Rinalgit

Patient Information Leaflet

Rinalgit 50 micrograms/spray

Nasal spray, suspension
Mometasone furoate (as monohydrate)
Please read this entire 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 side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What is Rinalgit and what is it used for

What is Rinalgit?
This product contains the active substance mometasone furoate (as monohydrate).
Mometasone furoate is a corticosteroid with anti-inflammatory action, reducing swelling and irritation that cause sneezing, itching, and a blocked or runny nose.
What is Rinalgit used for?
Hay fever and perennial rhinitis
This medicine 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 during certain times of the year and is an allergic reaction caused by inhaling pollen from trees, grass, weeds, as well as moulds and fungal spores. Perennial rhinitis occurs throughout the year, and symptoms may be triggered by sensitivity to various substances, including house dust mites, animal fur (or skin particles), feathers, and certain foods. This medicine reduces nasal swelling and irritation, thereby relieving sneezing, itching, and a blocked or runny nose caused by hay fever or perennial rhinitis.
Nasal polyps
This medicine is used to treat nasal polyps in adults aged 18 years and older.
Nasal polyps are small growths on the inner lining of the nose and usually affect both nostrils. This medicine reduces nasal inflammation, gradually shrinking the polyps, thus relieving the sensation of nasal blockage and improving nasal breathing.

2. What you need to know before using Rinalgit

Do not use Rinalgit

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

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Rinalgit if:

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

While using Rinalgit, contact your doctor:

• if your immune system does not function properly (if you have difficulty fighting infections) and 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.

Long-term use of high-dose corticosteroid nasal sprays may lead to unwanted effects due to systemic absorption of the medicine.
If you experience eye itching or irritation, your doctor may recommend additional treatments to use alongside this medicine.
Contact your doctor if you develop 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 delayed growth in children.
Regular monitoring of height is recommended in children undergoing long-term treatment with nasal corticosteroids, and you should inform your doctor if you notice any changes.

Other medicines and Rinalgit
Inform your doctor if you are taking or have recently taken any other medicines, including those obtained without a prescription.
Some medicines may increase the effects of Rinalgit, and your doctor may decide to monitor you closely if you are taking these (including certain HIV treatments: ritonavir, cobicistat).
If you are taking other corticosteroid medicines to treat allergies, either orally or by injection, your doctor may advise you to discontinue them when starting Rinalgit.
Some people may experience adverse effects when stopping oral or injectable corticosteroids, such as muscle or joint pain, weakness, and depression.
You may also feel as if you are developing other allergic symptoms such as itching, watery eyes, or red, itchy skin areas. If you experience any of these effects, contact your doctor.

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

Driving and operating machinery
There is no available information on the effects of this medicine on the ability to drive vehicles or operate machinery.

Rinalgit contains benzalkonium chloride
Benzalkonium chloride may cause nasal irritation and swelling, especially if used for prolonged periods.

3. How to use Rinalgit

Use this medicine exactly as directed by your doctor or pharmacist. 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 over 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 instruct you to increase the 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, Rinalgit begins to relieve symptoms within 12 hours of the first dose; however, the full benefit of treatment may not be apparent during the first 2 days.
Therefore, you must continue to use the medicine regularly to achieve the full therapeutic benefit.
If you or your child suffer from severe hay fever, your doctor may instruct you to start using Rinalgit several days before the start of pollen season, as this will help prevent the onset of hay fever symptoms. At the end of pollen season, hay fever symptoms should improve and treatment may no longer be necessary.

Nasal polyps

Use in adults over 18 years of age
The usual initial dose is DUE sprays into each nostril ONCE daily.

• If symptoms are not controlled after 5 or 6 weeks, 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 no improvement in symptoms is observed after 5–6 weeks of twice-daily administration, you must contact your doctor.

How to use the nasal spray

1. Gently shake the bottle and remove the protective cap.

2. If the nasal spray bottle is new or has not been used for 14 days or more, it must be "primed" by pressing the spray pump several times until a fine mist is produced. To do this, hold the bottle as shown. Place your index and middle fingers on the collar, on either side of the nozzle, and your thumb under the bottle. Keep your thumb steady and press down firmly with your fingers to spray, pointing the nozzle away from you. A minimum of 10 sprays is recommended to prime the bottle for first use, and at least 2 sprays are required to re-prime the bottle if it has not been used for 14 or more days.
   [If no spray is produced and you suspect the nozzle may be blocked, clean it. (For cleaning instructions, refer to those below). DO NOT attempt to unblock the spray hole with a pin or any other sharp object, as this may damage the delivery mechanism.]

