SEDITUS TOS PASTILLAS ES

Dénomination commerciale

SEDITUS TOS PASTILLAS ES

08056300622208

805630062FTPR111DN

Numéro de référence/catalogue

FTPR111

GS1

Classe IIa

Législation applicable

MDR [Règlement (UE) 2017/745 relatif aux dispositifs médicaux]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

Heliwall tablets is a medical device composed of substances, not sterile, intended for short term invasive contact with respect to body orifices (oral cavity), designed for the treatment of sore throat and relief of cough in children 4+, adolescent and adult.

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

Nomenclature européenne des dispositifs médicaux — la classification produit UE attribuée à ce dispositif.

• V9017ORAL ADMINISTRATION PREPARATIONS NOT INCLUDED IN OTHER CLASSES

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• Keep out of the reach of children. Do not use in case the package is not intact. The tablet should not be swallowed but chewed or dissolved slowly in the mouth. Do not administer the product to children under four years of age. No side effects associated by used the device have been observed. If you notice the appearance of side effects, inform your doctor. If symptoms persist or worsen after 5 days, or in case of fever, consult your doctor. Do not take it if you are allergic, intolerant or hypersensitive to any component. Do not use the product after the expiry date printed on the package. Expiry date refers to the product in its intact packaging and properly stored. Do not use for purposes other than that for which the product is intended. Since no data on use during pregnancy and lactation are available, its use is generally not recommended as a precaution due to lack of experimental data. Even if no side effects are known, it is recommended not to use the product during pregnancy or breastfeeding. In any case, consult your doctor before taking it. Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the Competent Authority. In case of any undesired event always seek medical advice. Do not exceed the recommended daily dose. In the event of concomitant pharmacological treatment, although no interactions with drugs are known, it is advisable to consult a doctor before use.

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