RINALGIT 50 MICROGRAMS Cutaneous spray, suspension

Зміст інструкції

1. Rinalgit 50 micrograms/spray
   1. What Rinalgit is and what it is used for
   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

Rinalgit 50 micrograms/spray

nasal spray, suspension
Mometasone furoate (as monohydrate)

Read this leaflet carefully before you start 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 pass it on to others, even if they have the same symptoms as you, as it may be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What is Rinalgit
• 2. What you need to know before you use 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 Rinalgit is and what it is used for

What isRinalgit ?
This product contains the active ingredient mometasone furoate (as monohydrate).
Mometasone furoate is a corticosteroid that has an anti-inflammatory action, reducing
swelling and irritation that is the cause of sneezing, itching and a stuffy or runny nose.

What is Rinalgit used for?
Hay fever and perennial rhinitis
This medicine is used for the treatment of the symptoms of hay fever (also called
seasonal allergic rhinitis) and perennial rhinitis in adults and children from 3
years of age.
Hay fever, which occurs during certain times of the year, is an allergic reaction caused
by inhaling pollen from trees, grass, weeds and also from molds and fungal spores. Perennial
rhinitis occurs throughout the year and symptoms may be caused by
sensitivity to a variety of things, including dust mites, animal fur (or
dander), feathers and certain foods. This medicine reduces swelling and irritation
of the nose, thereby relieving sneezing, itching and conditions of a stuffy or runny nose caused by hay fever or perennial rhinitis.
Nasal polyps
This medicine is used for the treatment of nasal polyps in adults from 18
years of age.
Nasal polyps are small growths on the inner wall of the nose and generally
affect both nostrils. This medicine reduces inflammation of the nose
causing a gradual narrowing of the polyps, thus relieving the feeling of a stuffy nose and improving breathing through the nose.

2. What you need to know before using Rinalgit

Do not use Rinalgit

• if you are allergicto 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 had nasal surgeryor have had a nasal injury. You should not use the nasal spray until the nasal problem has resolved.

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

• you have, or have had in the past, tuberculosis.
• you have any other type of infection.
• you are taking other corticosteroid medicines, by mouth or through injection.
• you have cystic fibrosis.

During the use of Rinalgit, talk to your doctor

• If your immune system is not working properly (if you have 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 are using this medicine for several months or longer.
• if you have persistent irritation of the nose or throat.

The use of nasal sprays based on corticosteroids at high doses for long periods of time can
lead to the development of undesirable effects due to the absorption of the medicine
into the body.
If you experience itchy or irritated eyes, your doctor may recommend the use of other
treatments to use together with this medicine.
Contact your doctor if you experience blurred vision or other visual disturbances.

Children
If used at high doses and for long periods of time, nasal sprays based on
corticosteroids can cause some undesirable effects, for example a delay in
growth in the child.
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 Rinalgit
Tell your doctor if you are taking or have recently taken any other medicines, including
medicines obtained without a prescription.
Some medicines can increase the effects of Rinalgit and your doctor may want to
keep you under close observation if you are taking these medicines (including some
medicines for the treatment of HIV: ritonavir, cobicistat).
If you are taking other corticosteroid medicines to treat allergies, by mouth or
through injection, your doctor may advise you to stop them when you start taking
Rinalgit.
Some people may find that, when they stop oral or
injection corticosteroids, they suffer from some undesirable effects such as muscle or joint pain,
weakness and depression.
You may also feel that you are developing other allergic reactions such as itching,
watery eyes or red and itchy skin areas. If you develop any of
these effects, you should contact your doctor.

Pregnancy, breastfeeding and fertility
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.
Information on the use of mometasone furoate nasal spray suspension in
pregnant women is scarce or absent. It is not known whether mometasone furoate passes into
breast milk.

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

Rinalgit contains benzalkonium chloride
Benzalkonium chloride can cause irritation and swelling inside the nose, especially if
used
for long periods.

3. How to use Rinalgit

Use this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, ask your doctor or pharmacist. Do not use higher doses or 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 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 tell you to increase the dose; the maximum daily dose is four sprays in each nostril once a day.

