Arinit

Italy
Brand name Arinit
Form spray, nasal suspension
Active substance / Dosage
MOMETASONE FUROATE MONOHYDRATE
Prescription type Prescription only
ATC code
R01AD09
Registration number 047440
Manufacturer D.M.G. ITALIA S.R.L.

Table of Contents

PACKAGE LEAFLET

Package leaflet: Information for the user

MOMETIC 50 micrograms/dose Nasal Spray, Suspension
mometasone furoate
Generic medicine
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 they have the same symptoms as yours, because it could be harmful.
  • If you experience any side effect, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What is MOMETIC nasal spray and what is it used for

What is MOMETIC Nasal Spray?
MOMETIC Nasal Spray contains mometasone furoate, which belongs to a group of medicines known as corticosteroids. Mometasone furoate must not be confused with "anabolic" steroids—substances improperly used by some athletes and administered intravenously or orally in tablet form. When mometasone furoate is sprayed into the nose, it helps relieve inflammation (swelling and irritation of the nose), sneezing, itching, nasal congestion, and runny nose.

What is MOMETIC Nasal Spray used for?
Hay fever and perennial rhinitis
MOMETIC Nasal Spray 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, which occurs during certain times of the year, is an allergic reaction caused by breathing in 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 allergens, including house dust mites, animal fur (or dander), feathers, and certain foods. MOMETIC Nasal Spray reduces nasal swelling and irritation, thereby relieving sneezing, itching, nasal congestion, and runny nose caused by hay fever or perennial rhinitis.

Nasal polyps
MOMETIC Nasal Spray 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. MOMETIC Nasal Spray reduces inflammation in the nose, leading to a gradual shrinkage of the polyps, thus relieving nasal obstruction and improving nasal breathing.

2. What you need to know before using MOMETIC Nasal Spray

Do not use MOMETIC Nasal Spray:

  • if you are allergic to mometasone furoate or to any of the excipients of this medicinal product (listed in section 6).
  • if you have an untreated nasal infection. Using MOMETIC 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 must not use the nasal spray until your nose has healed.

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

  • if you have or have had tuberculosis.
  • if you have any other type of infection.
  • if you are taking other corticosteroid medicines, either by mouth or by injection.
  • if you have cystic fibrosis.

While using MOMETIC, talk to your doctor:

  • if your immune system is not working properly (difficulty fighting infections) and if you are exposed to people 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 have persistent irritation of the nose or throat.

Using corticosteroid nasal sprays at high doses for long periods may lead to unwanted effects due to absorption of the medicine into the body.
If you experience eye itching or irritation, your doctor may prescribe additional treatments to use alongside MOMETIC.
Contact your doctor if you experience blurred vision or other visual disturbances.
Children
When used at high doses and for prolonged periods, corticosteroid nasal sprays may cause certain adverse effects, such as growth retardation in children.
Regular monitoring of height is recommended in children undergoing long-term treatment with nasal corticosteroids. If you notice any changes, inform your doctor.
Other medicines and MOMETIC Nasal Spray
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
If you are taking other corticosteroid medicines for allergy treatment, either by mouth or by injection, your doctor may advise you to stop such treatment when you start using MOMETIC. 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 though you are developing other allergies, such as itching, tearing, or red, itchy skin rashes. Contact your doctor if you experience any of these effects.
Some medicines may increase the effects of MOMETIC, and your doctor may wish to closely monitor you if you are taking these medicines (including certain HIV treatments: ritonavir, cobicistat).
Pregnancy, breastfeeding and fertility
Information on the use of MOMETIC Nasal Spray in pregnant women is limited or unavailable.
It is not known whether mometasone furoate passes into breast milk.
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
Driving and using machines
No information is available regarding the effects of MOMETIC Nasal Spray on the ability to drive or operate machinery.
MOMETIC Nasal Spray contains benzalkonium chloride
MOMETIC contains 20 micrograms of benzalkonium chloride per spray, which may cause irritation or swelling inside the nose, especially if used for a prolonged period.

3. How to use MOMETIC Nasal Spray

Use MOMETIC Nasal Spray exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist. Do not use a higher dose, or use the spray more frequently or for longer than prescribed by your doctor.

Treatment of hay fever and perennial rhinitis

Use in adults and children over 12 years of age
The recommended dose is 2 sprays in each nostril once daily.
In some patients, MOMETIC Nasal Spray begins to relieve symptoms within 12 hours of the first dose. However, it may take more than two days to achieve the full benefit of treatment. Therefore, it is necessary to continue using it regularly to fully benefit from its effectiveness.

  • Once symptoms are under control, your doctor may advise you to reduce the dose to one spray once daily in each nostril.
  • If you do not experience any improvement, consult your doctor, who may prescribe an increase in dose; the maximum daily dose is 4 sprays in each nostril once daily.

