Metacort

Package leaflet: Information for the patient

Metacort 50 micrograms/dose Nasal Spray, suspension

mometasone furoate
Equivalent 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 their symptoms are the same as yours, as it may be harmful.
• If any adverse reaction occurs, including those not listed in this leaflet, contact 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 Metacort is and what it is used for

What Metacort is
Metacort contains mometasone furoate, which belongs to a group of medicines known as corticosteroids. Mometasone furoate should not be confused with the "anabolic" steroids abused by some athletes and taken in tablet form or by injection. When mometasone furoate is sprayed into the nose, it can help relieve inflammation (swelling and irritation of the nose), sneezing, itching, and blocked or runny nose.
What is Metacort Nasal Spray used for?
Allergic rhinitis and perennial rhinitis
Metacort is indicated for use in adults and children aged 3 years and older to treat 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, as well as moulds and fungal spores. Perennial rhinitis is present throughout the year, and symptoms may be triggered by sensitivity to various allergens, including house dust mites, animal hair (or dander), feathers, and certain foods. Metacort reduces nasal swelling and irritation, thereby relieving sneezing, itching, and blocked 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 older.
Nasal polyps are small growths that develop on the lining inside the nose and usually affect both nostrils. Metacort reduces nasal inflammation, leading to a gradual shrinkage of nasal polyps, thereby relieving the sensation of nasal blockage that can impair 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 to 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 must wait until the infection has resolved before starting to use the nasal spray.
• if you have recently had nasal surgery or a nasal injury. You should not use the nasal spray until the nasal injury has healed.

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

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

While using Metacort, contact your doctor:

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

When corticosteroid nasal sprays are used at high doses for prolonged periods,
undesirable effects due to systemic absorption of the drug may occur.
If your eyes are itchy or irritated, your doctor may recommend using other treatments
in addition to Metacort.
Contact your doctor if you experience blurred vision or other visual disturbances.
Children and adolescents
When used at high doses for prolonged periods, corticosteroid nasal sprays may
cause certain adverse effects, such as slowed growth in children.
Regular monitoring of height is recommended in children undergoing prolonged treatment with
nasal corticosteroids, and any changes should be reported to the doctor.
Other medicines and Metacort
Inform your doctor or pharmacist if you are taking, have recently taken, or might take
any other medicines.
If you are taking other allergy medications belonging to the corticosteroid family, either
orally or by injection, your doctor may advise you to discontinue such treatment once you start
using Metacort. Some people may find that after stopping oral or injectable corticosteroids,
they experience certain adverse effects such as joint or muscle pain, weakness, and depression.
You may also feel as though you are developing other allergic symptoms, such as itching, tearing, or red, itchy skin rashes. If any of these effects occur, contact your doctor.
Some medicines may increase the effects of Metacort, and your doctor may wish to monitor you closely if you are taking these medicines (including certain HIV treatments: ritonavir, cobicistat).
Pregnancy, breastfeeding, and fertility
There are no data or very limited data on the use of Metacort in pregnant women.
It is not known whether mometasone furoate is excreted in human breast milk.
Metacort should not be used during pregnancy or breastfeeding.
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding,
consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Metacort does not affect the ability to drive or operate machinery.
Metacort contains benzalkonium chloride
This medicine contains 20 micrograms of benzalkonium chloride per spray, which may cause
irritation and swelling inside the nose, especially if used for prolonged periods.

3. How to use Metacort

Use this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist. Do not take a higher dose or use the spray more frequently or for longer than your doctor has instructed.

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 daily.
In some patients, Metacort begins to relieve symptoms within 12 hours of the first dose; however, full therapeutic benefit may not be apparent during the first two days. Therefore, regular use must be continued to achieve the full benefit of treatment.

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

Use in children aged 3 to 11 years
The recommended dose is one spray in each nostril once daily.
If you or your child suffers from severe hay fever, your doctor may recommend starting treatment with mometasone furoate before the start of the pollen season to prevent the onset of hay fever symptoms. At the end of the 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 recommended initial dose is two sprays in each nostril once daily.

• If symptoms are not controlled after 5 or 6 weeks, the dose may be increased to two sprays in each nostril twice daily. Once symptoms are under control, your doctor will instruct you to reduce the dose.
• If you do not observe any improvement in symptoms after 5 or 6 weeks of twice-daily administration, contact your doctor to discuss alternative treatments to replace Metacort.

Preparing the nasal spray for use
Metacort comes with a dust cap that protects the atomizer and keeps it clean. Remember to remove it before using the spray and replace 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 either side of the atomizer and your thumb under the bottle. Do not pierce the nasal applicator.
3. Point the atomizer away from yourself and press with your fingers to actuate the spray 10 times until a fine mist appears. If the spray has not been used for 14 days or more, you must "re-prime" the bottle by actuating the spray 2 times until a fine mist is produced.

How long the nasal spray will last
At a dose of two sprays in each nostril once daily, the product should provide sufficient doses for 15 days (for the 60-metered-spray bottle) and 35 days (for the 140-metered-spray 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 insert the atomizer into the other nostril as shown (Figure 2).

Gently tilt your head forward, keeping the bottle upright.

4. Breathe in gently or slowly through your nose and, during inhalation, administer one spray into the nose by pressing ONCE with your fingers.
5. Breathe out through your mouth. Repeat step 4 to inhale a second spray into the same nostril, if required.
6. Remove the atomizer from the nostril and breathe out through your mouth.

7. Repeat steps 3 to 6 for the other nostril (Figure 3). After using the spray, carefully clean the atomizer with a tissue or clean cloth and replace 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 atomizer.
• Wash the atomizer and dust cap with warm water and 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 you from receiving the correct dose of medicine.
• Allow the dust cap and atomizer to dry thoroughly.
• Reattach the atomizer to the bottle and replace the dust cap.
• After cleaning, the spray must be re-primed with 2 sprays before first use.

If you use more Metacort than you should
If you accidentally use more medicine than prescribed, inform your doctor.
Long-term or high-dose use of steroids may, although rarely, affect certain hormones. In children, this may affect growth and development.

If you forget to use Metacort
If you forget to use the nasal spray at the scheduled 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 using Metacort
In some patients, Metacort begins to relieve symptoms within 12 hours of the first dose; however, full therapeutic benefit may not be evident for two days. It is very important to continue using the nasal spray regularly. Do not stop treatment, even if you feel better, unless instructed by your doctor.

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 everyone gets them.
After using this product, immediate hypersensitivity (allergic) reactions may occur.
These reactions can be severe. You must stop taking Metacort Nasal Spray and seek immediate medical help if any of the following symptoms occur:

• swelling of the face, tongue or throat
• difficulty swallowing
• hives
• wheezing or difficulty breathing.

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

Other side effects
Some people may experience the following after using Metacort or other corticosteroid nasal sprays:
Common side effects (may affect up to 1 in 10 people)

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

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

• increased pressure in the eye (glaucoma) and/or cataracts causing visual disturbances
• damage to the nasal septum (the wall separating the nostrils)
• changes in taste or 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 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 vial and on the outer carton after
Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions. Do not freeze.
The vial should be used within 2 months of first opening.
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 Metacort contains

• The active substance is mometasone furoate. Each spray (0.1 ml) delivers 50 micrograms of mometasone furoate (as monohydrate). The total amount per spray is 100 mg.
• The other components are microcrystalline cellulose and sodium carmellose, 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 white to off-white suspension.
Metacort is a nasal spray, suspension.
Each bottle contains 60 or 140 sprays.
Marketing Authorization 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