RINOFF 50 MICROGRAMS Nasal spray, suspension

Зміст інструкції

1. RINOFF 50 micrograms/spray nasal spray, suspension
   1. What is RINOFF and what is it 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

RINOFF 50 micrograms/spray nasal spray, suspension

Mometasone furoate

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 only for you. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell 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 is RINOFF and what is it 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 can help to
reduce inflammation (swelling and irritation of the nose), sneezing, itching and conditions of
nasal congestion or runny nose.

What is RINOFF for?
Hay fever and perennial rhinitis
RINOFF is used for the treatment of symptoms of hay fever (also called seasonal allergic rhinitis) and perennial rhinitis in adults and children starting from 3 years of age.
Hay fever that occurs during certain times of the year is an allergic reaction caused
by inhaling pollen from trees, grass, weeds, and also molds and fungal spores. Perennial rhinitis is present all year round and symptoms may be caused by
sensitivity to a variety of elements, including dust mites, animal hair
(or dander), feathers and certain foods. RINOFF reduces nasal swelling and irritation and thus sneezing, itching and conditions of nasal congestion or runny nose caused by hay fever or
perennial rhinitis.
Nasal polyps
RINOFF is used for the treatment of nasal polyps in adults starting from 18 years of age.
Nasal polyps are small growths on the nasal mucosa and usually affect both
nostrils. RINOFF reduces inflammation of the nose causing a gradual narrowing of the
polyps, thus relieving the sensation of nasal obstruction and improving breathing through
the nose.

2. What you need to know before using RINOFF

Do not use RINOFF

• if you are allergic (hypersensitive) to mometasone furoate or 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 should wait for the infection to resolve before starting to use the nasal spray.
• if you have recently had nasal surgery or suffered a nasal trauma. You should not use the nasal spray until the nasal problem has resolved.

Warnings and precautions
Consult your doctor or pharmacist before using RINOFF

• if you suffer from or have suffered from tuberculosis
• if you suffer from any other infection
• if you are taking other medicines containing corticosteroids, either orally or by injection
• if you have cystic fibrosis

During the use of RINOFF, consult your doctor

• if your immune system is not functioning properly (difficulty fighting infections) and if you should come into contact with a person affected by measles or chickenpox. Avoid contact with people who have these infections.
• if you have an infection of the nose or throat.
• if you use this medicine for several months or longer.
• if you have persistent irritation of the nose or throat.

When nasal sprays containing corticosteroids are used at high doses for long periods of time, undesirable effects due to the absorption of the medicine into the body may occur.
If you experience itching or irritation of the eyes, your doctor may prescribe other treatments to use together with RINOFF.
Contact your doctor if you experience blurred vision or other visual disturbances.
For athletes: the use of the drug may result in a positive doping test.

Children
If used at high doses and for long periods of time, nasal sprays containing corticosteroids can cause some undesirable effects, such as delayed growth in children.
It is recommended to regularly check the height of children undergoing prolonged treatment with nasal corticosteroids and to inform the doctor if any changes are noticed.

Other medicines and RINOFF
Tell 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 such treatment when you start using RINOFF. Stopping treatment with oral or injectable corticosteroids, some people may experience undesirable effects such as joint or muscle pain, weakness and depression. You may also seem to develop other allergies, such as itching, tearing or red and itchy patches on the skin. Consult your doctor if you notice the appearance of any of these effects.
Some medicines can increase the effects of RINOFF and your doctor may want to monitor you closely if you are taking these medicines (including some medicines for the treatment of HIV: ritonavir, cobicistat).

Pregnancy and breastfeeding
Information on the use of RINOFF in pregnant women is limited or absent. It is not known whether mometasone furoate passes into breast milk.
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.

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

RINOFF contains benzalkonium chloride
RINOFF contains benzalkonium chloride, a substance that can cause irritation and swelling inside the nose, especially if used for long periods.

3. How to use RINOFF

Use RINOFF always following exactly the doctor's instructions. If you have any doubts consult your
doctor or pharmacist. Do not use higher or more frequent or longer doses than prescribed
by the doctor.

Treatment of hay fever and perennial rhinitis
Use in adults and children over 12 years of age
The usual dose is two sprays in each nostril once a day.

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

Use in children from 3 to 11 years of age
The usual dose is one spray in each nostril once a day.
In some patients RINOFF starts to relieve symptoms within 12 hours of
administration of the first dose; however, the full benefit of treatment may not be seen within
the first two days. Therefore, you must continue regular use to obtain the full benefit of
treatment.
If you or your child suffer from severe hay fever, your doctor may advise you to start
using RINOFF a few days before the expected start of the pollen season: this will help to
prevent the onset of hay fever symptoms.

