Label: information for the user

Mometasona furoate Cipla 50micrograms/spray nasal suspension

Mometasona furoate (in the form of monohydrate)

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor, or pharmacist.
• This medication has been prescribed only to you, and you should not give it to others who have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

Contents of the package and additional information.

What is Mometasona furoato Cipla nasal spray?

This medication contains the active ingredient mometasona furoate (in the form of monohydrate). Mometasona furoate is a corticosteroid that exerts an anti-inflammatory effect, reducing inflammation and irritation that cause sneezing, itching, and nasal congestion or runny nose.

What is Mometasona furoato 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 breathing in pollen from trees, herbs, weeds, and also fungal spores and molds. Perennial rhinitis occurs throughout the year and symptoms can be caused by sensitivity to a variety of things including dust mites, animal hair (or epithelium), feathers, and certain foods. Mometasona furoate Cipla reduces nasal inflammation and irritation, thereby alleviating sneezing, itching, and nasal congestion 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 formations in the nasal mucosa and generally affect both nasal passages. Mometasona furoate reduces nasal inflammation, causing polyps to shrink gradually, thereby alleviating nasal congestion that can affect breathing through the nose.

Do not use Mometasona furoate Cipla nasal spray:

• if you are allergic to mometasona furoate or any of the other ingredients of this medicine (listed in section 6).
• if you have an untreated nasal infection. Using Mometasona furoate Cipla while you have an untreated nasal infection, such as herpes, may worsen the infection. You should wait until the infection has cleared up before starting to use the nasal spray.
• if you have recently undergone surgery or had a recent injury to your nose. 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 or have ever hadtuberculosis.
• If you have anyother type of infection.
• If you are takingother corticosteroids,either by mouth or by injection.
• If you havefibrosis cystica.

While using mometasona furoate nasal spray, you should inform your doctor if:

• Your immune system does not work properly (if you have difficulty fighting off infections) and you come into contact with someone with chickenpox or measles. You should avoid coming into contact with anyone who hasthese infections.
• If you have any nasal or throat infection.
• If you are using this medicine for several months or more.
• If you have persistent irritation of the throat or nose.

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

If your eyes itch or are irritated, your doctor may advise you to use other treatments at the same time asMometasona furoate Cipla.

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

Children

Corticosteroid nasal sprays used at high doses for long periods of time may cause side effects, such as slowing down growth in children.

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

Using Mometasona furoate Cipla nasal spray with other medicines

Inform your doctor if you are taking or have recently taken other medicines, including those purchased without a prescription.

Some medicines may increase the effects of Mometasona Furoate Cipla nasal spray, so your doctor will perform close monitoring 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 Mometasona furoate Cipla. When discontinuing corticosteroids, by mouth or by injection, some people may experience side effects such as muscle pain or joint pain, muscle weakness and depression. You may also develop other allergies, such as itchy eyes, runny eyes, or red, itchy skin. If you develop any of these side effects, you should see your doctor.

Pregnancy, breastfeeding

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

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

Driving and operating machinery

No information is known about the effect of mometasona furoate on driving or operating machinery.

Mometasona furoate Cipla nasal spray contains benzalkonium chloride

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

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist.In case of doubt, consult your doctor or pharmacist again.Do not use a higher dose, nor 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 in each nostril ONCE a day.

• Once you have achieved control of symptoms, your doctor may recommend reducing the dose.
• If you do not start to feel better, you should consult your doctor and they may tell you 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 begins to relieve symptoms within 12 hours after the first dose; however, it is unlikely that the optimal effect of treatment will be observed before the first two days. Therefore, regular use should be maintained to achieve the optimal effect of treatment.

If you or your child experiences severe hay fever, your doctor may advise you to start using mometasone furoate some 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 after 5 to 6 weeks symptoms are not controlled, the dose may be increased to two sprays in each nostril TWICE a day. Once symptoms have been controlled, your doctor may advise you to reduce the dose.
• If no improvement of symptoms is observed after 5-6 weeks administering twice a day, you should consult your doctor.

