Package leaflet: Information for the patient

RINAZINA 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.

Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.
Keep this leaflet. You may need to read it again.
If you need more information or advice, contact your pharmacist.
If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice any improvement or if your symptoms worsen after a few days. The treatment should not last longer than one week.

Contents of this leaflet

What RINAZINA is and what it is used for
What you need to know before using RINAZINA
How to use RINAZINA
Possible side effects
How to store RINAZINA
Contents of the pack and other information

1. What RINAZINA is and what it is used for

RINAZINA contains the active substance naphazoline nitrate, which belongs to a group of medicines called NASAL DECONGESTANTS, topical-acting sympathomimetics with vasoconstrictor action, meaning they reduce the dilation of blood vessels in the nasal mucosa.
RINAZINA is indicated for relieving nasal congestion (nasal decongestant) in cases of:

cold (rhinitis) and throat inflammation with mucus (acute catarrhal pharyngitis),
allergic cold (allergic rhinitis),
inflammation of the mucous membrane of the sinuses (acute sinusitis). RINAZINA is for use in adults and children aged 12 years and above.

Consult your doctor if you do not feel better or if you feel worse after a few days. The treatment should not last longer than one week.

2. What you need to know before using RINAZINA

DO NOT use RINAZINA

If you are allergic (hypersensitive) to naphazoline or to any of the other ingredients of this medicine (listed in section 6).
If you suffer from heart diseases and very high blood pressure (severe hypertension), optic nerve disease with increased eye pressure (glaucoma), or increased production of thyroid hormones (hyperthyroidism).
If you are taking or will take within two weeks after stopping treatment with RINAZINA, medicines for the treatment of depression.

This medicine must not be taken by children under 12 years of age.
Warnings and precautions
Ask your doctor or pharmacist for advice before using RINAZINA:

If you are elderly.
If you have an enlarged prostate (prostatic hypertrophy), as this may cause difficulty in urinating (urinary retention).
If you have heart and blood vessel diseases (cardiovascular diseases) and especially if you suffer from high blood pressure (hypertension), the use of RINAZINA should occur only after consulting your doctor.
Prolonged use of medicines such as RINAZINA, which reduce the dilation of blood vessels (vasoconstrictors), may alter the normal function of the mucosa of both the nose and the facial bone cavities around the nose (paranasal sinuses) and may also lead to dependence (rebound congestion). Long-term use may be harmful.
The use, especially if prolonged, of locally acting medicines such as RINAZINA may cause allergic reactions (sensitization phenomena). In this case, stop treatment and consult your doctor.
Rare cases of a syndrome with symptoms such as headache, nausea, vomiting, and visual disturbances (reversible posterior encephalopathy/reversible cerebral vasoconstriction syndrome) have been reported with use of medicines like RINAZINA that stimulate the sympathetic nervous system (sympathomimetics), which improved and resolved after medical treatment.
Stop using RINAZINA and consult your doctor immediately if you develop symptoms and signs of reversible posterior encephalopathy/reversible cerebral vasoconstriction syndrome.

Children and adolescents
RINAZINA is contraindicated in children under 12 years of age.
Other medicines and RINAZINA
Inform your doctor or pharmacist if you are using, have recently used, or might use any other
medicine.
RINAZINA may interact with medicines used to treat depression (see section "Do not use RINAZINA").
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, ask your
doctor or pharmacist for advice before using this medicine.
During pregnancy and breastfeeding, RINAZINA should only be used after consulting your doctor,
who will evaluate the possible risks and benefits for both mother and child.
Driving and using machines
No undesirable effects on the ability to drive or use machines are known.
RINAZINA contains benzalkonium chloride
This medicine contains 0.1 mg/ml of benzalkonium chloride. Benzalkonium chloride (BAC) may
cause irritation and swelling inside the nose, especially if used for long periods. It may cause
bronchospasm (narrowing of the bronchi causing severe breathing difficulty).
For those engaged in sports activities
Caution for those engaged in sports activities: the product contains substances prohibited for doping.
Any use differing from the recommended dosage regimen or route of administration is prohibited.
3 How to use RINAZINA
Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 1-2 sprays in each nostril, 2-3 times daily.
Do not exceed the recommended dose, even if only for a short period and applied locally, as serious
systemic side effects may occur.
Children up to 12 years
This medicine must not be used in children under 12 years of age (see section "Do not use RINAZINA").

