Mometasone furoate Cipla 50 micrograms/spray suspension for nasal spray

Package Leaflet: Information for the User

Introduction

Package Leaflet: Information for the User

Mometasone furoate Cipla 50 micrograms/spray nasal suspension

Mometasone furoate (as monohydrate)

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet Contents:

1. What Mometasone furoate Cipla nasal suspension is and what it is used for.
2. What you need to know before using Mometasone furoate Cipla nasal suspension.
3. How to use Mometasone furoate Cipla nasal suspension.
4. Possible side effects.
5. How to store Mometasone furoate Cipla nasal suspension.

Contents of the pack and other information.

1. What Mometasona furoato Cipla nasal spray suspension is and what it is used for

What is Mometasona furoato Cipla nasal spray suspension?

This medicine contains the active substance mometasona furoato (in the form of monohydrate). Mometasona furoato is a corticosteroid that has an anti-inflammatory effect, as it reduces inflammation and irritation causing sneezing, itching, nasal congestion, or runny nose.

What is Mometasona furoato nasal spray suspension 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, as well as mold and fungal spores. Perennial rhinitis occurs throughout the year, and symptoms may be triggered by sensitivity to various allergens including house dust mites, animal hair (or epithelial cells), feathers, and certain foods. Mometasona furoato Cipla reduces inflammation and irritation in your nose, thereby relieving sneezing, itching, nasal congestion, and nasal discharge 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 nasal passages and usually affect both nostrils. Mometasona furoato reduces inflammation in the nose, gradually shrinking the polyps and thereby relieving nasal congestion that may impair your ability to breathe through the nose.

2. What you need to know before using Mometasone furoate Cipla nasal spray suspension

Do not use Mometasone furoate Cipla nasal spray suspension:

• 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 furoate Cipla while you have an untreated nasal infection, such as herpes, may worsen the infection. You should wait until the infection has cleared before starting to use the nasal spray.
• if you have recently undergone nasal surgery or have had a recent injury to your nose. You should not use the nasal spray until your nose has healed.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before using this medicine if:

• You have or have ever had tuberculosis.
• You have any other type of infection.
• You are taking other corticosteroids, either by mouth or by injection.
• You have cystic fibrosis.

While using mometasone furoate nasal spray suspension, inform your doctor if:

• Your immune system does not work properly (if you have difficulty fighting infections) and you come into contact with someone who has chickenpox or measles. You should avoid contact with anyone who has these infections.
• You develop a nasal or throat infection.
• You are using this medicine for several months or longer.
• You experience persistent irritation of the throat or nose.

If corticosteroid nasal sprays are used at high doses over long periods of time, adverse effects may occur because the medicine is absorbed into the body.

If your eyes are itchy or irritated, your doctor may recommend using other treatments alongside Mometasone furoate Cipla.

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

Children

When used at high doses over long periods of time, corticosteroid nasal sprays may cause side effects such as slowed growth rate in children.

It is recommended that the height of children receiving long-term treatment with nasal corticosteroids be monitored regularly. If any changes are observed, inform your doctor.

Using Mometasone furoate Cipla nasal spray suspension 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 suspension, so your doctor will monitor you closely if you are taking these medicines (including some used 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 discontinuing oral or injectable corticosteroids, some people may experience adverse effects such as muscle or joint pain, muscle weakness, or depression. You may also develop other allergic symptoms such as watery eyes, itchy eyes, or red, itchy skin rashes. If you experience any of these adverse effects, consult your doctor.

Pregnancy and breastfeeding

If you are pregnant, breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

There is limited or no information available on the use of mometasone furoate in pregnant women. It is unknown whether mometasone furoate is excreted in human breast milk.

Driving and using machines

There is no known information regarding the effect of mometasone furoate on driving or operating machinery.

Mometasone furoate Cipla nasal spray suspension contains benzalkonium chloride

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

3. How to use Mometasone furoate Cipla nasal spray

Follow exactly the instructions for use of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. Do not use a higher dose, or use the spray more frequently or for a longer period than indicated 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 into each nostril ONCE daily.

• Once symptoms are under control, your doctor may recommend reducing the dose.
• If you do not start to feel better, consult your doctor, who may advise increasing the dose to the maximum daily dose of four sprays into each nostril once daily.

Use in children aged 3 to 11 years

The usual dose is ONE spray into each nostril ONCE daily.

In some patients, mometasone furoate begins to relieve symptoms within 12 hours of the first dose; however, optimal treatment effect is unlikely to be seen before the first two days. Therefore, regular use should be maintained to achieve the optimal treatment effect.

If you or your child suffers from severe hay fever, your doctor may advise starting mometasone furoate a few days before the pollen season begins, as this 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 no longer be necessary.

