Vancenase (Nasal)

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

You can get this medicine only with your doctor's prescription.

It is very important for your doctor to check how you or your child are doing at regular visits. This helps your doctor see if the medicine is working properly and decide if you or your child should keep using it.

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

This medicine may raise your risk of having 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 breathing while using this medicine.

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

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

This medicine can lead to serious allergic reactions, including angioedema and anaphylaxis. Call your doctor right away if you notice swelling of your face, lips, tongue, throat, arms, or legs, or if you have 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 like chickenpox or measles, especially if you have never had these infections. This is particularly important for children. Tell 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 produces steroids for your body. This is more likely for people who use steroids for a long time or in high doses. Contact your doctor right away if you or your child experience 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 the menstrual cycle, acne, pimples, or weight gain (fat deposits) around the face, neck, and trunk may happen while taking this medicine.

This medicine may cause children to grow more slowly than normal. This means 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 should consider the risks of taking it compared to the benefits it offers. This is a choice you will make with your doctor. For this medicine, the following should be taken into account:

Allergies

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

Pediatric

Studies to date have not shown any specific problems that would limit the use of beclomethasone nasal spray in children aged 4 years and older. However, safety and effectiveness have not been established in children younger than 4 years.

Geriatric

Studies to date have not indicated any specific problems for older adults that would limit the usefulness of beclomethasone nasal spray. However, older patients 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 adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if there is a possibility of interaction. In these situations, your doctor may adjust the dose or take other precautions. When using this medicine, it is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are significant but not necessarily all-inclusive.

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

• Desmopressin

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

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

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

• Auranofin

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken at or around mealtimes or with certain foods, as interactions may happen. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare professional about using 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 needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately 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.