QVAR REDIHALER (Page 6 of 8)

16 HOW SUPPLIED/STORAGE AND HANDLING

Product: 53002-2436

NDC: 53002-2436-3 1 AEROSOL, METERED in a INHALER / 1 in a CARTON

Product: 53002-3477

NDC: 53002-3477-3 1 AEROSOL, METERED in a INHALER / 1 in a CARTON

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA‑Approved Patient Labeling (Patient Information and Instructions for Use).

Patients should be given the following information:

Oropharyngeal Candidiasis

Inform patients that localized infections with Candida albicans occurred in the mouth and pharynx in some patients. If oropharyngeal candidiasis develops, treat it with appropriate local or systemic (i.e., oral) antifungal therapy while still continuing therapy with QVAR REDIHALER, but at times therapy with QVAR REDIHALER may need to be temporarily interrupted under close medical supervision. Rinsing the mouth with water without swallowing after inhalation is advised to help reduce the risk of thrush.

Status Asthmaticus and Acute Asthma Symptoms

Inform patients that QVAR REDIHALER is not a bronchodilator and is not intended for use as rescue medicine for acute asthma exacerbations. Advise patients to treat acute asthma symptoms with an inhaled, short‑acting beta2 ‑agonist such as albuterol. Instruct the patient to contact their physicians immediately if there is deterioration of their asthma.

Immunosuppression and Risk of Infections

Warn patients who are on immunosuppressant doses of corticosteroids to avoid exposure to chickenpox or measles and, if exposed, to consult their physicians without delay. Inform patients of potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex.

Hypercorticism and Adrenal Suppression

Advise patients that QVAR REDIHALER may cause systemic corticosteroid effects of hypercorticism and adrenal suppression. Additionally, instruct patients that deaths due to adrenal insufficiency have occurred during and after transfer from systemic corticosteroids. Patients should taper slowly from systemic corticosteroids if transferring to QVAR REDIHALER.

Immediate Hypersensitivity Reactions

Advise patients that immediate hypersensitivity reactions (e.g., urticaria, angioedema, rash, bronchospasm, and hypotension), including anaphylaxis, may occur after administration of QVAR REDIHALER. Patients should discontinue QVAR REDIHALER if such reactions occur and contact their healthcare provider or get emergency medical help.

Reduction in Bone Mineral Density

Advise patients who are at an increased risk for decreased BMD that the use of corticosteroids may pose an additional risk.

Reduced Growth Velocity

Inform patients that orally inhaled corticosteroids, including QVAR REDIHALER, may cause a reduction in growth velocity when administered to pediatric patients. Physicians should closely follow the growth of adolescents taking corticosteroids by any route.

Ocular Effects

Long-term use of inhaled corticosteroids may increase the risk of some eye problems (cataracts, glaucoma or blurred vision); consider regular eye examinations.

Pregnancy

Inform patients who are pregnant or nursing that they should contact their physician about the use of QVAR REDIHALER.

Use Daily for Best Effect

Patients should use QVAR REDIHALER at regular intervals as directed. The daily dosage of QVAR REDIHALER should not exceed 8 inhalations per day. Advise patients, if they miss a dose, to take their next dose at the same time they normally do. Individual patients will experience a variable time to onset and degree of symptom relief and the full benefit may not be achieved until treatment has been administered for 1 to 2 weeks or longer. Patients should not increase the prescribed dosage but should contact their physicians if symptoms do not improve or if the condition worsens. Instruct patients to not stop use of QVAR REDIHALER abruptly. Patients should contact their physicians immediately if they discontinue use of QVAR REDIHALER.

Caring for and Storing the Inhaler

For normal hygiene, the mouthpiece of QVAR REDIHALER should be cleaned weekly with a clean, dry tissue or cloth. Never wash or put any part of QVAR REDIHALER in water. Patient should replace QVAR REDIHALER if washed or placed in water.

Instruct patients to store the inhaler at room temperature and to avoid exposure to extreme heat and cold.

Inform patients that shaking the inhaler prior to use is not necessary. Instruct patients not to shake the inhaler with the cap open to avoid possible actuation of the device.

Instruct patients to never take QVAR REDIHALER apart.

