Karos

Karos
Karos

KAROS® ORAL SPRAY

0.3% Sodium Hyaluronate Solution

For oral use

Patient Information Leaflet:
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PRODUCT CHARACTERISTICS:

KAROS ORAL SPRAY is a hyaluronic acid-based solution to be sprayed into the throat in case of oropharyngeal mucosal inflammation (inflammation of the oral and pharyngeal mucosa). Thanks to its particular viscoelastic and physical properties, hyaluronic acid forms a protective barrier on the inflamed oropharyngeal mucosa; in fact, being a hydrophilic molecule, it is able to absorb water up to 1000 times its volume, forming almost a gel. For this reason, spraying hyaluronic acid-based KAROS ORAL SPRAY directly into the aqueous environment of the oropharyngeal area allows the formation of a thin film. This film acts as a protective barrier for the pharyngolaryngeal mucosa in case of mucosal inflammation caused by gastroesophageal nonerosive reflux disease (NERD) or diseases of the upper respiratory tract, such as pharyngitis and laryngitis, in both acute and chronic phases. Reflux disease is significantly widespread, especially in the western world, and is closely related to lifestyle and dietary habits. Reflux of stomach acid into the oral cavity, i.e. into the pharynx and larynx, is recognised within the category of gastroesophageal nonerosive reflux disease (NERD) and is defined as laryngopharyngeal reflux disease, often abbreviated as LPR. In this disease the gastroduodenal contents refluxed from the stomach overcome the antireflux barrier of the upper oesophageal sphincter and diffuse into the aqueous environment typical of the oropharyngeal area, irritating and inflaming the mucous membrane of the laryngopharyngeal region and causing various symptoms, such as: dysphonia, need to clear the voice, need to scrape the throat, excess mucus in the throat, the sensation of retronasal discharge, chronic cough, pharyngeal globus with foreign body sensation. The same symptoms can be associated with mucosal inflammation due to diseases of the upper respiratory tract. Here too, the protective barrier created by the hyaluronic acid in KAROS ORAL SPRAY relieves the painful symptoms of acute or chronic pharyngitis and laryngitis, and, thanks to hyaluronic acid’s ability to attract and retain water, also helps to thin mucus.

INDICATIONS

KAROS ORAL SPRAY is indicated in the treatment of symptoms related to oropharyngeal mucosal inflammation (inflammation of the mucosa of the mouth up to the pharynx) such as inflammation of the vocal cords with and without dysphonia (voice disorders), hoarseness, need to clear the voice, need to scrape the throat, excess mucus in the throat, retronasal discharge sensation, chronic cough, pharyngeal globus with foreign body sensation (feeling of constriction or foreign body in the throat), when these disorders are related to laryngopharyngeal reflux disease (LPR) or to diseases of the upper respiratory tract such as pharyngitis and laryngitis, both acute and chronic. KAROS ORAL SPRAY is in addition to and does not replace other therapeutic treatments that may be prescribed to patients.

 

PACKAGE CONTENTS

KAROS ORAL SPRAY is a solution for oral administration.

The package contains one 20ml multi-dose bottle.

 

COMPOSITION

Each 20ml multi-dose bottle contains: 0.3% sodium hyaluronate (Hyaluronic Acid Sodium Salt), sodium chloride, potassium sorbate, sodium benzoate, citric acid, purified water.

 

FREQUENCY OF USE

2 puffs in the mouth 3 times a day, 1 hour after meals is recommended.

Continue treatment for a period of 2 weeks unless otherwise advised by your doctor.

Each spray delivers 140 microlitres of solution.

 

INSTRUCTIONS FOR USE

Press on the nozzle, directing the jet towards the bottom of the oral cavity.

Keep the bottle upright.

Shake before use.

Do not take food or drink for about 1 hour after treatment.

 

WARNINGS

Do not use KAROS ORAL SPRAY after the expiry date stated on the package.

Do not use KAROS ORAL SPRAY if the packaging is open or damaged.

