Beconase AQ

Nose/throat dryness or irritation, sneezing, nosebleeds, 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 immediately if any of these rare but serious side effects occur: loss 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 beclomethasone). The risk may be increased if high doses are used, especially when used for a long time. Tell your doctor immediately 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.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.Check all prescription medicine labels carefully since similar medications (other corticosteroids such as prednisone) may increase your risk of side effects if taken together with this drug. Ask your doctor or pharmacist if you have any questions about your medications.This document does not contain all possible drug interactions. Keep a list of all the products you use. Share this list with your doctor and pharmacist to lessen your risk for serious medication problems.

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

Before using beclomethasone, tell your doctor if you have been sick or have had any infections. You may not be able to use beclomethasone nasal until you are well.

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

• asthma;

• glaucoma or cataracts;

• herpes simplex virus of your eyes;

• tuberculosis or any other infection or illness;

• sores or ulcers inside your nose; or

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

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

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

Beclomethasone nasal can affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using this medicine.

Beconase should not be given to a child younger than 6 years old. Qnasl should not be given to a child younger than 4 years old.

It is very important that your doctor check the progress of you or your child at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you or your child should continue to use it.

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

This medicine may increase your risk of having some unwanted effects in the nose. Check with 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 you are using this medicine.

This medicine may cause thrush (a type of fungus 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 you eat or swallow.

Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs 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 you are using this medicine.

You may get infections more easily while you are using this medicine. Avoid being around people who are sick or have infections such as chickenpox or measles or if you have never had these infections. This is especially 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 makes steroids for your body. This is more likely for people who use steroids for a long time or use high doses. Check with 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, menstrual cycle changes, 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 cause a child not to 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.

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.

• It is used to keep nose polyps from coming back.
• It is used to ease allergy signs.
• It may be given to you for other reasons. Talk with the doctor.

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:

• Headache.
• Nose or throat irritation.
• Signs of a common cold.

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.

General:

Intranasal corticosteroids may cause a reduction in growth velocity when administered to pediatric patients (see PRECAUTIONS: Pediatric Use).

During withdrawal from oral corticosteroids, some patients may experience symptoms of withdrawal, e.g., joint and/or muscular pain, lassitude, and depression.

Rarely, immediate hypersensitivity reactions may occur after the intranasal administration of beclomethasone (see ADVERSE REACTIONS).

Rare instances of nasal septum perforation have been spontaneously reported.

Rare instances of wheezing, cataracts, glaucoma, and increased intraocular pressure have been reported following the intranasal use of beclomethasone dipropionate.

In clinical studies with beclomethasone dipropionate administered intranasally, the development of localized infections of the nose and pharynx with Candida albicans has occurred only rarely. When such an infection develops, it may require treatment with appropriate local therapy and discontinuation of treatment with Beconase Aq Nasal Spray.

If persistent nasopharyngeal irritation occurs, it may be an indication for stopping Beconase Aq Nasal Spray.

Beclomethasone dipropionate is absorbed into the circulation. Use of excessive doses of Beconase Aq Nasal Spray may suppress HPA function.

Intranasal corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculous infections of the respiratory tract, untreated local or systemic fungal or bacterial infections, systemic viral or parasitic infections, or ocular herpes simplex.

For Beconase Aq Nasal Spray to be effective in the treatment of nasal polyps, the spray must be able to enter the nose. Therefore, treatment of nasal polyps with Beconase Aq Nasal Spray should be considered adjunctive therapy to surgical removal and/or the use of other medications that will permit effective penetration of Beconase Aq Nasal Spray into the nose. Nasal polyps may recur after any form of treatment.

As with any long-term treatment, patients using Beconase Aq Nasal Spray over several months or longer should be examined periodically for possible changes in the nasal mucosa.

Because of the inhibitory effect of corticosteroids on wound healing, patients who have experienced recent nasal septal ulcers, nasal surgery, or nasal trauma should not use a nasal corticosteroid until healing has occurred.

Although systemic effects have been minimal with recommended doses, this potential increases with excessive doses. Therefore, larger than recommended doses should be avoided.

Information for Patients:

Patients being treated with Beconase Aq Nasal Spray should receive the following information and instructions. This information is intended to aid them in the safe and effective use of this medication. It is not a disclosure of all possible adverse or intended effects.

