Mometason Orion 50 micrograms/dose nasal spray mometasone furoate suspension
What Mometason Orion Is And What It Is Used For
What is Mometasone Orion?
Mometasone Orion nasal spray contains mometasone furoate, which belongs to 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 Mometasone Orion Used For?
Hay fever and perennial rhinitis ( allergy to, e.g., mites and fur animals)
Mometasone Orion is used to treating hay fever symptoms (also called seasonal allergic rhinitis ) and perennial rhinitis in adults and children 3 years of age and older.
Hay fever, which occurs at certain times of the year, is an allergic reaction caused by inhaling pollen from trees, grass, weeds, mold, and fungal spores. Perennial rhinitis occurs throughout the year, and the symptoms can be caused by a sensitivity to a variety of things as. House dust mites,
animal hair (or skin deposits), feathers, and certain foods. Mometasone Orion 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 Orion treats nasal polyps in adults 18 years and older.
Nasal polyps are small growths on the mucous membrane inside the nose and usually affect both nostrils. Mometasone Orion reduces inflammation in the nose, which causes the polyps to shrink gradually and thus reduces a stuffy feeling in the nose, which can affect breathing through the nose.
Mometasone furoate nasal spray contained in Mometasone Orion may also be approved for treating other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have further questions, and always follow their instructions.
What You Need To Know Before Using Mometason Orion
Do Not Use Mometasone Orion
- If you are allergic to mometasone furoate nasal spray or any of the other ingredients of this medicine (listed in section 6).
- If you have an untreated nose infection, using Mometason Orion in an untreated nose infection, such as herpes, can aggravate an infection. It would help if you waited until the infection had healed before using the nasal spray.
- If you have recently undergone nose surgery or have a nose injury. It would help if you waited until the nose had healed before using the nasal spray.
Warnings And Cautions
Talk to your doctor or pharmacist before using Mometason Orion.
- If you have or have ever had tuberculosis.
- If you have any other infection.
- If you take other medicines containing corticosteroids, either by mouth or by injection.
- If you have cystic fibrosis.
Talk to your doctor while you are using Mometason Orion.
- If your immune system is weakened (if you have difficulty fighting infection ) and you come in contact with someone with measles or chickenpox. It will help if you avoid contact with anyone who has these infections.
- If you get a nose or throat infection.
- If you are taking medicine for several months or longer.
- If you have persistent irritation of the nose or throat.
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.
If you have itchy or irritated eyes, your doctor may recommend using other medicines with Mometason Orion.
Contact a doctor if you experience blurred vision or other visual disturbances.
Children And Young People
During long-term treatment with high doses of nasal sprays containing corticosteroids, certain side effects may occur, such as children growing more slowly.
It is recommended to regularly check the length of children who are treated for a long time with nasal sprays containing corticosteroids. Talk to a doctor if changes occur.
Other Medicines And Mometason Orion
Tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Some medicines may increase the effects of Mometasone Orion, and your doctor may want to monitor you closely if you are taking these medicines (e.g., some HIV medicines: ritonavir, cobicistat).
Suppose you take other medicines containing corticosteroids for your allergy, either by mouth or injection. In that case, your doctor may decide to stop taking them while you are taking Mometason Orion. When you stop using corticosteroids, either by mouth or as an injection, you may experience symptoms such as joint or muscle pain, weakness, and depression. You may also have allergies, such as itchy, watery eyes or spotty red and itchy skin. About these symptoms occur, consult your doctor.
Pregnancy, Breastfeeding, And Fertility
There is no or limited information on the use of Mometasone in pregnancy. 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 available information on whether the effect of Mometason Orion affects the ability to drive or use machines.
You are responsible for assessing whether you can drive a motor vehicle or perform work that requires sharpened vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and 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.
Mometason Orion Contains Excipients.
Mometasone Orion contains benzalkonium chloride, which may irritate the nose.
How To Use Mometason Orion
Always use this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure. Do not use a larger dose or spray more often or longer than your doctor prescribes.
Treatment of hay fever and perennial rhinitis ( allergy to eg, mites and fur animals)
Use in adults and children 12 years and older.
The usual dose is two sprays in each nostril once a day.
- When symptoms are under control (asymptomatic), your doctor may advise you to reduce dose one.
- If you do not feel better, consult your doctor, who can recommend increasing dose one to the maximum daily dose one, four sprays in each nostril once daily.
Nasal polyps
Use in adults 18 years and older.
The usual starting dose is two sprays in each nostril once a day.
- If the symptoms do not improve after 5 to 6 weeks, the dose can be increased to two sprays in each nostril twice daily. When your symptoms are under control, your doctor may advise you to reduce your dose.
- If the symptoms do not improve after 5 to 6 weeks with two daily sprays, you should contact your doctor.
