Mometasone Teva

Package leaflet: Information for the user

Mometasone Teva 50 micrograms/dose Nasal Spray

Mometasone Furoate
Generic medicine
Please read all of this leaflet carefully before you start 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 other people, even if they have the same symptoms as you, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Mometasone Teva Nasal Spray is and what it is used for

What is Mometasone Teva Nasal Spray?
Mometasone Teva 50 micrograms/dose Nasal Spray, Suspension 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, which are taken in tablet or injectable form. When mometasone furoate is sprayed into the nose, it helps relieve inflammation (swelling and irritation of the nose), sneezing, itching, and nasal congestion or runny nose.
What is Mometasone Teva Nasal Spray used for?
Hay fever and perennial rhinitis
Mometasone Teva Nasal Spray 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 at certain times of the year and is an allergic reaction caused by inhaling pollens from certain plants, grasses, and weeds, as well as moulds and fungal spores. Perennial rhinitis occurs throughout the year, and its symptoms may be due to sensitivity to a wide range of allergens such as house dust mites, animal hair (or dander), feathers, and certain foods. Mometasone Teva Nasal Spray reduces nasal swelling and irritation, thereby relieving sneezing, itching, and blocked or runny nose caused by hay fever or perennial rhinitis.
Nasal polyps
Mometasone Teva Nasal Spray is used to treat 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. Mometasone Teva Nasal Spray reduces nasal inflammation, leading to a gradual shrinkage of nasal polyps, thus relieving the sensation of nasal obstruction that can affect breathing through the nose.

2. What you need to know before using Mometasone Teva Nasal Spray

Do not use Mometasone Teva Nasal Spray:

• if you are allergic to mometasone furoate or to any of the other excipients of this medicine (listed in section 6).
• if you have an untreated nasal infection. The use of Mometasone Teva Nasal Spray 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 sustained a nasal injury. You must not use the nasal spray until the nasal injury has healed.

Warnings and precautions
Before using Mometasone Teva Nasal Spray, speak to your doctor or pharmacist

• if you have or have ever had tuberculosis
• if you have any other infection
• if you are taking other medicines belonging to the corticosteroid family, either by mouth or by injection
• if you have cystic fibrosis.

While using Mometasone Teva Nasal Spray, speak to your doctor

• if your immune system is not working properly (if you have difficulty fighting infections) and you have been in contact with people who have 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 of the nose or throat.

When nasal corticosteroid sprays are used at high doses for prolonged periods,
adverse effects due to systemic absorption of the drug may occur.
If your eyes are itchy or irritated, your doctor may recommend additional treatments with
Mometasone Teva Nasal Spray.
Contact your doctor if you experience blurred vision or other visual disturbances.
Children
When used at high doses for prolonged periods, nasal corticosteroid sprays
may cause certain adverse effects, such as slowed growth in children.
Regular monitoring of height is recommended in children receiving long-term treatment with
nasal corticosteroids, and any changes should be reported to the doctor.
Other medicines and Mometasone Teva Nasal Spray
Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including
medicines obtained without a prescription.
If you are taking other allergy medications belonging to the corticosteroid family, either by mouth or
by injection, your doctor may advise you to stop taking them once you start using
Mometasone Teva Nasal Spray. 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 develop other allergic manifestations, such as itchy eyes, increased tearing, or red, itchy skin rashes.
If any of these effects occur, contact your doctor.
Some medicines may increase the effects of Mometasone Teva Nasal Spray, 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, or very limited, data on the use of Mometasone Teva Nasal Spray in
pregnant women. It is not known whether mometasone furoate is excreted in breast milk.
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding,
please consult your doctor or pharmacist before using this medicine.
Driving and using machines
There is no information available on the effects of Mometasone Teva Nasal Spray on the ability to drive or
use machinery.
Mometasone Teva Nasal Spray contains benzalkonium chloride
Mometasone Teva Nasal Spray contains the ingredient benzalkonium chloride, which may cause nasal irritation.

3. How to use Mometasone Teva Nasal Spray

Use this medicine exactly as your doctor has instructed you. 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 your doctor has prescribed.

Treatment of hay fever and perennial rhinitis

Use in adults and children aged 12 years and over
The recommended dose is two sprays into each nostril once daily.
In some patients, Mometasone Teva Nasal Spray begins to relieve symptoms within 12 hours of the first dose; however, full benefit from treatment may not be apparent within the first two days. Therefore, regular use must be continued to achieve the full therapeutic effect.

• Once symptoms are under control, your doctor may advise you to reduce the dose to one spray into each nostril once daily.
• If you do not begin to improve, consult your doctor, who may recommend increasing the dose. The maximum daily dose is four sprays into each nostril once daily.

Use in children aged between 3 and 11 years
The recommended dose is one spray into each nostril once daily.
If you or your child suffers from severe hay fever, your doctor may suggest starting treatment with Mometasone Furoate before the start of pollen season to prevent the onset of hay fever symptoms. At the end of pollen season, hay fever symptoms should have improved and treatment may no longer be necessary.

Nasal polyps
Use in adults aged over 18 years
The recommended initial dose is two 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. Once symptoms are under control, your doctor will ask you to reduce the dose to the lowest amount that keeps symptoms under control.
• If there is no improvement in symptoms after 5 or 6 weeks of twice-daily administration, contact your doctor to discuss alternative treatments to replace Mometasone Teva Nasal Spray.

Preparing the nasal spray for use
The Mometasone Teva Nasal Spray pump is equipped with a dust cap that protects the nozzle 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 pump 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 nozzle and your thumb under the bottle. Do not pierce the nasal applicator.
3. Point the nozzle away from you and press down with your fingers to actuate the pump 10 times until a fine mist appears. If the spray has not been used for 14 days or more, you need to “re-prime” the bottle by actuating the pump twice until a fine mist is produced.

