Mometasone Zentiva

Package Leaflet: Information for the User

MOMETASONE ZENTIVA 50 micrograms/dose nasal spray, suspension

For prescription-only medicines - RX
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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

For non-prescription medicines - OTC
Read this leaflet carefully before taking this medicine because it contains
important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or
pharmacist has instructed.

• Keep this leaflet. You may need to read it again.
• If you need further information or advice, consult your pharmacist.
• If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement or if your symptoms worsen after 14 days.

Contents of this leaflet:

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

1. What MOMETASONE ZENTIVA is and what it is used for

What MOMETASONE ZENTIVA is
MOMETASONE ZENTIVA nasal spray contains mometasone furoate, which belongs to a group of
medicines called corticosteroids. When mometasone furoate is sprayed into the nose, it helps reduce inflammation (swelling and irritation in the nose), sneezing, itching, and symptoms of a blocked or runny nose.
What MOMETASONE ZENTIVA is used for
Mometasone Zentiva is used to treat symptoms of hay fever (also known as seasonal allergic rhinitis) in adults, after seasonal allergic rhinitis has been initially diagnosed by a doctor.
Hay fever occurring at certain times of the year is an allergic reaction caused by inhaling pollen from trees, grass, weeds, as well as moulds and fungal spores.
Mometasone Zentiva reduces nasal swelling and irritation, thereby relieving sneezing, itching, and a blocked or runny nose caused by hay fever.
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2. What you need to know before using MOMETASONE ZENTIVA

Do not use MOMETASONE ZENTIVA

• 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 Mometasone Zentiva 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 undergone nasal surgery or have suffered a nasal injury. You should not use the nasal spray until the nasal condition has healed.

Warnings and precautions
Talk to your doctor or pharmacist before using MOMETASONE ZENTIVA if

• You have or have had tuberculosis.
• You have any other infection.
• You are taking other corticosteroid medicines, either orally or by injection.
• You have cystic fibrosis.

While using MOMETASONE ZENTIVA, contact your doctor if

• Your immune system is not working properly (difficulty fighting infections) and you are exposed to someone with measles or chickenpox. Avoid contact with people who have these infections.
• You develop a nasal or throat infection.
• You have been using this medicine for several months or longer.
• You experience persistent irritation of the nose or throat.

Prolonged 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 prescribe additional treatments to be used alongside Mometasone Zentiva.
Contact your doctor if you experience blurred vision or other visual disturbances.
For athletes: using this medicine without a therapeutic need constitutes doping and may result in a positive anti-doping test.

Children and adolescents
Mometasone Zentiva must not be used in children and adolescents under 18 years of age.

Other medicines and MOMETASONE ZENTIVA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those obtained without a prescription.
If you are taking other corticosteroid medicines for allergy treatment, either orally or by injection, your doctor may advise you to discontinue that treatment when starting MOMETASONE ZENTIVA. 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 develop other allergic symptoms, such as itching, tearing, or red, itchy skin rashes. Consult your doctor if any of these effects occur.
Some medicines can increase the effects of MOMETASONE ZENTIVA, and your doctor may wish to monitor you closely if you are taking these (including certain HIV treatments: ritonavir, cobicistat).
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Pregnancy, breastfeeding and fertility
Information on the use of Mometasone Zentiva in pregnant women is limited or lacking. It is not known whether mometasone furoate passes into breast milk.
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.

Driving and using machines
There is no available information on the effects of Mometasone Zentiva on the ability to drive vehicles or operate machinery.

MOMETASONE ZENTIVA contains benzalkonium chloride
This medicine contains 20 micrograms of benzalkonium chloride per dose. Benzalkonium chloride may cause irritation or swelling inside the nose, especially if used for prolonged periods.

3. How to use MOMETASONE ZENTIVA

[Rx]
Use this medicine exactly as directed by your doctor or pharmacist. If you are unsure, 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.
[Rx]
Use in adults
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.

In some patients, use of MOMETASONE ZENTIVA may provide symptom relief as early as 12 hours after the first dose. However, full benefit from treatment may not occur until up to two days after the first administration. Therefore, you must continue using the medicine regularly to obtain the full benefit of treatment, and you should not stop treatment even if you feel better, unless instructed otherwise by your doctor.
[OTC]
Always use this medicine exactly as described in this leaflet or as directed by your doctor, pharmacist, or nurse. If you are not sure, consult your doctor, pharmacist, or nurse.
[OTC]
Use in adults
The usual dose is two sprays into each nostril once daily.

• Once symptoms are under control, the dose may be reduced to one spray into each nostril once daily. If symptoms worsen, increase the dose again to two sprays into each nostril once daily.

