Mometason Apofri 50 micrograms/dose nasal spray, mometasone furoate suspension
What Mometason Apofri Is And What Mometason Apofri Used For
Mometasone Apofri 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
- Runny nose
Mometasone Apofri is used to treat the 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. Mometasone Apofri 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 contained in Mometason Apofri may also be approved for treating other conditions not mentioned in this leaflet. 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 Mometason Apofri
Do Not Use Mometason Apofri
- 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 nose infection. Using Mometasone Apofri in an untreated nose infection, such as herpes, can aggravate infection one. It would help if you waited until the infection had healed before using the nasal spray.
- If you have recently had nose surgery or have a nose injury. It would help to wait until your nose has healed before using the nasal spray.
Warnings And Cautions
Talk to your doctor or pharmacist before using Mometason Apofri
- 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 taking Mometason Apofri
- If your immune system is weakened (if you have difficulty fighting infections ) 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 use 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 Medicines And Mometason Apofri
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
If you are taking other medicines that contain corticosteroids for your allergies, either by mouth or by injection, your doctor may decide to stop using them while you are taking Mometason Apofri. 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. If these symptoms occur, consult your doctor.
Some medicines may increase the effects of Mometasone Apofri and your doctor may want to monitor you closely if you are taking these medicines (eg some medicines for HIV: ritonavir, cobicistat).
Pregnancy And Breastfeeding
There is no or limited amount of information from the use of Mometasone Apofri 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
Mometasone Apofri nasal spray is unlikely to affect your 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 vigilance. 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.
Mometason Apofri Contains Benzalkonium Chloride
Mometasone Apofri contains 0.02 mg benzalkonium chloride per dose. Benzalkonium chloride can irritate and swell inside the nose, especially with prolonged use.
How To Use Mometason Apofri
- Dosage for adults from 18 years is 2 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, Mometason Apofri nasal spray 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 Mometasone Apofri nasal spray for more than 3 months without consulting a doctor.
Please note that Mometason Apofri should only be given to children on the prescription of a doctor.
Prepare Your Nasal Spray For Use
Your Mometason Apofri nasal spray has a protective cover that protects the nozzle and keeps it clean. Remember to remove it before using the spray and return it afterward.
If you are using the spray for the first time, you should prepare the bottle by pumping the spray ten times until a fine mist is obtained:
1. Shake the bottle well.
2. Place the index finger and middle finger on opposite sides of the nozzle and thumb under the bottle (Figure 1).
3. Turn the nozzle away from you and then press down with your fingers to pump the spray (Figure 1).
Figure 1
If you have not used the spray for 14 days, you should prepare the bottle again by pumping the spray twice until a fine mist is obtained.
How to use your nasal spray
1. Shake the bottle well and remove the protective cover (figure 2)
Figure 2
2. Cheat carefully.
3. Plug in one nostril and insert the nozzle into the other.
4. Bend your head slightly forward while holding the bottle upright.
5. Begin gently or slowly inhaling through the nose while spraying a spray of fine mist into the nose by pressing down ONCE with your fingers (Figure 3).
Figure 3
6. Exhale through your mouth. Repeat step 5 to inhale a second spray into the same nostril.
7. Remove the mouthpiece from the nostril and exhale through the mouth.
8. Repeat steps 3 to 7 for the other nostril.
After spraying, wipe the nozzle thoroughly with a clean handkerchief or tissue paper and put the protective cap back on.
Clean your nasal spray
It is important to regularly clean your nasal spray for it to work properly. Remove the protective cover and carefully pull off the nozzle. Wash the nozzle and protective cover in warm water and then rinse them under running water. Let them dry in a warm place. Push the nozzle back onto the bottle and replace the protective cap. The spray needs to be prepared again with two sprays when it is used for the first time after it has been cleaned.
If You Use More Mometason Apofri Than You Should
You must take the dose indicated on the package leaflet or as prescribed by your doctor. If you use more or less, your symptoms may worsen. 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 Mometason Apofri
If you forget to use your nasal spray at the right time, use it as soon as you remember, and then continue as usual. Do not take a double dose to make up for a forgotten dose.
If You Stop Using Mometason Apofri
In some patients, Mometason Apofri 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.
Possible Mometason Apofri 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 Apofri 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 Apofri 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
- Nosebleeds
- Nose 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 vision changes, blurred vision
- Damage to the septum of the nose that separates the nostrils
- Change in taste and smell
- Difficulty breathing and wheezing
How To Store Mometason Apofri
- Keep this medicine out of the reach and sight of children.
- Do not use this medicine after the expiry date which is stated on the label 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 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, polysorbate 80, benzalkonium chloride, and purified water.
What The Medicine Looks Like And Contents Of The Pack
Mometasone Apofri nasal spray is a white spray suspension packaged in a white plastic bottle with a spray pump.
- 1 bottle contains 10.0 g nasal spray suspension, which corresponds to 60 spray doses
- 2 bottles of 10.0 g nasal spray, suspension, corresponding to 120 spray doses.
- 1 bottle contains 17.0 g nasal spray, suspension, corresponding to 120 spray doses.
- 1 bottle contains 18.0 g nasal spray suspension corresponding to 140 spray doses.
Not all pack sizes may be marketed.
Marketing Authorization Holder And Manufacturer
Marketing Authorisation Holder
Evolan Pharma AB
Box 120
182 12 Danderyd
Manufacturer
FARMEA, 10, rue Bouché Thomas, ZAC d’Orgemont, 49000 ANGERS, France
FARMACLAIR, 440 avenue du Général de Gaulle, 14200 Hérouville Saint Clair, France
Local representative / Information provided by:
Apofri AB
Box 120
182 12 Danderyd
Phone: 08-544 960 30
Email: info@apofri.se