Name
RINAZINA 1 mg/ml NASAL SPRAY, SOLUTION
Naphazoline
What is it and what is it used for?
RINAZINA contains the active ingredient naphazoline nitrate, which belongs to a group of medicines called NASAL DECONGESTANTS, sympathomimetics for topical use, with vasoconstrictor action, i.e. they reduce the dilation of the blood vessels present in the nasal mucosa.
RINAZINA is indicated to clear a stuffy nose (nasal decongestant), in case of:
• cold (rhinitis) and inflammation of the throat with presence of phlegm (acute catarrhal pharyngitis);
• allergic cold (allergic rhinitis);
• inflammation of the mucosa of the cavities of the facial bones around the nose (acute sinusitis).
RINAZINA is used in adults and children aged 12 years and over.
Contact your doctor if you don't feel better or if you feel worse after a few days. Treatment should not last longer than a week.
What you need to know before taking the medicine
DO NOT use RINAZINA:
• if you are allergic (hypersensitive) to naphazoline or any of the other ingredients of this medicine (listed in section 6);
• if you suffer from heart disease and very high blood pressure (severe hypertension), optic nerve disease with increased pressure in the eyes (glaucoma) or increased production of thyroid hormones (hyperthyroidism);
• if you are taking or will take within two weeks of stopping treatment with RINAZINA medicines to treat depression.
The medicine should not be taken by children under 12 years of age.
Warnings and precautions
Ask your doctor or pharmacist for advice before using RINAZINA:
• if he is elderly;
• if you have an enlarged prostate (prostatic hypertrophy), because you may have difficulty urinating (urinary retention);
• if you suffer from heart and blood vessel diseases (cardiovascular diseases) and especially from high blood pressure (hypertension), the use of RINAZINA must take place, from time to time, after consulting your doctor;
• Continued use of medicines such as RINAZINA, which reduce the dilation of blood vessels (vasoconstrictors), can alter the normal function of the mucosa of both the nose and the cavities of the bones of the face around the nose (paranasal sinuses) and can also cause dependence (addiction) to the drug. Long-term use may be harmful;
• the use, especially if continued, of local medicines such as RINAZINA can cause allergic reactions (sensitization phenomena). In this case, stop treatment and contact your doctor;
• with the use of medicines like RINAZINA which stimulate the sympathetic nervous system (sympathomimetics), rare cases of a syndrome with symptoms such as headache, nausea, vomiting and visual disturbances (posterior reversible encephalopathy/reversible cerebral vasoconstriction syndrome) have occurred, which improved and healed after medical treatment;
• stop using RINAZINA and consult your doctor immediately if you experience symptoms and signs of posterior reversible encephalopathy/reversible cerebral vasoconstriction syndrome.
Children and adolescents
RINAZINA is contraindicated in children under 12 years of age.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
RINAZINA can cause local swelling of the nasal mucosa due to intense vasodilation of the blood vessels in the nose (rebound sensitization phenomena), worsening the sensation of a blocked nose instead of improving it.
The rapid absorption of naphazoline through inflamed mucous membranes can cause effects on the body (systemic effects) such as increased blood pressure (high blood pressure), reduced heart rate (reflex bradycardia), severe headache (cephalea) and difficulty urinating (micturition disorders).
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.