loss of mobility and ciliary motility as well as accumulation of muco-purulent secretions in the nasosinusal cavities and in the auditory tubes.

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20,13

Ciliacell nasal spray 15 ml

Indications: Non-sterile solution indicated in nasosinusal diseases and their complications (acute rhinosinusitis, chronic bacterial rhinosinusitis, nasosinusal polyposis, allergic rhinopathies, fungal rhinitis, otitis media with effusion) characterised by: nasosinusal mucosal edema, altered pneumatisation of the sinuses, reduction or loss of mobility and ciliary motility as well as accumulation of muco-purulent secretions in the nasosinusal cavities and in the auditory tubes.

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Composition:

CiliaCell Nasal Spray contains:

Active ingredients: Cucurbitacins B-D-l-E 50 µg/mI extracted from Ecballium Elaterium.

Other ingredients: Purified water, Mint flavour, Methyl paraoxybenzoate, Propyl paraoxybenzoate.

Mechanism of action:

The solution containing Cucurbitacins B-D-l-E, administered as micro droplets into the nostrils in the form of a nasal spray, produces an action on the surface of the mucosal epithelium that causes an electrolytic and osmotic alteration, which is followed by a physiological process of the expulsion of mucopurulent secretions present in the nasosinusal cavities and in the auditory tubes, the restoration of ciliary mobility and motility, the reduction of nasosinusal mucosal oedema, the restoration of pneumatisation of the sinuses as well as the reduction of the size of nasosinusal polyps.

Dose, method and frequency of administration:

Adults and children (age > 10 years)

Administer 2 sprays per nostril 2 times a day (morning and evening) for 7 consecutive days. The treatment may be prolonged up to 14 days or repeated 6-7 days after the first treatment (depending on the symptoms and muco-purulent secretions present).

For the use of the product in chronic nasosinusal diseases or after surgery, it is advisable to repeat the treatment for at least 2 cycles, interspersed with 6-7 days of non-treatment.

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Drug interactions:

CiliaCell Nasal Spray 50 µg/ml, being limited to a mechanical and non-systemic action, does not interfere with medications used to treat rhinologic conditions.

CiliaCell Nasal Spray 50 µg/ml can be combined with antibiotics and corticosteroids for inhalation and systemic use.

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Precautions:

All the steps described must be performed gently, avoiding the introduction of the spray dispenser too deeply into the nostrils and maintaining an upright position during administration.

Close the bottle after each application. Avoid exposing the product to light and keep away from direct heat.

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Warnings:

The product must not be used by pregnant women or by children under 10 years of age.

The use of CiliaCell Nasal Spray 50 µg/ml in combination with sympathomimetic drugs is not recommended, as this may result in the decreased efficacy of the product.

After opening, the product can be used within a period of 60 days.

Contraindications:

Hypersensitivity to any of the components of CiliaCell Nasal Spray 50 µg/ml.

Adverse effects:

The tests carried out have not shown any specific side effects, but slight signs of irritation and congestion of the nasal mucosa can occur in rare cases, with a temporary sensation of nose blockage.

Other rare side effects can include rhinorrhoea and mild irritation of the fauces nose.

Frequent and continued overdose of the product does not under any circumstances endanger the health of the user, although it does increase the probability of the above-mentioned undesirable effects occurring.

In rare cases, overdose may result in a fever (only for 3-4 hours).

It is advised that you inform your doctor or pharmacist if you experience any side effects.

Production:

NEVIA Biotech s.r.l. via Piedipastini 14, 83048 Montella (AV) ltaly

FAQ – Frequently Asked Questions CiliaCell

  1. Ciliacell is a product that acts on the three clinical characterizations of rhinosinusitis (edema of the naso-sinus mucosa, reduction or blockage of ciliary mobility and motility, and accumulation of mucus-pus in the rhinosinusal district and auditory tubes), the true causes of the typical symptoms of rhinosinusitis.
  2. The action of Ciliacell is very vigorous, so its effect is highly visible and can lead to an intensification of symptoms for a few days, especially if the rhinosinusitis has become chronic or we are in the acute phase.
  3. Ciliacell should be used when you are certain that you have rhinosinusitis or when the typical symptoms of rhinosinusitis are present. An indication of the possible diagnosis can be made using the OCHEMA multimedia application https://neviabiotech.ch/diagnosi-online/

Ciliacell is the only product on the market capable of effectively acting on the three clinical characterizations of rhinosinusitis (edema of the naso-sinus mucosa, reduction or blockage of ciliary mobility and motility, and accumulation of mucus-pus in the rhinosinusal district and auditory tubes), the true causes of the typical symptoms of rhinosinusitis

Ciliacell is indicated when you are certain that you have rhinosinusitis or when the typical symptoms of rhinosinusitis are present. An indication of the possible diagnosis can be made using the OCHEMA multimedia application https://neviabiotech.ch/diagnosi-online/

