50 micrograms/dose nasal spray, suspension 
mometasone furoate

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

– Save this information, you may need to read it again.

– If you have any further questions, ask your doctor or pharmacist.

– This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.

– If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

This leaflet contains information about: 
1. What Aphiahsone is and what it is used for 
2. What you need to know before you use Aphiahsone 
3. How to use Aphiahsone 
4. Possible side effects 
5. How to store Aphiahsone 
6. Contents of the packaging and other information 

1. What Aphiahsone is and what it is used for

What is Aphiahsone?

Aphiahsone 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 Aphiahsone used for?

Hay fever and perennial rhinitis ( allergy to eg mites and fur animals)

Aphiahsone is used to treat the symptoms of hay fever (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, 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. 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 gradually shrink, 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. You should wait until the infection has healed before using the nasal spray.
  • If you have recently had nose surgery or have a nose injury. You must then wait until your nose has healed before using the nasal 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. You should avoid contact with anyone who has these infections.
  • If you get a nose or throat infection.
  • If you are 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 that you use 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 are taking, have recently taken, or might take any other medicines, including medicines 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 (eg 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 other types of 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 amount of information from the use of Aphiahsone in pregnant women. It is unknown whether mometasone furoate is excreted in human milk.

If you are pregnant or breast-feeding, 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 are fit to 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 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.

Aphiahsone contains benzalkonium chloride

This medicine contains 20 micrograms of benzalkonium chloride per spray.

Benzalkonium chloride may cause irritation and swell inside the nose, especially with prolonged use of the medicine.

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 use the spray more often or for 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 start to feel better, consult your doctor who may recommend increasing dose one to the maximum daily dose one, which is 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 that you start 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 to put it back after use.

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.

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 begin to 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 to 6 for the other nostril.

After using the spray, 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 then 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, which will prevent 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 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 is very important that you use 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 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 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 the 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 in the nose
  • respiratory tract infection.

Has been reported (occurs in an unknown number of users):

  • increased pressure in the eye ( glaucoma ) and/or 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/or wheezing.
  • dimsyn

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. 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 the sight and reach of children.

Do not store above 25 ° C

Do not use this medicine after the expiry date which is 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 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, and carmellose sodium, citric acid monohydrate, sodium 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 doses 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

Muhammad Nadeem

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