METACORT 50 MICROGRAMS Nasal spray, suspension

Зміст інструкції

1. Metacort 50 micrograms/spray Nasal Spray, suspension
   1. What is Metacort and what is it used for
   2. What you need to know before using Metacort
   3. How to use Metacort
   4. Possible side effects
   5. How to store Metacort
   6. Contents of the pack and other information

Metacort 50 micrograms/spray Nasal Spray, suspension

mometasone furoate
Equivalent medicinal product

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 pass it on to others, 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 Metacort is and what it is used for
• 2. What you need to know before using Metacort
• 3. How to use Metacort
• 4. Possible side effects
• 5. How to store Metacort
• 6. Contents of the pack and other information

1. What is Metacort and what is it used for

What is Metacort
Metacort contains mometasone furoate, which belongs to a group of medicines called
corticosteroids. Mometasone furoate should not be confused with the “anabolic” steroids abused by some athletes and taken in tablet or injection form. When mometasone
furoate is sprayed into the nose, it can help relieve inflammation (swelling and irritation
of the nose), sneezing, itching and a stuffy or runny nose.

What is Metacort Nasal Spray used for?
Seasonal allergic rhinitis and perennial rhinitis
Metacort is indicated for use in adults and children aged 3 years and over to treat the
symptoms of seasonal allergic rhinitis (also known as hay fever) or perennial rhinitis.
Hay fever, which occurs at certain times of the year, is an allergic reaction caused
by breathing in pollen from trees, grasses, 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 house dust mites, animal dander (or flakes), feathers and
certain foods. Metacort reduces nasal swelling and irritation, thereby relieving sneezing, itching and
a stuffy or runny nose caused by hay fever or perennial rhinitis.
Nasal polyps
Metacort is indicated for the treatment of nasal polyps in adults aged 18 years and over.
Nasal polyps are small growths that grow on the lining of the nose and usually
affect both nostrils. Metacort reduces nasal inflammation, causing a gradual reduction
in nasal polyps, thereby relieving the feeling of a blocked nose which can affect breathing
through the nose.

2. What you need to know before using Metacort

Do not use Metacort:

• if you are allergic to mometasone furoate or any of the other ingredients of this medicine (listed in section 6).
• if you have an untreated nasal infection. Using Metacort during an untreated nasal infection, such as herpes, may worsen the infection. You should wait for the infection to pass before starting to use the nasal spray.
• if you have recently had nasal surgery, or if you have injured your nose. You should not use the nasal spray until the nasal wound has healed.

Warnings and precautions
Talk to your doctor or pharmacist before using Metacort:

• if you suffer from or have suffered from tuberculosis
• if you suffer from any other infection
• if you have a perforation of the nasal septum
• if you are taking other medicines belonging to the corticosteroid family, either by mouth or by injection
• if you suffer from cystic fibrosis.

While you are using Metacort, contact your doctor:

• if your immune system is not working properly (if you have difficulty fighting infections) and if you have been in contact with a person suffering from measles or chickenpox. You should avoid contact with someone who has these infections.
• if you have an infection in your nose or throat
• if you are using the medicine for several months or longer
• if you have persistent irritation of the nose or throat.

When nasal sprays based on corticosteroids are used at high doses for long periods of time,
undesirable effects may occur due to the absorption of the drug into the body.
If your eyes itch or are irritated, your doctor may recommend using other treatments
along with Metacort.
Contact your doctor if you experience blurred vision or other visual disturbances.

Children and adolescents
When used at high doses for long periods of time, nasal sprays based on corticosteroids can
cause some undesirable effects, such as slowed growth in children.
It is recommended to regularly monitor the height of children undergoing prolonged treatment with
nasal corticosteroids and, if any changes are noticed, to report them to the doctor.

Other medicines and Metacort
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
If you are taking other medicines for allergies belonging to the corticosteroid family, either by
mouth or by injection, your doctor may advise you to stop this treatment once you
start using Metacort. Some people may find that once they stop taking corticosteroids by mouth or by injection, they experience some undesirable effects, such as joint or muscle pain, weakness and depression. You may also seem to develop other forms
of allergies, such as itching, tearing or red and itchy patches on the skin. If any of these effects occur, contact your doctor.
Some medicines can increase the effects of Metacort 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).

Pregnancy, breastfeeding and fertility
There is no information, or there are too few data, on the use of Metacort in pregnant women.
It is not known whether mometasone furoate is released into breast milk.
Metacort should not be used during pregnancy or breastfeeding.
If you are pregnant, suspect you are pregnant, are planning a pregnancy, or are breastfeeding with
breast milk, ask your doctor or pharmacist for advice before taking this medicine.

Driving and operating machinery
Metacort does not affect the ability to drive vehicles or operate machinery.

Metacort contains benzalkonium chloride
This medicine contains 20 micrograms of benzalkonium chloride per delivery, which may cause
irritation and swelling inside the nose, especially if used for long periods.

3. How to use Metacort

Use this medicine following the instructions of your doctor exactly. If you have any doubts, consult your
doctor or pharmacist. Do not take a higher dose or use the spray more often or for longer than
told by your doctor.

