MOMANOSE / Momanos nasal spray 50mcg - 10g
MOMANOS NASAL SPRAY 50 mcg 60 doses
Patient information leaflet
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, please tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
If you do not feel better after 14 days 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 you use MomaNos
3. How to use MomaNos
4. Possible side effects
5. How to store MomaNos
6. Contents of the pack and other information
1. What MomaNos is and what it is used for
What is MomaNos?
Mometasone furoate contains the active substance mometasone furoate, which belongs to a group of medicines called corticosteroids. When mometasone furoate is sprayed into the nose, it helps to relieve inflammation (swelling and irritation in the nose).
What is MomaNos used for?
MomaNos 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 a blocked or runny nose caused by hay fever.
If you do not feel better after 14 days or your condition worsens, you should consult your doctor.
2. What you need to know before you use 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 infection in your nose. Using MomaNos for an untreated nasal infection, such as herpes, may make it worse. You should wait until the infection has cleared up before you start using the nasal spray;
if you have recently had surgery on your nose or have 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 as an 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 fighting infections) and you have been in contact with someone who has measles or chickenpox. 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 long-term 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 for a long period of time, side effects may occur due to the absorption of the medicine into the body.
If your eyes are itchy or inflamed, your doctor may advise you to use another treatment besides 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 medicines obtained without a prescription.
Some medicines may increase the effect of MomaNos and your doctor may decide to monitor your condition carefully if you are taking such medicines (including some medicines for the treatment of HIV: ritonavir, cobicistat).
If you are taking other allergy medicines called corticosteroids, either by mouth or by injection, your doctor may advise you to stop taking them while you are using MomaNos. When stopping treatment with corticosteroids, 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 itchy and watery eyes, red and itchy skin. If any of these reactions occur, you should consult your doctor.
Pregnancy and breastfeeding
There is little or no information on the use of Mometasone Furoate 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 operate machinery.
MomaNos contains benzalkonium chloride
MomaNos contains benzalkonium chloride, which may 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 daily.
Once symptoms are controlled, you may reduce the daily dose to one spray in each nostril. If symptoms worsen, increase the dose to two sprays in each nostril once a day.
In some patients, MomaNos starts to relieve symptoms 12 hours after the first dose; however, the full effect of the treatment may take up to two days. If your hay fever is severe, treatment may need to be started a few days before the start of the pollen season. By the end of the pollen season, your hay fever symptoms should improve and no further 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 nozzle from contamination and keeps it clean. Remember to remove the cap before using the spray and put it back after use.
Shake the bottle before each use.
Do not pierce the nasal applicator (the hole in the tip) with a needle or other sharp object.
If you are using the spray for the first time, you should “clean” the pump of the bottle by spraying it into the air 10 times until a uniform stream appears:
1. Shake the bottle well.
2. Remove the plastic cap.
3. Place your index and middle fingers on either side of the nozzle and your thumb under the bottle. Do not pierce the nasal applicator.
4. Point the nozzle away from you and, pressing the pump with your fingers, spray 10 times until the jet becomes even.
If the pump has not been used for more than 14 days, before the next use it must be cleaned with 2 sprays until an even jet is obtained.
How to use the nasal spray
1. Shake the bottle well and remove the cap.
2. Gently blow your nose to clear your nostrils.
3. Close one nostril and place the nozzle in the other nostril. Tilt your head slightly forward, holding the bottle upright.
4. Begin to breathe in slowly through your nose and as you breathe in, spray a steady stream of the spray into your nose by pressing down with your fingers ONCE.
5. Exhale through your mouth. Repeat step 4 to give a second spray in the same nostril, if necessary.
6. Remove the tip from the nostril and exhale through the mouth.
7. Repeat steps 3 to 6 to apply to the other nostril.
After using the spray, carefully 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 nozzle and cap with warm water and rinse them under running water.
Do not try to unclog the nasal applicator by piercing 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 nozzle to dry in a warm place.
Put the nozzle back on and replace the cap.
When using the spray for the first time after cleaning, prime the pump again with 2 sprays.
If you use more MomaNos than you should
Always use the dose exactly as described in this leaflet or as your doctor has told you. If you use more or less than the dose you need, 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 may affect the levels of certain hormones.
If you forget to use 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 on 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 medicine, immediate hypersensitivity reactions (allergic reactions) may occur. These reactions can be severe. You should stop using MomaNos and seek medical help immediately if you have 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 into the body.
Other side effects
Common side effects (may affect up to 1 in 10 people):
headache;
sneezing;
nosebleed;
inflammation of the nose;
nose injury;
respiratory tract infections.
Not known (frequency cannot be estimated from the available data):
increased intraocular pressure (glaucoma) and/or cataracts, which can cause vision problems;
blurred vision;
damage to the nasal septum that separates the nostrils;
changes in taste and smell;
difficulty breathing and/or wheezing.
Reporting side effects
If you get any side effects, please tell your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system:
The Executive Agency for Medicines,
8 Damyan Gruev Street,
1303 Sofia,
tel.: +35928903417,
website: www.bda.bg.
By reporting side effects, you can help provide 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 expiry date refers to the last day of that 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 a uniform jet is obtained). If the pump has not been used for more than 14 days, it should be primed again by 2 sprays until a uniform jet is obtained before the next use.
Once opened, the bottle should be used within two months. Open only one bottle at a time.
Do not unscrew the nasal spray pump mechanism.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help to protect the environment.
6. Contents of the pack and other information
What does MomaNos contain?
The active substance is: mometasone furoate. Each actuation of the pump delivers a metered dose of 50 micrograms of mometasone furoate (as mometasone furoate monohydrate). The total weight of one actuation 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 the pack contains
MomaNos is a white, homogeneous nasal spray, suspension, packaged in a white pump bottle, with a [blue] protective cap.
1 bottle containing 10 g of nasal spray, suspension, corresponding to 60 sprays.
1 bottle containing 17 g of nasal spray, suspension, corresponding to 120 sprays.
1 bottle containing 18 g of nasal spray, suspension, corresponding 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 released for sale.
Marketing Authorisation Holder:
Sandoz dd, Slovenia.
Manufacturer:
LEK Pharmaceuticals dd, Slovenia.
