MOMANOSE nasal spray 50mcg 10g
MOMANOS NOSE SPRAY 50 mcg 60 doses
Leaflet: patient information
MomaNos 50 micrograms/injection nasal spray, suspension
MomaNose 50 micrograms / actuation nasal spray, suspension
mometasone furoate/ mometasone furoate
For use in adults only
For use In adults only
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.
Keep this leaflet. You may need to read it again.
If you need further information or advice, ask your pharmacist.
If you get any side effects, tell your doctor or pharmacist. This also includes any possible side effects not described in this leaflet. See point 4.
If after 14 days you do not feel better or your condition worsens, you should seek medical attention.
What this leaflet contains
1. What MomaNos is and what it is used for
2. What you need to know before using MomaNos
3. How to use MomaNos
4. Possible side effects
5. How to store MomaNos
6. Contents of the package and additional information
1. What MomaNos is and what it is used for
What is MomaNos?
MomaNos contains the active substance mometasone furoate, from the group of medicines called corticosteroids. When mometasone furoate is sprayed into the nose, it helps relieve inflammation (swelling and irritation in the nose).
What is MomaNos used for?
MomoNos is used to treat the symptoms of hay fever (also called seasonal allergic rhinitis) in adults after a doctor has diagnosed seasonal allergic rhinitis.
Hay fever, which occurs at certain times of the year, is an allergic reaction caused by the inhalation of pollen from trees, grasses, weeds, as well as mold and fungal spores. MomaNos reduces swelling and irritation in the nose and thus relieves sneezing, itching and stuffy or runny noses caused by hay fever.
If after 14 days you do not feel better or your condition worsens, you should consult your doctor.
2. What you need to know before using MomaNos
Do not use MomaNos:
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 MomaNos for an untreated nose infection, such as herpes, can make it worse. You should wait until the infection has subsided before you start using the nasal spray;
if you have recently had a nose operation or injured it. You should not use the nasal spray until your nose has healed.
Warnings and precautions
Talk to your doctor or pharmacist before using MomaNos:
if you have or have ever had tuberculosis;
if you have another infection;
if you are taking other corticosteroids by mouth or by injection;
if you have cystic fibrosis.
While using MomaNos, talk to your doctor or pharmacist:
if your immune system is not working well (if you have difficulty coping with infections) and you have been in contact with a person infected with measles or chicken pox. You should avoid contact with anyone who has such an infection;
if you have a nose or throat infection;
if you have been using the medicine for several months or longer;
if you have a persistent inflammation of the nose or throat.
Consult your doctor if you have blurred vision or other visual disturbances.
When a nasal spray containing a corticosteroid is used in high doses over a long period of time, side effects may occur due to the absorption of the drug in the body.
If your eyes are itchy or sore, your doctor may advise you to use a treatment other than MomaNos.
Children and adolescents
MomaNos should not be used in children and adolescents under 18 years of age.
Other medicines and MomaNos
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those obtained without a prescription.
Some medicines may increase the effect of MomaNos and your doctor may decide to monitor your condition closely if you are taking such medicines (including some medicines to treat HIV: ritonavir, cobicistat).
If you are taking other allergy medicines from the corticosteroid group, either by mouth or by injection, your doctor may advise you to stop taking them while you are using MomaNos. When corticosteroids are stopped, some people may experience side effects such as joint or muscle pain, weakness and feeling depressed. You may also develop other allergic reactions, such as itching and watering of the eyes, redness and itching of the skin. If any of these reactions occur, you should consult your doctor.
Pregnancy and breastfeeding
Little or no information is available on the use of MomaNos in pregnant women. It is not known whether mometasone furoate passes into breast milk.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine.
Driving and using machines
There is no information on the effect of MomaNos on the ability to drive or use machines.
MomaNos contains benzalkonium chloride
MomaNos contains benzalkonium chloride, which can cause irritation and swelling in the nose, especially if used for a long time.
3. How to use MomaNos
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. If you are not sure, ask your doctor or pharmacist.
The recommended dose is two sprays in each nostril once a day.
Once the symptoms are under control, you can reduce the daily dose to one spray in each nostril. If symptoms worsen, increase the dose to two sprays in each nostril once daily.
In some patients, MomaNos begins to relieve symptoms 12 hours after administration of the first dose; however, the full effect of treatment can be seen for up to two days. If your hay fever is severe, treatment may need to start a few days before the pollen season begins. At the end of the pollen season, your hay fever symptoms should improve and then no treatment is needed.
If there is no / insufficient improvement in symptoms after a maximum of 14 days of use, a doctor's consultation is necessary. MomaNos should not be used continuously for more than 3 months without consulting a doctor.
Preparing the nasal spray for use
MomaNos has a cap that protects the tip from contamination and keeps it clean. Remember to remove the cap before using the spray and replace it after use.
Shake the bottle before each use.
Do not pierce the nasal applicator (tip hole) with a needle or other sharp object.
If you are using the spray for the first time, you must "purge" the pump of the bottle by spraying into the air 10 times until an even stream appears:
1. Shake the bottle well.
2. Remove the plastic cap.
3. Place your index and middle fingers on either side of the tip and your thumb under the bottle. Do not puncture the nasal applicator.
