Momcort 50 micrograms/spray suspension for nasal spray
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Momcort 50 micrograms/spray Nasal spray suspension
mometasone furoate
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 could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Momcort is and what it is used for
- What you need to know before using Momcort
- How to use Momcort
- Possible side effects
- How to store Momcort
- Contents of the pack and other information
1. What Momcort is and what it is used for
What is Momcort?
Momcort contains mometasone furoate, a medicine that belongs to a group of medicines called corticosteroids. When mometasone furoate is sprayed into the nose, it helps relieve inflammation (swelling and irritation in the nose), sneezing, itching, and nasal congestion or runny nose.
What is Momcort used for?
Hay fever and perennial rhinitis
Momcort 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 occurs at certain times of the year and is an allergic reaction caused by inhaling pollen from trees, grasses, weeds, as well as mould and fungal spores. Perennial rhinitis occurs throughout the year, and symptoms may be triggered by sensitivity to various substances, including house dust mites, animal hair (or epithelial particles), feathers, and certain foods. Momcort reduces inflammation and irritation in the nose, thereby relieving sneezing, itching, and nasal congestion or runny nose caused by hay fever or perennial rhinitis.
Nasal polyps
Momcort is used to treat nasal polyps in adults aged 18 years and older.
Nasal polyps are small growths on the lining of the nasal passages and usually affect both nostrils. Mometasone furoate reduces inflammation in the nose, gradually shrinking the polyps and thereby relieving nasal congestion that may affect your ability to breathe through the nose.
2. What you need to know before using Momcort
Do not use Momcort
- 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 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 had nasal surgery or a recent injury to the nose. You should not use the nasal spray until your nose has healed.
Warnings and precautions
Talk to your doctor or pharmacist before starting to use Momcort
- if you have or have ever had tuberculosis,
- if you have any other infection,
- if you are taking other corticosteroids, either by mouth or by injection,
- if you have cystic fibrosis.
While using mometasone furoate, consult your doctor
- if your immune system is not working properly (if you have difficulty fighting infections) and you come into contact with someone who has 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 this medicine for several months or longer.
- if you have persistent irritation of the nose or throat.
If corticosteroid nasal sprays are used at high doses for 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 advise you to use other treatments alongside mometasone furoate.
Contact your doctor if you experience blurred vision or other visual disturbances.
Children
When used at high doses for prolonged periods, 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, and any changes should be reported to the doctor.
Other medicines and Momcort
Tell your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines, including those obtained without a prescription.
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. When stopping oral or injectable corticosteroids, some people may experience adverse effects such as muscle or joint pain, muscle weakness, and 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, you should see your doctor.
Some medicines may increase the effects of mometasone furoate, so your doctor will monitor you closely if you are taking these medicines (including some used for HIV: ritonavir, cobicistat).
Pregnancy and breastfeeding
There is little or no information available on the use of mometasone furoate in pregnant women. It is not known whether mometasone furoate is excreted in human breast milk.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Driving and using machines
There is no known information regarding the effect of mometasone furoate on driving or operating machinery.
Momcort contains benzalkonium chloride
This medicine contains 0.02 mg of benzalkonium chloride per nasal spray.
Benzalkonium chloride may cause irritation or inflammation inside the nose, especially when used for long-term treatment.
3. How to use Momcort
Follow exactly the instructions for administering this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. Do not use higher doses or use the spray more often, or for longer than your doctor has told you.
Treatment of hay fever and perennial rhinitis
Use in adults and children over 12 years of age
The recommended dose is two sprays into each nostril once daily.
- Once symptoms are under control, your doctor may advise you to reduce the dose.
- If you do not begin to feel better, you should consult your doctor, who may advise you to increase the dose to the maximum daily dose of 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.
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, you should maintain regular use to achieve the optimal treatment effect.
If you or your child has severe hay fever, your doctor may advise you to start using mometasone furoate a few days before the start of pollen season, as this will help prevent hay fever symptoms before they occur.
Nasal polyps
Use in adults over 18 years of age
The recommended initial 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 you to reduce the dose.
- If there is no improvement in symptoms after 5–6 weeks of twice-daily administration, you should consult your doctor.
