Rinelon

PACKAGE LEAFLET

Package leaflet: information for the user

RINELON 50 micrograms/dose, nasal spray, suspension

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What RINELON is and what it is used for

What is RINELON?
RINELON nasal spray contains mometasone furoate, which belongs to a group of medicines called corticosteroids. When mometasone furoate is sprayed into the nose, it can help reduce inflammation (swelling and irritation in the nose), sneezing, itching, and symptoms of a blocked or runny nose.

What is RINELON used for?

Hay fever and perennial rhinitis
RINELON is used to treat symptoms of hay fever (also known as seasonal allergic rhinitis) and perennial rhinitis in adults and children aged 3 years and older.
Hay fever that occurs at certain times of the year is an allergic reaction caused by inhaling pollen from trees, grass, weeds, as well as moulds and fungal spores.
Perennial rhinitis is present throughout the year, and symptoms may be triggered by sensitivity to a variety of substances, including house dust mites, animal fur (or dander), feathers, and certain foods. RINELON reduces nasal swelling and irritation, thereby relieving sneezing, itching, and a blocked or runny nose caused by hay fever or perennial rhinitis.

Nasal polyps
RINELON is used to treat nasal polyps in adults aged 18 years and older.
Nasal polyps are small growths on the nasal mucosa and usually affect both nostrils. RINELON reduces nasal inflammation, leading to a gradual shrinkage of the polyps, thus relieving the sensation of nasal obstruction and improving nasal breathing.

2. What you need to know before using RINELON

Do not use RINELON

• if you are allergic (hypersensitive) to mometasone furoate or to any of the excipients of this medicine (listed in section 6).
• if you have an untreated nasal infection. Using RINELON during an untreated nasal infection, such as herpes, may worsen the infection. You must wait until the infection has resolved before starting to use the nasal spray.
• if you have recently had nasal surgery or nasal trauma. You should not use the nasal spray until the nasal condition has healed.

Warnings and precautions
Talk to your doctor or pharmacist before using RINELON

• if you have or have had tuberculosis.
• if you have any other infection.
• if you are taking other corticosteroids, either orally or by injection.
• if you have cystic fibrosis.

While using RINELON, contact your doctor

• if your immune system does not function properly (difficulty fighting infections) and if you are exposed to someone with measles or chickenpox. Avoid contact with people who have these infections.
• if you develop a nasal or throat infection.
• if you have been using this medicine for several months or longer.
• if you experience persistent irritation of the nose or throat.

When corticosteroid nasal sprays are used at high doses for prolonged periods,
adverse effects due to systemic absorption of the medicine may occur.
If you experience eye itching or irritation, your doctor may prescribe additional treatments to use
together with RINELON.
Contact your doctor if you experience blurred vision or other visual disturbances.
Children
When corticosteroid nasal sprays are used at high doses for prolonged periods,
they may cause certain adverse effects, such as growth retardation in children.
Regular monitoring of height is recommended in children undergoing prolonged treatment with
nasal corticosteroids, and you should inform your doctor if you notice any changes.
Other medicines and RINELON
Inform your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicines, including medicines obtained without a prescription.
If you are taking other corticosteroid medicines for allergy treatment, either orally or by injection,
your doctor may advise you to discontinue that treatment when starting RINELON.
When stopping oral or injectable corticosteroid therapy, some people may experience adverse effects such as
joint or muscle pain, weakness, and depression. You may also feel as if you are developing other allergies,
such as itching, tearing eyes, or red, itchy skin rashes. Consult your doctor if you notice any of these effects.
Some medicines may increase the effects of RINELON, and your doctor may decide to monitor you closely
if you are taking these medicines (including certain HIV treatments: ritonavir, cobicistat).
Pregnancy and breastfeeding
Information on the use of RINELON in pregnant women is limited or lacking. It is not known whether
mometasone furoate passes into breast milk.
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding,
please consult your doctor or pharmacist before using this medicine.
Driving and using machines
There is no information available on the effects of RINELON on the ability to drive vehicles or
operate machinery.
RINELON contains benzalkonium chloride
Benzalkonium chloride may cause irritation and swelling inside the nose, especially if used for
prolonged periods.

3. How to use RINELON

Use RINELON exactly as directed by your doctor. If you have any doubts, consult your doctor or
pharmacist. Do not use higher doses, more frequently, or for longer than prescribed by your doctor.
Treatment of hay fever and perennial rhinitis
Use in adults and children above 12 years of age
The usual dose is two sprays into each nostril once daily.

• Once symptoms are under control, your doctor may advise you to reduce the dose.
• If you do not notice any improvement, consult your doctor, who may prescribe an increase in dose; the maximum daily dose is four sprays into each nostril once daily.

Use in children aged 3 to 11 years
The usual dose is one spray into each nostril once daily.
In some patients, RINELON begins to relieve symptoms within 12 hours after the first dose; however, the full benefit of treatment may not be evident within the first two days. Therefore, you must continue regular use to achieve the full therapeutic benefit.
If you or your child suffers from severe hay fever, your doctor may advise you to start using RINELON several days before the expected start of pollen season: this will help prevent the onset of hay fever symptoms.
Nasal polyps
Use in adults over 18 years of age
The usual starting dose is two sprays into each nostril once daily.

• If after 5 or 6 weeks symptoms are not under control, the dose may be increased to two sprays into each nostril twice daily. When symptoms are under control, your doctor may advise you to reduce the dose.
• If symptoms do not improve within 5 or 6 weeks after starting twice-daily dosing, contact your doctor.

