Rinazina antiallergic

PACKAGE LEAFLET: Information for the patient

RINAZINA ANTIALLERGICA 1 mg/ml nasal spray, solution

Azelastine hydrochloride
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 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 short period of treatment.

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

1. What RINAZINA ANTIALLERGICA is and what it is used for
RINAZINA ANTIALLERGICA contains the active substance azelastine hydrochloride, which belongs to a group of medicines called antihistamines.
RINAZINA ANTIALLERGICA is used for the short-term treatment of symptoms of allergic rhinitis in adults, adolescents, and children over six years of age.
Contact your doctor if you do not feel better or if you feel worse after a short period of treatment.

2. What you need to know before using RINAZINA ANTIALLERGICA

DO NOT use RINAZINA ANTIALLERGICA

• if you are allergic to azelastine hydrochloride or to any of the other ingredients of this medicine (listed in section 6)
• in children under 6 years of age
• during pregnancy and while breastfeeding (see "Pregnancy and breastfeeding").

Warnings and precautions
If during treatment you notice persistence or worsening of symptoms, consult your doctor.
Children
RINAZINA ANTIALLERGICA must not be administered to children under 6 years of age.
Other medicines and RINAZINA ANTIALLERGICA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
No interactions have been observed with other commonly used medicines taken concomitantly.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using any medicine.
Do NOT use RINAZINA ANTIALLERGICA during pregnancy and/or breastfeeding. Its use should also be avoided if you suspect you are pregnant or are planning a pregnancy.
Driving and using machines
When using this medicine, no particular negative effects on alertness are expected.
RINAZINA ANTIALLERGICA contains benzalkonium chloride
This medicine contains 0.0175 mg of benzalkonium chloride per single spray, equivalent to 0.125 mg/ml. Benzalkonium chloride (BAC), included as a preservative in RINAZINA ANTIALLERGICA, may cause nasal irritation and swelling, especially if used for prolonged periods. If such a reaction is suspected (persistent nasal congestion), a nasal medicine without BAC should be used, if possible. If nasal medicines without BAC are not available, another pharmaceutical form should be considered. It may cause bronchospasm. Bronchospasm is a narrowing of the bronchi due to contraction of the bronchial smooth muscles. This narrowing causes breathing difficulties due to reduced airflow. Wheezing and whistling sounds may occur, and sometimes also persistent dry cough.

3. How to use RINAZINA ANTIALLERGICA

Use RINAZINA ANTIALLERGICA exactly as stated in this
package leaflet or according to your doctor’s or pharmacist’s instructions.
If in doubt, consult your doctor or pharmacist.
Adults and children aged 6 years and older
The recommended dose is: one spray (0.14 mg) in each nostril once or twice daily, corresponding to
0.28 – 0.56 mg of azelastine hydrochloride per day.
The 5 ml bottle provides a total of 36 sprays.
The 10 ml bottle provides a total of 72 sprays.
During administration, keep your head upright (follow the instructions shown in the figures below):

1. Remove the protective cap 2. Only when using for the first time, press firmly several times until the spray appears 3. Spray once into each nostril, keeping your head upright
2. Replace the protective cap

Warning:

• do not exceed the recommended doses without medical advice;
• use this medicine only for short-term treatment;
• consult your doctor if symptoms recur frequently or if you notice any recent changes in their characteristics.

If you use more RINAZINA ANTIALLERGICA than you should
No cases of intoxication due to overdose have been reported so far. According to experimental studies, toxic doses may cause central nervous system-related symptoms (malaise, excitation, seizures, sedation); in such cases symptomatic treatment should be administered. There is no known specific antidote for azelastine.
In case of accidental ingestion/overdose of RINAZINA ANTIALLERGICA, contact your doctor immediately or go to the nearest hospital.
If you forget to use RINAZINA ANTIALLERGICA
Do not use a double dose to make up for a forgotten dose; continue treatment as indicated in this leaflet.
If you have any doubts about how to use RINAZINA ANTIALLERGICA, consult your doctor or
pharmacist.

4. Possible side effects

Like all medicines, RINAZINA ANTIALLERGICA may cause side effects, although
not everyone experiences them.
A bitter taste sensation, typical of the drug itself, has been reported, which may occur
especially if the head is in an incorrect position, tilted backward, during
administration.
In rare cases, nasal mucosa irritation with possible slight bleeding has been observed. These
side effects are generally transient. However, if they occur, it is advisable to consult your doctor or pharmacist.
Following the instructions provided in this leaflet reduces the risk of side effects.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor or pharmacist. You can also report side effects directly through the national reporting system at the website
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. Error! Hyperlink
reference not valid.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store RINAZINA ANTIALLERGICA

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and on the bottle. The expiry
date refers to the last day of that month.
The expiry date applies to the product in its original packaging, correctly stored.
Do not use the medicine more than 6 months after first opening the bottle.
Do not store the medicine at temperatures above 25°C.
Keep the bottle in an upright position. Do not turn it upside down.
Do not use this medicine if you notice that the bottle seal is broken or damaged.
It is important to always keep the medicine information available; therefore, keep both the
carton and this leaflet.
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.

6. Package contents and other information

What RINAZINA ANTIALLERGICA contains
5 ml bottle of solution.
The active substance is: azelastine hydrochloride 5 mg.
Each ml of solution contains 1 mg of azelastine hydrochloride.
The other components are: hypromellose, disodium edetate, benzalkonium chloride solution,
anhydrous citric acid, disodium phosphate dodecahydrate, sodium chloride, purified water.
10 ml bottle of solution.
The active substance is: azelastine hydrochloride 10 mg.
Each ml of solution contains 1 mg of azelastine hydrochloride.
The other components are: hypromellose, disodium edetate, benzalkonium chloride solution,
anhydrous citric acid, disodium phosphate dodecahydrate, sodium chloride, purified water.

Description of the appearance of RINAZINA ANTIALLERGICA and package contents
RINAZINA ANTIALLERGICA nasal spray is presented as a solution.
The package contains either a 5 ml solution bottle with spray pump or a 10 ml solution bottle with spray pump.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder
Haleon Italy S.r.l. - Via Monte Rosa 91 - 20149 Milano.

Manufacturer
Zeta Farmaceutici S.p.A. - Via Galvani, 10 - Sandrigo (VI).