MOMETASONE FUROATE CIPLA 50 micrograms/spray NASAL SUSPENSION

Introduction

Package Leaflet: Information for the User

Mometasone Furoate Cipla 50micrograms/spray suspension for nasal spray

Mometasone furoate (as monohydrate)

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 further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What Mometasone Furoate Cipla nasal spray is and what it is used for.
2. What you need to know before you use Mometasone Furoate Cipla nasal spray.
3. How to use Mometasone Furoate Cipla nasal spray.
4. Possible side effects.
5. Storing Mometasone Furoate Cipla nasal spray.

Contents of the pack and further information.

1. What Mometasone Furoate Cipla nasal spray is and what it is used for

What is Mometasone Furoate Cipla nasal spray?

This medicine contains the active ingredient mometasone furoate (as monohydrate). Mometasone furoate is a corticosteroid that has an anti-inflammatory effect, as it reduces inflammation and irritation that causes sneezing, itching, and a blocked or runny nose.

What is Mometasone Furoate Cipla nasal spray used for?

Hay fever and perennial rhinitis

It is used to treat the symptoms of hay fever (also known as seasonal allergic rhinitis) and perennial rhinitis in adults and children aged 3 years and older.

Hay fever, which occurs at certain times of the year, is an allergic reaction caused by inhaling pollen from trees, grasses, weeds, and also mold and fungus spores. Perennial rhinitis occurs throughout the year and symptoms can be caused by sensitivity to a variety of things including house dust mites, animal hair (or dander), feathers, and certain foods. Mometasone Furoate Cipla reduces the inflammation and irritation of your nose and thereby relieves sneezing, itching, and a blocked or runny nose caused by hay fever or perennial rhinitis.

Nasal polyps

It is used to treat nasal polyps in adults aged 18 years and older.

Nasal polyps are small growths in the lining of the nose and usually affect both nostrils. Mometasone furoate reduces the inflammation in the nose, causing the polyps to shrink gradually, thereby relieving the nasal blockage that can affect your breathing through your nose.

2. What you need to know before you use Mometasone Furoate Cipla nasal spray

Do not use Mometasone Furoate Cipla nasal spray:

• 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 Mometasone Furoate Cipla while you have an untreated nasal infection, such as herpes, can make the infection worse. You should wait until the infection has cleared up before starting to use the nasal spray.
• if you have had recent nasal surgery or injury. You should not use the nasal spray until your nose has healed.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use this medicine if:

• If you have ever suffered from tuberculosis.
• If you have any other type of infection.
• If you are taking other corticosteroids, either by mouth or by injection.
• If you have cystic fibrosis.

While you are using Mometasone Furoate Cipla nasal spray, you must tell your doctor if:

• Your immune system is not functioning properly (if you have difficulty fighting off infections) and you come into contact with someone who has chickenpox or measles. You should avoid coming into contact with anyone who has these infections.
• If you have a nasal or throat infection.
• If you have been using this medicine for several months or more.
• If you have persistent throat or nasal irritation.

If nasal corticosteroid sprays are used at high doses for long periods of time, side effects can occur due to the medicine being absorbed into the body.

If your eyes are itchy or irritated, your doctor may advise you to use other treatments at the same time as Mometasone Furoate Cipla.

Consult your doctor if you experience blurred vision or other visual disturbances.

Children

When used at high doses for long periods of time, nasal corticosteroid sprays can cause side effects, such as slowing down the growth rate in children.

It is recommended to monitor the height of children on long-term treatment with nasal corticosteroids, and if any changes are noticed, you should inform your doctor.

Using Mometasone Furoate Cipla nasal spray with other medicines

Tell your doctor if you are taking or have recently taken any other medicines, including those obtained without a prescription.

Some medicines may increase the effects of Mometasone Furoate Cipla nasal spray, so your doctor will monitor you closely if you are taking these medicines (including some for HIV: ritonavir, cobicistat).

