50 micrograms/dose nasal spray, suspension
mometasone furoate
What Mommox is and what it is used for
What is Mommox?
Mommox nasal spray contains mometasone furoate, a group of medicines called corticosteroids ( cortisone ). When mometasone furoate is sprayed into the nose, it can help relieve inflammation (swelling and irritation of the nose), sneezing, itching, nasal congestion, or runny nose.
What is Mommox used for?
Hay fever and perennial rhinitis ( allergy to eg mites and fur animals)
Mommox is used to treat symptoms of allergic rhinitis: hay fever (also called seasonal allergic rhinitis ) and perennial rhinitis ( allergy to eg mites and fur animals) in adults over 18 years of age.
Hay fever, which occurs at certain times of the year, is an allergic reaction caused by inhaling pollen from trees, grass, weeds or mold, and fungal spores. Perennial rhinitis occurs throughout the year and the symptoms can be caused by a sensitivity to a variety of things such as house dust mites, animal hair (or skin deposits), feathers, and certain foods. Mommox reduces swelling and irritation in the nose and thus relieves sneezing, itching, nasal congestion, or runny nose caused by hay fever or perennial rhinitis.
Mometasone furoate contained in Mommox may also be approved for the treatment of other diseases not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
What you need to know before using Mommox
Do not use Mommox
- 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. Use of Mommox in an untreated nose infection , such as herpes , may aggravate an infection . You should wait until infection has healed before using the nasal spray.
- if you have recently undergone nose surgery or have a nose injury. You must then wait until the nose has healed before using the nasal spray.
Warnings and cautions
Talk to your doctor or pharmacist before using Mommox
- if you have or have ever had tuberculosis .
- if you have any other infection .
- if you are taking other medicines containing corticosteroids , either by mouth or by injection .
- if you have cystic fibrosis .
Talk to your doctor while you are using Mommox
- if your immune system is weakened (if you have difficulty fighting infection ) and you come in contact with someone who has measles or chickenpox. You should avoid contact with anyone who has these infections .
- if you get a nose or throat infection .
- if you are taking the medicine for several months or longer.
- if you have persistent irritation of the nose or throat.
Contact a doctor if you experience blurred vision or other visual disturbances.
When nasal sprays containing corticosteroids are used in high doses for a long time, side effects may occur due to the drug being absorbed into the body.
Other drugs and Mommox
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 effects of Mommox and your doctor may want to monitor you closely if you are taking these medicines (eg some HIV medicines: ritonavir, cobicistat).
If you are taking other medicines that contain corticosteroids for your allergy, either by mouth or by injection, your doctor may decide to stop taking them when you use Mommox. When you stop taking corticosteroids, either by mouth or by injection, you may experience symptoms such as joint or muscle pain, weakness, and depression. You may also have other types of allergies, such as itchy, watery eyes or spotty red and itchy skin. If these symptoms occur, consult your doctor.
Pregnancy and breastfeeding
There is no or limited amount of information from the use of Mommox in pregnant women. It is unknown whether mometasone furoate is excreted in human milk.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
There is no known information on whether the effect of Mommox affects the ability to drive or use machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Mommox contains benzalkonium chloride
This medicine contains benzalkonium chloride which may cause irritation and swell inside the nose, especially with prolonged use of the medicine.
How to use Mommox
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Do not use a larger dose or use the spray more often or for longer than stated in this leaflet or as your doctor advised.
Use in adults from 18 years
The recommended dose is two sprays in each nostril once daily.
- When a good effect has been achieved, the dose can be reduced to 1 spray in each nostril once a day. Do not exceed this dosage .
In some patients, Mommox may begin to relieve symptoms 12 hours after the first dose. However, it may take up to two days before the full effect of the treatment is seen. If you have previously had severe problems with hay fever, treatment may need to be started a few days before the pollen season begins.
If you get any effect within 14 days, consult a doctor. Do not use Mommox for more than 3 months without consulting a doctor.
Please note that Mommox should only be given to children on the prescription of a doctor.
How to prepare your nasal spray for use
Your Mommox nasal spray has a plastic cover that protects the spout and keeps it clean. Remember to remove the plastic cover before using the spray and to put it back after use.
Shake the bottle before each use.
Do not insert a needle or other sharp object into the nozzle.
If you are using the spray for the first time, you must prepare the bottle by pumping the spray 10 times until a fine spray shower is obtained:
1. Shake the bottle well.
2. Remove the plastic cover
3. Place the index finger and middle finger on opposite sides of the spout and thumb under the bottle (Figure 1). Do not make holes in the spout.