At first use, hold the

bottle in an upright position and
press the spray pump several times
without inserting it into the nostrils
until a spray appears.
2) After blowing your nose, keep the
bottle upright and insert the tip into
one nostril. While inhaling, press
the spray pump firmly and quickly.
For subsequent applications, follow instructions from step 2).
If RINAZINA does not work within a few days of starting treatment, consult your doctor.
In any case, do not use RINAZINA for more than one week.
If you use more RINAZINA than you should
If RINAZINA is ingested or used at higher than recommended doses for prolonged periods, systemic
toxic effects may occur. Keep the medicine out of the reach of children, as accidental ingestion may
cause excessive drowsiness (sedation).
A significantly higher than recommended dose of RINAZINA, 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 problems, increased
heart rate (tachycardia), and chest pain.
If an excessive dose of RINAZINA is taken, increased blood pressure (arterial hypertension), light
sensitivity of the eyes (photophobia), and in children, lowered body temperature (hypothermia) and
severe depression of the Central Nervous System causing excessive drowsiness (sedation) may occur,
requiring urgent medical treatment.
If you experience any adverse effects or in case of accidental ingestion/overdose of RINAZINA, seek
immediate medical attention.
If you forget to use RINAZINA
Do not use a double dose to make up for a forgotten dose.
If you stop using RINAZINA
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.
RINAZINA may locally cause swelling of the nasal mucosa due to intense vasodilation of nasal blood
vessels (rebound congestion, sensitization phenomena), worsening the sensation of nasal blockage
instead of improving it.
Rapid absorption of naphazoline through inflamed mucous membranes may cause systemic effects
such as increased blood pressure (hypertension), reduced heart rate (reflex bradycardia), severe
headache (cephalalgia), and difficulty urinating (urinary disorders).
Reporting of side effects
If you experience any side effect, 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/segnalazioni-
reazioni-avverse. Reporting side effects can help provide more information on the safety of this
medicine.
5 How to store RINAZINA
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the bottle and on the carton after
"Exp". The expiry date refers to the last day of that month.
The expiry date refers to the product in its original packaging, correctly stored.
Do not use this medicine if the bottle seal is broken.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose
of medicines no longer used. This will help protect the environment.
6 Contents of the pack and other information
What RINAZINA contains

The active substance is naphazoline nitrate. Each ml of solution contains 1 mg of naphazoline nitrate, equivalent to 0.77 mg of naphazoline.
The other ingredients are: sodium chloride, disodium edetate, monobasic sodium phosphate dihydrate, concentrated phosphoric acid, benzalkonium chloride, balsamic flavour, purified water.

Description of the appearance of RINAZINA and contents of the pack
RINAZINA is a clear, colourless solution.
Each pack contains one 15 ml dark glass bottle equipped with a spray dispenser and protective cap.
Marketing Authorization Holder
Haleon Italy S.r.l. - Via Monte Rosa 91 - 20149 Milan, Italy
Manufacturer
Haleon Germany GmbH - Barthstraße 4 - 80339 Munich, Germany

Patient information leaflet

RINAZINA 1 MG/ML NASAL DROPS, SOLUTION

naphazoline
Please read this leaflet carefully before using this medicine because it contains important information for you.

Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.
Keep this leaflet. You may need to read it again.
If you need more information or advice, consult your pharmacist.
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
Consult your doctor if you do not notice any improvement or if your symptoms worsen after a few days. Treatment should not last longer than one week.

Contents of this leaflet

What RINAZINA is and what it is used for
What you need to know before using RINAZINA
How to use RINAZINA
Possible side effects
How to store RINAZINA
Contents of the pack and other information

1. What RINAZINA is and what it is used for

RINAZINA contains the active substance naphazoline nitrate, which belongs to a group of medicines called NASAL DECONGESTANTS, topical-acting sympathomimetics with vasoconstrictor activity, meaning they reduce the dilation of blood vessels in the nasal mucosa.
RINAZINA is indicated to relieve nasal congestion (nasal decongestant) in the following conditions:

cold (rhinitis) and throat inflammation with catarrh (acute catarrhal pharyngitis),
allergic cold (allergic rhinitis),
inflammation of the mucous membranes of the sinuses (acute sinusitis).

RINAZINA is for use in adults and children aged 12 years and older.

Consult your doctor if you do not feel better or if you feel worse after a few days.
Treatment should not last longer than one week.

2. What you need to know before using RINAZINA

DO NOT use RINAZINA

If you are allergic (hypersensitive) to naphazoline or to any of the other ingredients of this medicine (listed in section 6).
If you suffer from heart diseases and very high blood pressure (severe hypertension), optic nerve disease with increased eye pressure (glaucoma), or overproduction of thyroid hormones (hyperthyroidism).
If you are taking or will take within two weeks after stopping treatment with RINAZINA, medicines for the treatment of depression. This medicine must not be used in children under 12 years of age.

Warnings and precautions
Ask your doctor or pharmacist for advice before using RINAZINA:

If you are elderly.
If you have an enlarged prostate (prostatic hypertrophy), as you may experience difficulty in urinating (urinary retention).
If you have heart and blood vessel diseases (cardiovascular diseases), and especially if you suffer from high blood pressure (hypertension), the use of RINAZINA should only occur after consulting your doctor.
Prolonged use of medicines such as RINAZINA, which reduce the dilation of blood vessels (vasoconstrictors), may alter the normal function of the mucous membranes of both the nose and the facial bone cavities around the nose (paranasal sinuses), and may also lead to drug dependence (rebound congestion). Long-term use may be harmful.
The use, especially if prolonged, of locally acting medicines such as RINAZINA may cause allergic reactions (sensitization phenomena). In this case, discontinue treatment and consult your doctor.
Rare cases of a syndrome characterized by symptoms such as headache, nausea, vomiting, and visual disturbances (reversible posterior encephalopathy/reversible cerebral vasoconstriction syndrome) have been reported with the use of medicines like RINAZINA that stimulate the sympathetic nervous system (sympathomimetics). These symptoms improved and resolved with medical treatment.
Discontinue use of RINAZINA and consult your doctor immediately if you experience symptoms or signs of reversible posterior encephalopathy/reversible cerebral vasoconstriction syndrome.

