Tantum Verde nasal decongestant

Package leaflet: Information for the patient

TANTUM VERDE NASO CHIUSO 1 mg/ml nasal spray, solution

Naphazoline
Please read all of this leaflet carefully before you start 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 told 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 effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice any improvement or if your symptoms worsen after a few days of treatment.

Contents of this leaflet:

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

1. What TANTUM VERDE NASO CHIUSO nasal spray is and what it is used for

TANTUM VERDE NASO CHIUSO 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, that is, by reducing the size of the blood vessels in the nose.
TANTUM VERDE NASO CHIUSO nasal spray is indicated to relieve nasal congestion (nasal decongestant) in cases of:

• acute inflammations of the inner lining of the nose and throat with catarrh (acute catarrhal rhinitis and pharyngitis);
• allergic inflammations of the inner lining of the nose (allergic rhinitis);
• acute inflammations of the internal tissues (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 if you feel worse after a few days of treatment.

2. What you need to know before using TANTUM VERDE NASO CHIUSO nasal spray Do not use

TANTUM VERDE NASO CHIUSO 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 suffer from severe heart disease and have very high blood pressure (severe arterial hypertension);
• if you have a condition caused by increased 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 TANTUM VERDE NASO CHIUSO nasal spray”);
• if it is for a child under 12 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before using TANTUM VERDE NASO CHIUSO nasal spray

• if you are elderly;
• if you have an enlarged prostate gland (prostatic hypertrophy), as there may be a risk of urine retention in the bladder (urinary retention);
• if you have heart and blood vessel diseases (cardiovascular), especially if you have high blood pressure; in such cases, use of the 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 intended to relieve nasal congestion may alter the normal function of the inner lining (mucosa) of the nose and the adjacent 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 (for local use) may cause allergic reactions (sensitization); if this occurs, you must stop treatment and, if necessary, consult your doctor to establish appropriate therapy.
Stop using the medicine and consult your doctor immediately if you suddenly develop severe headache.

Children and adolescents
TANTUM VERDE NASO CHIUSO nasal spray is contraindicated in children under 12 years of age.

Other medicines and TANTUM VERDE NASO CHIUSO nasal spray
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
TANTUM VERDE NASO CHIUSO nasal spray may interact with medicines used to treat depression (see “Do not use TANTUM VERDE NASO CHIUSO 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, TANTUM VERDE NASO CHIUSO 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.

TANTUM VERDE NASO CHIUSO nasal spray contains benzalkonium chloride (BAC)
This medicine contains 0.007 mg of benzalkonium chloride per spray dose, equivalent to 0.1 mg/ml.
The benzalkonium chloride (BAC) contained as a preservative in TANTUM VERDE NASO CHIUSO nasal spray 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 consider using, if possible, a nasal medicine without BAC. If nasal medicines without BAC are not available, your doctor should consider an alternative pharmaceutical form of the medicine.
BAC may cause narrowing of the bronchi (bronchospasm).

3. How to use TANTUM VERDE NASO CHIUSO nasal spray

Use this medicinal product exactly as described in this leaflet or as directed by your doctor or pharmacist. If you are in doubt, consult your doctor or pharmacist.

Dosage
The recommended dose is 1-2 sprays into each nostril, 2-3 times daily.
Strictly adhere to the recommended dosage. Higher doses of the medicinal product, even if administered locally and for a short period, may cause serious effects affecting the entire organism (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 symptoms recur repeatedly or if you have noticed any recent changes in their characteristics.

How to use
Blow your nose before using the medicinal product.
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 appears. After this, the device is ready for administration of the medicinal product.
Hold the bottle in an upright position, insert the tip into the nostril and press firmly and quickly 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 nozzle. Performing or not performing cleaning procedures does not affect the performance of the spray device.

Use in children and adolescents
TANTUM VERDE NASO CHIUSO nasal spray is contraindicated in children under 12 years of age (see "Do not use TANTUM VERDE NASO CHIUSO nasal spray").

If you use more TANTUM VERDE NASO CHIUSO nasal spray than you should
Significantly exceeding the recommended dose of TANTUM VERDE NASO CHIUSO nasal spray, for example in case of 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.
Accidental ingestion of the medicinal product, especially in children, may cause marked drowsiness (pronounced sedation).
In case of overdose, symptoms such as increased blood pressure (arterial hypertension), discomfort to light (photophobia), chest tightness, and in children, decreased body temperature (hypothermia) and severe nervous depression with pronounced sedation may occur, requiring immediate emergency measures.
If adverse effects occur or in case of accidental ingestion or overdose of TANTUM VERDE NASO CHIUSO nasal spray, seek immediate medical advice.
The doctor will determine the most appropriate treatment depending on the severity of the symptoms.

If you forget to use TANTUM VERDE NASO CHIUSO nasal spray
Do not use a double dose to make up for the forgotten dose.

If you stop using TANTUM VERDE NASO CHIUSO nasal spray
If you have any doubts about using this medicinal product, 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 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 affecting the whole body (systemic effects):

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

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 TANTUM VERDE NASO CHIUSO nasal spray

Keep the medicine in its 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 or not intact.
Do not use this medicine after the expiry date stated on the carton after "Exp.".
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 no longer in 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 TANTUM VERDE NASO CHIUSO 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.

• 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 TANTUM VERDE NASO CHIUSO nasal spray and contents of the pack
TANTUM VERDE NASO CHIUSO nasal spray is an aqueous solution for nasal spray.
The bottle contains 15 ml.
Marketing Authorization Holder
Angelini Pharma S.p.A., Viale Amelia 70, 00181 Rome, Italy
Manufacturer
Genetic S.p.A., Contrada Canfora – 84084 Fisciano (SA)