4. Turn the spout away from you and then press down with your fingers to pump the spray 10 times until a fine spray shower is obtained.
If you have not used the spray for 14 days or longer, you should prepare the bottle again by pumping the spray twice until a fine spray shower is obtained.
How to use your nasal spray
1. Shake the bottle well and remove the plastic cover (Figure 2).
2. Cheat gently to clean the nostrils.
Hold one nostril and insert the spout into the other nostril. Bend your head slightly forward while holding the bottle upright.
4. Slowly and gently begin to inhale through your nose while spraying a fine shower into your nose by pressing down ONCE with your fingers (Figure 3).
5. Exhale through your mouth. Repeat step 4 to inhale a second spray into the same nostril, depending on the dose you have.
6. Remove the spout from the nostril and exhale through the mouth.
7. Repeat steps 3 through 6 for the other nostril.
After using the spray, wipe the pipe thoroughly with a clean handkerchief or soft paper and put the plastic cover back on.
How to clean your nasal spray
- It is important to clean your nasal spray regularly, otherwise it may not work properly.
- Remove the plastic cover and carefully pull off the spout.
- Clean the spout and plastic cover in warm water and then rinse under running water.
- Do not try to clean the spout by inserting a needle or other sharp object as this will damage the spout, which will prevent you from getting the correct dose of medicine.
- Let the plastic cover and spout dry in a warm place.
- Put the spout back on the bottle and put on the plastic cover.
- The spray will need to be pushed back on with 2 sprays the first time it is used after cleaning.
If you use more Mommox than you should
If you use steroids for a long time or in large amounts, they can in rare cases affect some of your hormones.
If you forget to use Mommox
If you forget to use your nasal spray at the right time, use it as soon as you remember, then continue as usual.
Do not take a double dose to make up for a forgotten dose.
If you stop using Mommox
In some patients, Mommox may begin to relieve symptoms 12 hours after the first dose. However, it may take up to two days before the full effect of the treatment is seen. You must use your nasal spray regularly.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Sudden hypersensitivity reactions (allergic reactions) may occur when using this medicine. These reactions can be very serious. Stop taking Mommox and contact a doctor immediately if you get symptoms such as:
- swelling of the face, tongue or throat
- difficulty swallowing
- hives
- wheezing or difficulty breathing.
When nasal sprays containing corticosteroids are used in high doses for a long time, side effects may occur due to the drug being absorbed into the body.
Other side effects are
Most people have no problem using nasal spray. Some people who have used Mommox or other nasal sprays containing corticosteroids may experience the following side effects:
Common side effects (may affect up to 1 in 10 people):
- headache
- sneezing
- nosebleed
- nasal or throat irritation
- sores in the nose
- respiratory tract infection.
Has been reported (occurs in the unknown number of users):
- increased pressure in the eye ( glaucoma ) and / or cataracts that cause changes in vision
- dimsyn
- damage to the septum of the nose that separates the nostrils
- change of taste and smell
- difficulty breathing and / or wheezing.
How to store Mommox
- Keep this medicine out of the sight and reach of children.
- Do not use this medicine after the expiry date which is stated on the label after EXP. or EXP. The expiration date is the last day of the specified month.
- Medicines in opened packaging must be used within 2 months. Only open one bottle at a time.
- Do not freeze.
- Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Contents of the package and other information
Content declaration
- The active substance is mometasone furoate. Each spray with the pump delivers a measured dose containing 50 micrograms of mometasone furoate (as mometasone furoate monohydrate).
- The other ingredients are microcrystalline cellulose and carmellose sodium, glycerol , citric acid monohydrate, sodium citrate dihydrate, polysorbate 80, benzalkonium chloride and water for injections.
What the medicine looks like and contents of the pack
This medicine is a white, homogeneous suspension packaged in a white plastic bottle with a spray pump and packed in a carton.
Pack sizes:
1×10 g (60 spray doses)
1×17 g (120 spray doses)
1×18 g (140 spray doses)
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Sandoz A / S, Edvard Thomsens Vej 14, 2300 Copenhagen S, Denmark
Manufacturer
Lek Pharmaceuticals dd, Verovškova 57, 1526 Ljubljana, Slovenia
or
Lek Pharmaceuticals dd, Trimline 2D, 9220 Lendava, Slovenia
or
SC Sandoz, SRL, Str. Livezeni nr. 7A, RO-540472 Targu-Mures, Romania