How long the nasal spray will last
At a dose of two sprays into each nostril once daily, the product should provide sufficient doses for 15 days (60-spray bottle), 30 days (120-spray bottle), and 35 days (140-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 nozzle into the other nostril as shown (Figure 2). Tilt your head slightly forward, keeping the bottle upright.
4. Breathe in gently or slowly through your nose and, during inhalation, press down ONCE with your fingers to spray into the nostril.
5. Breathe out through your mouth. Repeat step 4 to administer a second spray into the same nostril, if applicable.
6. Remove the nozzle from the nostril and breathe out through your mouth.

7. Repeat steps 3 to 6 for the other nostril (Figure 3).

After using the nasal spray, clean the nozzle carefully with a tissue or clean cloth and replace the dust cap.

Cleaning the nasal spray pump

• It is important to clean the nasal spray pump regularly; otherwise, it may not work properly.
• Remove the dust cap and gently pull the nozzle outward.
• Wash the nozzle and dust cap with warm water and rinse under running water.
• Do not try to unblock the nasal applicator by inserting a needle or any other sharp object, as this may damage the applicator and prevent the correct dose of medicine from being delivered.
• Allow the dust cap and nozzle to dry thoroughly.
• Reattach the nozzle to the bottle and replace the dust cap.
• After cleaning, the spray must be re-primed with two sprays before first use.

If you use more Mometasone Teva Nasal Spray than you should
If you accidentally use more medicine than prescribed, inform your doctor.
If steroids are used for a long time or in large amounts, they may, although rarely, affect certain hormones. In children, this may affect growth and development.

If you forget to use Mometasone Teva Nasal Spray
If you forget to use the nasal spray at the correct time, use it as soon as you remember, then continue as before. Do not take a double dose to make up for a forgotten dose.

If you stop using Mometasone Teva Nasal Spray
In some patients, Mometasone Teva Nasal Spray begins to relieve symptoms 12 hours after the first dose; however, full benefits of treatment may not occur before 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 doubts about how to use 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.
After using this product, immediate hypersensitivity reactions (allergic reactions) may occur. These reactions can be severe. You must stop taking Mometasone Teva 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 nasal corticosteroid sprays are used at high doses for long periods of time, side effects due to drug absorption into the body may occur.

Other side effects
Most people do not experience any problems after using the nasal spray. However, some people, after using Mometasone Teva Nasal Spray or other nasal corticosteroid sprays, may experience:

Common (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 Mometasone Teva Nasal Spray 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 eye pressure (glaucoma) and/or cataract causing visual disturbances
• damage to the nasal septum (the wall dividing the nostrils)
• changes in taste or smell
• difficulty breathing and/or wheezing
• 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 the following website: http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Mometasone Teva

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial and carton after 'Exp.'.
The expiry date refers to the last day of that month.
Do not store above 25°C. Do not freeze.
The nebulizer must be used within 8 weeks of first use.
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 Teva Nasal Spray contains

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

Description of the appearance of Mometasone Teva Nasal Spray and contents of the pack
Mometasone Teva is a nasal spray suspension.
Each bottle contains 60, 120 or 140 sprays.
Bottles containing 60 or 120 sprays are supplied in single packs.
Bottles containing 140 sprays are supplied in packs of 1, 2 or 3 nasal sprayers.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Teva Italia S.r.l. - Piazzale Luigi Cadorna, 4 - 20123 Milan, Italy
Manufacturers:
Teva Czech Industries s.r.o.
Ostravská 29, č.p. 305, 747 70 Opava – Komárov, Czech Republic
Merckle GmbH (Batch release site – Germany only)
Ludwig-Merckle-Str. 3
89143 Blaubeuren, Germany
Teva Pharma B.V.
Swensweg 5, 2031 GA, Haarlem, Netherlands

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Austria – Mometason Ratiopharm 50 µg/Dosis Nasenspray
Belgium – Mometasone Teva 50 microgram per verstuiving, neusspray, suspensie
Bulgaria – Mometasone Teva
Cyprus – Mometasone Teva 50 mcg/ψεκασμό Ρινικό εκνέφωμα, εναιώρημα
Germany – Mometasonfuroat AbZ 50 Mikrogramm/Sprühstoß Nasenspray, Suspension
Denmark – Mometasonfuroat Teva
Estonia – Mometasone Teva
Greece – Mometasone Teva 50 mcg/ψεκασμό Ρινικό εκνέφωμα, εναιώρημα
Spain – Mometasona Teva 50 microgramos suspensión para pulverizacion nasal EFG
Finland – Momesonex 50 mikrog/annos nenäsumute, suspensie
France – MOMETASONE TEVA 50 microgrammes/dose, suspension pour pulvérisation nasale
Hungary – Nasotasone 50 mcg szuszpenziós adagolt orrspray
Ireland – Mometasone furoate Teva 50 micrograms/actuation nasal spray suspension
Iceland – Momesonex 50 míkrógrömm/skammt nefúði, dreifa
Italy – Mometasone TEVA
Lithuania – Mometasone Teva 50 mikrogramų/dozėje nosies purškalas (suspensija)
Latvia – Mometasone Furoate Teva 50 mikrogrami/izsmidzinājumā deguna aerosols, suspensija
Netherlands – Mometasonfuroaat Teva 50 microgram/verstuiving, neusspray, suspensie
Poland – Pronasal
Portugal – Mometasona Teva
Sweden – Mometasone Teva 50 mikrogram/dos nässpray, suspension
Slovenia – Mometazonfuroat Teva Pharma 50 mikrogramov/vpih pršilo za nos, suspenzija
United Kingdom – Mometasone Furoate 50 micrograms/actuation Nasal Spray, Suspension