If you are taking other corticosteroids for allergies, either by mouth or by injection, your doctor may advise you to stop taking them when you start using Mometasone Furoate Cipla. When stopping corticosteroids by mouth or injection, some people may experience side effects such as muscle or joint pain, muscle weakness, and depression. You may also develop other allergies, such as itchy, watery eyes, or itchy, red, and blistered skin. If you develop any of these side effects, you should consult your doctor.

Pregnancy, breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

There is limited or no data on the use of mometasone furoate in pregnant women. It is not known whether mometasone furoate is excreted in breast milk.

Driving and using machines

There is no known effect of mometasone furoate on driving or using machines.

Mometasone Furoate Cipla nasal spray contains benzalkonium chloride

Benzalkonium chloride may cause irritation or swelling of the nasal cavity, especially if used for a long period of time.

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3. How to use Mometasone Furoate Cipla nasal spray

Follow the instructions for administration of this medicine exactly as told by your doctor or pharmacist. If you are not sure, ask your doctor or pharmacist again. Do not use a higher dose or use the spray more frequently or for a longer period 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 symptoms are under control, your doctor may recommend reducing the dose.
• If you do not start to feel better, you should consult your doctor and may be advised to increase the dose to the maximum daily dose of four sprays in each nostril once a day.

Use in children aged 3 to 11 years

The usual dose is ONE spray in each nostril ONCE a day.

In some patients, mometasone furoate starts to relieve symptoms within 12 hours of the first dose; however, it is unlikely that the full benefit of treatment will be seen before the first two days. Therefore, regular use should be maintained to achieve the full benefit of treatment.

If you or your child has very severe hay fever, your doctor may advise you to start using mometasone furoate a few days before the start of the pollen season, as it will help prevent hay fever symptoms before they occur. At the end of the pollen season, your hay fever symptoms should have improved, and treatment may then not be necessary.

Nasal polyps

Use in adults over 18 years of age

The usual initial dose is TWO sprays in each nostril ONCE a day.

• If symptoms are not controlled after 5 to 6 weeks, the dose may be increased to two sprays in each nostril twice a day. Once symptoms are under control, your doctor may recommend reducing the dose.
• If there is no improvement in symptoms after 5-6 weeks of using two sprays in each nostril twice a day, you should consult your doctor.

Using the spray

1. Shake the bottle and remove the dust cap.
2. If the spray bottle is new or has not been used for 14 days or more, it will need to be "primed" by pumping the spray a few times until a fine spray is produced. To do this, hold the bottle as shown in the illustration. Place your index and middle fingers on either side of the nozzle, and your thumb underneath the bottle. Keep your thumb firm and press the nozzle with your fingers to pump the spray, keeping the nozzle away from you. It is recommended to perform at least ten sprays to prime the bottle before the first use and at least two sprays to re-prime it if it has not been used for 14 days or more. [If no spray is produced and you think the nozzle may be blocked, clean it. (See the cleaning instructions below). Do nottry to unblock the spray nozzle with a needle or other sharp object, as this will damage the spray mechanism.]
3. Blow your nose gently.
4. Hold the bottle as shown in the illustration. Place one finger on the nose to close one nostril and insert the nozzle into the other nostril. Tilt your head forward and keep the bottle upright. Start to breathe in slowly through your nose and, at the same time, press the bottle down firmly with your finger to release a spray of mometasone furoate.
5. Exhale through your mouth. Repeat step 4 if you need to administer more than one spray in the same nostril.

Remove the nozzle from the nostril and exhale through your mouth. Repeat steps 4 and 5 in the other nostril. After using the spray, clean the nozzle thoroughly with a clean tissue and replace the dust cap.

Cleaning the Mometasone Furoate Cipla bottle

1. Clean the nasal spray at least once a week, as it may become blocked and not work properly.
2. Remove the dust cap.
3. Gently pull the white neck to remove the nozzle.
4. Soak the nozzle and dust cap in warm water for a few minutes, then rinse them under running water.
5. Let it dry in a warm place before reassembling. Do not dry it near a heat source.
6. Reattach the nozzle and prime the bottle by releasing a few sprays into the air until a fine spray is produced.

