BRUNIZINA*NASAL DROPS 10ML 0.2%

BRUNIZINA 2 mg/ml nasal drops, solution
BRUNIZINA 2 mg/ml nasal spray, solution
Naphazoline hydrochloride

What it is and what it is used for
BRUNIZINA contains the active ingredient naphazoline hydrochloride, which belongs to a group of medicines called decongestants that reduce blood circulation in the nasal and ocular mucosa and reduce congestion.

This topical medicine is used to clear the nose in case of a cold or other conditions of nasal congestion, such as sinusitis and allergic rhinitis (inflammatory processes in the nose, paranasal sinuses, and nasopharynx).

Consult your doctor if you do not feel better or if you feel worse after 4 days.

What you need to know before taking the medicine
Do not use BRUNIZINA
- if you are allergic to naphazoline hydrochloride, to similar substances (imidazoline sympathomimetics), or to any of the components of this medicine (listed in section 6);
- if you have persistent nasal inflammation (chronic rhinitis);
- if you suffer from severe heart disease or a marked increase in blood pressure (severe arterial hypertension);
- if your thyroid is overactive (hyperthyroidism);
- if you have a disease due to high intraocular pressure (narrow-angle glaucoma) or if you have other severe eye diseases;
- if you suffer from an enlarged prostate (prostatic hypertrophy);
- in children under 12 years of age (See the "Children" section);
- if you are taking monoamine oxidase inhibitors, medicines used to treat depression, or if you have taken them in the last 2 weeks (See the "Other medicines and BRUNIZINA" section).

Do not take BRUNIZINA orally.
Do not use this medicine for more than 4 consecutive days.

Warnings and precautions
Talk to your doctor or pharmacist before using BRUNIZINA.

Before using this medicine, talk to your doctor if you suffer or have suffered from heart and circulation problems (heart failure, cardiovascular diseases), especially if you have high blood pressure (hypertensive); they will assess the potential risks and benefits of BRUNIZINA therapy.

If you use BRUNIZINA for a long time, the normal function of the nasal mucosa and the mucous membranes around the nose (paranasal sinuses) may be altered, and your body risks becoming accustomed to this medicine (tolerance), making the dose taken less effective.

If you repeat applications for a long time, damage to the mucous membranes may occur. Therefore, stop treatment and consult your doctor if you do not see improvements after using BRUNIZINA for a few days.

The use of BRUNIZINA or similar decongestant products can cause mucous membrane congestion (rebound congestion), triggering a vicious cycle that can lead to overuse of the medicine.

Therefore, never exceed the recommended doses.

Use BRUNIZINA with caution and inform your doctor if any of the following conditions apply to you:
- if you are elderly;
- if you are in the first months of pregnancy (See the "Pregnancy and breastfeeding" section);
- if you are a sensitive subject. In this case, use a lower concentration of naphazoline, equal to 0.50 per mille, which is obtained by diluting 1 part of BRUNIZINA with 3 parts of water.

Children
The use of BRUNIZINA is contraindicated in children under 12 years of age (See the "Do not use BRUNIZINA" section).
Use this medicine with particular caution in children and at a lower concentration of naphazoline, as overdose is more frequent and presents with more severe symptoms (See the "Use in children" and "If you use more BRUNIZINA than you should" sections).

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

The following side effects may occur:
- local reactions of intolerance to the medicine;
- mucous membrane congestion (rebound congestion);
- increase in blood pressure (arterial hypertension), slowing of the heart rate (reflex bradycardia), headache (cephalea), difficulty urinating (urinary disorders), especially if you use this medicine at high doses or for more than 4 days, as naphazoline can pass throughout the body through inflamed mucous membranes (systemic effects).
If you accidentally ingest this medicine or take it in high doses, you may experience an increase in blood pressure (arterial hypertension), increased heart rate (tachycardia), chest tightness, severe headache (intense cephalea). Furthermore, in children, a decrease in body temperature (hypothermia) and depression of brain activity (central nervous system) with marked sedation may occur, phenomena that require the application of adequate emergency measures.

Reporting of side effects
If you get any side effects, including those 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.