Rinoff

Patient Information Leaflet: Information for the User

RINOFF 50 micrograms/dose nasal spray, suspension

Mometasone furoate
Please read this leaflet carefully before using this medicine as 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 they have the same symptoms as yours, as it may be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What RINOFF is and what it is used for

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

What is RINOFF used for?
Hay fever and perennial rhinitis
RINOFF 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 occurs at certain times of the year and is an allergic reaction caused by inhaling tree, grass, and weed pollens, as well as moulds and fungal spores. Perennial rhinitis is present all year round, and symptoms may be triggered by sensitivity to various substances, including house dust mites, animal fur (or dander), feathers, and certain foods. RINOFF reduces nasal swelling and irritation, thereby relieving sneezing, itching, and symptoms of a blocked or runny nose caused by hay fever or perennial rhinitis.

Nasal polyps
RINOFF 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. RINOFF reduces nasal inflammation, leading to a gradual shrinkage of the polyps, thereby relieving the sensation of nasal obstruction and improving nasal breathing.

2. What you should know before using RINOFF

Do not use RINOFF

• 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 RINOFF 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 have suffered a nasal injury. You must not use the nasal spray until the nasal condition has healed.

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

• if you suffer from or have previously suffered from tuberculosis
• if you have any other infection
• if you are taking other corticosteroid medicines, either by mouth or by injection
• if you have cystic fibrosis

While using RINOFF, 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 long periods of time, side effects due to systemic absorption of the medicine may occur.
If you experience eye itching or irritation, your doctor may prescribe other treatments to use alongside RINOFF.
Contact your doctor if you experience blurred vision or other visual disturbances.
For those engaged in sports: the use of this medicine may lead to positive results in doping tests.

Children
When corticosteroid nasal sprays are used at high doses and for long periods of time, they may cause certain side effects, such as delayed growth in children.
It is recommended to regularly monitor the height of children undergoing prolonged treatment with nasal corticosteroids and to inform your doctor if you notice any changes.

Other medicines and RINOFF
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 the treatment of allergies, either orally or by injection, your doctor may advise you to stop this treatment when you start using RINOFF. When stopping oral or injectable corticosteroid therapy, some people may experience side effects such as joint or muscle pain, weakness, and depression. You may also feel as though you are developing other allergic reactions, such as itching, tearing, or red, itchy skin rashes. Consult your doctor if you notice any of these effects.
Some medicines may increase the effects of RINOFF, and your doctor may want to monitor you closely if you are taking these medicines (including certain HIV treatments: ritonavir, cobicistat).

Pregnancy and breastfeeding
Information on the use of RINOFF in pregnant women is limited or unavailable. It is not known whether mometasone furoate passes into breast milk.
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.

Driving and using machines
There is no available information on the effects of RINOFF on the ability to drive vehicles or operate machinery.

RINOFF contains benzalkonium chloride
RINOFF contains benzalkonium chloride, a substance which may cause irritation and swelling inside the nose, especially if used for prolonged periods.

3. How to use RINOFF

Use RINOFF exactly as instructed by your doctor. If you have any doubts, consult your doctor or pharmacist. Do not use higher doses, more frequent doses, or use it 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 from 3 to 11 years of age
The usual dose is one spray into each nostril once daily.
In some patients, RINOFF 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 effect.
If you or your child suffers from severe hay fever, your doctor may advise you to start using RINOFF several days before the expected start of pollen season: this will help prevent the onset of hay fever symptoms.
Nasal polyps
Use in adults above 18 years of age
The usual initial 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 after 5 or 6 weeks of twice-daily administration, contact your doctor.

How to prepare the nasal spray for use
RINOFF nasal spray is equipped with a dust cap that protects the nozzle 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 observe a fine, uniform spray:

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

If you have not used the spray for 14 days or more, you must re-prime the pump 2 times until you observe a uniform spray.
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 nozzle 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 down ONCE with your fingers.
5. Exhale through your mouth. Repeat step 4 to administer a second spray into the same nostril, if needed.
6. Remove the nozzle from this nostril and exhale through your mouth.
7. Repeat steps 3 to 6 for the other nostril. (Figure 3)

After using the product, clean the nozzle thoroughly with a clean tissue or 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 nozzle.
• Wash the nozzle and dust cap with warm 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 you from receiving the correct dose of medication.
• Allow the dust cap and nozzle to dry in a warm place.
• Reattach the nozzle 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 RINOFF than you should
Inform your doctor if you have accidentally used more than you should.
In rare cases, prolonged use or high doses of steroids may affect levels of certain hormones. In children, this effect may impact growth and development.
If you forget to use RINOFF
If you forget to use the nasal spray at the scheduled time, use it as soon as you remember, then continue as usual. Do not use a double dose to make up for the missed dose.
If you stop using RINOFF
In some patients, symptoms begin to improve within 12 hours after the first dose of RINOFF; however, complete 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 instructed by your doctor.
For further questions regarding 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 experiences them.
Immediate hypersensitivity (allergic) reactions may occur with the use of this medicine. These reactions can be severe. You must stop using RINOFF 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, adverse 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 RINOFF or other corticosteroid nasal sprays:

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

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

Not known (frequency cannot be determined from available data):

• increased pressure inside the eye (glaucoma) and/or cataracts causing visual disturbances
• damage to the nasal septum separating the nostrils
• alterations 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 the following website:
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 RINOFF

• Keep this medicine out of the sight and reach of children.
• 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.
• This medicine has no special storage requirements.
• The bottle should be used within two months of first opening.

Do not dispose of medicines 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 RINOFF contains

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

Description of the appearance of RINOFF and contents of the pack
RINOFF is a nasal spray, suspension.
Each bottle contains either 60 sprays (10 g) or 140 sprays (18 g).
Bottles containing 60 sprays or 140 sprays are supplied in packs of 1 nasal spray.
It is possible that not all pack sizes are marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
FIRMA S.p.A. – Via di Scandicci, 37 – Florence, Italy.
Manufacturer:
FARMEA – 10 rue Bouché Thomas – Z.A.C d’Orgemont – 49000 Angers, France.