Pulmicort Respules

What is Pulmicort Respules?

Pulmicort Respules is an inhaled corticosteroid medicine. Pulmicort Respules is a long-term maintenance medicine used to control and prevent asthma symptoms in children ages 12 months to 8 years.

Inhaled corticosteroids help to decrease inflammation in the lungs. Inflammation in the lungs can lead to asthma symptoms. Pulmicort Respules helps reduce swelling and inflammation in the lungs, and helps keep the airways open to reduce asthma symptoms.

Pulmicort Respules does not treat the sudden symptoms (wheezing, cough, shortness of breath, and chest pain or tightness) of an asthma attack. Always have a short-acting beta2-agonist medicine (rescue inhaler) with you to treat sudden symptoms. If your child does not have an inhaled, short-acting bronchodilator, ask your healthcare provider to have one prescribed for your child.

It is not known if Pulmicort Respules is safe or effective in children younger than 12 months or older than 8 years.

What is the most important information I should know about Pulmicort Respules?

For inhalation only.

Do not swallow.

Only use Pulmicort Respules with a jet nebulizer machine that is connected to an air compressor. Do not use with an ultrasonic nebulize.

Who should not use Pulmicort Respules?

Do not use Pulmicort Respules:

• to treat sudden symptoms of asthma
• if your child is allergic to budesonide or any of the ingredients in Pulmicort Respules. See the end of this guide for a complete list of ingredients in Pulmicort Respules.

What should I tell my healthcare provider before using Pulmicort Respules?

Before your child uses Pulmicort Respules, tell your healthcare provider if your child:

• has an allergy. See the section “Who should not use Pulmicort Respules?” There is a complete list of ingredients in Pulmicort Respules at the end of this guide.
• has or recently had chicken pox or measles, or has recently been near anyone with chicken pox or measles.
• has or had tuberculosis of the respiratory tract.
• has certain kinds of infections that have not been treated, including:
  • fungal infections
  • bacterial infections
  • viral infections
  • parasitic infections
  • herpes simplex infection of the eye (ocular herpes simplex)Pulmicort Respules may not be right for children who have had any of these types of infections.
• has decreased bone mineral density (bone strength). Your child is at risk for decreased bone mineral density if he or she:
  • is inactive for a long period of time
  • has a family history of osteoporosis
  • does not eat well (poor nutrition)
  • takes bone thinning medicines (such as anticonvulsant medicines or corticosteroids) for a long time.
• has an eye problem such as increased pressure in the eye, glaucoma or cataracts.
• has liver problems.
• is planning to have surgery.
• has any other medical conditions.
• is pregnant or plans to become pregnant. It is not known if Pulmicort Respules will harm your unborn baby.
• is breast-feeding or plans to breast-feed. Pulmicort Respules can pass into breast milk. You and your healthcare provider should decide if you will use Pulmicort Respules or breast-feed.

Tell your healthcare provider about all the medicine your child takes, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Using Pulmicort Respules with certain other medicines may affect each other causing side effects. Especially tell your healthcare provider if your child takes:

• corticosteroids
• anti-seizure medicine (anticonvulsants)
• medicines that suppress the immune system (immunosuppressant)
• ketoconazole (Nizoral)
• certain medicines that can affect how your liver breaks down medicine

Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure.

Know the medicines your child takes. Keep a list of them and show it to your healthcare provider and pharmacist when your child gets a new medicine.

How should I use Pulmicort Respules?

• Use Pulmicort Respules exactly as prescribed by your healthcare provider. Your child must use Pulmicort Respules regularly for it to work.
• Pulmicort Respules comes in three strengths. Your healthcare provider has prescribed the strength that is best for your child.
• Do not stop using Pulmicort Respules, and do not change your child’s dose of Pulmicort Respules without talking to your healthcare provider.
• Pulmicort Respules is for inhaled use only. Use Pulmicort Respules with a jet nebulizer connected to an air compressor set up with a mouthpiece or face mask. Do not use an ultrasonic nebulizer to give Pulmicort Respules.
• Do not mix Pulmicort Respules with other nebulizer medicines. If your child uses another medicine by inhalation to treat asthma, talk with your healthcare provider for instructions on when to use the other medicine.
• If your child misses a dose, just give the next regularly scheduled dose when it is due. Do not use Pulmicort Respules more often than has been prescribed.
• Improvement in the control of asthma symptoms with Pulmicort Respules can occur within 2-8 days. It may take up to 4-6 weeks before maximum improvement is seen.
• Make sure your child always has a short-acting beta2-agonist medicine with him or her. Your child should use the short-acting beta2-agonist medicine for breathing problems between doses of Pulmicort Respules or if a sudden asthma attack happens. Call your healthcare provider right away if:
  • the short-acting rescue medicine does not work as well for relieving asthma symptoms.
  • your child needs to use the short-acting rescue medicines more often than usual.
  • your child’s breathing problems worsen with Pulmicort Respules
• Rinse your child’s mouth with water and have him or her spit the water out after each Pulmicort Respules treatment. Do not swallow the water. This will lessen the chance of getting a fungal infection (thrush) in the mouth.
• If your child has used long-term corticosteroids and the dose is now being lowered or stopped, a warning card should be carried stating that your child may need corticosteroids during times of stress or during an asthma attack that does not get better with bronchodilator medicines.
• Your healthcare provider may check your child’s blood, breathing and do eye exams while using Pulmicort Respules.
• Read the Patient Information and Instructions for Use that come with Pulmicort Respules.