How to prepare the nasal spray for use
RINELON nasal spray is equipped with a dust cap that protects the atomizer and keeps it clean. Remember to remove it before using the spray and to replace it after use.
If you are using the spray for the first time, you must prime the pump 10 times until you see a uniform mist:

1. Gently shake the bottle.
2. Place your index and middle fingers on either side of the atomizer, and your thumb under the base of the bottle. Do not pierce the nasal applicator.
3. To prime the spray, point the atomizer away from yourself and press down 10 times with your fingers until a uniform spray appears.

If you have not used the spray for 14 days or more, you must re-prime the pump 2 times until you see a uniform mist.
How to use the nasal spray

Figure 1 Figure 2 Figure 3

1. Gently shake the bottle and remove the dust cap. (Figure 1)
2. Gently blow your nose.
3. Close one nostril and insert the atomizer into the other, as illustrated. (Figure 2) Tilt your head slightly forward, keeping the bottle upright.
4. Begin to inhale gently or slowly through your nose and administer one spray into the nostril by pressing ONCE with your fingers.
5. Exhale through your mouth. Repeat step 4 to inhale a second spray into the same nostril, if required.
6. Remove the atomizer from the nostril and exhale through your mouth.
7. Repeat steps 3 to 6 for the other nostril. (Figure 3)

After using the product, clean the atomizer thoroughly with a tissue or clean cloth and replace the dust cap.
How to clean the nasal spray

• It is important to clean the nasal spray regularly; otherwise, it may not work properly.
• Remove the dust cap and gently pull off the atomizer.
• Wash the atomizer and dust cap with lukewarm water, then rinse under running water.
• Do not attempt to unblock the nasal applicator by inserting a pin or any other sharp object, as this may damage the applicator and prevent delivery of the correct dose of medication.
• Allow the dust cap and atomizer to dry in a warm place.
• Reattach the atomizer to the bottle and replace the dust cap.
• After cleaning, the spray must be re-primed with at least 2 sprays before first use.

If you use more RINELON than you should
Inform your doctor if you have accidentally used more than prescribed.
In rare cases, prolonged use or high doses of steroids may affect levels of certain hormones. In children, this effect may influence growth and development.
If you forget to use RINELON
If you forget to use the nasal spray at the correct time, use it as soon as you remember, then continue as usual. Do not use a double dose to make up for a missed dose.
If you stop using RINELON
In some patients, symptoms begin to improve within 12 hours after the first dose of RINELON; however, a full therapeutic benefit may not be evident until after two days. It is very important that you use the nasal spray regularly. Do not stop treatment, even if you feel better, unless your doctor tells you to do so.
For further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Immediate hypersensitivity (allergic) reactions may occur with the use of this medicine.
These reactions can be severe. You must stop using RINELON and seek immediate medical assistance if any of the following symptoms occur:

• swelling of the face, tongue or pharynx
• difficulty swallowing
• hives
• shortness of breath or breathing difficulties

When corticosteroid nasal sprays are used at high doses over long periods of time, side effects due to systemic absorption of the medicine may occur.

Other side effects
Most people do not experience problems when using the nasal spray. However, some people may experience the following after using RINELON or other corticosteroid nasal sprays:

Common side effects (may affect up to 1 in 10 people):

• headache
• sneezing
• nosebleeds [very commonly reported (may affect more than 1 in 10 people) in patients with nasal polyps treated with two sprays of RINELON in each nostril twice daily]
• nasal or throat pain
• nasal ulcers
• respiratory tract infections

Not known (frequency cannot be estimated from the available data):

• increased pressure inside the eye (glaucoma) and/or cataracts causing visual disturbances
• damage to the nasal septum separating the nostrils
• changes in taste and smell
• difficulty breathing and/or breathlessness
• blurred vision

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 RINELON

• Keep this medicine out of the sight and reach of children.
• Do not store the nasal spray above 25 °C. Do not freeze.
• Do not use this medicine after the expiry date stated on the bottle and carton after "Exp.". The expiry date refers to the last day of that month.
• The bottle should be used within 2 months of first opening. Open one bottle at a time.

Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What RINELON contains

• The active substance is mometasone furoate. Each spray contains 50 micrograms of mometasone furoate as monohydrate.
• The excipients are dispersible cellulose, glycerol, sodium citrate, citric acid monohydrate, polysorbate 80, benzalkonium chloride, purified water.
• This medicinal product contains 0.02 mg of benzalkonium chloride per spray.

Description of the appearance of RINELON and package contents
RINELON is a nasal spray, suspension.
Each bottle contains 60 or 140 sprays.
Bottles containing 60 sprays are supplied in individual packs.
Bottles containing 140 sprays are supplied in packs of 1, 2 or 3 bottles.
It is possible that not all pack sizes are marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Organon Italia S.r.l.
Piazza Carlo Magno, 21
00162 Rome
Italy

Manufacturer:
Organon Heist bv
Industriepark 30
2220 Heist-op-den-Berg
Belgium

This medicinal product is authorised in the European Economic Area countries under the following names:
Austria: Nasonex aquosum – Nasenspray
Belgium, Croatia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Slovenia, Sweden, United Kingdom: Nasonex
Bulgaria, Czech Republic, Romania, Slovak Republic: NASONEX
Latvia: Nasonex 50 mikrogrami/deva deguna aerosols, suspensija
Portugal: Nasomet
Spain: NASONEX 50 microgramos suspensión para pulverización nasal