If you use more Mometasone Furoate Cipla than you should

If you accidentally use more than you should, tell your doctor. You can also contact the Toxicology Information Service, telephone 91.562.04.20, stating the medicine and the amount taken.

If you use steroids for a long time or in large amounts, it can, in rare cases, affect some of your hormones. In children, it can affect growth and development.

If you forget to use Mometasone Furoate Cipla

If you forget to use your nasal spray at the right time, use it as soon as you remember, then follow your normal routine. Do not take a double dose to make up for forgotten doses.

If you stop using Mometasone Furoate Cipla

In some patients, mometasone furoate starts to relieve symptoms 12 hours after the first dose; however, it may take two days to show the full benefit of treatment. It is very important that you use your nasal spray regularly. Do not stop your treatment even if you feel better, unless your doctor tells you to.

If you have any further questions on 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.

Like all medicines, this medicine can cause side effects, although not everybody gets them. Immediate allergic reactions (hypersensitivity) can occur after using this medicine. These reactions can be serious. You should stop using Mometasone Furoate Cipla and seek medical help immediately if you experience symptoms such as:

• swollen face, tongue, or pharynx
• difficulty swallowing
• hives
• fatigue or difficulty breathing

If nasal corticosteroid sprays are used at high doses for long periods of time, side effects can occur due to the medicine being absorbed into the body.

Other side effects

Most people do not have any problems when using the nasal spray. However, some people after using Mometasone Furoate Cipla or other nasal corticosteroid sprays may experience:

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

• headache
• sneezing
• nasal bleeding [very common (may affect more than 1 in 10 people) in people with nasal polyps who are using two sprays of mometasone furoate in each nostril twice a day.]
• nasal or throat pain
• nasal ulcers
• respiratory infection

Frequency not known (cannot be estimated from the available data)

• increased eye pressure (glaucoma) and/or cataracts that can lead to visual disturbances
• damage to the nasal septum that separates the nostrils
• changes in taste and smell
• difficulty breathing and/or fatigue
• Blurred vision

Tell your doctor if you notice any of these side effects.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es/. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Mometasone Furoate Cipla nasal spray

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 carton and bottle after EXP. The expiry date is the last day of the month stated.

Use within two months of first opening.

Do not store above 25°C. Do not freeze. Store in the original package.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

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6. Container Content and Additional Information

Composition of Mometasone Furoate Cipla 50 micrograms/spray suspension for nasal spray

• The active ingredient is mometasone furoate.
• The other components are glycerol, microcrystalline cellulose, sodium carmellose, citric acid monohydrate, polysorbate 80, benzalkonium chloride, sodium citrate dihydrate, and water for injectable preparations.

Each bottle of Mometasone Furoate Cipla 50 micrograms/spray suspension for nasal spray delivers 140 sprays. Each spray delivers 50 micrograms of the active ingredient mometasone furoate (as monohydrate).

Bottles containing 140 metered sprays are presented in packs of 1, 2, or 3 nasal sprays. Only certain pack sizes may be marketed.

Appearance and Container Content

A white opaque plastic bottle equipped with a white metered-dose pump, a white nasal adapter, and a translucent dust cap for the nozzle.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Cipla Europe NV

De Keyserlei 58-60, Box-19, 2018 Antwerp, Belgium.

Manufacturer:

S&D Pharma CZ, spol. s r.o,

Theodor 28, Pchery (Pharmos a.s. facility),

273 08, Czech Republic

or

Cipla Europe NV

De Keyserlei 58-60 Box 19, 2018 Antwerp, Belgium

or

Orion Corporation

Orionpharma, Orionintie, 1 FI- 02200, Finland

or

Orion Corporation

Orion Pharma, Joensuunkatu 7, FI-24100 Salo, Finland

Local Representative:

Cipla Europe NV branch in Spain.

C/Guzmán el Bueno, 133 Edif Britannia-28003- Madrid

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Date of the last revision of this leaflet: May 2021

Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.