Nasal polyps

Use in adults over 18 years of age

The initial usual dose is TWO sprays into each nostril ONCE daily.

• If symptoms are not controlled after 5 to 6 weeks, the dose may be increased to two sprays into each nostril twice daily. Once symptoms are under control, your doctor may advise reducing the dose.
• If there is no improvement in symptoms after 5–6 weeks of twice-daily administration, consult your doctor.

Use of 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 must be "primed" by pumping the spray several times until a fine mist appears. Hold the bottle as shown in the illustration. Place your index and middle fingers on the neck, one on each side of the nozzle, and your thumb beneath the bottle. Keep your thumb steady and press down on the neck with your fingers to pump the spray, keeping the nozzle pointed away from you. At least ten sprays are recommended to prime the bottle before first use, and at least two sprays to re-prime if not used for 14 days or more. [If no spray comes out and you suspect the nozzle may be blocked, clean it. (See cleaning instructions below). Do not attempt to unblock the spray nozzle with a needle or other sharp object, as this will damage the spray mechanism.]
3. Gently blow your nose.
4. Hold the bottle as shown in the illustration. Place a finger on one nostril to close it, and insert the nozzle into the other nostril. Tilt your head forward and keep the bottle upright. Begin to inhale slowly through your nose and, at the same time, press firmly down on the neck of the bottle with your finger to release a spray of mometasone furoate.
5. Breathe out through your mouth. Repeat step 4 if more than one spray is required in the same nostril.

Remove the nozzle from the nostril and breathe out 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 stop working properly.
2. Remove the dust cap.
3. Gently pull the white neck to remove the nozzle.
4. Soak the nozzle and dust cap in hot water for a few minutes, then rinse them under running tap water.
5. Allow them to dry in a warm place before reassembling. Do not dry near a source of excessive heat.
6. Reattach the nozzle and prime the bottle by releasing a few sprays into the air until a fine mist is obtained.

If you use more Mometasone furoate Cipla than you should

If you accidentally use more than you should, inform your doctor. You may also call the Toxicology Information Service at telephone number 91.562.04.20, indicating the medicine and the amount taken.

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

If you forget to use Mometasone furoate Cipla

If you forget to use your nasal spray at the scheduled time, use it as soon as you remember, then continue with your normal dosing schedule. Do not use a double dose to make up for a missed dose.

If you stop using Mometasone furoate Cipla

In some patients, mometasone furoate begins to relieve symptoms within 12 hours of the first dose; however, the full benefit of treatment may not be evident until two days later. It is very important that you use your nasal spray regularly. Do not stop treatment even if you feel better, unless your doctor tells you to do so.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Immediate hypersensitivity (allergic) reactions may occur after using this medicine. These reactions can be serious. You must stop treatment with Mometasona furoato Cipla and seek immediate medical help if you experience symptoms such as:

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

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

Other adverse effects

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

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

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

Frequency not known (cannot be estimated from available data)

• increased intraocular pressure (glaucoma) and/or cataracts, which may lead to visual disturbances
• damage to the nasal septum separating the nostrils
• disturbances in taste and smell
• difficulty breathing and/or fatigue
• blurred vision

Consult your doctor if you notice any of these adverse effects.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es/. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Mometasone furoate Cipla nasal spray suspension

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 on the bottle after EXP. The expiry date refers to the last day of the month indicated.

Use within a maximum of two months after first use.

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

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Mometasona furoato Cipla 50 micrograms/spray nasal suspension for nasal spray

• The active substance is mometasona furoato.
• The other components are glycerol, microcrystalline cellulose, sodium carboxymethylcellulose, citric acid monohydrate, polysorbate 80, benzalkonium chloride, sodium citrate dihydrate and water for injections.

Each bottle of Mometasona furoato Cipla 50 micrograms/spray nasal suspension for nasal spray delivers 140 sprays. Each spray delivers 50 micrograms of the active substance mometasona furoato (in the form of monohydrate).

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

Appearance of the product and contents of the pack

A white opaque plastic bottle equipped with a white metered dose spray 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 60C, Bus-1301,
2018 Antwerp, Belgium.

Manufacturer:

S&D Pharma CZ, spol. s r.o,
Theodor 28, Pchery (Pharmos a.s. facility),
273 08, Czech Republic

Cipla Europe NV
De Keyserlei 60C Bus-1301,
2018 Antwerp, Belgium

Orion Corporation
Orionpharma, Orionintie,
1 FI-02200, Finland

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

Local Representative:

Cipla Europe NV, Spanish branch
C/Guzmán el Bueno, 133, Edif. Britannia, 28003 Madrid, Spain

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 up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.