Children and adolescents
RINAZINA is contraindicated in children under 12 years of age.
Other medicines and RINAZINA
Inform your doctor or pharmacist if you are using, have recently used, or might use any other
medicines.
RINAZINA may interact with medicines used to treat depression (see section “Do not use RINAZINA”).
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding,
consult your doctor or pharmacist before using this medicine.
During pregnancy and breastfeeding, RINAZINA should only be used after consulting your doctor, who will evaluate the potential risks and benefits for both mother and child.
Driving and using machines
No undesirable effects on the ability to drive or use machinery are known.
RINAZINA contains benzalkonium chloride
This medicine contains 0.1 mg/ml of benzalkonium chloride. Benzalkonium chloride (BAC) may
cause irritation and swelling inside the nose, especially if used for long periods. It may cause
bronchospasm (narrowing of the bronchi causing severe breathing difficulties).
The container of this medicine contains latex rubber. It may cause severe allergic reactions.
For those engaged in sports activities
Caution for those involved in sports: the product contains substances prohibited in doping.
Any use differing from the recommended dosage regimen or route of administration is prohibited.
3 How to use RINAZINA
Use this medicine exactly as described in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
The recommended dose is 2–3 drops in each nostril, 2–3 times daily.
Do not exceed the recommended dose, even if only for a short period and locally, as serious systemic adverse effects may occur.
Children up to 12 years of age
This medicine must not be used in children under 12 years of age (see section “Do not use RINAZINA”).
Warning: the bottle is equipped with a child-resistant safety closure to make opening difficult for children. Follow the illustrated instructions carefully.

Place the bottle on a flat surface. To

Two hands holding a medical bottle, one pressing downward and the

open the bottle, press down and
simultaneously unscrew the cap.

To close the bottle, screw the cap back on normally.
For subsequent uses, follow the instructions from step 1.

If RINAZINA does not work within a few days of starting treatment, consult your doctor.
In any case, do not use RINAZINA for longer than one week.
If you use more RINAZINA than you should
If RINAZINA is ingested or used in doses higher than recommended for prolonged periods, systemic toxic effects may occur. Keep the medicine out of the reach of children, as accidental ingestion may cause excessive drowsiness (sedation).
Significantly exceeding the recommended dose of RINAZINA, for example in case of accidental ingestion, may cause serious adverse effects on the heart and circulation. Symptoms may include: reduced heart rate (bradycardia), severe headache, nausea, vomiting, breathing difficulties, increased heart rate (tachycardia), and chest pain.
Overdosing on RINAZINA may lead to increased blood pressure (arterial hypertension), light sensitivity of the eyes (photophobia), and in children, decreased body temperature (hypothermia) and severe depression of the Central Nervous System causing excessive drowsiness (sedation), requiring urgent medical treatment.
If you experience any adverse effects or in case of accidental ingestion or overdose of RINAZINA, seek immediate medical attention.
If you forget to use RINAZINA
Do not use a double dose to make up for a forgotten dose.
If you stop using RINAZINA
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.
RINAZINA may locally cause swelling of the nasal mucosa due to intense vasodilation of nasal blood vessels (rebound congestion or sensitization phenomena), worsening the sensation of nasal blockage rather than improving it.
Rapid absorption of naphazoline through inflamed mucous membranes may cause systemic effects such as increased blood pressure (hypertension), reduced heart rate (reflex bradycardia), severe headache (cephalalgia), and difficulty urinating (urinary disorders).
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact 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. Reporting side effects can help provide more information on the safety of this medicine.
5 How to store RINAZINA
Keep this medicine out of the sight and reach of children.
Store below 25°C.
Store in an upright position.
Do not use this medicine after the expiry date stated on the bottle and packaging after "Exp". The expiry date refers to the last day of that month.
The expiry date applies to the product if unopened and properly stored.
Do not use this medicine if the closure seal on the cap is not intact.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
6 Contents of the pack and other information
What RINAZINA contains

The active substance is naphazoline nitrate. Each ml of solution contains 1 mg of naphazoline nitrate, equivalent to 0.77 mg of naphazoline.
The other ingredients are: sodium chloride, disodium edetate, monosodium phosphate dihydrate, concentrated phosphoric acid, benzalkonium chloride, purified water.

Description of the appearance of RINAZINA and contents of the pack
RINAZINA is a clear, colourless solution.
Each pack contains one 10 ml dark glass bottle with dropper cap and child-resistant safety closure.
Marketing Authorization Holder
Haleon Italy S.r.l. - Via Monte Rosa 91 - 20149 Milano
Manufacturer
FARMACLAIR - 440, Avenue du Général de Gaulle - Hérouville Saint Clair (F).