Preparing the nasal spray for use
Momcort nasal spray has a 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 pressing the spray pump 10 times until a fine mist is produced:
- First, gently shake the bottle.
- Place your index and middle fingers on either side of the nozzle and your thumb underneath the bottle. Do not pierce the nasal spray.
- Point the nozzle away from yourself and press the spray pump 10 times until a fine mist is produced.
If you have not used your nasal spray for 14 days or more, you need to re-prime the bottle by pressing the spray 2 times until a fine mist is produced.
How to use your nasal spray
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Gently shake the bottle and remove the cap (Figure 1).
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Gently blow your nose.
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Close one nostril and insert the nozzle into the other nostril as shown (Figure 2). Tilt your head slightly forward, keeping the bottle upright.
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Begin to inhale gently or slowly through your nose, and while inhaling, press ONCE with your fingers to release the spray into your nose.
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Breathe out through your mouth. Repeat step 4 to inhale a second spray into the same nostril, if applicable.
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Remove the nozzle from this nostril and breathe out through your mouth.
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Repeat steps 3 to 6 in the other nostril (Figure 3).
After using the spray, carefully clean the nozzle with a clean tissue or paper towel and replace the cap.
Cleaning your nasal spray
- It is important to clean your nasal spray regularly; otherwise, it may not work properly.
- Remove the cap and gently pull out the nozzle.
- Wash the nozzle and cap with lukewarm water, then rinse with 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 you from receiving the correct dose of medication.
- Allow the cap and nozzle to dry in a warm place.
- Press the nozzle back onto the bottle and replace the cap.
- The spray will need to be re-primed with 2 sprays the first time it is used after cleaning.
If you use more Momcort than you should
If you accidentally use more than you should, inform your doctor.
If you use steroids for a long period or in large amounts, it may, in rare cases, affect some of your hormones. In children, it may affect growth and development.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.
If you forget to use Momcort
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 missed doses.
If you stop treatment with Momcort
In some patients, mometasone furoate should begin 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 your treatment even if you feel better, unless your doctor tells you to.
If you have any further questions about 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 everyone experiences them.
Immediate hypersensitivity (allergic) reactions may occur after using this medicine. These reactions can be serious. You must stop treatment with mometasone furoate and seek immediate medical help if you experience symptoms such as:
- swollen face, tongue or throat
- 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 side effects
Most people have no problems after using the nasal spray. However, some people after using Momcort or other corticosteroid nasal sprays may experience:
Frequent side 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 mometasone furoate in each nostril twice daily.]
- pain in the nose or throat
- 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
Reporting of side effects
If you experience any side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.
5. Storage of Momcort
Keep this medicine out of the sight and reach of children.
Unopened container: this medicine has no special storage temperature requirements. Do not freeze.
Once opened: do not store above 25°C. Do not freeze.
Do not use this medicine after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.
The spray should be used within 2 months from first use.
Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE point located in your pharmacy. Ask your pharmacist how to properly 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 Momcort
- The active substance is mometasone furoate. Each spray (0.1 ml) contains 50 micrograms of mometasone furoate (as monohydrate). The total weight of one spray is 100 mg.
- The other components are: glycerol, microcrystalline cellulose and sodium carboxymethylcellulose, sodium citrate, citric acid monohydrate, benzalkonium chloride, polysorbate 80, and water for injections.
Appearance of the medicine and contents of the pack
Momcort is a white, opaque suspension for nasal spray.
Each bottle contains 60 or 140 sprays.
Only certain pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Laboratorios Cinfa, S.A.
Carretera Olaz-Chipi, 10. Polígono Industrial Areta
31620 Huarte (Navarra) - Spain
Manufacturer
Teva Czech Industries s.r.o.
Ostravská 29, c.p. 305, 747 70 Opava–Komárov, Czech Republic
or
Laboratorios Cinfa, S.A.
Carretera Olaz-Chipi, 10. Polígono Industrial Areta
31620 Huarte (Navarra) - Spain
Date of the most recent revision of this leaflet: January 2020
Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/
You can access detailed and up-to-date information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the leaflet and packaging. You may also access this information at the following internet address:
https://cima.aemps.es/cima/dochtml/p/82795/P_82795.html
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