Patients should use Beconase Aq Nasal Spray at regular intervals since its effectiveness depends on its regular use. The patient should take the medication as directed. It is not acutely effective, and the prescribed dosage should not be increased. Instead, nasal vasoconstrictors or oral antihistamines may be needed until the effects of Beconase Aq Nasal Spray are fully manifested. One to 2 weeks may pass before full relief is obtained. The patient should contact the physician if symptoms do not improve, if the condition worsens, or if sneezing or nasal irritation occurs.

For the proper use of Beconase Aq Nasal Spray and to attain maximum improvement, the patient should read and follow carefully the patient’s instructions accompanying the product.

Persons who are using immunosuppressant doses of corticosteroids should be warned to avoid exposure to chickenpox or measles. Patients should also be advised that if they are exposed, medical advice should be sought without delay.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

The carcinogenicity of beclomethasone dipropionate was evaluated in rats that were exposed for a total of 95 weeks, 13 weeks at inhalation doses up to 0.4 mg/kg and the remaining 82 weeks at combined oral and inhalation doses up to 2.4 mg/kg. There was no evidence of carcinogenicity in this study at the highest dose, approximately 60 times the maximum recommended daily intranasal dose in adults on a mg/m2 basis or approximately 35 times the maximum recommended daily intranasal dose in children on a mg/m2 basis.

Beclomethasone dipropionate did not induce gene mutation in bacterial cells or mammalian Chinese hamster ovary (CHO) cells in vitro. No significant clastogenic effect was seen in cultured CHO cells in vitro or in the mouse micronucleus test in vivo.

In rats, beclomethasone dipropionate caused decreased conception rates at an oral dose of 16 mg/kg (approximately 390 times the maximum recommended daily intranasal dose in adults on a mg/m2 basis). There was no significant effect of beclomethasone dipropionate on fertility in rats at oral doses of 1.6 mg/kg (approximately 40 times the maximum recommended daily intranasal dose in adults on a mg/m2 basis). Inhibition of the estrous cycle in dogs was observed following oral dosing at 0.5 mg/kg (approximately 40 times the maximum recommended daily intranasal dose in adults on a mg/m2 basis). No inhibition of the estrous cycle in dogs was seen following 12 months’ exposure at an estimated inhalation dose of 0.33 mg/kg (approximately 25 times the maximum recommended daily intranasal dose in adults on a mg/m2 basis).

Pregnancy:

Teratogenic Effects: Like other corticosteroids, beclomethasone dipropionate was teratogenic and embryocidal in the mouse and rabbit at a subcutaneous dose of 0.1 mg/kg in mice or 0.025 mg/kg in rabbits (approximately equal to the maximum recommended daily intranasal dose in adults on a mg/m2 basis). No teratogenicity or embryocidal effects were seen in rats when exposed to an inhalation dose of 0.1 mg/kg plus oral doses of up to 10 mg/kg per day for a combined dose of 10.1 mg/kg (approximately 240 times the maximum recommended daily intranasal dose in adults on a mg/m2 basis).

There are no adequate and well-controlled studies in pregnant women. Beclomethasone dipropionate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nonteratogenic Effects: Hypoadrenalism may occur in infants born of mothers receiving corticosteroids during pregnancy. Such infants should be carefully observed.

Nursing Mothers:

It is not known whether beclomethasone dipropionate is excreted in human milk. Because other corticosteroids are excreted in human milk, caution should be exercised when Beconase Aq Nasal Spray is administered to a nursing woman.

Pediatric Use:

The safety and effectiveness of Beconase Aq Nasal Spray have been established in children aged 6 years and above through evidence from extensive clinical use in adult and pediatric patients. The safety and effectiveness of Beconase Aq Nasal Spray in children below 6 years of age have not been established.