4. Point the nozzle away from you and, pressing the pump with your fingers, spray 10 times until the stream becomes uniform.
If the pump has not been used for more than 14 days, before the next use it must be cleaned with 2 sprays until a uniform stream is obtained.
How to use the nasal spray
1. Shake the bottle well and remove the cap.
2. Gently blow your nose to clear the nostrils.
3. Close one nostril and insert the tip into the other nostril. Tilt your head slightly forward, holding the bottle upright.
4. Start inhaling slowly through your nose and as you inhale, spray an even stream of the spray into your nose by pressing down with your fingers ONCE.
5. Exhale through the mouth. Repeat step 4 to make a second spray in the same nostril if needed.
6. Remove the tip from the nostril and exhale through the mouth.
7. Repeat steps 3 through 6 to apply in the other nostril.
After using the spray, gently wipe the tip with a clean cloth or paper towel and replace the cap.
Cleaning the nasal spray
It is important to clean the nasal spray regularly, otherwise it may not work properly.
Remove the cap and carefully remove the tip.
Wash the tip and cap with warm water and rinse under running water.
Do not try to unclog the nasal applicator by puncturing it with a needle or other sharp object, as this will damage it and you will not receive the correct dose of medicine.
Allow the cap and tip to dry in a warm place.
Replace the nozzle and replace the cap.
When using the spray for the first time after cleaning, clean the pump again with 2 sprays.
If you have used more than the required dose of MomaNos
Always use the dose exactly as described in this leaflet or as your doctor has told you. If you use more or less than you should, your symptoms may get worse.
If you accidentally use more than your prescribed dose, tell your doctor.
If you use steroids for a long time or in high doses, it is possible, although rare, that they can affect the levels of certain hormones.
If you missed using MomaNos
If you forget to use the nasal spray on time, do it as soon as you remember and then continue using it as before.
Do not take a double dose to make up for a missed dose.
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 everybody gets them.
After using this medicinal product, rapid hypersensitivity reactions (allergic reactions) may occur. These reactions can be severe. You should stop using MomaNos and seek immediate medical attention if you experience symptoms such as:
swelling of the face, tongue, or throat;
difficulty swallowing;
urticaria;
wheezing or difficulty breathing.
When a nasal spray containing a corticosteroid is used for a long time, side effects may occur due to the absorption of the medicine in the body.
Other side effects
Common side effects (may affect up to 1 in 10 people):
headache;
sneezing;
nosebleeds;
inflammation of the nose;
wounding of the nose;
respiratory tract infections.
Not known (frequency cannot be estimated from the available data):
increased intraocular pressure (glaucoma) and/or cataracts, which can cause visual disturbances;
blurred vision;
damage to the nasal septum that separates the nostrils;
changes in taste and smell;
difficulty breathing and/or wheezing.
Reporting adverse reactions
If you get any side effects, tell your doctor, pharmacist or nurse. This includes all possible side effects not described in this leaflet. You can also report side effects directly through the national reporting system to:
The Medicines Executive Agency,
Damyan Gruev St. No. 8,
1303 Sofia,
phone: +35928903417,
website: www.bda.bg.
By reporting side effects, you can contribute to getting more information about the safety of this medicine.
5. How to store MomaNos
Keep out of the reach of children.
Do not use this medicine after the expiry date which is stated on the label or carton after EXP. The expiration date corresponds to the last day of the specified month.
Do not freeze.
Before administering the first dose, patients should be advised to shake the bottle well and press the pump 10 times (until an even stream is obtained). If the pump has not been used for more than 14 days, before the next use it must be cleaned again with 2 sprays until an even stream is obtained.
After opening the bottle should be used within two months. Open only one bottle at a time.
Do not unscrew the pump mechanism of the nasal spray.
Do not dispose of medicines down the drain or in the household waste container. Ask your pharmacist how to dispose of medicines you no longer use. These measures will help protect the environment.
6. Contents of the package and additional information
What MomaNos contains
The active substance is: mometasone furoate. Each push from the pump delivers a metered dose of 50 micrograms of mometasone furoate (as mometasone furoate monohydrate). The total weight of one injection is 100 mg.
The other ingredients are: microcrystalline cellulose, carmellose sodium, glycerol, citric acid monohydrate, sodium citrate dihydrate, polysorbate 80, benzalkonium chloride, water for injections.
What MomaNos looks like and what it contains
MomaNos is a white, homogeneous nasal spray suspension packaged in a white pump bottle with a [blue] safety cap.
1 bottle containing 10 g of nasal spray, suspension, which corresponds to 60 sprays.
1 bottle containing 17 g of nasal spray, suspension, which corresponds to 120 sprays.
1 bottle containing 18 g of nasal spray, suspension, which corresponds to 140 sprays.
2 bottles containing 18 g of nasal spray, suspension, corresponding to 140 sprays per bottle.
3 bottles containing 18 g of nasal spray, suspension, corresponding to 140 sprays per bottle.
Not all types of packaging can be put on sale.
Marketing Authorization Holder:
Sandoz dd, Slovenia.
Manufacturer:
LEK Pharmaceuticals dd, Slovenia.