Treatment of hay fever and perennial rhinitis
Use in adults and children over 12 years of age
The recommended dose is two sprays in each nostril once a day.
In some patients, Metacort begins to relieve symptoms within 12 hours of the first dose; however, a
complete benefit of treatment may not be seen in the first two days. Therefore, it is necessary to
continue regular use to achieve the full benefit of treatment.

• Once the symptoms are under control, your doctor may advise you to reduce the dose to one spray in each nostril once a day.
• If you do not experience any improvement, you should 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 aged 3 to 11 years
The recommended dose is one spray in each nostril once a day.
If you or your child suffer from severe hay fever, your doctor may suggest starting to use
mometasone furoate before the start of the pollen season, in order to prevent the onset of
hay fever symptoms. At the end of the pollen season, hay fever symptoms should be improved and treatment may no longer be necessary.

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

• If the symptoms are not under control after 5 or 6 weeks, it is possible to increase the dose to two sprays in each nostril twice a day. Once the symptoms are under control, your doctor will ask you to reduce the dose.
• If you do not observe any improvement in symptoms after 5 or 6 weeks of administration twice a day, you should contact your doctor to discuss other treatments to replace Metacort.

Preparing the nasal spray for use
Metacort is equipped with a dust cap that protects the spray nozzle 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 need to “prime” the bottle by actuating the spray 10
times until a fine mist is produced:

• 1. Gently shake the bottle.
• 2. Place your index and middle fingers on the sides of the nozzle and your thumb under the bottle. Do notpuncture the nasal applicator.
• 3. Point the nozzle away from yourself and press with your fingers to actuate the spray for 10 times until a light mist is obtained. If the spray has not been used for 14 days or more, you need to “recharge” the bottle by actuating the spray 2 times until a fine mist is produced.

How long will the nasal spray last
At a dose of two sprays in each nostril once a day, the product should provide sufficient doses for 15 days (for the 60-dose bottle) and 35 days (for the 140-dose bottle
bottle).

How to use the nasal spray

• 1. Gently shake the bottle and remove the dust cap. (Figure 1)
• 2. Gently blow your nose.
• 3. Close one nostril and position the nozzle in the other nostril as shown (Figure 2).

Tilt your head slightly forward, keeping the bottle upright.

• 4. Gently or slowly inhale through your nose and, during inhalation, administer one spray into your nose by pressing ONCE with your fingers.
• 5. Exhale through your mouth. Repeat step 4 to inhale a second spray into the same nostril, if necessary.
• 6. Remove the nozzle from the nostril and exhale through your mouth.

• 7. Repeat steps 3 to 6 for the other nostril (Figure 3). After using the spray, carefully clean the nozzle with a tissue or clean cloth and reposition the dust cap.

Cleaning 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 and rinse with running water.
• Do not try to unblock the nasal applicator by inserting a pin or other sharp object, as this maneuver will damage the applicator and therefore will not allow you tohave the right dose of medicine.
• Let the dust cap and nozzle air dry in a warm place.
• Reposition the nozzle on the bottle and replace the dust cap.
• At the first use after cleaning, the spray will need to be primed again with 2 sprays.

If you use more Metacort than you should
If you accidentally use more medicine than you should, inform your doctor.
If you use steroids for a long time or in large quantities, they can, although rarely, affect some hormones. In children, this can affect growth and development.

If you forget to use Metacort
If you forget to use the nasal spray at the right time, use it as soon as you remember, then
continue as before. Do not take a double dose to make up for the missed dose.

If you stop treatment with Metacort
In some patients, Metacort starts to relieve symptoms 12 hours after the first dose; however, the full benefit of treatment may not be seen before two days. It is very important to continue to
use the nasal spray regularly. Do not stop taking it, even if you feel better, unless
told by your doctor.
If you have any doubts about 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.
After using this product, immediate hypersensitivity (allergic) reactions may occur.
These reactions can be serious. You must stop taking Metacort Spray Nasale and
seek immediate medical help if you experience symptoms such as:

• 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 drug into the body may occur.

Other side effects
Some people, after using Metacort or other corticosteroid nasal sprays, may
suffer from:

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

• headache
• sneezing and irritation/burning sensation in the nose
• nosebleeds [occurred very commonly (may affect more than 1 in
• 10) in people with nasal polyps treated with two sprays of Metacort 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 in the eye (glaucoma) and/or cataracts causing visual disturbances
• damage to the nasal septum separating the nostrils
• changes in taste or 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 Metacort

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 bottle and the packaging after
Exp. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions. Do not freeze.
The bottle must be used within 2 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 Metacort contains

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

Description of the appearance of Metacort and contents of the pack
Metacort is an opaque suspension of colour from white to whitish.
Metacort is a nasal spray, suspension.
Each bottle contains 60 or 140 sprays.

Marketing Authorisation Holder
S.F. Group S.r.l.
Via Tiburtina 1143
00156 Roma

Manufacturer
Teva Czech Industries s.r.o.
Ostravská 29, č.p. 305
Opava, Komárov 74770
Czech Republic