3. Gently blow your nose.

4. Hold the bottle as shown. Use one finger to close one nostril and insert the nozzle into the other nostril. Tilt your head forward and keep the bottle in an upright position. Begin to inhale slowly through your nose and, at the same time, press firmly on the collar of the bottle with your finger to release one spray of mometasone furoate.

5. Exhale through your mouth. Repeat step 4 if more than one spray is required in the same nostril. Remove the nozzle from the nostril and exhale through your mouth. Repeat steps 4 and 5 for the other nostril. After using the spray, clean the nozzle thoroughly with a clean tissue and replace the protective cap.

How to clean the Rinalgit bottle

1. Clean the nasal spray at least once a week, as it may become blocked and prevent proper functioning.
2. Remove the protective cap.
3. Gently push upwards on the white collar to remove the nozzle.
4. Soak the nozzle and protective cap in warm water for a few minutes and rinse under running water.
5. Allow to dry in a warm place before reinserting. Do not dry near a very hot area.
6. Reinsert the nozzle and "prime" the bottle by pumping the spray several times to produce a fine mist.

If you use more Rinalgit than you should
If you accidentally use more Rinalgit than the prescribed dose, inform your doctor as soon as possible.
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 Rinalgit
If you forget a dose of Rinalgit, use it as soon as you remember, then continue as usual. Do not take a double dose to make up for the missed dose.

If you stop using Rinalgit
Consult your doctor before stopping treatment.
In some patients, this medicine should begin to relieve symptoms 12 hours after the first dose; however, the full benefit of treatment may not be evident until after two days. It is very important to use the nasal spray regularly. Do not stop treatment even if you feel better, unless your doctor has instructed you to do so.
If you have any questions about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

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

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

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

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

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

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

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

• increased eye pressure (glaucoma) and/or cataracts causing vision 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 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 Rinalgit

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of that month.
Use within 2 months after first opening.
Do not store above 25°C.
Do not freeze.
Keep in the original container.
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 Rinalgit contains

• The active substance is mometasone furoate. Each spray delivers 50 micrograms of mometasone furoate (as monohydrate) as the inhaled dose.
• The other ingredients are glycerol, microcrystalline cellulose, sodium carmellose, citric acid monohydrate, polysorbate 80, benzalkonium chloride, disodium citrate dihydrate, water for injections.

Description of the appearance of Rinalgit and contents of the pack
Rinalgit is a homogeneous, redispersible suspension, white to off-white in colour.
Mometasone furoate nasal spray, suspension is supplied in a white opaque high-density polyethylene bottle equipped with a manual metered-dose spray pump, a white polypropylene atomizer, a nasal adapter, and a translucent protective cap. Each bottle contains 18.0 g of suspension, sufficient for 140 metered doses.
Pack sizes: 1 bottle, 2 bottles or 3 bottles.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
ABC Farmaceutici S.p.A.
Corso Vittorio Emanuele II, 72
10121 Torino - Italy

Responsible manufacturers for batch release
S&D Pharma CZ, spol. S.r.o.
Theodor 28, Pchery (Pharmos a.s. facility)
Czech Republic
Cipla Europe NV
De Keyserlei 58-60
Box-19, 2018 Antwerp
Belgium
Orion Corporation
Orion Pharma
Orionintie 1
FI-02200 Espoo
Finland

This medicinal product is authorised in the European Economic Area Member States and in the
United Kingdom (Northern Ireland) under the following names:
Austria Mometason Cipla 50 Mikrogramm/Sprühstoß – Nasenspray, Suspension
Croatia Mometazonfuorat Cipla 50 mikrograma po potisku sprej za nos, suspenzija
Denmark Mometason Orion næsespray, suspension
Finland Mometason Orion, 50 mikrog/annos, nenäsumute, suspensio
Germany Mometasonfuroat Cipla 50 Mikrogramm/Sprühstoß Nasenspray, Suspension
Italy Rinalgit
Norway Mometason Orion 50 mikrogram/dose nesespray, suspensjon
Spain Mometasona furoato Cipla 50 microgramos/pulverización suspension para pulverización nasal
United Kingdom (Northern Ireland) Mometasone furoate 50 micrograms/actuation Nasal Spray, Suspension