  1. It is appropriate to administer Ciliacell morning and evening. Ciliacell can also be effective with one administration per day, in which case it is preferable to administer the product in the morning.
  2. Especially for the first administration, it is recommended not to do it in the evening.
  3. Evening administration of Ciliacell is recommended to be done at least three hours before bedtime.
  1. Ciliacell nasal spray should be taken in an upright position, taking care not to introduce the spray nozzle very deeply into the nostrils.
  2. Dispense the product by directing the tip of the spray nozzle toward the outside of the nose. In this regard, it is recommended to administer the product with the right hand in the left nostril and with the left hand in the right nostril.
  1. The action of Ciliacell begins to be seen about two hours after administration; in some cases more time is needed.
  2. Immediately after administration, sneezing may occur; if not excessive, the effect should be considered acceptable; nevertheless, in normalcy, sneezing does not occur or sneezing is infrequent.
  3. Dryness of the lips may occur, in which case it is recommended to hydrate by drinking water or other liquid to your liking.
  4. A slight fever may occur a few hours after administration; if this wears off within a few hours, it is completely normal.
  5. A few hours after administration, you may feel mucus going down your throat, or evacuation of mucus from your nose; this action is completely normal; in fact, it represents clear evidence that the product is performing its action effectively.
  6. An intensification of typical symptoms of rhinosinusitis may be experienced after administration of Ciliacell; this effect should be considered normal if the same symptoms are bearable and do not last for more than 2-3 days.
  1. The effects of Ciliacell’s action become evident about 2 to 3 hours after its administration.
  2. The effects of Ciliacell’s action last for about 24 to 36 hours after administration, which is why one administration every 24 hours is sufficient in most cases.
  1. Sneezing after the administration of Ciliacell may be normal if not very frequent; in any case, the sneezing should wear off after 10-20 minutes. There is usually no evidence of sneezing after administration, except for some sporadic sneezing.
  2. During the period of administration of Ciliacell sporadic sneezing to evacuate mucus should be considered normal, unless the evacuated mucus is mixed with blood or actual nosebleeds occur, in which case the administration of the product should be discontinued and medical advice sought.
  3. It is appropriate to be concerned when sneezing is very frequent and does not subside within 10 to 20 minutes after administration.

The action of Ciliacell begins to be noticeable about two hours after administration; in some cases more time is needed. Continue to administer the product according to the dosage stated in the package insert even without any visible effect, in any case do not increase the dosage, either in terms of dispensing per day or dispensing per nostril.

A few coughing fits during treatment with Ciliacell should be considered normal if these are sporadic or infrequent. Should the coughing fits be frequent, it is recommended that the treatment be interrupted.

  1. Dryness of the lips associated or not with general dehydration may be considered normal, in which case hydrate with water or other liquid as desired.
  2. Dryness is evident precisely as a result of the action of Ciliacell, as it acts by evacuating fluids from the tissues.

After administration of Ciliacell a mild fever (36.5-37.5 °C) can be considered normal if it wears off a few hours after its onset, usually after 3-4 hours.

  1. It is possible that after administration of Ciliacell there may be an intensification of symptoms, particularly craniofacial algia (diffuse pain in the face at the sinuses), as the sinus ostia may be totally closed and not allow air to enter the sinuses. As soon as the sinus ostia become pervious again, oxygen will re-enter the sinuses reestablishing their normal pneumatization, making the pain disappear quickly.
  2. It is quite normal that after administration of Ciliacell there is an intensification of mucus evacuation; this effect highlights the action of Ciliacell. The evacuated mucus may be foul-smelling and of various colors (yellow to green), and in some cases bits of solid mucus may be evident in the evacuated mucus.

After the administration of Ciliacell, it is quite normal that in a lying position with belly up, mucus may go down the throat; to limit this phenomenon, it is recommended to lie on the side to allow mucus to flow out of the nostrils of the nose.

You may experience headaches (widespread pain in the temples or high forehead) during treatment with Ciliacell; you should discontinue the product if the pain is difficult to bear and does not subside within a few hours, usually 3-4 hours.

From ten years of age, the dosage of Ciliacell is the same as for adults, nevertheless it is recommended to start with a single administration per nostril once a day and then increase to the prescribed dose after 2-3 days if the product is well tolerated, otherwise continue to administer Ciliacell with the initial dosage.

The effect of Ciliacell is visible about 2 to 3 hours after its administration. The most noticeable effect is evacuation of mucus from the nose or throat, in some cases dryness of the lips.

  1. It is not at all recommended to increase the dose of Ciliacell from that stated in the package insert. Increasing the dose of the product will inevitably give rise to an intensification of the side effects reported in the product package insert or an intensification of the painful symptoms typical of rhinosinusitis.
  2. There is no need to increase the dose of the product administered as Ciliacell perfectly exerts its effects at the prescribed dosage; in fact, the product is effective even with just one administration per day.

Feeling exhausted during treatment with Ciliacell should be considered normal if motor and mental functions are not particularly disabling; otherwise, treatment should be discontinued.

In the presence of rhinosinusitis with evidence of craniofacial algias and mucus-pus accumulation in the rhinosinusal district and auditory tubes, it is not absolutely necessary to combine the administration of other medicines (indeed, it is not recommended), except in the presence of fever, in which case the administration of an antibiotic may be necessary and must be prescribed by a physician.

At the end of treatment with Ciliacell, evacuation of clear mucus should be considered normal if this is exhausted 24-48 hours after the last administration.

  1. Generally, a seven-day course of therapy is sufficient to restore the physiological condition of the upper respiratory system and make painful symptoms disappear if present.
  2. In cases of overt chronic rhinosinusitis that has persisted for a long time (several years), it may be necessary to prolong treatment for 14 consecutive days. In any case, it is recommended to do an initial seven-day course of treatment, suspend treatment for another seven days, and then repeat the course of treatment for another seven days.
  3. After the first treatment with Ciliacell finished successfully, that is, with the disappearance of the typical symptoms of rhinosinusitis, episodes of rhinosinusitis flare-ups will be much less frequent, in which case a few applications of Ciliacell will be enough to re-establish normal physiological conditions and make the symptoms disappear (usually 2-3 days of treatment are sufficient).
  1. After the first seven-day treatment with Ciliacell, the same treatment can be repeated after seven days of no treatment.
  2. After the first two treatment cycles of seven days interspersed with seven days of no treatment, a new course of therapy can be given after about 20 to 30 days. It is never recommended to administer Ciliacell continuously for a period longer than 14 consecutive days.

Using Ciliacell, nasal washes are not absolutely necessary; in fact, if done after Ciliacell administration, they may reduce its effect.

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