Cerulisina

Cerulisina
Cerulisina

CERULISINA® ear drops

Solution based on Dimethylbenzene and Sweet Almond Oil

FOR OTOLOGICAL USE – 20ml bottle

PROPERTIES

CERULISINA® ear drops is a solution consisting of 5% xylene (dimethylbenzene) in sweet almond oil.

PACKAGE CONTENTS

20ml bottle equipped with dropper pipette.

COMPOSITION

95% almond oil, 5% dimethylbenzene

FREQUENCY OF USE

Apply CERULISINA® ear drops in the ear; the recommended dose is the entire contents of the dropper.

If necessary, you can repeat the instillations 2-3 times a day and continue the treatment for 3-5 days depending on the amount of earwax to be extracted.

If the symptom persists, contact your doctor or pharmacist.

INSTRUCTIONS FOR USE

1. Fill the dropper.

2. Tilt your head and instil the drops in your ear.

3. Stay in this position for 5-10 minutes.

4. Wash your ear with lukewarm water.

WARNINGS
  • Do not use CERULISINA® ear drops after the expiry date indicated on the package.
  • Get a doctor’s opinion before using this product immediately following surgery.
  • Do not use CERULISINA® ear drops if the packaging is open or damaged.
  • No special storage precautions are necessary.
  • Once used, dispose of the bottle according to the normal rules for differentiated disposal of household waste.
  • KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.
  • FOR OTOLOGICAL USE
CONTRAINDICATIONS
  • CERULISINA® ear drops must not be used in case of known hypersensitivity to one or more of the components.
  • CERULISINA® ear drops must not be used in case of middle ear diseases such as inflammation (otitis) or perforated eardrum.
  • If you are pregnant, if you suspect you are or are planning to become pregnant, or are breast-feeding, ask your doctor or pharmacist for advice before using CERULISINA® ear drops. In any event, there are no known harmful effects on pregnant women at the indicated therapeutic doses.
UNDESIRABLE EFFECTS

During treatment with CERULISINA® especially if prolonged, you may notice itching and/or redness (sensitization phenomena). In this case, stop the therapy and consult your doctor.

NONETHELESS, IF YOU NOTICE THE ONSET OF AN UNDESIRABLE EFFECT, SUSPEND THE TREATMENT AND ASK YOUR DOCTOR OR PHARMACIST FOR ADVICE.

INTERACTIONS

Consult your doctor or pharmacist before using other medicines, medical devices and/or cosmetics in conjunction with CERULISINA® ear drops.

However, there are no known interactions between CERULISINA® and other drugs.

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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).

    2. Nature of the provision of the personal data and consent We inform you that the processing of your personal data for the purpose referred to in point 1a of this information is carried out in accordance with art. 6.1 lett. b) of the EU Regulation 2016/679, so the provision of data is optional but necessary for the performance of the relationship between the parties. Any refusal will make it impossible for the Data Controller to execute the purpose above. We inform you that the processing of your personal data for the purpose referred to in point 1b of this information is carried out pursuant to art. 6.1 lett. a) of the EU Regulation 2016/679, so the consent is optional but essential for the achievement of the purpose itself. Any refusal to provide consent will not allow the achievement of the purpose itself.

    3. How the data are processed The data are processed through computer procedures or by automated means or paper by persons, internal or external, specifically assigned to this task and required to confidentiality with logic closely related to the purposes for which the data were collected in any case suitable to ensure the security and confidentiality of the data are protected by security measures provided by law, to prevent unauthorized access, loss or destruction.

    4. How long the data are kept The data will be kept for the time strictly necessary for the accomplishment of the purposes set out in this notice and in any event up to the statutory and legal time limit in compliance with the rights and the resulting obligations.

    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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