What is Aphiahsone Nasal Spray & Side Effects

Aphiahsone contains mometasone furoate, a group of corticosteroid ( cortisone ) medicines. 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 Aphiahsone used for?

Hay fever and perennial rhinitis ( allergy to, e.g., mites and fur animals)

Aphiahsone treats hay fever symptoms (also known as 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. The symptoms can be caused by a sensitivity to various things, such as house dust mites, animal hair (or skin deposits), feathers, and certain foods. Aphiahsone reduces swelling and irritation in the nose and thus relieves sneezing, itching, nasal congestion, or runny nose caused by hay fever or perennial rhinitis.

Nasal polyps

Aphiahsone is used to treat 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. Aphiahsone reduces inflammation in the nose, which causes the polyps to shrink gradually, thus reducing a stuffy feeling in the nose, which can affect breathing through the nose.

2. What You Need To Know Before Using Aphiahsone

Do Not Use Aphiahsone

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. The use of Aphiahsone 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 had nose surgery or have a nose injury. It would be best if you waited until your nose had healed before using the Aphiahsone spray.

Warnings And Cautions

Talk to your doctor or pharmacist before using Aphiahsone:

If you have or have ever had tuberculosis
If you have any other infection
If you are taking other medicines that contain corticosteroids, either by mouth or by injection.
If you have cystic fibrosis.
Contact a doctor if you experience blurred vision or other visual disturbances.

Talk to your doctor while you are using Aphiahsone

If your immune system is weakened (if you have difficulty fighting infections ) and you come in contact with someone who has measles or chickenpox. It would be best if you avoid contact with anyone who has these infections.
If you get a nose or throat infection.
If you have been taking this medicine for several months or more.
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 Aphiahsone.

Children

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 your doctor if changes occur.

Other Medicines And Aphiahsone

Tell your doctor or pharmacist if you have recently taken or might take any other medicines, including those obtained without a prescription.
Some medicines may increase the effects of Aphiahsone, and your doctor may want to monitor you closely if you are taking these medicines (e.g., some medicines for HIV: ritonavir, cobicistat)
If you are taking other medicines containing corticosteroids for your allergy, either by mouth or by injection, your doctor may decide to stop taking them when you use Aphiahsone. 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 get allergies, such as itchy, watery eyes or spotty red and itchy skin. If these symptoms occur, consult your doctor.

Pregnancy, Breastfeeding, And Fertility

There is no or limited information on the use of Aphiahsone 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 Aphiahsone 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 increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects 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.

Aphiahsone Contains Benzalkonium Chloride.

This medicine contains 20 micrograms of benzalkonium chloride per Aphiahsone spray.
Benzalkonium chloride may irritate and swell inside the nose, especially with prolonged medicine use.

3. How To Use Aphiahsone

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, e.g., 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 may recommend increasing dose one to the maximum daily dose one, four sprays in each nostril once daily.

Use in children aged 3 to 11 years.

The usual dose is a spray in each nostril once a day

If you or your child have severe hay fever problems, your doctor may recommend using Aphiahsone before the pollen season begins, as this will help prevent your hay fever symptoms. At the end of the pollen season, your hay fever symptoms should improve, and treatment may no longer be needed.

Nasal polyps

Use in adults 18 years and older.

The usual starting dose is two sprays in each nostril once a day.

If 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 Aphiahsone 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 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 Aphiahsone nasal spray

1. Shake the bottle gently and remove the plastic cover.

2. Cheat carefully.

3. 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 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 your dose.

6. Remove the spout from the nostril and exhale through the mouth.

7. Repeat steps 3 to 6 for the other nostril.

After spraying, wipe the spout 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 attempt 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.
Allow the plastic cover and spout to 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.

If You Use More Aphiahsone Than You Should

Contact a doctor if you have inadvertently used more medicines than prescribed.

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 Aphiahsone

In some patients, Aphiahsone will start relieving symptoms 12 hours after the first dose. 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.

4. Possible Aphiahsone 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 Aphiahsone 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 Aphiahsone 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 given Aphiahsone, 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 or wheezing
Dimsyn

Reporting of side effects

Talk to your doctor, pharmacist, or nurse if you get any side effects. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.

5. How To Store Aphiahsone

Keep this medicine out of sight and reach of children.
Do not store above 25 ° C
Do not use this medicine after the expiry date stated on the label and carton after EXP. The expiration date is the last day of the specified month.
Each bottle should be used within 2 months of the first opening. Only open one bottle at a time.

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.

6. Contents Of The Packaging And Other Information

Content Declaration

The active substance is Mometasone furoate. Each spray contains 50 micrograms of mometasone furoate as monohydrate.
The other ingredients are benzalkonium chloride, glycerol, polysorbate 80, microcrystalline cellulose, carmellose sodium, citric acid monohydrate, and citrate purified water.

What The Medicine Looks Like And The Contents Of The Pack

Aphiahsone is a suspension for nasal spray.
Bottles containing 60 doses, 120 doses, or 140 doses.
Bottles containing 60 and 120 doses are available in packs of 1 nasal spray.
Bottles containing 140 doses are available in packs of 1 nasal spray or 3 nasal sprays.
Not all pack sizes may be marketed.

Marketing Authorization Holder And Manufacturer

Holder of approval

Glenmark Arzneimittel GmbH, Industriestr. 31, 82194 Gröbenzell, Germany

Manufacturer

Farmea

10, rue Bouché Thomas ZAC Sud d’Orgemont

49000 Angers, France

This medicinal product is authorized in the EEA Member States under the following names:

Denmark	Aphiahsone 50 micrograms/dose nasal spray, suspension
Poland	Eztom, 50 micrograms / dawkę, aerozol do nosa, zawiesina

Germany	Aphiasone 50 micrograms/spray nasal spray, suspension

Aphiahsone – Mometasone Furoate Uses, Dose, And Side Effects

1. What Aphiahsone Is And What It Is Used For