NAZAR

Package leaflet: Information for the patient

NAZAR 1 mg/ml nasal spray, solution

Naphazoline nitrate
Read this leaflet carefully before using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you to do.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice improvement or if you experience worsening of symptoms after a few days of treatment.

Contents of this leaflet:

1. What NAZAR nasal spray is and what it is used for
2. What you need to know before using NAZAR nasal spray
3. How to use NAZAR nasal spray
4. Possible side effects
5. How to store NAZAR nasal spray
6. Contents of the pack and other information

1. What NAZAR nasal spray is and what it is used for

NAZAR nasal spray contains the active substance Nafazoline, which belongs to a group of medicines called decongestants. It acts as a vasoconstrictor on the venous vessels of the nasal mucosa, thereby reducing the size of the blood vessels in the nose.
NAZAR nasal spray is indicated to relieve nasal congestion (nasal decongestant) in cases of:

• acute inflammation of the inner lining of the nose and throat with mucus (acute catarrhal rhinitis and pharyngitis)
• inflammation of the nasal lining due to allergy (allergic rhinitis)
• acute inflammation of the internal mucous membranes of the cavities located within the skull bones near the nasal passages (acute sinusitis).

Consult your doctor if you do not feel better or feel worse after a few days of treatment.

2. What you need to know before using NAZAR nasal spray

Do not use NAZAR nasal spray

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6)
• if you have severe heart disease and your blood pressure is very high (severe arterial hypertension)
• if you have a condition caused by increased pressure inside the eye (glaucoma)
• if you have overactivity of a gland called the thyroid (hyperthyroidism)
• if you are taking medicines used to treat depression or have stopped taking them less than two weeks ago (see "Other medicines and NAZAR nasal spray")
• if it is for a child under 12 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before using NAZAR nasal spray

• if you are elderly.
• if you have an enlarged gland called the prostate (prostatic hypertrophy), as this may lead to difficulty in passing urine (urinary retention).
• if you have heart or blood vessel diseases (cardiovascular diseases), especially if you have high blood pressure; in such cases, the use of this medicine should be periodically evaluated by your doctor.
• if you are pregnant or breastfeeding (see "Pregnancy and breastfeeding").

Prolonged use of medicines used to relieve nasal congestion may alter the normal function of the inner nasal lining (mucosa) and the adjacent bony cavities (paranasal sinuses), and may also lead to dependence (rebound congestion). Long-term use may be harmful.
Prolonged, especially prolonged, use of topical medicines may cause allergic reactions (sensitization); in such cases, you must stop treatment and, if necessary, consult your doctor to start appropriate therapy.
Stop using the medicine and consult your doctor immediately if you experience a sudden, severe headache.
Caution for those engaged in sports activities: The product contains substances prohibited in doping. Any use differing from the recommended dosage regimen or route of administration is prohibited.
Children and adolescents
NAZAR nasal spray is contraindicated in children under 12 years of age.
Other medicines and NAZAR nasal spray
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
NAZAR nasal spray may interact with medicines used to treat depression (see "Do not use NAZAR nasal spray").
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
During pregnancy and breastfeeding, NAZAR nasal spray should only be used after consulting your doctor and evaluating the risk/benefit ratio in your individual case.
Driving and operating machinery
No effects on the ability to drive or operate machinery are known.
NAZAR nasal spray contains benzalkonium chloride (BAC)
This medicine contains 0.007 mg of benzalkonium chloride per spray, equivalent to 0.1 mg/ml.
Benzalkonium chloride (BAC) may cause irritation and swelling inside the nose, especially if used for prolonged periods.
If you suspect such a reaction (persistent nasal congestion), consult your doctor to switch, if possible, to a nasal medicine without BAC. If nasal medicines without BAC are not available, your doctor should consider an alternative pharmaceutical form of the medicine.
It may cause bronchospasm (narrowing of the airways causing severe breathing difficulty).