Use in children aged 3 to 11 years
The recommended dose is 1 spray in each nostril once daily.
If you or your child suffers from severe hay fever, your doctor may advise you to start using mometasone furoate several days before the expected start of pollen season: this will help prevent the onset of hay fever symptoms. At the end of pollen season, hay fever symptoms may subside, making treatment unnecessary.
Use MOMETIC Nasal Spray 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 recommended initial dose is 2 sprays in each nostril once daily.
If symptoms are not controlled after 5 or 6 weeks, the dose may be increased to 2 sprays in each nostril twice daily. Once symptoms are under control, your doctor may advise you to reduce the dose.

  • If no improvement is observed after 5 to 6 weeks of twice-daily dosing, contact your doctor to discuss alternative treatments instead of MOMETIC Nasal Spray.

How to prepare the nasal spray for use
MOMETIC Nasal Spray is equipped with a dust cap that protects the nozzle and keeps it clean. Remember to remove the cap 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 fine, uniform mist:

  1. Gently shake the bottle.
  2. Place your index and middle fingers on either side of the nozzle, and 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 mist appears. If you have not used the spray for 14 days or more, you must re-prime the pump by spraying twice until you see a uniform mist.

Duration of the nasal spray
With two sprays in each nostril once daily, the product should provide sufficient dosage for 15 days (for the bottle containing 60 metered sprays) and 35 days (for the bottle containing 140 metered sprays).

How to use the nasal spray

A hand holds vertically a cylindrical medical device with fingers wrapping around its body
  1. Gently shake the bottle and remove the dust cap. (Figure 1)
  2. Gently blow your nose.
Black and white drawing of a child holding a medical device near the nose with both hands, with the number 2 in the upper left corner
  1. Close one nostril and insert the nozzle into the other, as shown (Figure 2). Tilt your head slightly forward, keeping the bottle upright.
  2. Begin to inhale gently or slowly through your nose and administer one spray into the nostril by pressing down ONCE with your fingers.
  3. Exhale through your mouth. Repeat step 4 to administer a second spray into the same nostril, if required.
  4. Remove the nozzle from the nostril and exhale through your mouth.
Black and white drawing of a person holding an inhaler near the nose and mouth with both hands for
  1. 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 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 nozzle to dry in a warm place.
  • Reattach the nozzle to the bottle and replace the dust cap.
  • The spray must be re-primed with at least 2 sprays the first time it is used after cleaning.

If you use more MOMETIC Nasal Spray than you should
Inform your doctor if you have accidentally used more than the prescribed dose.
In rare cases, prolonged use or high doses of steroids may affect the levels of certain hormones. In children, this effect may impact growth and development.

If you forget to take MOMETIC
If you forget to take MOMETIC Nasal Spray at the scheduled time, use it as soon as you remember, then continue your treatment as usual. Do not use a double dose to make up for the missed dose.

If you stop using MOMETIC
In some patients, symptoms begin to improve within 12 hours of the first dose of MOMETIC Nasal Spray. 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.

If you have any questions about the use of 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.
Immediate hypersensitivity (allergic) reactions may occur with the use of this medicine. These reactions can be severe. You must stop using MOMETIC Nasal Spray and seek immediate medical attention 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 for 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, after using MOMETIC Nasal Spray or other corticosteroid nasal sprays, may experience:
Common side effects (may affect up to 1 in 10 people):

  • headache
  • sneezing and nasal irritation/burning sensation
  • nosebleeds (epistaxis) [reported very commonly (may affect more than 1 in 10 people) in patients with nasal polyps treated with MOMETIC Nasal Spray, two sprays in each nostril twice daily]
  • nasal or throat pain
  • nasal ulcers
  • respiratory tract infection

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 shortness of breath
  • 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 can also report side effects directly via the national reporting system at: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store MOMETIC

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial and carton after "Exp.".
The expiry date refers to the last day of that month.
Do not store above 25°C. Do not freeze.
The vial should be used within 8 weeks of first use. Open one vial 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 MOMETIC Nasal Spray contains

  • The active substance is mometasone furoate. Each spray (0.1 ml) contains 50 micrograms of mometasone furoate (as monohydrate). The total weight of one spray is 100 mg.
  • The other ingredients are microcrystalline cellulose and sodium carmellose, glycerol, disodium citrate dihydrate, citric acid monohydrate, polysorbate 80, benzalkonium chloride (see section 2), and water for injections.

Description of the appearance of MOMETIC Nasal Spray and contents of the pack
MOMETIC is a nasal spray suspension.
Each bottle contains 60 or 140 metered doses.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
DMG Italia SRL
Via Laurentina Km 26.700, Pomezia
Rome 00071, Italy

Manufacturer
Teva Czech Industries s.r.o.
Ostravská 305/29, 747 70 Opava-Komárov,
Czech Republic

This medicinal product is authorised in the European Economic Area Member States under the following names:
United Kingdom: Mometasone Furoate Nasal Spray, 50 micrograms/actuation nasal spray suspension
Italy: MOMETIC
[to be completed with national details]