Momenex – Mometasone furoate uses, dose and side effects

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50 micrograms/dose Nasal spray, suspension
Mometasone furoate as monohydrate

What Momenex is and what it is used for

Monex nasal spray contains mometasone furoate, which belongs to a group of medicines called corticosteroids.

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.

Hay fever and perennial rhinitis

Monex is used to treat the symptoms of hay fever (also called seasonal allergic rhinitis ) and inflammation of the nose caused by allergies (also called perennial rhinitis ) in adults and children 3 years 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. house dust mites, animal hair (or skin deposits), feathers, and certain foods. Monex 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

Monex 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. Monex reduces inflammation in the nose, which means that the polyps gradually shrink and thus reduces a stuffy feeling in the nose that can make it difficult to breathe through the nose.

What you need to know before using Momenex

Do not use Momenex

  • if you are allergic (hypersensitive) 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 Momenex in an untreated infection of the nose, such as herpes , can 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 your nose has healed before you start using the nasal spray.

Warnings and cautions

Talk to your doctor or pharmacist before using Momenex

  • 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 using Momenex

  • 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.

When nasal sprays containing corticosteroids are used in high doses for a long time, side effects may occur which are 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 Momenex.

Contact a doctor if you experience blurred vision or other visual disturbances.

Children

During long-term treatment with high-dose 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 any changes occur.

Other medicines and Momenex

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.

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 while you are taking Momenex. When you stop taking corticosteroids, either by mouth or by injection, you may experience symptoms such as joint or muscle pain, weakness, or 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.

Some medicines may increase the effects of Momenex 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 Momenex 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 Momenex 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

Momenex contains Benzalkonium chloride

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

How to use Momenex

Always use this medicine exactly 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 your doctor prescribes.

How to prepare your nasal spray before use

Momenex 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 7 times until a fine spray shower is obtained:

  1. Gently shake the bottle and remove the plastic cover.
  2. Place the index finger and middle finger on opposite sides 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 7 times until a fine spray shower is obtained.

If you have not used the spray for seven days or longer, you should prepare the bottle again by pumping the spray twice.

Use of the nasal spray

  1. Shake the nasal spray 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 and hold the bottle upright.
  4. Inhale slowly and gently through your nose while pressing down ONCE with your fingers.
  5. Exhale through the mouth.
  6. Repeat steps 4 and 5 to inject a second spray into the same nostril, depending on the dose you have.
  7. Repeat steps 3-6 for the other nostril.
  8. After using the spray, wipe the pipe thoroughly with a clean handkerchief or soft paper and put the plastic cover back on.

Cleaning the nasal spray

It is important to clean your nasal spray regularly, otherwise, it may not work properly.

  • Clean the spout and plastic cover once a week with lukewarm water and allow to dry at room temperature.
  • Do not try to clean the spout by inserting a needle or other sharp object as the spout will be damaged, which means that you will not receive the correct dose of the medicine.
  • 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.

Use for children and adolescents

Treatment of hay fever and perennial rhinitis

Adults and children over 12 years

The recommended dose is two sprays in each nostril once daily.

  • When symptoms are under control, your doctor may advise you to reduce dose one.
  • If you do not start to feel better, consult your doctor who may recommend increasing your dose . The maximum daily dose is four sprays in each nostril once daily.

Children aged 3–11 years

The recommended dose is a spray in each nostril once daily.

In some patients, Momenex may begin to relieve symptoms within 12 hours of the first dose. However, it may take more than 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 problems with hay fever, your doctor may recommend that you start using Momenex a few days before the start of the pollen season as this will help prevent your hay fever symptoms.

Treatment of nasal polyps

Adults 18 years or older

The recommended starting dose is two sprays in each nostril once daily.

  • 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 uses, you should contact your doctor.

If you use more Momenex 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 Momenex

If you forget to take a dose, take 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 Momenex

In some patients, Momenex 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. 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.

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 serious. Stop taking this medicine and contact a doctor immediately if you get the following symptoms:

  • 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 which are due to the drug being absorbed into the body.

Other side effects:

Most people have no problem using nasal spray. However, some people may experience any of the following side effects after using Momenex:

Common side effects (may affect up to 1 in 10 people)

  • headache
  • sneezing
  • nosebleeds [very common (may affect more than 1 in 10 people) in people with nasal polyps treated with two sprays of Momenex in each nostril twice daily]
  • sore nose or sore throat
  • 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

How to store Momenex

Keep this medicine out of the sight and reach of children.

No special storage instructions.

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.

Use the bottle within 3 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.

Contents of the package and other information

Content declaration

  • The active substance is mometasone furoate. One dose contains 50 micrograms mometasone furoate as monohydrate.
  • The other ingredients are benzalkonium chloride, sodium citrate dihydrate (E331 (ii)), citric acid monohydrate (E330), microcrystalline cellulose (E460i), carmellose sodium (E466), glycerol (E422), polysorbate 80 and water.

What the medicine looks like and contents of the pack

Momenex is a white opaque suspension.

Momenex is packaged in an HDPE bottle with a spray pump and plastic cover and is supplied in packs containing 60, 120, 140, or 420 (3 x 140) doses.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

2care4 Generics ApS

Stenhuggervej 12-14

6710 Esbjerg V

Denmark

Manufacturer

Basic Pharma Manufacturing BV

Mayor Lemmensstraat 352

6163 JT Geleen

Netherlands

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