Inform patients that QVAR REDIHALER has a dose counter attached to the actuator at the rear of the mouth piece. When the patient receives the inhaler, the number 120 will be displayed. The dose counter will count down each time a spray is released. The dose-counter window displays the number of sprays left in the inhaler in units of two (e.g., 120, 118, 116, etc). When the counter displays 20, the color of the numbers will change to red to remind the patient to contact their pharmacist for a refill of medication or consult their healthcare provider for a prescription refill. When the dose counter reaches 0, the background will change to solid red. Inform patients to discard QVAR REDIHALER when the dose counter displays 0 or after the expiration date on the product, whichever comes first.

Distributed by:

Teva Pharmaceuticals USA

Parsippany, NJ 07054

© 2021 Teva Respiratory, LLC

U.S. Patent 7,637,260; 8,132,712; 8,931,476

QVARH-003

PATIENT INFORMATION

PATIENT INFORMATION

QVAR REDIHALER ® (kue’ var red-ee-haye’ ler)

(beclomethasone dipropionate HFA) inhalation aerosol

What is QVAR REDIHALER?

  • QVAR REDIHALER is a breath‑actuated inhaled prescription medicine used as a maintenance treatment for the prevention and control of asthma in people 4 years of age and older.
  • QVAR REDIHALER is not used to relieve sudden breathing problems.

It is not known if QVAR REDIHALER is safe and effective in children less than 4 years of age.

Who should not use QVAR REDIHALER?

Do not use QVAR REDIHALER:

  • to treat sudden severe symptoms of asthma.
  • as a rescue inhaler.
  • if you are allergic to beclomethasone dipropionate or any of the ingredients in QVAR REDIHALER. See the end of this Patient Information leaflet for a complete list of ingredients in QVAR REDIHALER.
What should I tell my healthcare provider before using QVAR REDIHALER?

Before using QVAR REDIHALER, tell your healthcare provider about all of your medical conditions, including if you:

  • are exposed to chickenpox or measles.
  • have or have had tuberculosis (TB) or any untreated fungal, bacterial or viral infections, or eye infections caused by herpes.
  • have weak bones (osteoporosis).
  • have an immune system problem.
  • have or have had eye problems, such as blurred vision, increased pressure in your eye (glaucoma) or cataracts.
  • are pregnant or plan to become pregnant. It is not known if QVAR REDIHALER will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if QVAR REDIHALER passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you use QVAR REDIHALER.

Tell your healthcare provider about all of the medications you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I use QVAR REDIHALER?

Read the step-by-step Instructions for Use for QVAR REDIHALER at the end of this Patient Information leaflet.

  • Use QVAR REDIHALER exactly as your healthcare provider tells you to. Do not use QVAR REDIHALER more often than it is prescribed.
  • Do not shake the inhaler before using it. Especially, do not shake the inhaler with the cap open. This could cause the device to accidentally release medicine before you are ready to take it.
  • Do not prime QVAR REDIHALER. The inhaler does not need to be primed.
  • If your child needs to use QVAR REDIHALER, watch your child closely to make sure your child uses the inhaler correctly.
  • Do not change or stop using QVAR REDIHALER or other asthma medicines used to treat your breathing problems unless your healthcare provider tells you to. Your healthcare provider will change your medicines as needed.
  • You must use QVAR REDIHALER regularly. It may take 2 to 4 weeks, or longer, after you start using QVAR REDIHALER for your asthma symptoms to get better. Do not stop using QVAR REDIHALER, even if you are feeling better, unless your healthcare provider tells you to.
  • QVAR REDIHALER comes in 2 strengths (40 mcg and 80 mcg). Your healthcare provider has prescribed the strength that is best for you. Pay attention to the differences between QVAR REDIHALER and your other inhaled medicines, including their prescribed use and the way they look.
  • QVAR REDIHALER does not relieve sudden asthma symptoms. Always have a rescue inhaler with you to treat sudden symptoms. Use your rescue inhaler if you have breathing problems between doses of QVAR REDIHALER. If you do not have a rescue inhaler, call your healthcare provider to have a rescue inhaler prescribed for you.
  • Rinse your mouth with water without swallowing after each dose of QVAR REDIHALER. This will help lessen the chance of getting a yeast infection (thrush) in your mouth and throat.
  • Do not spray QVAR REDIHALER in your face or eyes. If you accidentally get QVAR REDIHALER in your eyes, rinse your eyes with water and if redness or irritation continues, call your healthcare provider.
What should I avoid while using QVAR REDIHALER?

If you have not had, or have not been vaccinated against, chickenpox or measles, you should stay away from people who are infected.

What are the possible side effects of QVAR REDIHALER?

