Nasoaldo 50 micrograms/dose nasal spray suspension
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
NASOALDO 50 micrograms/dose nasal spray suspension
mometasone furoate
Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, consult your doctor or pharmacist.
- This medicine has been prescribed for you only, and you should not give it to others, 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 adverse effects not listed in this leaflet. See section 4.
Leaflet Contents
- What NASOALDO is and what it is used for
- What you need to know before using NASOALDO
- How to use NASOALDO
- Possible side effects
- How to store NASOALDO
- Contents of the pack and other information
1. What NASOALDO is and what it is used for
What is NASOALDO?
NASOALDO 50 micrograms/spray nasal spray suspension contains mometasone furoate, a medicine belonging to a group of medicines called corticosteroids. 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 NASOALDO used for?
Hay fever and perennial rhinitis
NASOALDO 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 pollen from trees, grasses, weeds, as well as mold and fungus spores. Perennial rhinitis occurs throughout the year, and symptoms may be caused by sensitivity to a variety of substances including house dust mites, animal hair (or epithelial cells), feathers, and certain foods. This medicine 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
NASOALDO 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. This medicine 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 NASOALDO
Do not use NASOALDO
- if you are allergic (hypersensitive) to mometasone furoate or to any of the other components of this medicine (listed in section 6),
- if you have an untreated nasal infection. Using this medicine 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 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 this medicine:
- if you have or have ever had tuberculosis,
- if you have any other type of infection,
- if you are taking other corticosteroids, taken orally or by injection,
- if you have cystic fibrosis (a multi-organ genetic disease, primarily affecting the lungs and digestive system).
While using this medicine, consult your doctor:
- if your immune system is not working properly (if you have difficulty recovering from infection) 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 experience persistent irritation of the nose or throat.
Contact your doctor if you experience blurred vision or other visual disturbances.
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 advise you to use other treatments alongside NASOALDO.
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 to monitor the height of children undergoing long-term treatment with nasal corticosteroids, and any changes should be reported to the doctor.
Other medicines and NASOALDO
Tell your doctor if you are taking, have recently taken, or might need to take any other medicines.
If you are taking other corticosteroids for allergy, either orally or by injection, your doctor may advise you to stop taking them when you start using mometasone furoate. When discontinuing 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 Nasoaldo 50 micrograms/dose nasal spray suspension, so your doctor will monitor you closely if you are taking these medicines (including some used for HIV: ritonavir, cobicistat).
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 little or no information available 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 information regarding the effect of this medicine on driving or operating machinery.
NASOALDO contains benzalkonium chloride
This medicine contains 20 micrograms of benzalkonium chloride per dose. Benzalkonium chloride may cause irritation or inflammation inside the nose, especially when used for long-term treatment.
3. How to use NASOALDO
Follow exactly the instructions given by your doctor or pharmacist for the administration of this medicine. 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 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 begin to feel better, you should 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 between 3 and 11 years
The usual dose is one spray into each nostril once daily.
If you or your child suffers from severe hay fever, your doctor may advise you to start using NASOALDO 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 usual 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 reducing the dose.
- If there is no improvement in symptoms after 5–6 weeks of twice-daily administration, you should consult your doctor.
Method of administration
Preparing the nasal spray for use
NASOALDO 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 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 beneath the bottle.
Do not pierce the nasal spray.
- Point the nozzle away from you 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
- Gently shake the bottle and remove the cap (Figure 1).
- Gently blow your nose.
- Block one nostril and insert the nozzle into the other nostril as shown (Figure 2). Tilt your head slightly forward, keeping the bottle upright.
- Begin to inhale gently or slowly through your nose, and while inhaling, press ONCE with your fingers to release the spray into your nose.
- Breathe out through your mouth. Repeat step 4 to inhale a second spray into the same nostril, if required.
- Remove the nozzle from this nostril and breathe out through your mouth.
- 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 carefully 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.
- After cleaning, the spray will need to be re-primed with 2 sprays before first use.
If you use more NASOALDO than you should
If you accidentally use more than you should, inform your doctor.
If you use steroids over a long period of time or in large amounts, this may rarely affect some of your hormones. In children, this 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: 91 562 04 20, stating the medication and the amount ingested.
If you forget to use NASOALDO
If you forget to use your nasal spray at the correct time, use it as soon as you remember, then continue with your regular dosing schedule. Do not use a double dose to make up for missed doses.
If you stop using NASOALDO
In some patients, NASOALDO 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 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 experiences them. Immediate hypersensitivity (allergic) reactions may occur after using this medicine. These reactions can be severe. You must stop treatment with NASOALDO 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 systemic absorption of the medicine.
Other adverse effects
Most people do not have any problems after using the nasal spray. However, some people after using mometasone furoate 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 receiving two sprays of mometasone furoate 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
- taste and smell disturbances
- difficulty breathing and/or fatigue
- blurred vision
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 via the Spanish System for Pharmacovigilance of 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 NASOALDO
Keep this medicine out of the sight and reach of children.
Do not store above 30°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 of first opening.
Medicines should not be disposed of via wastewater or household waste. Unused medicines and their containers should be taken to the SIGRE collection point at your pharmacy. If you are unsure, please 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 NASOALDO
- The active substance is mometasone furoate. Each spray contains 50 micrograms of mometasone furoate monohydrate.
- The other components are dispersible cellulose (microcrystalline cellulose and sodium carboxymethylcellulose), glycerol, sodium citrate, anhydrous citric acid, benzalkonium chloride, polysorbate 80, and purified water.
Nature of the product and contents of the container
NASOALDO is a nasal spray suspension. It is supplied in a white opaque plastic bottle containing 115 or 140 sprays, equipped with a metered spray pump, a nasal adapter, and a dust cap.
Only certain pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Laboratorio Aldo-Unión, S.L.
Baronesa de Maldá, 73
08950 Esplugues de Llobregat
Barcelona - Spain
Date of the most recent revision of this leaflet: 10/2017
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/