3. How to use NAZAR nasal spray

Use this medicine exactly as stated in this leaflet or as directed by your
doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Dosage
The recommended dose is 1-2 sprays in each nostril, 2-3 times a day.
Strictly adhere to the recommended doses. Higher doses of the medicine, even if administered
locally and for a short period, may cause serious effects affecting the entire
body (systemic effects).
When and for how long
If there is no complete therapeutic response within a few days, consult your doctor; in any case, the
treatment should not last longer than one week.
Consult your doctor if the condition recurs repeatedly or if you have noticed any recent changes
in its characteristics.
How to use
Blow your nose before using the medicine.
When using the bottle for the first time after purchase, press the pump 10 times,
without inserting it into the nostrils, until the first spray is produced. After this, it can be
used for administering the medicine.
Hold the bottle in an upright position, insert its tip into the nostril and press quickly and firmly during
a breath, after having blown your nose.
After a prolonged period of non-use of the medicine (28 days), it is necessary to prime the
pump twice before taking the dose.
It is recommended to clean the pump with a dry cloth after each use. Cleaning is necessary for
hygienic reasons, to remove any mucus residues from the nozzle. Performing or not performing
cleaning operations does not affect the performance of the spray device.
Use in children and adolescents
NAZAR nasal spray is contraindicated in children under 12 years of age (see "Do not use NAZAR
nasal spray").
If you use more NAZAR nasal spray than you should
The medicine, if accidentally swallowed or used for a long period at excessive doses, may
cause toxic effects.
Accidental ingestion of the medicine, especially in children, may cause pronounced drowsiness
(markedly increased sedation).
A significantly higher dose than recommended of NAZAR nasal spray, for example in case
of accidental ingestion, may cause serious adverse effects on the
heart and the circulatory system. Symptoms may include: reduced heart rate
(bradycardia), severe headache, nausea, vomiting, breathing difficulties, increased heart rate
(tachycardia) and chest pain.
In case of overdose, increased blood pressure (arterial hypertension), sensitivity to light (photophobia), chest tightness, and in children, lowered body temperature (hypothermia) and severe nervous depression with marked sedation may also occur, requiring immediate emergency measures.
If adverse effects occur or in case of accidental ingestion/overdose of NAZAR nasal spray,
contact a doctor immediately or go to the nearest hospital.
If you forget to use NAZAR nasal spray
Do not use a double dose to make up for a forgotten dose.
If you stop treatment with NAZAR nasal spray
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

This medicine may worsen the sensation of nasal blockage and cause irritation and swelling of the blood vessels in the inner nasal wall (rebound phenomena of sensitization and mucosal congestion).

Rapid absorption of the medicine through the inflamed inner nasal walls (mucous membranes) may lead to effects involving the entire body (systemic effects):

• increase in blood pressure (arterial hypertension)
• slowing of heart rate (reflex bradycardia)
• headache
• urinary disturbances.

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

5. How to store NAZAR nasal spray

Keep in the original packaging. Do not freeze.
Keep this medicine out of the sight and reach of children.
Do not accept the medicine if the bottle seal is broken.
Do not use this medicine after the expiry date stated on the carton after "Expiry".
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.
It is important to always keep the medicine information available; therefore, retain both the carton and the leaflet.

6. Package contents and other information

What NAZAR nasal spray contains
The active substance is naphazoline nitrate: 1 ml of nasal spray solution contains 1 mg of naphazoline nitrate,
equivalent to approximately 70 micrograms per spray actuation.

• Other components are: sodium chloride, disodium edetate, sodium dihydrogen phosphate dihydrate, concentrated phosphoric acid, benzalkonium chloride, balsamic flavour, water for injections.

Description of the appearance of NAZAR nasal spray and contents of the pack
NAZAR nasal spray is an aqueous solution for nasal spray.
The bottle contains 15 ml.
Marketing Authorization Holder
Pietrasanta Pharma S.p.A. Via di Caprino, 7 – 55012 Capannori (LU)
Manufacturer
Genetic S.p.A. Contrada Canfora – 84084 Fisciano (SA)