In some patients, use of MOMETASONE ZENTIVA may provide symptom relief as early as 12 hours after the first dose; however, full benefit from treatment may not occur until up to two days after the first administration. It is very important that you use the nasal spray regularly to obtain the full benefit of treatment.
Duration of treatment:
If there is no improvement or only insufficient improvement in symptoms within a maximum of 14 days, you must consult a doctor. MOMETASONE ZENTIVA must not be used continuously for more than 3 months without medical supervision.
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Method of administration
How to prepare the nasal spray for use
MOMETASONE ZENTIVA nasal spray is equipped with a dust cap that protects the atomizer and keeps it clean.
Remember to remove the cap before using the spray and replace it after use.
If you are using the spray for the first time, you must "prime" the bottle by actuating the pump 10 times until you see a uniform mist:

1. Gently shake the bottle.
2. Place your index and middle fingers on either side of the atomizer and your thumb at the base of the bottle. Do not pierce the nasal applicator.
3. Point the atomizer away from yourself and press the dispenser with two fingers, releasing the spray 10 times until a uniform mist is produced.
   If you do not use the spray for more than 14 days, you must "re-prime" the pump by releasing 2 sprays until you observe a uniform mist.

At the usual dose of 2 sprays in each nostril once daily, for the treatment of hay fever, this product is sufficient to cover a 15-day treatment (bottle containing 60 sprays), 30 days (bottle containing 120 sprays), or 35 days (bottle containing 140 sprays).

How to use the nasal spray.

1. Gently shake the bottle and remove the dust cap.
2. Gently blow your nose.
3. Close one nostril and insert the atomizer into the other. Tilt your head slightly forward, keeping the container upright.
4. Begin to inhale gently or slowly through your nose, and administer one spray into the nostril by pressing ONCE with your fingers.
5. Exhale 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 exhale through your mouth.
7. Repeat steps 3 to 6 for the other nostril. After use, clean the atomizer 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 atomizer. Wash the atomizer and dust cap with lukewarm water, then rinse under running water. Do not attempt to unblock the nasal applicator by inserting a needle or any other sharp object, as this may damage the applicator and prevent correct delivery of the medicine.
Allow to dry in a warm place. Reinsert the atomizer into the container 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 MOMETASONE ZENTIVA than you should
Inform your doctor if you have accidentally taken a higher dose than prescribed.
If you use steroids for a long time or at high doses, in rare cases they may affect the levels of certain hormones.
If you forget to take MOMETASONE ZENTIVA
If you forget to take MOMETASONE ZENTIVA nasal spray at the scheduled time, take it as soon as you remember, then continue your treatment as usual. Do not take a double dose to make up for the missed dose.
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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 experiences them.
Immediate hypersensitivity (allergic) reactions may occur with the use of this medicine.
These reactions can be severe. You must stop using MOMETASONE ZENTIVA and seek immediate medical assistance 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, adverse 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 may experience the following after using mometasone furoate (the active substance in MOMETASONE ZENTIVA) or other corticosteroid nasal sprays:
Common (may affect up to 1 in 10 people)

• Headache.
• Sneezing.
• Nosebleeds.
• Nasal pain.
• Ulcers in the nose.
• Respiratory tract infections.

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

• Increased pressure inside the eyes (glaucoma) and/or cataracts causing visual disturbances.
• Damage to the nasal septum separating the nostrils.
• Taste and smell disturbances.
• 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 may also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.
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5. How to store MOMETASONE ZENTIVA

Keep this medicine out of the sight and reach of children.
Do not store above 25°C.
Do not use MOMETASONE ZENTIVA after the expiry date stated on the bottle and the carton after "exp". The expiry date refers to the last day of that month.
Each bottle should be used within two months of first opening. Open only one bottle 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 MOMETASONE ZENTIVA contains

• The active substance is: mometasone furoate. Each delivered dose contains 50 micrograms of anhydrous mometasone furoate.
• The other components are: benzalkonium chloride, glycerol, polysorbate 80, microcrystalline cellulose and sodium carboxymethylcellulose, citric acid monohydrate, sodium citrate, purified water.

Description of the appearance of MOMETASONE ZENTIVA and package contents
MOMETASONE ZENTIVA is a nasal spray, suspension.
Each bottle may contain: 60 sprays, 120 sprays, or 140 sprays (supplied in 1 nasal spray).
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Zentiva Italia S.r.l.
Via P. Paleocapa, 7
20121 Milano
Italy
Manufacturer
FARMEA
10, rue Bouché Thomas
Z.A.C d’Orgemont
49000 ANGERS
France
and
This medicinal product is authorized in the European Economic Area Member States under the following names:
Denmark: Mometasonfuroat Zentiva
Czech Republic, Slovakia: Metsandia
Germany: MOMETASON ADGC 50 Mikrogramm/Sprühstoß
Italy: Mometasone Zentiva
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Poland: Zodgane
Portugal: Zenayr Rinus
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