Flunisolide (Nasal)

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Burning.
• Stinging.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Hypersensitivity to flunisolide or any component of the formulation

Documentation of allergenic cross-reactivity for intranasal steroids is limited; however, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.

Canadian labeling: Additional contraindications (not in US labeling): Active or quiescent tuberculosis; untreated fungal, bacterial, or viral infections; children <6 years

There are no dosage adjustment provided in manufacturer's labeling.

There are no dosage adjustment provided in manufacturer's labeling.

Adverse effects were observed in some animal reproduction studies. Intranasal corticosteroids are recommended for the treatment of rhinitis during pregnancy; the lowest effective dose should be used (NAEPP, 2005; Wallace, 2008).

Flunisolide is a steroid. It prevents the release of substances in the body that cause inflammation.

Flunisolide nasal (for the nose) is used to treat nasal congestion, sneezing, and runny nose caused by seasonal or year-round allergies.

Flunisolide nasal may also be used for purposes not listed in this medication guide.

You should not use this medicine if you are allergic to flunisolide.

To make sure flunisolide nasal is safe for you, tell your doctor if you have:

• any type of untreated infection in your nose or sinuses;

• asthma;

• tuberculosis or any other infection or illness;

• herpes simplex infection of your eyes;

• sores or ulcers inside your nose; or

• if you have recently had injury of or surgery on your nose.

Flunisolide can weaken your immune system, making it easier for you to get an infection or worsening an infection you already have. Tell your doctor about any illness or infection you have had within the past several weeks.

Also tell your doctor if you have diabetes. Steroid medicines may increase the glucose (sugar) levels in your blood or urine. You may also need to adjust the dose of your diabetes medications.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether flunisolide nasal passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Steroid medicine can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using this medicine.

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Before your first use, prime the nasal spray pump by spraying 5 to 6 test sprays into the air (away from your face), until a fine mist appears. Prime the nasal spray any time you have not used it for 5 days or longer, or if you have taken apart the spray device to clean it.

Blow your nose gently to clear your nostrils before using this medicine.

Do not use flunisolide nasal in a child younger than 6 years old. Any child using flunisolide nasal should be supervised by an adult while using the nasal spray.

Use this medicine at regular intervals to keep a steady amount of the drug in your body at all times.

Adults should not use more than 8 sprays in each nostril per day. Children younger than 14 years old should not use more than 4 sprays in each nostril per day. Using more than your recommended dose will not make this medicine more effective, and may increase your risk of unwanted side effects.

While using flunisolide nasal, you may need frequent blood tests.

It may take 1 to 2 weeks before your symptoms improve. Keep using flunisolide nasal as directed and tell your doctor if your symptoms do not improve after 3 weeks of using this medicine.

You should not stop using steroid medicine suddenly or you may have unpleasant withdrawal symptoms. Follow your doctor's instructions about tapering your dose. If you were switched to flunisolide nasal from another steroid medicine, do not stop using the other medicine suddenly.

Do not share this medicine with another person, even if they have the same symptoms you have.

Store flunisolide nasal in an upright position at room temperature, away from moisture and heat. Throw the spray bottle away after you have used 200 sprays, even if there is still medicine left in the bottle.

Tell your doctor about all your current medicines and any you start or stop using, especially prednisone.

It is not likely that other drugs you take orally or inject will have an effect on flunisolide used in the nose. But many drugs can interact with each other. Tell each of your healthcare providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

Temporary nose/throat dryness or irritation, cough, nosebleeds, sneezing and unpleasant taste/smell may occur. If any of these side effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these rare but seriousloss of taste or smell, pain/sores in your nose.

Rarely, it is possible that corticosteroids given in the nose will be absorbed into the bloodstream. This can lead to side effects of too much corticosteroid. These side effects are more likely in children and people who use this medication for a long time and in high doses. Tell your doctor right away if any of the following side effects occur: unusual/extreme tiredness, weight loss, headache, swelling ankles/feet, increased thirst/urination, vision problems.

Corticosteroids may weaken the body's ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. This effect might also rarely occur with corticosteroids inhaled through the nose (such as flunisolide). The risk may be increased if high doses are used, especially when used for a long time. Tell your doctor right away if you have any signs of infection (such as ear pain, persistent sore throat, fever, chills, white patches inside the nose or on the back of the throat).

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, wheezing/trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.