Use of the spray pump

1. Shake the bottle and remove the dust cap.
2. If the spray pump bottle is new or has not been used for 14 days or more, it will need to be "primed" by pumping the spray pump a few times until a fine spray is obtained. To do this, hold the bottle as indicated in the illustration. Place the index and middle finger on either side of the nozzle, and the thumb underneath the bottle. Keep the thumb firm and press the neck with the fingers to pump the spray, keeping the nozzle away from you. It is recommended to perform a minimum of 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 comes out and you think the nozzle may be blocked, clean it. (See the cleaning instructions below). Do not attempt to unblock the spray nozzle with a needle or other pointed object, as it will damage the spray mechanism.]
3. Gently blow your nose.
4. Hold the bottle as indicated in the illustration. Place one finger in the nostril to close one nostril and insert the nozzle in the other nostril. Tilt your head forward and keep the bottle in a vertical position. Begin to inhale slowly through the nose and, at the same time, press firmly down on the neck of the bottle with the finger, releasing a spray of mometasone furoate.
5. Breathe out through the mouth. Repeat step 4 if more than one spray is needed in the same nostril.

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

Cleaning of the Mometasona furoato Cipla bottle

1. Clean the spray pump 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 warm water for a few minutes and then rinse them under running water.

5. Allow it to dry in a warm place before reassembling. Do not dry it near a hot place.

6. Reattach the nozzle and prime the bottle by releasing a few sprays into the air until a fine spray is obtained.

If you use moreMometasona furoato Ciplathan you should

If you accidentally use more than you should, tell your doctor. You can also call the Toxicological Information Service, phone 91.562.04.20, indicating the medication and the amount administered.

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

If you forgot to useMometasona furoato Cipla

If you forgot to use your nasal spray at the right time, use it as soon as you remember, and then follow the normal administration schedule. Do not apply a double dose to compensate for the missed doses.

If you interrupt treatment withMometasona furoato Cipla

In some patients, mometasone furoate should begin to relieve symptoms within 12 hours after the first dose; however, it is unlikely that the full benefit of treatment will be observed before the first two days. It is very important to use your nasal spray regularly. Do not interrupt your treatment even if you feel better unless your doctor tells you to.

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

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them. You may experience immediate hypersensitivity reactions (allergic) after using this medicine. These reactions can be severe. You must stop treatment with Mometasona furoato Cipla and seek immediate medical help if you experience symptoms such as:

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

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

Other side effects

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

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

• headache
• runny nose
• nosebleeds [very frequent (may affect more than 1 in 10 people) in people with nasal polyps who are administering twomoments ofmometasona furoatoin each nasal orifice twice a day.]
• nasal or throat pain
• ulcers in the nose
• respiratory infection

Unknown frequency (cannot be estimated from available data)

• increased eye pressure (glaucoma) and/or cataracts that may cause visual disturbances
• damage to the nasal septum that separates the nasal orifices
• alterations in taste and smell
• difficulty breathing and/or fatigue
• blurred vision

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

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es/.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and on the bottle after CAD. The expiration date is the last day of the month indicated.

Use for a maximum of two months after the first use.

Do not store at a temperature above 25°C. Do not freeze. Store in the original packaging.

Medicines should not be disposed of through drains or in the trash.Deposit the containers and medicines you no longer need at the Sigre collection point of the pharmacy.Ask your pharmacist if you are unsure how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

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Composition of Mometasona furoate Cipla 50micrograms/pulverization suspension for nasal pulverization

• The active principle is mometasona furoate.
• The other components are glycerol, microcrystalline cellulose, sodium carmelose, citric acid monohydrate, polisorbate 80, benzalkonium chloride, sodium citrate dihydrate, and water for injection preparations.

Each bottle of Mometasona furoate Cipla 50micrograms/pulverization suspension for nasal pulverization releases 140pulverizations. Each pulverization releases 50micrograms of the active principle mometasona furoate (in the form of monohydrate).

Bottles containing 140 dosed pulverizations that are presented in containers of 1, 2, or 3 nasal pulverizers.Only some container sizes may be commercially marketed

Appearance of the product and contents of the container

A white opaque plastic bottle equipped with a white dosing atomizer, a white nasal adapter, and a translucent dust-proof stopper for the nozzle.

Holder of the marketing authorization and responsible manufacturer

Holder of the marketing authorization:

Cipla Europe NV

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

Responsible 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 subsidiary in Spain.

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

This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) with the following trade names:

Last review date of this leaflet: May 2021

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.