How to prepare your nasal spray for use
Your Mometason Orion 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 put it back afterward.
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 gently.
2. Place the index finger and middle finger on each side of the spout and thumb under the bottle. Do not make holes in the spout.
3. 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 gently and remove the plastic cover (figure 1).
2. Cheat carefully.
3. Hold one nostril and insert the spout into the other nostril shown (Figure 2). Bend your head slightly forward while holding the bottle upright.
4. Slowly and gently inhale through your nose while spraying a nice shower into your nose by pressing down ONCE with your fingers.
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 and 6 for the second nostril (Figure 3).
After spraying, 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 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, preventing you from getting the correct dose of the medicine.
- Let the plastic cover and spout dry in a warm place.
- Put the spout back on the bottle and put it on the plastic cover.
- The spray will need to be pushed back on with 2 sprays the first time it is used after cleaning.
Use For Children And Adolescents
Use in children aged 3 to 11 years
The usual dose is a spray in each nostril once a day.
In some patients, Mometason Orion may begin to relieve symptoms within 12 hours of the first dose. However, it may take up to two days before the full effect of the treatment is seen. Therefore, you should continue with regular use to achieve the full benefit of the treatment.
If you or your child has severe hay fever symptoms, your doctor may recommend that you start using Mometason Orion a few days before the start of the pollen season, as this will help prevent your hay fever symptoms.
If You Use More Mometason Orion 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. In children, this can affect growth and development.
If You Forget To Use Mometason Orion
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 Mometason Orion
Mometason Orion may begin relieving symptoms 12 hours after the first dose in some patients. However, it may take up to two days before the full effect of the treatment is seen. It would help if you used your nasal spray regularly. Do not stop treatment even if you feel better unless your doctor tells you to.
If you have any further questions about the use of this product, ask your doctor or pharmacist.
Possible Mometasone Furoate Side Effects
This medicine can cause side effects like all medicines, although not everybody gets them. Sudden hypersensitivity reactions (allergic reactions) may occur when using this medicine. These reactions can be very serious. Stop taking Mometason Orion 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 the nasal spray. Some people who have used Mometason Orion or other nasal sprays containing corticosteroids may experience the following side effects:
Common (may affect up to 1 in 10 people):
- Headache
- Sneezing
- Nosebleeds [nosebleeds were very common (may affect more than 1 in 10 people) in people treated for nasal polyps and received Mometason Orion, two sprays in each nostril twice daily.]
- Nasal or throat irritation
- Sores on the nose
- Respiratory tract infection
Has been reported (occurs in an unknown number of users):
- Increased pressure in the eye ( glaucoma ) and cataracts that cause changes in vision
- Damage to the septum of the nose that separates the nostrils
- Change of taste and smell
- Difficulty breathing and wheezing
- Dimsyn
Reporting of side effects ar
If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects that are not mentioned in this information. You can also report side effects directly (see details below).
By reporting side effects, you can help increase drug safety information.
How To Store Mometason Orion
- Do not freeze.
- Keep this medicine out of sight and reach of children.
- Do not use this medicine after the expiry date stated on the carton after EXP. The expiration date is the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are 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 contains 50 micrograms of mometasone furoate as a monohydrate.
- The other ingredients are glycerol, microcrystalline cellulose, carmellose sodium, citric acid monohydrate, polysorbate 80, benzalkonium chloride, sodium citrate dihydrate, and Water for injections.
What The Medicine Looks Like And The Contents Of The Pack
- Mometasone Orion is a nasal spray suspension.
- A white opaque plastic bottle equipped with a white dosing pump, a white tip to insert into the nose, and a transparent top cover.
- One bottle of Mometason Orion is equivalent to 140 spray doses. Each spray emits a mometasone furoate monohydrate equivalent to 50 micrograms of mometasone furoates.
- Pack sizes: 1 x 140 spray cans, 3 x 140 spray cans
- Not all pack sizes may be marketed.
Marketing Authorization Holder And Manufacturer
Marketing Authorisation Holder:
Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland
Manufacturer:
Orion Corporation Orion Pharma
Orionintie 1
FI-02200 Espoo
Finland
S&D Pharma CZ, spol. s ro
Písnická 22
142 00 Prague 4
Czech Republic
Cipla (EU) Limited,
Dixcart House, Addlestone Road,
Bourne Business Park, Addlestone,
KT15 2LE
UK
Cipla Europe NV
De Keyserlei 58-60,
bus 19, Antwerp, 2018,
Belgium
Orion Corporation Orion Pharma
Joensuunkatu 7
FI-24100 Salo
Finland
For further information on this medicine, don’t hesitate to get in touch with your local representative:
Orion Pharma AB, Danderyd
medinfo@orionpharma.com
The Medical Products Agency
Box 26
751 03 Uppsala
www.lakemedelsverket.se