NAFAZOLINA 1 mg /Ml Spray Do Nosa, Roztwór

Treść ulotki

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

NAFAZOLINA PENSA 1 mg/ml nasal spray, solution

Nafazoline nitrate

Read this leaflet carefully before using this medicine as it contains important
information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or
pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.
• See a doctor if you do not feel better or if your symptoms worsen after a few days of treatment.

Contents of this leaflet:

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

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

NAFAZOLINA PENSA nasal spray contains the active ingredient Nafazoline which belongs to a
group of medicines called decongestants and acts as a vasoconstrictor at the level of the venous vessels
of the nasal mucosa, that is, reducing the size of the blood vessels in the nose.
NAFAZOLINA PENSA nasal spray is indicated to clear the nose (nasal decongestant) when
you have:

• acute inflammation of the inner wall of the nose and throat with catarrh (acute catarrhal rhinitis and pharyngitis)
• inflammation of the inner wall of the nose due to allergy (allergic rhinitis)
• acute inflammation of the inner parts (mucous membranes) of the cavities located in the bones of the skull near the nasal cavities (acute sinusitis).

See 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 NAFAZOLINA PENSA nasal spray

Do not use NAFAZOLINA PENSA nasal spray

• if you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in section 6)
• if you have serious heart problems and your blood pressure is very high (severe arterial hypertension)
• if you have a disease due to high pressure inside the eye (glaucoma)
• if you suffer from excessive activity of a gland called the thyroid (hyperthyroidism)
• if you are taking medicines used to treat depression or have stopped using them less than two weeks ago (see “Other medicines and NAFAZOLINA PENSA nasal spray”)
• if you are a child under 12 years of age.

Warnings and precautions
Consult your doctor or pharmacist before using NAFAZOLINA PENSA nasal spray

• if you are elderly.
• if you have an enlargement of the volume of a gland called the prostate (prostatic hypertrophy) as there is a risk that your urine may be retained in the bladder (urinary retention).
• if you have heart and blood vessel (cardiovascular) diseases, especially if you have high blood pressure, the use of the medicine will be evaluated from time to time by your doctor.
• if you are pregnant or breastfeeding (see “Pregnancy and breastfeeding”).

Continued use of medicines used to clear a blocked nose can alter the normal function
of the inner wall (mucosa) of the nose and nearby bony cavities (paranasal sinuses) and can also cause
habituation to the medicine, which may no longer be effective. Long-term use can
be harmful.
Use, especially if prolonged, of medicines for local (topical) use can lead to allergic reactions
(sensitization); in this case it is necessary to stop treatment and, if necessary, consult
your doctor to adopt suitable therapy
Stop taking the medicine and consult your doctor immediately if a
sudden severe headache occurs.

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

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

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before using this medicine.
During pregnancy and breastfeeding, NAFAZOLINA PENSA nasal spray should only be used after
you have consulted your doctor and have assessed with him the risk/benefit of your case.

Driving and operating machinery
No effects on the ability to drive vehicles or operate machinery are known.

NAFAZOLINA PENSA nasal spray contains benzalkonium chloride (BAC)
This medicine contains 0.007 mg of benzalkonium chloride per dose, equivalent to 0.1 mg/ml.
Benzalkonium chloride (BAC) can cause irritation and swelling inside the nose, especially if used
for long periods.
If you suspect such a reaction (persistent nasal congestion), consult your doctor to use if possible,
a nasal medicine without BAC. If such nasal medicines without BAC are not
available, your doctor should consider another pharmaceutical form of the medicine.
It may cause bronchospasm (narrowing of the bronchi causing severe difficulty breathing).

3. How to use NAFAZOLINA PENSA nasal spray

Use this medicine following exactly as described in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

How much
The recommended dose is 1-2 sprays in each nostril, 2-3 times a day.
Strictly adhere to the recommended doses. A higher dosage of the medicine, even if taken locally and for a short period of time, can lead to serious effects involving the whole 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 prolonged for more than one week.
Consult your doctor if the disorder occurs repeatedly or if you have noticed any recent change in its characteristics.

How
Blow your nose before using the medicine.
When using the bottle for the first time after purchase, it is necessary to press the dispenser 10 times, without inserting it into the nostrils, until the first spray occurs. After that, it can be used to administer the medicine.
Hold the bottle in a vertical position, insert its end into the nostril and press with a rapid and decisive movement during a breath, after blowing your nose.
After a prolonged period of non-use of the medicine (28 days), it is necessary to press the dispenser twice before taking the dose.
It is recommended to clean the dispenser with a dry cloth after each use. Cleaning is necessary for hygienic reasons to remove any mucus residue from the applicator. Performing or not performing the cleaning operations does not affect the performance of the applicator.

Use in children and adolescents
NAFAZOLINA PENSA nasal spray is contraindicated in children under 12 years of age (see “Do not use NAFAZOLINA PENSA nasal spray”).

If you use more NAFAZOLINA PENSA nasal spray than you should
The medicine, if accidentally ingested or if used for a long period at excessive doses, can determine toxic phenomena.
Accidental ingestion of the medicine, especially in children, can cause severe drowsiness (marked sedation).
A significantly greater use than the recommended dose of NAFAZOLINA PENSA nasal spray, for example in case of accidental ingestion of NAFAZOLINA PENSA nasal spray, can cause serious adverse effects on the heart and blood circulation. Symptoms may include: slowed heart rate (bradycardia), severe headache, nausea, vomiting, breathing problems, increased heart rate (tachycardia) and chest pain.
In case of overdose, an increase in blood pressure (hypertension), light sensitivity (photophobia), chest tightness and, in children, a decrease in body temperature (hypothermia) and severe nervous depression with marked sedation may also occur, requiring the adoption of appropriate emergency measures.
If you experience any adverse effects or in case of accidental intake/ingestion of an excessive dose of NAFAZOLINA PENSA nasal spray, immediately inform your doctor or go to the nearest hospital.

If you forget to use NAFAZOLINA PENSA nasal spray
Do not use a double dose to make up for a missed dose.

If you stop the treatment with NAFAZOLINA PENSA nasal spray
If you have any doubts about the use of 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.
The medicine may cause a worsening of the sensation of nasal obstruction, irritation and
swelling of the blood vessels in the inner nasal wall (rebound sensitization and
congestion of the mucous membranes).
The rapid absorption of the medicine through the inflamed inner nasal walls (mucous membranes) can
determine effects involving the whole body (systemic):

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

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform
your doctor or pharmacist. You can also report side effects directly through 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 NAFAZOLINA PENSA nasal spray

Store in the original packaging. Do not freeze
Keep this medicine out of sight and reach of children.
Do not use the medicine if the bottle seal is broken.
Do not use this medicine after the expiry date which is stated on the pack after “Expiry”.
The expiry date refers to the last day of that month.
Do not dispose of any medicine in 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 have the information about the medicine available, therefore keep both the pack

6. Contents of the pack and other information

What NAFAZOLINA PENSA nasal spray contains
The active ingredient is naphazoline nitrate: 1 ml of nasal spray, solution contains 1 mg of naphazoline nitrate
equivalent to approximately 70 micrograms/spray.

• The other ingredients are: sodium chloride, disodium edetate, monosodium phosphate dihydrate, concentrated phosphoric acid, benzalkonium chloride, balsamic aroma, water for injections.

Description of the appearance of NAFAZOLINA PENSA nasal spray and contents of the pack
NAFAZOLINA PENSA nasal spray is presented as an aqueous solution for nasal spray.
The content of the bottle is 15 ml.

Marketing Authorisation 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)