Controlled clinical studies have shown that intranasal corticosteroids may cause a reduction in growth velocity in pediatric patients. This effect has been observed in the absence of laboratory evidence of HPA axis suppression, suggesting that growth velocity is a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of HPA axis function. The long-term effects of this reduction in growth velocity associated with intranasal corticosteroids, including the impact on final adult height, are unknown. The potential for “catch-up” growth following discontinuation of treatment with intranasal corticosteroids has not been adequately studied. The growth of pediatric patients receiving intranasal corticosteroids, including Beconase Aq Nasal Spray, should be monitored routinely (e.g., via stadiometry). The potential growth effects of prolonged treatment should be weighed against the clinical benefits obtained and the risks/benefits of treatment alternatives. To minimize the systemic effects of intranasal corticosteroids, including Beconase Aq Nasal Spray, each patient should be titrated to the lowest dose that effectively controls his/her symptoms.

In a double-blind, controlled trial, 100 children between the ages of 6 and 9½ years with allergic rhinitis were randomized to receive aqueous intranasal beclomethasone dipropionate 168 mcg twice daily or placebo for 1 year. As measured by stadiometry, children who received beclomethasone dipropionate grew more slowly than those who received placebo. A difference in mean change in height was observed within 1 month of drug initiation. At the end of 12 months, the beclomethasone dipropionate-treated group had a growth velocity on average of 4.75 cm/year compared to 6.20 cm/year in the placebo group (p<0.01). While the placebo group had an expected distribution of growth velocity, approximately 50% of the beclomethasone dipropionate-treated children grew below the 10th percentile.

In children 7.3 years of age, the mean age of children in this study, the range for expected growth velocity is: boys − 3rd percentile = 4.1 cm/year, 50th percentile = 5.8 cm/year, and 97th percentile = 7.5 cm/year; girls − 3rd percentile = 4.3 cm/year, 50th percentile = 5.9 cm/year, and 97th percentile = 7.5 cm/year. The potential reversibility of the reduction in growth velocity was not studied. No significant differences were observed between the 2 groups for mean basal plasma cortisol or ACTH-stimulated plasma cortisol levels.

Geriatric Use:

Clinical studies of Beconase Aq Nasal Spray did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

In general, side effects in clinical studies have been primarily associated with irritation of the nasal mucous membranes.

Adverse reactions reported in controlled clinical trials and open studies in patients treated with Beconase Aq Nasal Spray are described below.

Mild nasopharyngeal irritation following the use of beclomethasone aqueous nasal spray has been reported in up to 24% of patients treated, including occasional sneezing attacks (about 4%) occurring immediately following use of the spray. In patients experiencing these symptoms, none had to discontinue treatment. The incidence of transient irritation and sneezing was approximately the same in the group of patients who received placebo in these studies, implying that these complaints may be related to vehicle components of the formulation.

Fewer than 5 per 100 patients reported headache, nausea, or lightheadedness following the use of Beconase Aq Nasal Spray. Fewer than 3 per 100 patients reported nasal stuffiness, nosebleeds, rhinorrhea, or tearing eyes.

Rare cases of ulceration of the nasal mucosa and instances of nasal septum perforation have been spontaneously reported (see PRECAUTIONS).

Reports of dryness and irritation of the nose and throat and unpleasant taste and smell have been received. There are rare reports of loss of taste and smell.

Rare instances of wheezing, cataracts, glaucoma, and increased intraocular pressure have been reported following the use of intranasal beclomethasone dipropionate (see PRECAUTIONS).

Rare cases of immediate and delayed hypersensitivity reactions, including anaphylactoid/anaphylactic reactions, urticaria, angioedema, rash, and bronchospasm, have been reported following the oral and intranasal inhalation of beclomethasone dipropionate.

Cases of growth suppression have been reported for intranasal corticosteroids, including Beconase Aq (see PRECAUTIONS: Pediatric Use).

Beconase Aq Nasal Spray, 42 mcg is supplied in an amber glass bottle fitted with a metering atomizing pump and nasal adapter in a box of 1 (NDC 0173-0388-79) with patient’s instructions for use. Each bottle contains 25 g of suspension and will provide 180 metered sprays.

The correct amount of medication in each spray cannot be assured after 180 sprays even though the bottle is not completely empty. The bottle should be discarded when the labeled number of actuations has been used.

Store between 15° and 30°C (59° and 86°F).

GlaxoSmithKline

Research Triangle Park, NC 27709

Beconase Aq is a registered trademark of the GSK group of companies.

©2015 the GSK group of companies. All rights reserved.

September 2015

BCN:1PI

PHARMACISTDETACH HERE AND GIVE INSTRUCTIONS TO PATIENT