Nasal polyps
Use in adults over 18 years of age
The usual initial dose is two sprays in each nostril once a day.

• If after 5 or 6 weeks the symptoms are not under control, the dose may be increased to two sprays in each nostril twice a day. When the symptoms are under control, your doctor may advise you to reduce the dose.
• If symptoms do not improve after 5 or 6 weeks from the start of twice daily administration, contact your doctor.

How to prepare the nasal spray for use
RINOFF nasal spray is equipped with a dust cap, which protects the vaporizer and keeps it
clean. Remember to remove it before using the spray and reposition it after use.
If you are using the spray for the first time, you will need to prime the pump 10 times until you see a
uniform jet:

• 1. Gently shake the bottle
• 2. Place your index and middle fingers on either side of the vaporizer, your thumb under the base of the bottle. Do notpuncture the nasal applicator.
• 3. To prime the spray, point the vaporizer away from yourself and press 10 times with your fingers until you get a uniform jet.

If you have not used the spray for 14 days or more, you will need to re-prime the pump 2 times until you see a
uniform jet.

How to use the nasal spray

Figure 1Figure 2Figure 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 vaporizer into the other, as illustrated. (Figure 2) Tilt your head slightly forward, keeping the bottle upright.
• 4. Start to inhale gently or slowly through your nose, administer one spray of spray into your nose by pressing ONCE with your fingers.
• 5. Exhale through your mouth. Repeat point 4 to inhale a second spray into the same nostril, if necessary.
• 6. Remove the vaporizer from this nostril and exhale through your mouth.
• 7. Repeat points 3 to 6 for the other nostril. (Figure 3)

After using the product, carefully clean the vaporizer with a tissue or a clean cloth and reposition 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 vaporizer.
• Wash the vaporizer and dust cap with warm water, then rinse under running water.
• Do not attempt to unblock the nasal applicator by inserting a pin or other sharp object as this maneuver will damage the nasal applicator and will not allow youto have the right dose of the medicine.
• Let the dust cap and vaporizer dry in a warm place.
• Reposition the vaporizer on the bottle and put the dust cap back on.
• The spray needs to be re-primed with at least 2 sprays at first use after cleaning.

If you use more RINOFF than you should
Inform your doctor if you have accidentally used more than you should.
In rare cases, prolonged or high-dose use of steroids can affect levels of some hormones.
In children, this effect can affect growth and development.

If you forget to use RINOFF
If you forget to use the nasal spray at the right 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 treatment with RINOFF
In some patients, symptoms will begin to be relieved after 12 hours from the administration
of the first dose of RINOFF; however, a complete therapeutic benefit may not be seen
before 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.
For further questions related to 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 everybody gets them.
With the use of this medicine, immediate hypersensitivity (allergic) reactions may occur.
These reactions can be serious. You must stop using RINOFF and seek immediate medical
attention if any of the following symptoms appear:

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

When nasal sprays containing corticosteroids are used at high doses for long periods of
time, side effects due to absorption of the medicine into the body may occur.
Other side effects
Most people have no problems with the use of the nasal spray. However, some people,
after using RINOFF or other corticosteroid nasal sprays, may experience:
Common side effects (may affect up to 1 in 10 people):

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

Not known (frequency cannot be estimated based on 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 shortness of breath
• blurred vision

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects
directly through 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 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 the carton after “Exp”. The expiry date refers to the last day of that month.
• This medicine does not require any particular storage conditions.
• The bottle must be used within two months of first opening.

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

6. Contents of the pack and other information

What RINOFF contains

• The active ingredient is mometasone furoate. Each spray contains 50 micrograms of mometasone furoate as monohydrate.
• The excipients are microcrystalline cellulose and sodium carboxymethylcellulose, glycerol, sodium citrate, citric acid monohydrate, polysorbate 80, benzalkonium chloride, purified water.
• This medicine contains 0.02 mg of benzalkonium chloride per actuation.

Description of the appearance of RINOFF and contents of the pack
RINOFF is a nasal spray, suspension.
Each bottle may contain 60 sprays (10 g) or 140 sprays (18 g).
The bottles containing 60 sprays or 140 sprays are supplied in packs of 1 nasal spray.
Not all pack sizes may be marketed.

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