QVAR REDIHALER may cause serious side effects, including:

  • fungal infections (thrush) in your mouth and throat. You may develop a yeast infection (Candida albicans) in your mouth and throat. Tell your healthcare provider if you have any redness or white colored patches in your mouth or throat. Rinse your mouth with water without swallowing after using QVAR REDIHALER to help prevent an infection in your mouth or throat.
  • worsening asthma or sudden asthma attacks. You should contact your healthcare provider right away if you do not get relief from your sudden asthma attacks, after using your rescue inhaler, during your treatment with QVAR REDIHALER.
  • reduced adrenal function (adrenal insufficiency). Reduced adrenal function that can lead to death can happen when you stop taking oral corticosteroid medicines and start using inhaled corticosteroid medicines. Reduced adrenal function can also happen in people who take higher doses of QVAR REDIHALER than recommended over a long period of time. When your body is under stress such as from fever, trauma (such as a car accident), infection, or surgery, reduced adrenal function can get worse. Signs and symptoms of reduced adrenal function may include:

○ feeling tired or exhausted (fatigue) ○ lack of energy ○ low blood pressure (hypotension)

○ dizziness or feeling faint ○ nausea and vomiting ○ weakness

  • immune system effects and a higher chance for infections. Tell your healthcare provider about any signs or symptoms of infection such as:

○ fever ○ chills ○ pain ○ feeling tired

○ body aches ○ nausea ○ vomiting

  • increased wheezing (bronchospasm) right after using QVAR REDIHALER. Always have a rescue inhaler with you to treat sudden wheezing.
  • serious allergic reactions. Stop using QVAR REDIHALER and call your healthcare provider or get emergency medical help right away if you get any of the following signs or symptoms of a serious allergic reaction:

○ hives ○ swelling of your lips, tongue or face ○ rash ○ breathing problems

  • slowed growth in children. Children should have their growth checked regularly while using QVAR REDIHALER.
  • lower bone density. This may be a problem for people who already have a higher chance for low bone density (osteoporosis).
  • eye problems. If you have had glaucoma, cataracts or blurred vision in the past, you should have regular eye exams while using QVAR REDIHALER.

The most common side effects of QVAR REDIHALER include:

  • yeast infection in the mouth (oral candidiasis)
  • cold symptoms (upper respiratory tract infection)
  • pain in the throat (oropharyngeal pain)
  • pain or swelling in your nose and throat (nasopharyngitis)
  • sinus irritation (sinusitis)
  • hay fever (allergic rhinitis)

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 QVAR REDIHALER. Ask your healthcare provider or pharmacist for more information.

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 QVAR REDIHALER?
  • Store QVAR REDIHALER at room temperature between 68ºF to 77ºF (20ºC to 25ºC). Avoid exposure to extreme heat or cold.
  • Keep the white cap on the inhaler closed during storage.
  • Keep your QVAR REDIHALER inhaler dry and clean at all times.
  • Clean the mouthpiece of your QVAR REDIHALER weekly with a clean, dry tissue or cloth.
  • Your QVAR REDIHALER canister should only be used with the QVAR REDIHALER actuator. Do not use any other medicines in your QVAR REDIHALER actuator.
  • The contents of your QVAR REDIHALER canister are under pressure. Do not puncture the QVAR REDIHALER canister.
  • Do not take QVAR REDIHALER apart.
  • If you drop your QVAR REDIHALER, inspect it for damage before use. If the QVAR REDIHALER is damaged, do not use the damaged QVAR REDIHALER. Call your healthcare provider or pharmacist to replace the QVAR REDIHALER.
  • Do not store your QVAR REDIHALER canister near heat or a flame. Temperatures above 120ºF (49°C) may cause the canister to burst.
  • Do not throw your QVAR REDIHALER canister into a fire or incinerator.

Keep QVAR REDIHALER and all medicines out of the reach of children.

General information about the safe and effective use of QVAR REDIHALER.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use QVAR REDIHALER for a condition for which it was not prescribed. Do not give QVAR REDIHALER to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about QVAR REDIHALER that is written for health professionals.

What are the ingredients in QVAR REDIHALER?

Active ingredient: beclomethasone dipropionate.

Inactive ingredients: propellant HFA-134a and ethanol.

Distributed by:

Teva Pharmaceuticals USA, Inc.

Parsippany, NJ 07054

©2021 Teva Respiratory, LLC. All rights reserved.

For more information, go to www.QVAR.com or call 1-888-483-8279.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Revised: 01/2021

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