lundi 4 avril 2016

MOMETASONE FUROATE MONOHYDRATE Spray, Metered [Sandoz Inc.]

Patient Information

Mometasone Furoate Monohydrate Nasal Spray, 50 mcg

FOR INTRANASAL USE ONLY

Read the Patient Information that comes with Mometasone Furoate Monohydrate Nasal Spray before you start using it and each time you get a refill. There may be new information. This Patient Information does not take the place of talking to your healthcare provider about your medical condition or treatment. If you have any questions about Mometasone Furoate Monohydrate Nasal Spray, ask your healthcare provider.

What is Mometasone Furoate Monohydrate Nasal Spray?

Mometasone Furoate Monohydrate Nasal Spray is a man-made (synthetic) corticosteroid medicine that is used to:

  • treat the nasal symptoms of seasonal and year-round allergic rhinitis (inflammation of the lining of the nose) in adults and children 2 years of age and older.
  • treat nasal congestion that happens with seasonal allergic rhinitis in adults and children 2 years of age and older.
  • prevent nasal symptoms of seasonal allergic rhinitis in people 12 years of age and older.
  • treat nasal polyps in people 18 years and older.

The safety and effectiveness of Mometasone Furoate Monohydrate Nasal Spray has not been shown:

  • in children under 2 years of age to treat allergic rhinitis.
  • in children under 18 years of age to treat nasal polyps.

Who should not use Mometasone Furoate Monohydrate Nasal Spray?

Do not use Mometasone Furoate Monohydrate Nasal Spray if you are allergic to any of the ingredients in Mometasone Furoate Monohydrate Nasal Spray. See the end of this leaflet for a complete list of ingredients in Mometasone Furoate Monohydrate Nasal Spray.

What should I tell my healthcare provider before using Mometasone Furoate Monohydrate Nasal Spray?

Before you take Mometasone Furoate Monohydrate Nasal Spray, tell your healthcare provider if you:

  • have had recent nasal sores, nasal surgery, or nasal injury.
  • have eye or vision problems, such as cataracts or glaucoma (increased pressure in your eye).
  • have tuberculosis or any untreated fungal, bacterial, viral infections, or eye infections caused by herpes.
  • have been near someone who has chickenpox or measles.
  • are not feeling well or have any other symptoms that you do not understand.
  • have any other medical conditions.
  • are pregnant or planning to become pregnant. It is not known if Mometasone Furoate Monohydrate Nasal Spray will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
  • are breastfeeding or planning to breastfeed. It is not known whether Mometasone Furoate Monohydrate Nasal Spray passes into your breast milk.

Tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Mometasone Furoate Monohydrate Nasal Spray and other medicines may affect each other and cause side effects. Mometasone Furoate Monohydrate Nasal Spray may affect the way other medicines work, and other medicines may affect how Mometasone Furoate Monohydrate Nasal Spray works.

Know the list of medicine you take. Keep a list of your medications with you to show your healthcare provider and pharmacist when a new medication is prescribed.

How should I use Mometasone Furoate Monohydrate Nasal Spray?

  • Use Mometasone Furoate Monohydrate Nasal Spray exactly as prescribed by your healthcare provider.
  • This medicine is for use in the nose only. Do not spray it into your mouth or eyes.
  • An adult should help a young child use this medicine.
  • For best results, you should keep using Mometasone Furoate Monohydrate Nasal Spray regularly each day without missing a dose. If you do miss a dose of Mometasone Furoate Monohydrate Nasal Spray, take it as soon as you remember. However, do not take more than the daily dose prescribed by your doctor.
  • Do not use Mometasone Furoate Monohydrate Nasal Spray more often than prescribed. Ask your healthcare provider if you have any questions.
  • For detailed instructions on how to use Mometasone Furoate Monohydrate Nasal Spray, see the "Patient Instructions for Use" at the end of this leaflet.

See your healthcare provider regularly to assess your symptoms while taking Mometasone Furoate Monohydrate Nasal Spray and to check for side effects.

What should I avoid while taking Mometasone Furoate Monohydrate Nasal Spray?

If you are taking other corticosteroid medicines for allergy, either by mouth or injection, your healthcare provider may advise you to stop taking them once you begin using Mometasone Furoate Monohydrate Nasal Spray.

What are the possible side effects of Mometasone Furoate Monohydrate Nasal Spray?

Mometasone Furoate Monohydrate Nasal Spray may cause serious side effects, including:

  • Thrush (candida), a fungal infection in your nose and throat. Tell your doctor if you have any redness or white colored patches in your nose or throat.
  • Slow wound healing. Do not use Mometasone Furoate Monohydrate Nasal Spray until your nose has healed if you have a sore in your nose, if you have surgery on your nose, or if your nose has been injured.
  • Some people may have eye problems, including glaucoma and cataracts. You should have regular eye exams.
  • Immune system problems that may increase your risk of infections. You are more likely to get infections if you take medicines that weaken your immune system. Avoid contact with people who have contagious diseases such as chicken pox or measles while using Mometasone Furoate Monohydrate Nasal Spray. Symptoms of infection may include: fever, pain, aches, chills, feeling tired, nausea and vomiting. Tell your doctor about any signs of infection while you are using Mometasone Furoate Monohydrate Nasal Spray.
  • Adrenal insufficiency. Adrenal insufficiency is a condition in which the adrenal glands do not make enough steroid hormones. Symptoms of adrenal insufficiency can include: tiredness, weakness, nausea and vomiting and low blood pressure.

The most common side effects of Mometasone Furoate Monohydrate Nasal Spray include:

  • headache
  • viral infection
  • sore throat
  • nosebleeds
  • cough

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Mometasone Furoate Monohydrate Nasal Spray. For more information ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Mometasone Furoate Monohydrate Nasal Spray?

  • Store Mometasone Furoate Monohydrate Nasal Spray at room temperature between 59°F to 86°F (15°C to 30°C).
  • Avoid prolonged exposure of Mometasone Furoate Monohydrate Nasal Spray container to bright light.
  • Shake well before each use.

Keep Mometasone Furoate Monohydrate Nasal Spray and all medicines out of the reach of children.

General information about Mometasone Furoate Monohydrate Nasal Spray

Medicines are sometimes prescribed for conditions that are not listed in a Patient Information leaflet. Do not use Mometasone Furoate Monohydrate Nasal Spray for a condition for which it was not prescribed. Do not give Mometasone Furoate Monohydrate Nasal Spray to other people even if they have the same symptoms you have. It may harm them.

This Patient Information leaflet provides a summary of the most important information about Mometasone Furoate Monohydrate Nasal Spray. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Mometasone Furoate Monohydrate Nasal Spray that is written for health professionals.

For more information, call 1-800-622-4477.

What are the ingredients in Mometasone Furoate Monohydrate Nasal Spray?

Active Ingredients: mometasone furoate monohydrate

Inactive Ingredients: glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, sodium citrate, citric acid, benzalkonium chloride, and polysorbate 80.

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MOMETASONE FUROATE MONOHYDRATE Spray, Metered [Sandoz Inc.]

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