What are the possible side effects of Pulmicort Respules?

Pulmicort Respules may cause serious side effects including:

• Thrush (candida), a fungal infection in your mouth and throat. Tell your healthcare provider if your child has any redness or white colored patches in the mouth or throat.
• Worsening of asthma or sudden asthma attacks.
• Allergic reactions. Tell your healthcare provider or get medical help right away if your child has:
  • skin rash, redness or swelling
  • severe itching
  • swelling of the face, mouth and tongue
  • trouble breathing or swallowing
  • chest pain
  • anxiety (feeling of doom)
• Immune system effects and a higher chance of infections. Your child is more likely to get infections when taking medicines that weaken the immune system. Symptoms of infection may include: fever, pain, aches, chills, feeling tired, nausea and vomiting. Tell your healthcare provider about any signs of infection while your child uses Pulmicort Respules.
• Adrenal insufficiency. Adrenal insufficiency is a condition in which the adrenal glands do not make enough steroid hormones. Symptoms of adrenal insufficiency include tiredness, weakness, nausea and vomiting, and low blood pressure.
• Decrease in bone mineral density (bone strength). Your healthcare provider may want to check your child for this during treatment with Pulmicort Respules.
• Slowed or delayed growth problems. Your child’s healthcare provider may want to monitor your child’s growth while using Pulmicort Respules.
• Eye problems, including glaucoma and cataracts. Your child’s healthcare provider may suggest eye exams while using Pulmicort Respules.
• Increased wheezing right after taking Pulmicort Respules. Always have a fast-acting inhaled bronchodilator medicine with you to treat sudden wheezing.

Call your healthcare provider or get medical help right away if your child has any of the serious side effects listed above.

The most common side effects of Pulmicort Respules include:

• respiratory infections. Symptoms may include stuffy nose, sore nose and throat.
• runny nose
• cough
• viral infections
• viral irritation and inflammation of the stomach and intestine (gastroenteritis). Gastroenteritis symptoms may include: stomach area pain, diarrhea, nausea and vomiting, and loss of appetite.
• ear infections
• nosebleed
• pink eye (conjunctivitis)
• rash

Tell your healthcare provider if your child has any side effect that bothers him or her or that does not go away. For more information, ask your healthcare provider or pharmacist.

Call your healthcare provider for medical advice about side effects. You may report side effects to AstraZeneca at 1-800-236-9933 or the FDA at 1-800-FDA-1088 or WWW.FDA.GOV/MEDWATCH.

General information about the safe and effective use of Pulmicort Respules

Medicines are sometimes prescribed for conditions other than those listed in a Patient Information leaflet. Do not use Pulmicort Respules for a condition for which it was not prescribed. Do not give Pulmicort Respules to other people, even if they have the same symptoms that you have. It may harm them.

This Patient Information leaflet summarizes the most important information about Pulmicort Respules. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about Pulmicort Respules that is written for health professionals.

For more information, go to www.pulmicortrespules.com or call AstraZeneca at 1-800-236-9933.

How should I store Pulmicort Respules?

• Store Pulmicort Respules in an upright position between 68°F to 77°F (20°C to 25°C).
• Keep Pulmicort Respules in the aluminium foil envelope to protect from light until ready to use.
• After a Pulmicort Respules ampule is opened it should be used right away.
• Pulmicort Respules ampules can be stored for 2 weeks after opening the protective aluminium foil envelope.
• Throw away Pulmicort Respules ampules if not used within 2 weeks of opening the protective aluminium foil envelope.
• Do not refrigerate or freeze.

Keep Pulmicort Respules and all medicines out of the reach of children.

What are the ingredients in Pulmicort Respules?

Active ingredient: budesonide

Inactive ingredients: disodium edetate, sodium chloride, sodium citrate, citric acid, polysorbate 80 and water for injection.

Instructions for use for Pulmicort Respules?

Important:

Pulmicort Respules is only for use with a jet nebulizer machine. Make sure you know how to use your jet nebulizer machine before your child uses Pulmicort Respules.

Pulmicort Respules is a liquid that is turned into a mist by a nebulizer and inhaled into the lungs.

The face mask should be properly adjusted to optimize delivery and to avoid exposing the eyes to the nebulized medication. Corticosteroid effects on the skin can be avoided if the face is washed after the use of a face mask.

1. Pulmicort Respules come in a sealed protective aluminium foil envelope.

• Do not open the sealed pouch until you are ready to use a dose of Pulmicort Respules.
• Open the sealed foil envelope along the dotted line and take out 1 single-dose ampule from the strip. See Figure 1.
• Record the date that you opened the foil on the back of the envelope in the space provided.

Return the unopened Pulmicort Respules ampules on the strip back into the foil envelope before storing.

Figure 1

2. Gently shake the Pulmicort Respules ampule using a circular motion as shown in Figure 2.

Figure 2

3. Hold the Pulmicort Respules ampule upright without squeezing the ampule and open by twisting off the top as shown in Figure 3.

Figure 3

4. Place the open end of the Pulmicort Respules ampule into the nebulizer cup (reservoir) and slowly squeeze all of the medicine from the ampule into the nebulizer medicine cup as shown in Figure 4. Throw away the empty ampule.

Figure 4

5. Use your jet nebulizer as directed.