Vancenase AQ Double Strength (Nasal)

Beclomethasone nasal spray is used to treat an itchy or runny nose, sneezing, or other symptoms caused by perennial (year-round) or seasonal hay fever (allergic rhinitis). It is a steroid (cortisone-like medicine) that helps stop the inflammation caused by allergic reactions.

This medicine is available only with your doctor's prescription.

It is very important that your doctor checks the progress of you or your child at regular visits. This will help your doctor see if the medicine is working properly and decide if you or your child should keep using it.

If your or your child's symptoms do not improve within a few days or if they get worse, contact your doctor.

This medicine may increase your risk of experiencing some unwanted effects in the nose. Contact your doctor right away if you or your child have bloody mucus, sores inside the nose, unexplained nosebleeds, or a whistling sound when you breathe while using this medicine.

This medicine may cause thrush (a type of fungal infection) in the nose or throat. Inform your doctor right away if you or your child have white patches in the throat, or pain when you eat or swallow.

Contact your doctor immediately if you experience blurred vision, difficulty reading, or any other change in vision during or after treatment. Your doctor may want you or your child to have your eyes checked by an ophthalmologist (eye doctor).

This medicine can cause serious allergic reactions, including angioedema and anaphylaxis. Call your doctor right away if you start to have swelling of your face, lips, tongue, throat, arms, or legs, or if you are having trouble swallowing or breathing while using this medicine.

You may get infections more easily while using this medicine. Avoid being around people who are sick or have infections such as chickenpox or measles if you have never had these infections. This is especially important for children. Inform your doctor right away if you think you have been exposed to chickenpox or measles.

This medicine may increase your risk of having an adrenal gland that is less active than normal. The adrenal gland makes steroids for your body. This is more likely for people who use steroids for a long time or at high doses. Contact your doctor right away if you or your child have any of the following symptoms: darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting. Rarely, changes in menstrual cycles, acne, pimples, or weight gain (fat deposits) around the face, neck, and trunk may occur while taking this medicine.

This medicine may cause children to grow more slowly than normal. This would mean a child may not gain weight or get taller. Talk with your doctor if you think your child is not growing properly or if you have any questions about this.

In deciding to use a medicine, you and your doctor need to consider the risks of taking it against the benefits it will provide. Here are some important points to think about regarding this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, like to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Current studies have not shown any specific problems for children aged 4 years and older that would limit the use of beclomethasone nasal spray. However, safety and effectiveness have not been established for children younger than 4 years old.

Geriatric

Current studies have not shown any specific problems for elderly patients that would limit the use of beclomethasone nasal spray. However, older adults are more likely to have age-related liver, kidney, or heart issues, which may require caution when using beclomethasone nasal spray.

Breast Feeding

There are no sufficient studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits and risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others can be used together with caution. If you're taking this medicine, it's very important for your healthcare professional to know if you are taking any of the following medicines. The interactions listed below have been chosen for their potential significance and may not be all-inclusive.

Using this medicine with the following medicine is not recommended. Your doctor may decide not to treat you with this medication or change some of your other medicines.

• Desmopressin

Using this medicine with the following medicines is usually not recommended, but may be necessary in some cases. If both are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Aspirin
• Bemiparin
• Lutetium Lu 177 Dotatate
• Macimorelin
• Nadroparin
• Sargramostim
• Somatrogon-ghla

Using this medicine with the following medicine may increase the risk of certain side effects, but both drugs may still be necessary for your treatment. If both are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Auranofin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with some medicines may also cause interactions. Discuss with your healthcare professional how to take your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical conditions may affect how you can use this medicine. Make sure to inform your doctor if you have any other medical issues, especially:

• Asthma or wheezing
• Cataracts, history of
• Chicken pox (includes recent exposure)
• Glaucoma, history of
• Herpes simplex infection of the eye
• Infections (bacteria, fungus, virus, or parasite), active or untreated
• Measles (includes recent exposure)
• Tuberculosis, active or history of—Use with caution. May worsen these conditions.

• Injury to the nose
• Recent nose surgery
• Recent sores or ulcers in the nose—May hinder proper healing of these conditions.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may require medical attention.

Check with your doctor right away if any of the following side effects occur:

More common

• Chills
• Dizziness
• Fast heartbeat
• Lightheadedness
• Rapid, shallow breathing
• Rash
• Unusual bleeding or bruising

Less common

• Change in vision
• Eye pain
• Headache
• Nausea or vomiting
• Tearing
• Unexplained nosebleeds

Incidence not known

• Bloody mucus
• Cough or hoarseness
• Difficulty with breathing
• Dizziness
• Hives or welts, itching
• Loss of taste and smell
• Sores inside the nose

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

In the U.S.

• Beconase
• Beconase AQ
• QNASL
• Vancenase
• Vancenase AQ
• Vancenase AQ Double Strength

Available Dosage Forms:

• Aerosol Liquid
• Spray

Therapeutic Class: Anti-Inflammatory

Pharmacologic Class: Adrenal Glucocorticoid

Use this medicine only as directed. Do not use more of it and do not use it more often than your doctor ordered. To do so may increase the chance of side effects.

This medicine comes with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

This medicine is only used in the nose. Do not get it in your eyes or on your skin. If it does get on these areas, rinse it off right away and call your doctor.

To use the spray:

• When you use the medicine for the first time or if you have not used this medicine for 7 days in a row, you must prime the spray. Press down fully on the top of the canister four times or until a fine spray comes out.
• After you prime the nasal spray, there will only be 120 doses or sprays.
• Gently blow your nose before using the spray. Tilt your head back slightly and insert the tip of the nose piece into your nostril.
• Close the opposite nostril with a finger. Release 1 spray and at the same time, breathe in gently through the nostril.
• Hold your breath for a few seconds then breathe out slowly through your mouth.
• Spray the opposite nostril using the same steps.
• Do not blow your nose after using the spray.
• Wipe the tip of the outside of the nose piece with a clean, dry tissue or cloth and put the cap back on.
• Do not remove the canister from the actuator. Qnasl™ nasal aerosol canister should only be used with the Qnasl™ nasal aerosol actuator.
• Throw this medicine away after you use 120 sprays or when the dose indicator read zero "0".

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For nasal dosage form (spray):For treatment of allergic rhinitis: Adults and children 12 years of age and older—2 sprays in each nostril once a day. Each spray contains 80 micrograms (mcg). Adults and children 4 to 11 years of age—1 spray in each nostril once a day. Children younger than 4 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the canister at room temperature, away from heat and direct light. Do not freeze. Do not keep this medicine inside a car where it could be exposed to extreme heat or cold. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.