Use in children aged between 3 and 11 years
The usual dose is ONE spray in each nostril ONCE a day.
In some patients Rinalgit begins to relieve symptoms within 12 hours of the first dose; however, the overall benefit of treatment may not be visible for the first 2 days.
Therefore, you must continue to use the medicine regularly to achieve the overall benefit of treatment.
If you or your child suffer from a severe form of hay fever, your doctor may tell you to start using Rinalgit a few days before the start of the pollen season, as this will help prevent the occurrence of hay fever symptoms. At the end of the pollen season, the symptoms of hay fever should improve and treatment may therefore not be necessary.

Nasal polyps
Use in adults over 18 years of age
The usual starting dose is TWO sprays in each nostril ONCE a day.

• If after 5 or 6 weeks the symptoms are not controlled, 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 after 5-6 weeks of administration twice a day, you do not notice any improvement in symptoms, you should 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 suspension is produced. To do this, hold the bottle as shown. Position your index and middle finger on the collar, on both sides of the applicator, and your thumb under the bottle. Keep your thumb firm and press down with your fingers on the pump to spray, pointing the applicator away from you. It is recommended to perform at least 10 sprays to prime the bottle for the first use, and at least 2 sprays are needed to re-prime the bottle when it has not been used for 14 or more days.
  [If no sprays are formed and you believe the applicator may be blocked, clean it. (For cleaning, refer to the instructions below). DO NOTtry to unblock the spray hole with a pin or other sharp object, as this will damage the dispensing mechanism.]

3. Blow your nose gently.

4. Hold the bottle as shown. Place your finger on your nose to close one nostril and insert the applicator into the other nostril. Tilt your head forward and keep the bottle in a vertical position. Start to inhale slowly through your nose and at the same time press firmly on the bottle collar with your finger to release a 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 applicator from the nostril and exhale through your mouth. Repeat steps 4 and 5 for the other nostril. After using the spray, carefully clean the applicator with a clean paper 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 preventing it from working correctly.
• 2. Remove the protective cap.
• 3. Gently push up on the white collar to remove the applicator.
• 4. Immerse the applicator and the protective cap in warm water for a few minutes and rinse with running water.
• 5. Let it dry in a warm place before reinserting it. Do not dry near a very hot place.
• 6. Reattach the applicator and “prime” the bottle by pumping the spray several times to produce a fine suspension.

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 or high-dose use of steroids can affect the levels of some hormones. In children, this effect can affect 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 start 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 told you to.
If you have any doubts about the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

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

• 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 do not experience problems after using the nasal spray. However, some
people, after using this medicine or other corticosteroid nasal sprays, may experience:

• headache
• sneezing
• nasal bleeding [occurs very commonly (may affect more than 1 in 10 people) in people with
  nasal polyps treated with two sprays of this medicine in each nostril twice a day]
• nasal or throat pain
• nasal ulcers
• respiratory tract infections

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

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform
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 Rinalgit

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack. The expiry date refers to the last day of that month.
Use within 2 months of first use
Do not store at a temperature above 25°C.
Do not freeze.
Store in the original container.
Do not dispose of any medicine in waste water 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 Rinalgit contains

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

Description of Rinalgit and contents of the pack
Rinalgit is a homogeneous redispersible suspension ranging in colour from white to off-white.
Mometasone furoate nasal spray, suspension is supplied in an opaque white polyethylene bottle with a metered-dose manual spray pump, a white polypropylene vaporiser, a nasal adapter and a translucent protective cap.
Each bottle contains 18.0 g of suspension, equivalent to 140 metered sprays.
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 Turin - Italy

Manufacturers responsible for batch release
S&D Pharma CZ, spol. S.r.o.
Theodor 28, Pchery (Pharmos a.s. facility)
27308
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 Member States of the European Economic Areaand in the
United Kingdom (Northern Ireland)with the following denominations:
Austria Mometason Cipla 50 Micrograms/Spray – Nasal Spray, Suspension
Croatia Mometazonfuorat Cipla 50 micrograms per spray nasal spray, suspension
Denmark Mometason Orion nasal spray, suspension
Finland Mometason Orion, 50 micrograms/dose, nasal spray, suspension
Germany Mometasonfuroat Cipla 50 Micrograms/Spray Nasal Spray, Suspension
Italy Rinalgit
Norway Mometason Orion 50 micrograms/dose nasal spray, suspension
Spain Mometasona furoato Cipla 50 micrograms/spray suspension for nasal spray
United Mometasone furoate 50 micrograms/actuation Nasal Spray, Suspension
Kingdom (Northern
Ireland)