RINOFLUIMUCIL "1% + 0.5% NASAL SPRAY SOLUTION" 10 ML BOTTLE"

Name
Rinofluimucil 1% + 0.5% nasal spray solution
N-acetylcysteine ​​+ tuaminoheptane sulfate


What is it and what is it for?
Rinofluimucil contains the active substances N-acetylcysteine, which belongs to a group of medicines called mucolytics used to thin nasal mucus, and tuaminoheptane sulphate which belongs to a group of medicines called vasoconstrictors used as nasal decongestants.

This medicine is used for the treatment of inflammation of the nasal mucosa (acute and subacute rhinitis, with mucopurulent and slowly resolving exudates, chronic and muco-crusted rhinitis, vasomotor rhinitis) and of the paranasal sinuses (sinusitis).

Talk to your doctor if you do not feel better or if you feel worse after a week of treatment.


What you need to know before taking the medicine
Do not use Rinofluimucil - if you are allergic to N-acetylcysteine ​​or to tulaminoheptane sulphate or any of the other ingredients of this medicine (listed in section 6);
- if you have a disease of the heart and/or blood vessels, including high blood pressure (hypertension);
- if you have suffered from cerebrovascular disease in the past;
- if you have suffered from seizures in the past;
- if you have an eye disease with high pressure inside the eye (narrow-angle glaucoma);
- if you have excessive production of thyroid hormones (hyperthyroidism);
- if you are being treated with medicines for depression (selective monoamine oxidase inhibitors) or within two weeks of stopping such treatment (see “Other medicines and Rinofluimucil”);
- if you are using other sympathomimetic medicines, including other nasal decongestants (see “Other medicines and Rinofluimucil”);
- if you have a rare tumor of the adrenal gland called pheochromocytoma;
- if you have had your pituitary gland surgically removed (hypophysectomy) or have had surgery that exposed the outer membrane that surrounds the brain (dura mater);
- if you are under 12 years of age (see “Children and adolescents”).


Warnings and precautions
Talk to your doctor or pharmacist before using Rinofluimucil.
Stop treatment if you experience high blood pressure (hypertension), rapid heartbeat (tachycardia), palpitations, heart rhythm disturbances, nausea, or any neurological signs and symptoms (such as a headache or worsening of an existing headache).
In children over 12 years of age, the product should be used only if strictly necessary and under medical supervision.

Use this medicine only after consulting your doctor.
- If you are elderly or if you suffer from an enlarged prostate (prostatic hypertrophy), due to the risk of inability or reduced ability to empty your bladder (urinary retention),
- if you have heart and/or blood vessel problems, especially high blood pressure,
- if you suffer from asthma, diabetes, obstruction of blood vessels (occlusive vascular disease) or if you are taking beta-blocker drugs, used in the treatment of some cardiovascular diseases,
Consult your doctor even if these disorders have occurred in the past.

Prolonged use of medicines containing substances that act on blood vessels (vasoconstrictors) can alter the normal function of the mucosa of the nose and paranasal sinuses, also inducing tolerance to the medicine (habituation).
Repeating applications for long periods can be harmful.
Prolonged use may cause swelling of the nasal mucosa.
The action of the medicine can be integrated, at the doctor's discretion, with an appropriate antibacterial coverage.

Rinofluimucil is not an eye medicine.

Attention for those who practice sports:
- The product contains substances prohibited for doping. Any use other than those listed, in terms of dosage and route of administration, is prohibited.
- the use of medicines containing ethyl alcohol may result in a positive doping test in relation to the blood alcohol concentration limits indicated by some sports federations.

Children and adolescents
This medicine is contraindicated in children under 12 years of age (see “Do not use Rinofluimucil”).
In children and adolescents over 12 years of age, the medicine should only be used if clearly necessary and under medical supervision.


Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.

The medicine can cause local allergic reactions (sensitization) and congestion of the mucous membranes as a consequence of a phenomenon known as the “rebound effect” (reappearance of symptoms after a pharmacological treatment has been suspended).
Frequent administration of the drug at higher doses may cause sympathomimetic side effects (such as increased excitability, palpitations, tremors, etc.). Dryness of the nose and throat and acne rashes may sometimes occur. These effects disappear upon discontinuation of treatment.

Side effects with unknown frequency (frequency cannot be established on the basis of the available data):
- hypersensitivity,
- high blood pressure (hypertension),
- nausea,
- hives,
- appearance of red spots or patches (rash) on more or less large areas of the skin,
- inability or reduced ability to empty the bladder (urinary retention).

Particularly with prolonged and/or excessive use:
- anxiety,
- hallucination,
- delirium,
- heachache,
- restlessness,
- agitation,
- insomnia,
- tremor,
- palpitations,
- rapid heartbeat (tachycardia),
- irregular heartbeat (arrhythmia),- dry nose and throat,
- nasal discomfort and congestion,
- irritability,
- tolerance to the drug (habituation).

Following the information in the package leaflet reduces the risk of side effects. These side effects are generally transient.

Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazionireazioni-avverse .
By reporting side effects you can help provide more information on the safety of this medicine.