Do not take food or drink for about 1 hour after treatment with KAROS ORAL SPRAY.

Store between 0° and 25°C. Do not freeze.

Once used, dispose of the bottle according to the normal rules for differentiated disposal of household waste.

Consult your doctor before using KAROS ORAL SPRAY.

 

KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.

 

INTERACTIONS

There are currently no known interactions between KAROS ORAL SPRAY and any concomitant therapies.
However, as KAROS ORAL SPRAY consists of saline solution and hyaluronic acid, a natural constituent of human tissue, such interactions are, in principle, to be excluded.

 

CONTRAINDICATIONS AND SIDE EFFECTS

There are currently no known contraindications to the use of KAROS ORAL SPRAY, nor have any side effects been reported, nonetheless the product must not be used in case of known hypersensitivity to sodium hyaluronate or the other components. If you experience any undesirable effects, you should stop treatment and consult your doctor.

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    Information notice pursuant to art.13 of Regulation EU 2016/679 of the European Parliament and of the Council of 27 April 2016 (General Data Protection Regulation, so-called “GDPR”)

    Information notice – Business Development In accordance with the current personal data protection regulations, IBSA Farmaceutici Italia Srl (hereinafter, the "IBSA” or “Company") as "Data Controller", is required to provide certain information regarding the use of your personal data.

    1. Purpose of the personal data processing The processing of your personal data is necessary for the following purposes: a) Management of your request prior to entering into a contract further to the information provided by you. b) “Marketing communication”: information relating to IBSA products and services and related activities (training, seminaries, etc.), institutional communication on IBSA activities (congresses, launch of new products, marketing communication) through dedicated IBSA personnel and/or forwarding of promotional material through printed or digital channels (i.e. email).

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    5. Scope of circulation of the data The data may be used by personnel of the Company and of its parent company IBSA Institut Biochimique SA, that have been given appropriate operating instructions under an obligation of confidentiality. The data may also be used by third-party providing operational and additional services on behalf of the Company, which act as external data processors under the direction and supervision of the Company. The list of the Data Processors is available by sending a request to privacy@ibsa.ch.

    6. Communication of the data In accordance with the laws and regulations that we are subject to, we may be required to communicate the data to the competent Authorities and healthcare associations in third countries outside the EU and to legitimate recipients in accordance with the law and the regulations. These parties will act as independent Data Controllers.

    7. Transfer of the data abroad The aforementioned personal data are transferred to Institut Biochimique SA (IBSA SA) in Switzerland, solely for the purposes set out in paragraph 1. In accordance with the laws and regulations to which we are subject to, your personal data may also be communicated and/or transferred to organizations located in other countries, both in EU countries and outside the EU, including countries that may not provide the same level of protection as provided by the applicable legislation, we inform you that the transfer of data abroad is subject to specific guarantees for the protection of personal data through the adoption of standard contractual clauses.

    8. Rights of the data subject In relation to the processing of your personal data, you have the right to be informed at any time about your data held by the Company and how they are used. You also have the right to have the data updated, corrected or erased, to request their portability or restriction of processing, in the cases provided for by law, and to object to the processing of the data unless the Company has a legitimate interest in the data. To exercise your rights and to obtain more detailed information about the persons or categories of persons to whom the data are communicated and/or transferred or who become aware of the data as controllers or processors, you can contact us: - by e-mail, at: privacy@ibsa.ch ; - by post, at: IBSA Farmaceutici Italia Srl, Ufficio Privacy, via della Filanda 30 – 26900 Lodi – Italy; Lastly, we remind you that you have the right to lodge a complaint with the Personal Data Protection Authority if you consider that your rights have not been respected or that you have not received a response to your requests in accordance with the law.

    9. Data Controller The Data Controller is IBSA Farmaceutici Italia Srl with registered office in Via Martiri di Cefalonia, 2 – 26900 Lodi, Italy.

    10. Data Protection Officer The Company has appointed a Data Protection Officer or DPO. The DPO can be contacted via the following communication channel: dpo@ibsa.it



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