NAFAZOLINA PENSA

Package leaflet: Information for the patient

NAFAZOLINE PENSA 1 mg/ml nasal spray, solution

Naphazoline nitrate
Please read all of 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.

• 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 effects, 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 your symptoms worsen after a few days of treatment.

Contents of this leaflet:

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

1. What NAFAZOLINA PENSA nasal spray is and what it is used for

NAFAZOLINA PENSA nasal spray contains the active substance Naphazoline, 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.
NAFAZOLINA PENSA nasal spray is indicated for relieving nasal congestion (nasal decongestant) in cases of:

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

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

2. What you need to know before using NAFAZOLINE PENSA nasal spray

Do not use NAFAZOLINE PENSA 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 very high blood pressure (severe arterial hypertension)
• if you have a condition caused by high pressure inside the eye (glaucoma)
• if you have excessive activity 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 NAFAZOLINE PENSA nasal spray")
• if it is for a child under 12 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before using NAFAZOLINE PENSA 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, use of this medicine should be evaluated by your doctor on a case-by-case basis.
• 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 lining (mucosa) of the nose and the nearby bony cavities (paranasal sinuses), and may also lead to dependence (rebound congestion). Long-term use may be harmful.
The use, especially if prolonged, of topical medicines may cause allergic reactions (sensitization). In such cases, you must stop treatment and, if necessary, consult your doctor to adopt appropriate therapy.
Stop using the medicine and consult your doctor immediately if you suddenly develop severe headache.

Children and adolescents
NAFAZOLINE PENSA nasal spray is contraindicated in children under 12 years of age.

Other medicines and NAFAZOLINE PENSA nasal spray
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
NAFAZOLINE PENSA nasal spray may interact with medicines used to treat depression (see "Do not use NAFAZOLINE PENSA nasal spray").

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
During pregnancy and breastfeeding, NAFAZOLINE PENSA nasal spray should only be used after consulting your doctor and carefully evaluating the risk/benefit ratio in your individual case.

Driving and using machines
No effects on the ability to drive or operate machinery are known.

NAFAZOLINE PENSA nasal spray contains benzalkonium chloride (BAC)
This medicine contains 0.007 mg of benzalkonium chloride per spray dose, 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 formulation.
It may cause bronchospasm (narrowing of the airways causing severe breathing difficulty).

3. How to use NAFAZOLINE PENSA nasal spray

Use this medicinal product exactly as stated in this leaflet or according to your doctor’s or pharmacist’s instructions. If you have any doubts, consult your doctor or pharmacist.
Dosage
The recommended dose is 1-2 sprays in each nostril, 2-3 times daily.
Strictly adhere to the recommended dosage. Exceeding the recommended dose, even when applied locally and for a short period of time, may lead to serious effects involving 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, treatment should not be continued for longer than one week.
Consult your doctor if symptoms recur repeatedly or if you have noticed any recent changes in their 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 released. After this, the device is ready for administration of the medicine.
Hold the bottle in an upright position, insert its tip into the nostril and press rapidly and firmly while inhaling, after having blown your nose.
After a prolonged period of non-use (28 days), press the pump twice before taking the dose.
It is recommended to clean the spray nozzle with a dry cloth after each use. Cleaning is necessary for hygienic reasons, to remove any mucus residues from the dispenser. Performing or not performing cleaning procedures does not affect the performance of the dispenser.
Use in children and adolescents
NAFAZOLINE PENSA nasal spray is contraindicated in children under 12 years of age (see “Do not use NAFAZOLINE PENSA nasal spray”).
If you use more NAFAZOLINE PENSA nasal spray than you should
This medicine, if accidentally swallowed or used for a prolonged period at excessive doses, may cause toxic effects.
Accidental ingestion of the medicine, especially in children, may cause pronounced drowsiness (marked sedation).
Significantly exceeding the recommended dose of NAFAZOLINE PENSA nasal spray, for example by accidental ingestion, may cause serious adverse effects on the heart and blood circulation. 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), light sensitivity (photophobia), chest tightness, and in children, decreased body temperature (hypothermia) and severe nervous system depression with marked sedation may also occur, requiring immediate emergency measures.
If adverse effects occur or if an excessive dose of NAFAZOLINE PENSA nasal spray has been taken or accidentally ingested, contact your doctor immediately or go to the nearest hospital.
If you forget to use NAFAZOLINE PENSA nasal spray
Do not use a double dose to make up for the forgotten dose.
If you stop using NAFAZOLINE PENSA 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 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 (mucosa) 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, please inform 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 NAFAZOLINE PENSA nasal spray

Store 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 medicines 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 package leaflet.

6. Package contents and other information

What NAFAZOLINA PENSA 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.

• The 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 NAFAZOLINA PENSA nasal spray and contents of the pack
NAFAZOLINA PENSA nasal spray is a clear aqueous solution for nasal spray.
The bottle contains 15 ml of solution.
Marketing Authorization Holder
Genetic S.p.A. Via G. Della Monica, 26 - 84083 Castel San Giorgio (SA)
Manufacturer
Genetic S.p.A. Contrada Canfora – 84084 Fisciano (SA)