RINAZINA*NASAL SPRAY 15ML 0.1%

RINAZINA 1 mg/ml NASAL SPRAY, SOLUTION
Naphazoline

What it is and what it is used for
RINAZINA contains the active ingredient naphazoline nitrate, which belongs to a group of medicines called NASAL DECONGESTANTS, topical sympathomimetics, with vasoconstrictive action, meaning they reduce the dilation of blood vessels in the nasal mucosa.
RINAZINA is indicated for clearing a blocked nose (nasal decongestant), in cases of:
• common cold (rhinitis) and throat inflammation with catarrh (acute catarrhal pharyngitis),
• allergic cold (allergic rhinitis),
• inflammation of the mucous membrane of the facial bone cavities around the nose (acute sinusitis).
RINAZINA is for use in adults and children aged 12 years and over.
Consult your doctor if you do not feel better or if you feel worse after a few days. Treatment should not last more than one 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 eye pressure (glaucoma) or increased production of thyroid hormones (hyperthyroidism);
• If you are taking or will take medication for depression within two weeks after stopping RINAZINA treatment.
The medicine must not be taken by children under 12 years of age.

Warnings and precautions
Ask your doctor or pharmacist for advice before using RINAZINA:
• If you are elderly
• If you have an enlarged prostate (prostatic hypertrophy), as you may experience difficulty urinating (urinary retention).
• If you suffer from heart and blood vessel diseases (cardiovascular diseases) and especially high blood pressure (hypertension), the use of RINAZINA must always be after consulting your doctor.
• Continued use of medicines like RINAZINA, which reduce blood vessel dilation (vasoconstrictors), can alter the normal function of the mucous membrane of both the nose and the cavities of the facial bones around the nose (paranasal sinuses) and can also cause drug dependence (habituation). Long-term use can be harmful.
• The use, especially if continuous, of topical medicines like RINAZINA can cause allergic reactions (sensitisation phenomena). In this case, stop treatment and consult your doctor.
• With the use of medicines that stimulate the sympathetic nervous system (sympathomimetics) like RINAZINA, rare cases of a syndrome with symptoms such as headache, nausea, vomiting, and visual disturbances (reversible posterior encephalopathy/reversible cerebral vasoconstriction syndrome) have occurred, which improved and resolved after medical treatment.
• Stop using RINAZINA and consult your doctor immediately if you experience signs and symptoms of reversible posterior 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 locally cause swelling of the nasal mucosa due to intense vasodilation of blood vessels in the nose (rebound sensitisation phenomena), worsening the feeling of a blocked nose instead of improving it.
The rapid absorption of naphazoline through inflamed mucous membranes can cause systemic effects such as increased blood pressure (hypertension), reduced heart rate (reflex bradycardia), severe headache (cephalalgia), and difficulty urinating (urinary disorders).
Reporting of side effects
If you get any side effects, including any not listed in this leaflet, tell 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.